About Marker Therapeutics
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Houston, TX – August 6, 2019 – Marker Therapeutics, Inc. (Nasdaq:MRKR), a clinical-stage immuno-oncology company specializing in the development of next-generation T cell-based immunotherapies for the treatment of hematological malignancies and solid tumor indications, today announced the appointment of Steve Elms, to its Board of Directors, effective August 6.

“We are pleased to welcome Steve to our Board of Directors,” said Peter L. Hoang, President & CEO of Marker. “Steve has built an impressive career, holding numerous leadership positions in the healthcare sector and we look forward to his many contributions as we continue to advance our pipeline of next-generation T cell-based immunotherapies.”

Throughout his career, Mr. Elms has held numerous leadership roles in the healthcare sector. Mr. Elms currently serves as Managing Partner at Aisling Capital, a leading life sciences investment firm. Prior to joining Aisling, he was a Principal in the Life Sciences Investment Banking Group of Chase H&Q (formerly Hambrecht & Quist), where he was involved in over 60 financing and M&A transactions, helping clients raise in excess of $3.3 billion in capital.

Prior to H&Q, Mr. Elms traded mortgage-backed securities at Donaldson, Lufkin & Jenrette. His previous healthcare sector experience includes over two years as a pharmaceutical sales representative for Marion Laboratories and two years as a consultant for The Wilkerson Group. Mr. Elms currently serves as a director of ADMA Biologics, Ajax Health II and Zosano Pharma and was previously Chairman of the Board of LOXO Oncology. He also serves on the INVO Board at Northwestern University.

Mr. Elms received his M.B.A. from the Kellogg Graduate School of Management at Northwestern University and his B.A. in Human Biology from Stanford University.

About Marker Therapeutics, Inc.
Marker Therapeutics, Inc. is a clinical-stage immuno-oncology company specializing in the development of next-generation T cell-based immunotherapies for the treatment of hematological malignancies and solid tumor indications. Marker’s cell therapy technology is based on the selective expansion of non-engineered, tumor-specific T cells that recognize tumor associated antigens (i.e. tumor targets) and kill tumor cells expressing those targets. This population of T cells is designed to attack multiple tumor targets following infusion into patients and to activate the patient’s immune system to produce broad spectrum anti-tumor activity. Because Marker does not genetically engineer its T cells therapies, we believe that our product candidates will be easier and less expensive to manufacture, with reduced toxicities, compared to current engineered CAR-T and TCR-based approaches, and may provide patients with meaningful clinical benefit. As a result, Marker believes its portfolio of T cell therapies has a compelling product profile, as compared to current gene-modified CAR-T and TCR-based therapies.

Marker is also advancing a number of innovative peptide- and gene-based immuno-therapeutics for the treatment of metastatic solid tumors, including the Folate Receptor Alpha program (TPIV200) for breast and ovarian cancers and the HER2/neu program (TPIV100/110) for breast cancer, currently in Phase 2 clinical trials.

To receive future press releases via email, please visit: https://markertherapeutics.com/email-alerts/

Forward-Looking Statement Disclaimer
This release contains forward-looking statements for purposes of the safe harbor provisions of the Private Securities Litigation Reform Act of 1995. Statements in this news release concerning the Company’s expectations, plans, business outlook or future performance, and any other statements concerning assumptions made or expectations as to any future events, conditions, performance or other matters, are “forward-looking statements.” Forward-looking statements include statements regarding our intentions, beliefs, projections, outlook, analyses or current expectations concerning, among other things: our research and development activities relating to our non-engineered multi-tumor antigen specific T cell therapies; our TPIV200 and TPIV100/110 programs; the effectiveness of these programs or the possible range of application and potential curative effects and safety in the treatment of diseases; and, the timing and success of our clinical trials, as well as clinical trials conducted by our collaborators. Forward-looking statements are by their nature subject to risks, uncertainties and other factors which could cause actual results to differ materially from those stated in such statements. Such risks, uncertainties and factors include, but are not limited to the risks set forth in the Company’s most recent Form 10-K, 10-Q and other SEC filings which are available through EDGAR at www.sec.gov. The Company assumes no obligation to update our forward-looking statements whether as a result of new information, future events or otherwise, after the date of this press release.

Contacts

Investor
Solebury Trout
Chiara Russo
(617) 221-9197
crusso@nullsoleburytrout.com

Media
Solebury Trout
Amy Bonanno
(914) 450-0349
abonanno@nullsoleburytrout.com

 

AACR – Pancreatic Cancer Interim Data CLICK HERE for Full Screen View

TACTOPS Investor Presentation CLICK HERE for Full Screen View

T CELL INFILTRATION AND EXPANSION OBSERVED, SUPPORTING MULTITAA’S POTENTIAL AS A DURABLE TREATMENT IN THIS PATIENT POPULATION

COMPANY TO HOST CONFERENCE CALL AND WEBCAST ON MONDAY, JULY 22

San Francisco, CA—July 20, 2019—Marker Therapeutics, Inc. (Nasdaq:MRKR), a clinical-stage immuno-oncology company specializing in the development of next-generation T cell-based immunotherapies for the treatment of hematological malignancies and solid tumor indications, today announced interim data from an ongoing investigator-sponsored clinical trial led by Baylor College of Medicine, evaluating the Company’s MultiTAA T cell therapy in patients with pancreatic adenocarcinoma. The data were reviewed today in an oral presentation during a plenary session, as well as a poster presentation, at the American Association for Cancer Research’s (AACR) Immune Cell Therapies for Cancer: Successes and Challenges of CAR T Cells and Other Forms of Adoptive Therapy conference held in San Francisco, California from July 19-22, 2019.

“Pancreatic cancer continues to be one of the most challenging solid tumor malignancies to treat and survival rates have not seen a meaningful improvement in more than 40 years,” said Brandon G. Smaglo, M.D., FACP, lead investigator and Assistant Professor of Oncology at Baylor College of Medicine. “We are encouraged by these interim data which suggest that MultiTAA therapy may contribute to more durable responses without added toxicity when used in combination with standard-of-care chemotherapy, or as a second-line therapy for patients who are chemo-refractory. Additionally, despite the particularly dense desmoplastic stroma surrounding pancreatic tumors—which has been long considered a major obstacle for T cell effectiveness—our study of patients with borderline surgically resectable disease suggests that MultiTAA cells are capable of meaningfully infiltrating the tumor.”

Trial Overview

Title: Targeting pancreatic cancer using non-engineered, multi-antigen specific T cells (TACTOPS)

The trial plans to enroll a total of 45 patients with advanced or borderline resectable pancreatic adenocarcinoma in a three-arm trial. Arm A is for patients with unresectable/metastatic disease who are responding to standard first-line chemotherapy. Arm B is for patients with progressive disease or therapy intolerance. Arm C is an exploratory arm for patients with surgically resectable disease. To date, a total of 19 patients have been administered infusions of MultiTAA T cell therapy (ten patients in Arm A, six patients in Arm B and three patients in Arm C).

Interim Results

Arm A: This arm was designed to evaluate the safety and potential efficacy of using MultiTAA cells as part of first-line treatment for patients with pancreatic cancer. These patients in the chemo-responsive arm have completed or will complete at least three months of standard-of-care chemotherapy (gemcitabine/nab-paclitaxel or FOLFIRINOX) – the period during which a response to chemotherapy would typically occur – before receiving up to six administrations of MultiTAA T cells in conjunction with chemotherapy.

  • Out of the 9 evaluable patients (one patient was too early to be evaluated):
    • 3 patients experienced objective responses after administration of MultiTAA cells
      • 1 patient experienced a complete response
      • 2 patients experienced partial responses
    • 4 patients experienced stable disease; 2 patients within stable disease boundaries (+20%/-30%) saw reversal of tumor growth – tumors previously growing after chemotherapy alone showed shrinkage after administration of MultiTAA cells
    • 1 patient experienced a mixed response (some lesions increased in size and others decreased for a net zero change in size of tumor lesions)
    • 1 patient experienced disease progression
  • Overall tumor volume shrinkage was observed in six out of the eight patients with a measurable tumor after administration of MultiTAA cells. One evaluable patient did not have tumor measurements for analysis.
  • Of the 9 evaluable patients, over half have survived to or beyond the historical median overall survival associated with their respective chemotherapy regimens, and 7 of the 9 patients remain alive.
  • In patients responding to therapy, significant expansion of the infused MultiTAA cells was observed, along with broad-based epitope spreading, with significant expansion of endogenous T cells specific for other tumor specific antigens.

Arm B: This arm was designed to evaluate the use of MultiTAA cells as a second-line therapy for patients who have failed first-line chemotherapy. The patients in this chemo-refractory arm are either ineligible for chemotherapy or have progressed on chemotherapy and have received or are receiving up to six doses of MultiTAA T cells as a monotherapy.

  • Of the 6 patients treated and evaluable:
    • 3 patients experienced stable disease or clinical disease stabilization
      • 2 patients who previously had progressive disease experienced clinical disease stabilization for up to two months
      • 1 has maintained stable disease for 7 months (ongoing)
    • 3 experienced clinical decline
  • Among the patients who saw clinical disease stabilization, significant expansion of the infused MultiTAA cells was observed, along with broad-based epitope spreading, with significant expansion of endogenous T cells specific for other tumor specific antigens.

Arm C: This arm was designed to assess T cell infiltration and expansion. These patients with borderline surgically resectable disease received or will receive a dose of T cells following chemotherapy, radiotherapy or combination prior to surgical resection and up to five additional doses of T cells after surgery.

  • In these patients, MultiTAA T cells were measurable in meaningful numbers as detected by correlative analysis of resected tumor, and significant expansion of the infused MultiTAA cells was observed, along with broad-based epitope spreading, with significant expansion of endogenous T cells specific for other tumor specific antigens.

Overall, investigators observed a clinical benefit correlated with the detection of tumor-reactive T cells in patient peripheral blood (Arms A, B and C) and within tumor biopsy samples (Arm C) post-infusion. T cells exhibited activity against both targeted antigens as well as non-targeted TAAs including WT-1, AFP, MART-1 and numerous antigens of the MAGE family, indicating induction of antigen/epitope spreading.

No infusion-related systemic- or neurotoxicity was observed, and patients continue to be evaluated and enrolled in the trial.

Peter L. Hoang, President & CEO of Marker Therapeutics commented: “We are encouraged by the early clinical results we have seen in this clinical trial for patients who otherwise have few therapeutic options and a dire prognostic outcome, and we are optimistic about the prospect of potentially validating the use of MultiTAA therapy in the context of first-line and second-line care for patients with pancreatic adenocarcinoma. Moreover, we are very pleased with the data we see of MultiTAA T cell infiltration and subsequent epitope spreading observed in this trial, suggesting that MultiTAA therapy may initiate and contribute to a potent and durable treatment effect. We plan to continue following these patients and enroll new patients to further evaluate durability.”

Conference Call and Webcast
For those unable to attend the presentations at AACR, Marker will host a conference call and webcast on Monday, July 22nd at 5:30am PDT/8:30am EDT featuring Dr. Brandon Smaglo, as well as Marker senior management. A live webcast of the investor presentation will be available in the investors section of the Company’s website at https://markertherapeutics.com/ and will be available for replay following the event.

About MultiTAA

Marker’s Multi-Antigen Targeted (MultiTAA) platform is a novel, non-genetically modified cell therapy approach that selectively expands tumor-specific T cells from a patient’s blood capable of recognizing a broad range of tumor antigens. In early clinical trials, the multi-antigen approach has been well tolerated and shown to enhance tumor destroying capability and is one of the first therapies to consistently demonstrate epitope spreading – inducing the patient’s own T cells to expand, potentially contributing to a lasting anti-tumor effect. Unlike other cell therapies which require pre-conditioning regimens and hospitalization, MultiTAA is designed to be administered in an outpatient setting.

About Marker Therapeutics, Inc.
Marker Therapeutics, Inc. is a clinical-stage immuno-oncology company specializing in the development of next-generation T cell-based immunotherapies for the treatment of hematological malignancies and solid tumor indications. Marker’s cell therapy technology is based on the selective expansion of non-engineered, tumor-specific T cells that recognize tumor associated antigens (i.e. tumor targets) and kill tumor cells expressing those targets. This population of T cells is designed to attack multiple tumor targets following infusion into patients and to activate the patient’s immune system to produce broad spectrum anti-tumor activity. Because Marker does not genetically engineer its T cells therapies, we believe that our product candidates will be easier and less expensive to manufacture, with reduced toxicities, compared to current engineered CAR-T and TCR-based approaches, and may provide patients with meaningful clinical benefit. As a result, Marker believes its portfolio of T cell therapies has a compelling product profile, as compared to current gene-modified CAR-T and TCR-based therapies.

Marker is also advancing a number of innovative peptide- and gene-based immuno-therapeutics for the treatment of metastatic solid tumors, including the Folate Receptor Alpha program (TPIV200) for breast and ovarian cancers and the HER2/neu program (TPIV100/110) for breast cancer, currently in Phase 2 clinical trials.

To receive future press releases via email, please visit: https://markertherapeutics.com/email-alerts/

Forward-Looking Statement Disclaimer
This release contains forward-looking statements for purposes of the safe harbor provisions of the Private Securities Litigation Reform Act of 1995. Statements in this news release concerning the Company’s expectations, plans, business outlook or future performance, and any other statements concerning assumptions made or expectations as to any future events, conditions, performance or other matters, are “forward-looking statements.” Forward-looking statements include statements regarding our intentions, beliefs, projections, outlook, analyses or current expectations concerning, among other things: the final trial results for MultiTAA T cell therapy in patients with pancreatic adenocarcinoma; our research and development activities relating to our non-engineered multi-tumor antigen specific T cell therapies; our TPIV200 and TPIV100/110 programs; the effectiveness of these programs or the possible range of application and potential curative effects and safety in the treatment of diseases; and, the timing and success of our clinical trials, as well as clinical trials conducted by our collaborators. Forward-looking statements are by their nature subject to risks, uncertainties and other factors which could cause actual results to differ materially from those stated in such statements. Such risks, uncertainties and factors include, but are not limited to the risks set forth in the Company’s most recent Form 10-K, 10-Q and other SEC filings which are available through EDGAR at www.sec.gov. The Company assumes no obligation to update our forward-looking statements whether as a result of new information, future events or otherwise, after the date of this press release.

Contacts

Investor
Solebury Trout
Chiara Russo
(617) 221-9197
crusso@nulltroutgroup.com

Media
Solebury Trout
Brad Miles
(646) 513-3125
bmiles@nullsoleburytrout.com

– or –

Amy Bonanno
(914) 450-0349
abonanno@nullsoleburytrout.com

Houston, TX – July 17, 2019– Marker Therapeutics, Inc. (NASDAQ:MRKR), a clinical-stage immuno-oncology company specializing in the development of next-generation T cell-based immunotherapies for the treatment of hematological malignancies and solid tumor indications, today announced it will host a conference call and webcast with a question-and-answer session on Monday, July 22, 2019 at 5:30 a.m. PDT/ 8:30 a.m. EDT to review data from an investigator-sponsored Phase 1/2 clinical trial with its MultiTAA therapy in patients with pancreatic adenocarcinoma. The data will also be reviewed in plenary and poster sessions on Saturday, July 20 at a cell therapy conference hosted by the American Association for Cancer Research (AACR) in San Francisco by Brandon G. Smaglo, M.D., FACP, Assistant Professor, Medical Director of Hematology/Oncology at the Baylor College of Medicine, Houston, Texas.

The live conference call and webcast will be accessible in the Investors section of the Company’s website at markertherapeutics.com. The archived webcast will be available for replay on the Marker website following the event.[/vc_column_text][vc_column_text]About Marker Therapeutics, Inc.

Marker Therapeutics, Inc. is a clinical-stage immuno-oncology company specializing in the development of next-generation T cell-based immunotherapies for the treatment of hematological malignancies and solid tumor indications. Marker’s cell therapy technology is based on the selective expansion of non-engineered, tumor-specific T cells that recognize tumor associated antigens (i.e. tumor targets) and kill tumor cells expressing those targets. This population of T cells is designed to attack multiple tumor targets following infusion into patients and to activate the patient’s immune system to produce broad spectrum anti-tumor activity. Because Marker does not genetically engineer its T cells therapies, we believe that our product candidates will be easier and less expensive to manufacture, with reduced toxicities, compared to current engineered CAR-T and TCR-based approaches, and may provide patients with meaningful clinical benefit. As a result, Marker believes its portfolio of T cell therapies has a compelling product profile, as compared to current gene-modified CAR-T and TCR-based therapies.

Marker is also advancing a number of innovative peptide- and gene-based immuno-therapeutics for the treatment of metastatic solid tumors, including the Folate Receptor Alpha program (TPIV200) for breast and ovarian cancers and the HER2/neu program (TPIV100/110) for breast cancer, currently in Phase 2 clinical trials.

To receive future press releases via email, please visit: https://markertherapeutics.com/email-alerts/

Forward-Looking Statement Disclaimer
This release contains forward-looking statements for purposes of the safe harbor provisions of the Private Securities Litigation Reform Act of 1995. Statements in this news release concerning the Company’s expectations, plans, business outlook or future performance, and any other statements concerning assumptions made or expectations as to any future events, conditions, performance or other matters, are “forward-looking statements.” Forward-looking statements include statements regarding our intentions, beliefs, projections, outlook, analyses or current expectations concerning, among other things: our research and development activities relating to our non-engineered multi-tumor antigen specific T cell therapies; our TPIV200 and TPIV100/110 programs; the effectiveness of these programs or the possible range of application and potential curative effects and safety in the treatment of diseases; and, the timing and success of our clinical trials, as well as clinical trials conducted by our collaborators. Forward-looking statements are by their nature subject to risks, uncertainties and other factors which could cause actual results to differ materially from those stated in such statements. Such risks, uncertainties and factors include, but are not limited to the risks set forth in the Company’s most recent Form 10-K, 10-Q and other SEC filings which are available through EDGAR at www.sec.gov. The Company assumes no obligation to update our forward-looking statements whether as a result of new information, future events or otherwise, after the date of this press release.[/vc_column_text][vc_column_text]

 

Contacts

Investor
Solebury Trout
Chiara Russo
(617) 221-9197
crusso@nulltroutgroup.com

Media
Solebury Trout
Brad Miles
(646) 513-3125
bmiles@nullsoleburytrout.com

– or –

Amy Bonanno
(914) 450-0349
abonanno@nullsoleburytrout.com

Data selected for oral presentation during a plenary session at AACR’s Immune Cell Therapies for Cancer: Successes and Challenges of CAR T Cells and Other Forms of Adoptive Therapy Conference

Company to host investor event and webcast on Monday, July 22

Houston, TX – June 20, 2019 – Marker Therapeutics, Inc. (Nasdaq:MRKR), a clinical-stage immuno-oncology company specializing in the development of next-generation T cell-based immunotherapies for the treatment of hematological malignancies and solid tumor indications, today announced that updated clinical data from an investigator-sponsored Phase 1/2 trial led by Baylor College of Medicine were selected for oral presentation during a plenary session at the upcoming American Association for Cancer Research’s (AACR) Immune Cell Therapies for Cancer: Successes and Challenges of CAR T Cells and Other Forms of Adoptive Therapy conference. The data—which will also be presented in a poster session—will be reviewed by Brandon G. Smaglo, M.D., FACP, Assistant Professor, Medical Director of Hematology/Oncology at the Baylor College of Medicine, Houston, Texas.

Oral Presentation Details
Title: “Targeting pancreatic cancer using nonengineered, multiantigen-specific T cells (TACTOPS)”
Date: Saturday, July 20, 2019
Time (Plenary Session #1): 8:00 a.m. – 10:00 a.m. PST
Location: Hyatt Regency, San Francisco, CA

Poster Presentation Details
Title: “Targeting pancreatic cancer using nonengineered, multiantigen-specific T cells (TACTOPS)”
Date: Saturday, July 20, 2019
Time (Poster Session A): 12:30 p.m. – 2:30 p.m. PST
Location: Hyatt Regency, San Francisco, CA

Investor Event
For those unable to attend the presentations at AACR, Marker will host a live investor event following the conference on Monday, July 22nd at 1:30 p.m. PST in San Francisco featuring Dr. Brandon Smaglo, as well as Marker senior management. A live webcast of the investor presentation will be available in the investors section of the Company’s website at https://markertherapeutics.com/ and will be available for replay following the event.

About Marker Therapeutics, Inc.
Marker Therapeutics, Inc. is a clinical-stage immuno-oncology company specializing in the development of next-generation T cell-based immunotherapies for the treatment of hematological malignancies and solid tumor indications. Marker’s cell therapy technology is based on the selective expansion of non-engineered, tumor-specific T cells that recognize tumor associated antigens (i.e. tumor targets) and kill tumor cells expressing those targets. This population of T cells is designed to attack multiple tumor targets following infusion into patients and to activate the patient’s immune system to produce broad spectrum anti-tumor activity. Because Marker does not genetically engineer its T cells therapies, we believe that our product candidates will be easier and less expensive to manufacture, with reduced toxicities, compared to current engineered CAR-T and TCR-based approaches, and may provide patients with meaningful clinical benefit. As a result, Marker believes its portfolio of T cell therapies has a compelling therapeutic product profile, as compared to current gene-modified CAR-T and TCR-based therapies.

Marker is also advancing a number of innovative peptide- and gene-based immuno-therapeutics for the treatment of metastatic solid tumors, including the Folate Receptor Alpha program (TPIV200) for breast and ovarian cancers and the HER2/neu program (TPIV100/110) for breast cancer, currently in Phase 2 clinical trials.

For additional information, please call toll free at (904) 862-6490 or visit: markertherapeutics.com

To receive future press releases via email, please visit: https://markertherapeutics.com/email-alerts/

Follow us on Twitter @MRKRTherapeutic, or follow us on Facebook.

Forward-Looking Statement Disclaimer
This release contains forward-looking statements for purposes of the safe harbor provisions of the Private Securities Litigation Reform Act of 1995. Statements in this news release concerning the Company’s expectations, plans, business outlook or future performance, and any other statements concerning assumptions made or expectations as to any future events, conditions, performance or other matters, are “forward-looking statements.” Forward-looking statements include statements regarding our intentions, beliefs, projections, outlook, analyses or current expectations concerning, among other things: our research and development activities relating to our non-engineered multi-tumor antigen specific T cell therapies; our TPIV200 and TPIV100/110 programs; the effectiveness of these programs or the possible range of application and potential curative effects and safety in the treatment of diseases; and, the timing and success of our clinical trials, as well as clinical trials conducted by our collaborators. Forward-looking statements are by their nature subject to risks, uncertainties and other factors which could cause actual results to differ materially from those stated in such statements. Such risks, uncertainties and factors include, but are not limited to the risks set forth in the Company’s most recent Form 10-K, 10-Q and other SEC filings which are available through EDGAR at www.sec.gov. The Company assumes no obligation to update our forward-looking statements whether as a result of new information, future events or otherwise, after the date of this press release.

Contacts

Investor
Solebury Trout
Chiara Russo
(617) 221-9197
crusso@nulltroutgroup.com

Media
Solebury Trout
Brad Miles
(646) 513-3125
bmiles@nullsoleburytrout.com

– or –

Amy Bonanno
(914) 450-0349
abonanno@nullsoleburytrout.com

 

Houston, TX – May 21, 2019 – Marker Therapeutics, Inc. (NASDAQ: MRKR), a clinical-stage immuno-oncology company specializing in the development of next-generation T cell-based immunotherapies for the treatment of hematological malignancies and solid tumor indications, today announced that its President and Chief Executive Officer, Peter L. Hoang, will present at and participate in two upcoming investor conferences:

Sachs Associates 5th Annual Immuno-Oncology BD&L and Investment Forum – Latest Advances in Cell & Gene Therapies Panel
Date: Friday, May 31, 2019
Location: Waldorf Astoria Chicago Hotel
Time: 12:10pm CDT: Company Presentation
2:30pm CDT: Panel – Latest Advances in Cell & Gene Therapies

Jefferies 2019 Global Healthcare Conference
(UPDATE) Date: Tuesday, June 4, 2019
Location: New York, NY
(UPDATE) Time: 4:30pm EDT

A live webcast of both event presentations will be available in the investors section of the company’s website at markertherapeutics.com and will be available for replay following the events.

About Marker Therapeutics, Inc.
Marker Therapeutics, Inc. is a clinical-stage immuno-oncology company specializing in the development of next-generation T cell-based immunotherapies for the treatment of hematological malignancies and solid tumor indications. Marker’s cell therapy technology is based on the selective expansion of non-engineered, tumor-specific T cells that recognize tumor associated antigens (i.e. tumor targets) and kill tumor cells expressing those targets. This population of T cells is designed to attack multiple tumor targets following infusion into patients and to activate the patient’s immune system to produce broad spectrum anti-tumor activity. Because Marker does not genetically engineer its T cells therapies, we believe that our product candidates will be easier and less expensive to manufacture, with reduced toxicities, compared to current engineered CAR-T and TCR-based approaches, and may provide patients with meaningful clinical benefit. As a result, Marker believes its portfolio of T cell therapies has a compelling therapeutic product profile, as compared to current gene-modified CAR-T and TCR-based therapies.

Marker is also advancing a number of innovative peptide- and gene-based immuno-therapeutics for the treatment of metastatic solid tumors, including the Folate Receptor Alpha program (TPIV200) for breast and ovarian cancers and the HER2/neu program (TPIV100/110) for breast cancer, currently in Phase 2 clinical trials.

For additional information, please call toll free at (904) 862-6490 or visit: markertherapeutics.com

To receive future press releases via email, please visit: https://markertherapeutics.com/email-alerts/

Follow us on Twitter @MRKRTherapeutic, or follow us on Facebook.

Forward-Looking Statement Disclaimer
This release contains forward-looking statements for purposes of the safe harbor provisions of the Private Securities Litigation Reform Act of 1995. Statements in this news release concerning the Company’s expectations, plans, business outlook or future performance, and any other statements concerning assumptions made or expectations as to any future events, conditions, performance or other matters, are “forward-looking statements.” Forward-looking statements include statements regarding our intentions, beliefs, projections, outlook, analyses or current expectations concerning, among other things: our research and development activities relating to our non-engineered multi-tumor antigen specific T cell therapies; our TPIV200 and TPIV100/110 programs; the effectiveness of these programs or the possible range of application and potential curative effects and safety in the treatment of diseases; and, the timing and success of our clinical trials, as well as clinical trials conducted by our collaborators. Forward-looking statements are by their nature subject to risks, uncertainties and other factors which could cause actual results to differ materially from those stated in such statements. Such risks, uncertainties and factors include, but are not limited to the risks set forth in the Company’s most recent Form 10-K, 10-Q and other SEC filings which are available through EDGAR at www.sec.gov. The Company assumes no obligation to update our forward-looking statements whether as a result of new information, future events or otherwise, after the date of this press release.

Contacts
Marker Therapeutics, Inc.
Aaron Santos
(904) 862-6490
investor.relations@nullmarkertherapeutics.com

MEDIA:
Amy Bonanno
(914) 450-0349
abonanno@nullsoleburytrout.com

—Company on track to submit IND for Phase 2 AML clinical trial in the third quarter, with first patient enrolled by year end—

—MultiTAA T cell therapies continue to generate positive clinical results across various indications in investigator-sponsored trials—

—Company to report update from Phase 1/2 clinical trial in pancreatic cancer in Q3 2019—

Houston, TX –May 9th, 2019– Marker Therapeutics, Inc. (NASDAQ:MRKR), a clinical-stage immuno-oncology company specializing in the development of next-generation T cell-based immunotherapies for the treatment of hematological malignancies and solid tumor indications, today provided a corporate update and reported financial results for the first quarter ended March 31, 2019.

“We continued to make significant progress this quarter. Based on our early interactions with the U.S. FDA, we are confident in our submission package for our IND for post-transplant acute myeloid leukemia (AML). In light of the feedback from the FDA, we plan to submit an IND for a Phase 2 clinical trial in the third quarter, which should enable us to enroll the first patient by the end of the year,” said Peter L. Hoang, President & CEO of Marker Therapeutics. “Depending on the results and upon further discussions with the FDA, we believe that if results are positive, this has the potential to serve as a pivotal trial—particularly if results are consistent with data generated to date from our MultiTAA therapies in investigator-sponsored trials. We look forward to initiating our first company-sponsored trial in such an important disease area, for which there are limited treatment options. Additionally, we anticipate reporting an update from our solid tumor program in pancreatic cancer in the third quarter.”

 

PROGRAM HIGHLIGHTS AND CURRENT UPDATES

Multi-Antigen Targeted (MultiTAA) T Cell Therapies

  • Company Prepares IND for Potentially Pivotal Trial in Post-Transplant AML
    Based on interactions with the U.S. Food and Drug Administration (FDA) on the clinical trial design of the planned Marker-sponsored Phase 2 clinical trial in post-transplant AML, the Company remains on track to submit an Investigational New Drug (IND) application in the third quarter, and anticipates first patient enrolled by the end of 2019. The multicenter trial will evaluate clinical efficacy of Marker’s MultiTAA-specific T cells in patients with AML in both the adjuvant and active disease setting, following an allogeneic hematopoietic stem cell transplant (HSCT). The dose to be administered in the trial is expected to be the maximum tolerated dose currently determined in the Baylor College of Medicine-sponsored Phase 1 trial. In the adjuvant setting, patients will be randomized to either MultiTAA therapy at approximately 90 days post-transplant or standard of care observation, while the active disease patients will receive MultiTAA T cells as part of a single-arm group at approximately 90 days post-transplant.
  • MultiTAA T Cell Therapies Continue to Generate Positive Clinical Data Across Various Indications
    In several ongoing investigator-sponsored Phase 1 clinical trials led by Baylor College of Medicine (BCM), Marker’s MultiTAA therapies have demonstrated the potential to mediate a meaningful anti-tumor effect, as well as significant in vivo expansion of T cells. Across all hematological indications studied in these trials—including AML, lymphoma, acute lymphoblastic leukemia (ALL), and multiple myeloma—MultiTAA therapy has appeared to be well-tolerated, with no incidence of cytokine release syndrome, neurotoxicity or any other serious adverse events related to the therapy.
  • Company to Report Update from Phase 1/2 Trial in Pancreatic Cancer in Q3 2019
    Marker plans to report additional interim data from BCM’s ongoing Phase 1/2 clinical trial in pancreatic cancer in the third quarter of 2019. The Phase 1/2 trial is a three-arm trial which includes chemo-responsive patients (Arm A), chemo-refractory patients (Arm B) and an exploratory arm for patients who have surgically-resectable disease (Arm C). Patients in the chemo-responsive arm have completed at least three months of standard-of-care chemotherapy, and are receiving up to six administrations of MultiTAA T cells in alternation with chemotherapy. Patients in the chemo-refractory arm are either ineligible for chemotherapy or have progressed on chemotherapy, and are receiving up to six doses of MultiTAA T cells as a monotherapy. The surgically-resectable patients are receiving a dose of T cells prior to surgical resection which allows Marker to assess the tumor samples for T-cell infiltration, epitope spreading and other important characteristics. These patients are eligible to receive five additional doses of T cells after surgical resection.

T Cell Based Vaccines

  • Ovarian Cancer Data
    As of January 2019, the Company has completed enrollment in its Phase 2 clinical trial in ovarian cancer using TPIV200 as a maintenance therapy for patients in their first remission after surgery and platinum-based chemotherapy, with a total of 120 patients enrolled, randomized, and treated at 17 clinical sites. The trial completed enrollment six months faster than anticipated and the Company expects to reach its planned interim analysis trigger of 55 patients who have progressed before the end of 2019 and to report the results of this interim analysis in the fourth quarter of 2019.
  • Triple Negative Breast Cancer Data
    The Company reported initial findings from its dose-finding, four-arm Phase 2 clinical trial in triple negative breast cancer, including low- and high-dose TPIV200 with or without cyclophosphamide. Of 27 patients evaluated for immunogenicity, 26 showed significant immune response to the vaccine treatment. Of 80 patients treated at 11 clinical sites, 14 have shown disease progression, as of April 30, 2019, following treatment with TPIV200.

FIRST QUARTER 2019 FINANCIAL RESULTS

Net loss for the quarter ended March 31, 2019 was $5.3 million compared to a net loss of $3.2 million for the quarter ended March 31, 2018.

Research and development expenses were $2.8 million for the quarter ended March 31, 2019, an increase of $1.2 million, compared to $1.6 million for the quarter ended March 31, 2018. The increase was primarily attributable to increased headcount-related expenses, stock-based compensation expenses and consulting expenses resulting from the expansion of our internal infrastructure as we advance the clinical development of our MultiTAA T cell product candidates.

General and administrative expenses were $2.8 million for the quarter ended March 31, 2019, an increase of $1.2 million, compared to $1.6 million for the quarter ended March 31, 2018. The increase was primarily attributable to an increase in general and administrative headcount and stock-based compensation expenses.

CASH POSITION AND GUIDANCE

At March 31, 2019, Marker had cash and cash equivalents of $57.7 million. The Company believes that its existing cash and cash equivalents will fund the Company’s current operations into late 2020.

UPCOMING NEAR-TERM POTENTIAL MILESTONES

  • First update in solid tumor program planned for third quarter of 2019;
  • IND submission for Company-sponsored Phase 2 AML clinical trial in the third quarter of 2019, with first patient enrolled by end of 2019;
  • Interim analysis readout in the TPIV200 ovarian trial expected in fourth quarter of 2019; and
    Overall update on ongoing clinical trials in cell therapy to be provided by the end of 2019.

About Marker Therapeutics, Inc.
Marker Therapeutics, Inc. is a clinical-stage immuno-oncology company specializing in the development of next-generation T cell-based immunotherapies for the treatment of hematological malignancies and solid tumor indications. Marker’s cell therapy technology is based on the selective expansion of non-engineered, tumor-specific T cells that recognize tumor associated antigens (i.e. tumor targets) and kill tumor cells expressing those targets. This population of T cells is designed to attack multiple tumor targets following infusion into patients and to activate the patient’s immune system to produce broad spectrum anti-tumor activity. Because Marker does not genetically engineer its T cells therapies, we believe that our product candidates will be easier and less expensive to manufacture, with reduced toxicities, compared to current engineered CAR-T and TCR-based approaches, and may provide patients with meaningful clinical benefit. As a result, Marker believes its portfolio of T cell therapies has a compelling therapeutic product profile, as compared to current gene-modified CAR-T and TCR-based therapies.

Marker is also advancing a number of innovative peptide- and gene-based immuno-therapeutics for the treatment of metastatic solid tumors, including the Folate Receptor Alpha program (TPIV200) for breast and ovarian cancers and the HER2/neu program (TPIV100/110) for breast cancer, currently in Phase 2 clinical trials.

For additional information, please call toll free at (904) 862-6490 or visit: markertherapeutics.com

To receive future press releases via email, please visit: https://markertherapeutics.com/email-alerts/

Follow us on Twitter @MRKRTherapeutic, or follow us on Facebook.

Forward-Looking Statement Disclaimer
This release contains forward-looking statements for purposes of the safe harbor provisions of the Private Securities Litigation Reform Act of 1995. Statements in this news release concerning the Company’s expectations, plans, business outlook or future performance, and any other statements concerning assumptions made or expectations as to any future events, conditions, performance or other matters, are “forward-looking statements.” Forward-looking statements include statements regarding our intentions, beliefs, projections, outlook, analyses or current expectations concerning, among other things: our research and development activities relating to our non-engineered multi-tumor antigen specific T cell therapies; our TPIV200 and TPIV100/110 programs; the effectiveness of these programs or the possible range of application and potential curative effects and safety in the treatment of diseases; and, the timing and success of our clinical trials, as well as clinical trials conducted by our collaborators. Forward-looking statements are by their nature subject to risks, uncertainties and other factors which could cause actual results to differ materially from those stated in such statements. Such risks, uncertainties and factors include, but are not limited to the risks set forth in the Company’s most recent Form 10-K, 10-Q and other SEC filings which are available through EDGAR at www.sec.gov. The Company assumes no obligation to update our forward-looking statements whether as a result of new information, future events or otherwise, after the date of this press release.

Contacts
Marker Therapeutics, Inc.
Aaron Santos
(904) 862-6490
investor.relations@nullmarkertherapeutics.com

MEDIA:

Amy Bonanno
(914) 450-0349
abonanno@nullsoleburytrout.com

Houston, TX – May 7, 2019 – Marker Therapeutics, Inc. (Nasdaq:MRKR), a clinical-stage immuno-oncology company specializing in the development of next-generation T cell-based immunotherapies for the treatment of hematological malignancies and solid tumor indications, today announced that its President and Chief Executive Officer, Peter L. Hoang, will be presenting at the 2019 Bank of America Merrill Lynch Health Care Conference on Thursday, May 16, 2019.

Presentation Details

Date: Thursday, May 16, 2019
Time: 10:40 a.m. PDT
Location: Encore Hotel, Las Vegas, NV

A live webcast of the presentation will be available in the investors section of the company’s website at markertherapeutics.com and will be available for replay two hours following the event.

About Marker Therapeutics, Inc.
Marker Therapeutics, Inc. is a clinical-stage immuno-oncology company specializing in the development of next-generation T cell-based immunotherapies for the treatment of hematological malignancies and solid tumor indications. Marker’s cell therapy technology is based on the selective expansion of non-engineered, tumor-specific T cells that recognize tumor associated antigens (i.e. tumor targets) and kill tumor cells expressing those targets. Once infused into patients, this population of T cells attacks multiple tumor targets and acts to activate the patient’s immune system to produce broad spectrum anti-tumor activity. Because Marker does not genetically engineer its T cells, when compared to current engineered CAR-T and TCR-based approaches, its products (i) are significantly less expensive and easier to manufacture, (ii) appear to be markedly less toxic, and (iii) are associated with meaningful clinical benefit. As a result, Marker believes its portfolio of T cell therapies has a compelling therapeutic product profile, as compared to current gene-modified CAR-T and TCR-based therapies.

Marker is also advancing a number of innovative peptide- and gene-based immuno-therapeutics for the treatment of metastatic solid tumors, including the Folate Receptor Alpha program (TPIV200) for breast and ovarian cancers and the HER2/neu program (TPIV100/110) for breast cancer, currently in Phase II clinical trials. In parallel, we are developing a proprietary DNA expression technology named PolyStart™ that can enhance the ability of the immune system to recognize and destroy diseased cells.

For additional information, please call toll free at (904) 862-6490 or visit: markertherapeutics.com

To receive future press releases via email, please visit: https://markertherapeutics.com/email-alerts/

Follow us on Twitter @MRKRTherapeutic, or follow us on Facebook.

Forward-Looking Statement Disclaimer
This release contains forward-looking statements for purposes of the safe harbor provisions of the Private Securities Litigation Reform Act of 1995. Statements in this news release concerning the Company’s expectations, plans, business outlook or future performance, and any other statements concerning assumptions made or expectations as to any future events, conditions, performance or other matters, are “forward-looking statements.” Forward-looking statements include statements regarding our intentions, beliefs, projections, outlook, analyses or current expectations concerning, among other things: our research and development activities relating to our non-engineered multi-tumor antigen specific T cell therapies; our TPIV200 and TPIV100/110 programs and our PolyStart™ program; the effectiveness of these programs or the possible range of application and potential curative effects and safety in the treatment of diseases; and, the timing and success of our clinical trials, as well as clinical trials conducted by our collaborators. Forward-looking statements are by their nature subject to risks, uncertainties and other factors which could cause actual results to differ materially from those stated in such statements. Such risks, uncertainties, and factors include, but are not limited to the risks set forth in the Company’s most recent Form 10-K, 10-Q and other SEC filings which are available through EDGAR at www.sec.gov. The Company assumes no obligation to update our forward-looking statements whether as a result of new information, future events or otherwise, after the date of this press release.

Contacts
Marker Therapeutics, Inc.
Aaron Santos
(904) 862-6490
investor.relations@nullmarkertherapeutics.com

Solebury Trout
Brad Miles
(646) 513-3125
bmiles@nullsoleburytrout.com

– or –

Amy Bonanno
(914) 450-0349
abonanno@nullsoleburytrout.com

—MultiTAA T cell therapies continue to demonstrate positive clinical data across multiple indications in investigator-sponsored trials—

—Marker plans IND submission for Company-sponsored Phase 2 AML study in the third quarter, with first patient enrolled by the end of 2019—

—First update in the solid tumor program planned for second quarter—

—Company to host business update call and webcast today at 5:00 p.m. EDT­—

Houston, TX –March 28, 2019– Marker Therapeutics, Inc. (NASDAQ:MRKR), a clinical-stage immuno-oncology company specializing in the development of next-generation T cell-based immunotherapies for the treatment of hematological malignancies and solid tumor indications, today provided a business and clinical update, as well as an overview of upcoming milestones for 2019.

“Our MultiTAA T cell therapies have continued to generate positive and compelling clinical data across various indications in several ongoing investigator-sponsored clinical trials led by Baylor College of Medicine (BCM). We plan to advance a Phase 2 Company-sponsored clinical trial in post-transplant acute myeloid leukemia (AML)—a disease area and patient population for which there are limited treatment options. We expect to finalize our clinical trial protocol in AML by the end of the second quarter of 2019 and to submit our IND in the third quarter, with the first patient enrolled by the end of the year,” said Peter L. Hoang, President & CEO of Marker Therapeutics.

Continued Mr. Hoang: “While our T cell therapies remain our primary clinical focus, we are also advancing our T cell vaccine candidates, TPIV200 and TPIV100/110, for the treatment of ovarian and breast cancers. Overall, there are two Phase 2 Company-sponsored studies ongoing for TPIV200 in triple-negative breast cancer and ovarian cancer, and we anticipate reporting interim data from the ovarian cancer Phase 2 study in Q4 2019.”

PROGRAM HIGHLIGHTS AND CURRENT UPDATES

Multi-Antigen Targeted (MultiTAA) T Cell Therapies

Acute Myeloid Leukemia Data

  • The Company reported a clinical update from a Phase 1 clinical trial in post-transplant AML in oral and poster presentations at ASH in December and ASBMT and CIBMTR in February. Results from the BCM-sponsored study showed that the treatment is safe and well-tolerated and has the potential to mediate a meaningful anti-tumor effect, as well as significant in vivoexpansion of T cells. Among the highlights from the study, 11 out of 13 patients dosed with MultiTAA T cells as a maintenance therapy after receiving allogeneic stem cell transplant remain alive, ranging from 6 weeks to 2.5 years post-infusion. Nine of these patients have never relapsed after MultiTAA therapy and continue to remain in complete remission (CR). Patients with active disease, overall survival ranged from 4 and 21 months as compared to 4.5 months in historical results after standard of care.
  • Marker will pursue post-transplant AML as the lead indication of its T cell therapy program. Based on findings from various dose cohorts in the Phase 1 BCM-sponsored trial, Marker has made a strategic decision to focus on post-transplant AML, and plans to initiate pre-IND discussions with the U.S. FDA in the second quarter of 2019, with an IND submission for the Company-sponsored potentially pivotal Phase 2 study in the third quarter. The multicenter study will evaluate clinical efficacy of MultiTAA specific T cells in patients with AML or myelodysplastic syndromes (MDS) in both the adjuvant and active disease setting, following an allogeneic hematopoietic stem cell transplant (HSCT). The dose administered will be the maximum tolerated dose from the BCM-sponsored Phase 1 trial. In the adjuvant setting, patients will be randomized 2:1 to either MultiTAA therapy at approximately 90 days post-transplant versus standard of care observation, while the active disease patients will receive MultiTAA T cells as part of a single-arm group.

Lymphoma Data

As reported in January, 2019:

  • To date, no relapses have been observed for any patient entering a complete response (CR);
  • Patients with active disease are now between 1 and 5+ years in CR after infusion of MultiTAA cells (ongoing);
    Several patients with stable disease show potential durable disease stabilization, with two patients experiencing stable disease for over 9 months and 24 months, respectively;
  • Responses in all six patients who entered CR were associated with an expansion of infused T cells, as well as induction of antigen spreading.

Acute Lymphoblastic Leukemia (ALL) Data

As reported at ASBMT and CIBMTR in February:

  • Patients are now up to 28 months in continued complete remission (CCR);
  • The one patient who experienced relapse displayed mixed donor/recipient chimerism after transplant, but remained in CCR for 6 months;
  • Patients who remain in CCR have been durable for between 4 to 28 months, with a median of 16 months.

Multiple Myeloma Data

As the Company reported in January, 2019, ten patients with active disease have been treated, including:

  • One patient with a CR durable for approximately 29 months before relapse, was subsequently given a second treatment infusion of MultiTAA T cells, resulting in stable disease for 3 months (ongoing) after the second treatment;
  • Two patients achieved partial responses (PR) of between 14 and 22 months (ongoing) as of last follow-up;
  • All seven remaining patients experienced stabilization of disease following infusion of MultiTAA cells initially. Three patients developed transient disease stabilization of between 3-7 months with subsequent progression, and four patients have ongoing stable disease.
  • Eight patients were treated in remission, with a median follow-up of 21 months. Only one patient has relapsed to date;
  • Correlative studies show significant expansion of MultiTAA T cells, as well as significant evidence of epitope spreading with expansion of endogenous T cells specific for tumor-associated antigens that were not targeted by the MultiTAA product.
  • Overall, across all indications, MultiTAA therapy appears to be safe and well-tolerated, with no incidence of cytokine release syndrome, neurotoxicity or any other serious adverse events related to the therapy.

T Cell Based Vaccines

Ovarian Cancer Data

  • As the Company reported in January, 2019, it has completed enrollment in its Phase 2 study in ovarian cancer using TPIV200 as a maintenance therapy for patients in their first remission after surgery and platinum-based chemotherapy. To date, Marker has enrolled, randomized, and treated 120 patients at 17 clinical sites. The study completed enrollment six months faster than anticipated and the Company expects to reach its planned interim analysis trigger of 55 patients who have progressed before the end of 2019.

Triple Negative Breast Cancer Data

  • The Company also reported initial findings from its interim analysis of its dose-finding study in triple negative breast cancer, using TPIV200 as a maintenance therapy for patients in remission following first-line therapy. The four-arm study included low- and high-dose TPIV200 with or without cyclophosphamide. Of 27 patients evaluated to date for immunogenicity, 26 showed significant immune response to the vaccine treatment. Of 80 patients treated at 11 clinical sites, 11 have shown disease progression to date following treatment with TPIV200.

Marker continues to advance the development of its proprietary PolyStart™ platform, a nucleic acid-based technology with the potential to increase the potency of our vaccines by conferring a four-fold increase in expression of target-cell-specific, naturally processed antigenic epitopes on a cell’s surface. This approach boosts helper and/or long-lived killer T cells, enabling their potential to effectively seek out and destroy target cells.

CASH POSITION AND GUIDANCE

Marker reported cash and cash equivalents totaling $61.7 million as of December 31, 2018. Based on current operating plans, Marker expects that current cash resources will be sufficient to meet operating requirements into Q4 of 2020.

UPCOMING NEAR-TERM POTENTIAL MILESTONES

Pre-IND discussions for AML with the U.S. FDA in Q2;
First update in solid tumor program in Q2 concurrently with a major medical meeting;
IND submission for Company-sponsored Phase 2 AML study in Q3, with first patient enrolled by end of 2019;
Interim analysis readout in the TPIV200 ovarian trial in Q4;
Overall update on ongoing clinical trials in cell therapy at end of 2019.
Business Update Call and Webcast

Marker management will host business update conference call and webcast today at 5:00 p.m. EDT. To access the call, participants should dial 1-855-238-2333 (domestic) or 1-412-317-5215 (international) and refer to the “Marker Therapeutics, Inc. call.” The webcast will be accessible in the Investors section of the Company’s website at markertherapeutics.com. The archived webcast will be available for replay on the Marker website approximately two hours after the event.

About Marker Therapeutics, Inc.
Marker Therapeutics, Inc. is a clinical-stage immuno-oncology company specializing in the development of next-generation T cell-based immunotherapies for the treatment of hematological malignancies and solid tumor indications. Marker’s cell therapy technology is based on the selective expansion of non-engineered, tumor-specific T cells that recognize tumor associated antigens (i.e. tumor targets) and kill tumor cells expressing those targets. Once infused into patients, this population of T cells attacks multiple tumor targets and acts to activate the patient’s immune system to produce broad spectrum anti-tumor activity. Because Marker does not genetically engineer its T cells, when compared to current engineered CAR-T and TCR-based approaches, its products (i) are significantly less expensive and easier to manufacture, (ii) appear to be markedly less toxic, and (iii) are associated with meaningful clinical benefit. As a result, Marker believes its portfolio of T cell therapies has a compelling therapeutic product profile, as compared to current gene-modified CAR-T and TCR-based therapies.

Marker is also advancing a number of innovative peptide- and gene-based immuno-therapeutics for the treatment of metastatic solid tumors, including the Folate Receptor Alpha program (TPIV200) for breast and ovarian cancers and the HER2/neu program (TPIV100/110) for breast cancer, currently in Phase II clinical trials. In parallel, we are developing a proprietary DNA expression technology named PolyStart™ that can enhance the ability of the immune system to recognize and destroy diseased cells.

For additional information, please call toll free at (904) 862-6490 or visit: markertherapeutics.com

To receive future press releases via email, please visit: https://markertherapeutics.com/email-alerts/

Follow us on Twitter @MRKRTherapeutic, or follow us on Facebook.

Forward-Looking Statement Disclaimer
This release contains forward-looking statements for purposes of the safe harbor provisions of the Private Securities Litigation Reform Act of 1995. Statements in this news release concerning the Company’s expectations, plans, business outlook or future performance, and any other statements concerning assumptions made or expectations as to any future events, conditions, performance or other matters, are “forward-looking statements.” Forward-looking statements include statements regarding our intentions, beliefs, projections, outlook, analyses or current expectations concerning, among other things: our research and development activities relating to our non-engineered multi-tumor antigen specific T cell therapies; our TPIV200 and TPIV100/110 programs and our PolyStart™ program; the effectiveness of these programs or the possible range of application and potential curative effects and safety in the treatment of diseases; and, the timing and success of our clinical trials, as well as clinical trials conducted by our collaborators. Forward-looking statements are by their nature subject to risks, uncertainties and other factors which could cause actual results to differ materially from those stated in such statements. Such risks, uncertainties and factors include, but are not limited to the risks set forth in the Company’s most recent Form 10-K, 10-Q and other SEC filings which are available through EDGAR at www.sec.gov. The Company assumes no obligation to update our forward-looking statements whether as a result of new information, future events or otherwise, after the date of this press release.

Contacts
Marker Therapeutics, Inc.
Aaron Santos
(904) 862-6490
investor.relations@nullmarkertherapeutics.com

Solebury Trout
Brad Miles
(646) 513-3125
bmiles@nullsoleburytrout.com

– or –

Amy Bonanno
(914) 450-0349
abonanno@nullsoleburytrout.com

Houston, TX – March 18, 2019 – Marker Therapeutics, Inc. (NASDAQ:MRKR), a clinical-stage immuno-oncology company specializing in the development of next-generation T cell-based immunotherapies for the treatment of hematological malignancies and solid tumor indications, today announced that it will host a business update conference call and webcast on Thursday, March 28th at 5:00 p.m. EDT.

Business Update Conference Call and Webcast

Individuals can participate in the conference call by dialing 1-855-238-2333 (domestic) or 1-412-317-5215 (international) and refer to the “Marker Therapeutics, Inc. call.” The webcast will be accessible in the Investors section of the Company’s website at markertherapeutics.com. The archived webcast will be available for replay on the Marker website approximately two hours after the event.

About Marker Therapeutics, Inc.
Marker Therapeutics, Inc. is a clinical-stage immuno-oncology company specializing in the development of next-generation T cell-based immunotherapies for the treatment of hematological malignancies and solid tumor indications. Marker’s cell therapy technology is based on the selective expansion of non-engineered, tumor-specific T cells that recognize tumor associated antigens (i.e. tumor targets) and kill tumor cells expressing those targets. Once infused into patients, this population of T cells attacks multiple tumor targets and acts to activate the patient’s immune system to produce broad spectrum anti-tumor activity. Because Marker does not genetically engineer its T cells, when compared to current engineered CAR-T and TCR-based approaches, its products (i) are significantly less expensive and easier to manufacture, (ii) appear to be markedly less toxic, and (iii) are associated with meaningful clinical benefit. As a result, Marker believes its portfolio of T cell therapies has a compelling therapeutic product profile, as compared to current gene-modified CAR-T and TCR-based therapies.

Marker is also advancing a number of innovative peptide- and gene-based immuno-therapeutics for the treatment of metastatic solid tumors, including the Folate Receptor Alpha program (TPIV200) for breast and ovarian cancers and the HER2/neu program (TPIV100/110) for breast cancer, currently in Phase II clinical trials. In parallel, we are developing a proprietary DNA expression technology named PolyStart™ that can enhance the ability of the immune system to recognize and destroy diseased cells.

For additional information, please call toll free at (904) 862-6490 or visit: markertherapeutics.com

To receive future press releases via email, please visit: https://markertherapeutics.com/email-alerts/

Follow us on Twitter @MRKRTherapeutic, or follow us on Facebook.

Forward-Looking Statement Disclaimer
This release contains forward-looking statements for purposes of the safe harbor provisions of the Private Securities Litigation Reform Act of 1995. Statements in this news release concerning the Company’s expectations, plans, business outlook or future performance, and any other statements concerning assumptions made or expectations as to any future events, conditions, performance or other matters, are “forward-looking statements”. Forward-looking statements include statements regarding our intentions, beliefs, projections, outlook, analyses or current expectations concerning, among other things: our research and development activities relating to our non-engineered multi-tumor antigen specific T cell therapies; our TPIV200 and TPIV100/110 programs and our PolyStart™ program; the effectiveness of these programs or the possible range of application and potential curative effects and safety in the treatment of diseases; and, the timing and success of our clinical trials, as well as multi-tumor antigen specific T cell clinical trials conducted by our collaborators. Forward-looking statements are by their nature subject to risks, uncertainties and other factors which could cause actual results to differ materially from those stated in such statements. Such risks, uncertainties and factors include, but are not limited to the risks set forth in the Company’s most recent Form 10-K, 10-Q and other SEC filings which are available through EDGAR at www.sec.gov. The Company assumes no obligation to update our forward-looking statements whether as a result of new information, future events or otherwise, after the date of this press release.

Contacts
Marker Therapeutics, Inc.
Aaron Santos
(904) 862-6490
investor.relations@nullmarkertherapeutics.com

Solebury Trout
Brad Miles
(646) 513-3125
bmiles@nullsoleburytrout.com

– or –

Amy Bonanno
(914) 450-0349
abonanno@nullsoleburytrout.com

Houston, TX – February 25, 2019 – Marker Therapeutics, Inc. (NASDAQ:MRKR), a clinical-stage immuno-oncology company specializing in the development of next-generation T cell-based immunotherapies for the treatment of hematological malignancies and solid tumor indications, today announced updated data from four clinical trials using the Company’s multi-antigen targeted T cell (MultiTAA) therapies. The data was reviewed in oral and poster presentations at the Transplantation & Cellular Therapy Meetings of ASBMT and CIBMTR 2019 which took place in Houston, TX from February 20-24. Among the highlights, were results from an ongoing study including patients with acute myeloid leukemia (AML), which were reviewed in an oral presentation by Dr. Premal Lulla, M.B.B.S., Assistant Professor of Medicine, Baylor College of Medicine.

“We continue to be highly encouraged by the clinical results we’ve seen to date with our MultiTAA therapies. In AML, we believe we are seeing increasing evidence of meaningful therapeutic benefit for patients with limited treatment alternatives. Our MultiTAA therapy appears to be safe and well-tolerated with the potential to mediate a meaningful anti-tumor effect, in addition to demonstrating a compelling correlation between therapeutic responses, with superior in vivo expansion of our T cells,” said Peter L. Hoang, President & CEO of Marker Therapeutics. “Similarly, the studies ongoing in acute lymphoblastic leukemia, or ALL, lymphoma and multiple myeloma continue to demonstrate positive results, and are supportive of the data we presented at ASH in December, importantly with no additional disease relapses. Overall, this data update and our update at ASH 2018 in December collectively have increased our total reported number of patients to 78 as compared to the 57 patients we had reported as of November.”

AML Study Results

In Arm A of the AML study, 13 patients at Baylor College of Medicine were dosed with MultiTAA T cells as a maintenance therapy after receiving allogeneic stem cell transplant. Results demonstrated:

  • 11 out of 13 patients remain alive, ranging from 6 weeks to 2.5 years post-infusion. Nine of these patients have never relapsed after MultiTAA therapy and continue to remain in complete remission (CR), durable between 6 weeks to 2.5 years;
  • Two patients saw local relapse in the central nervous system, but in both cases these patients were successfully treated with local therapy alone;
  • One patient saw extramedullary relapse and was subsequently treated in the active disease arm (Arm B) of the trial, generating a CR that was durable for 13 months; and
  • One patient relapsed 8 months after receiving MultiTAA T cells but following a second allogeneic stem cell transplant this patient remains alive in relapse 1.5 years following his initial T cell infusion.

In Arm B of the AML study, 6 patients suffering from active disease with relapsed/refractory (r/r) AML have been treated, with 1 patient having been treated twice for active disease with MultiTAA T cells;

  • 2 patients were non-responsive to MultiTAA therapy and progressed with r/r disease;
  • 1 patient developed a complete response (CR), which was durable for 13 months; and
  • 1 patient developed a partial response (PR) that enabled that patient to receive a second allogeneic stem cell transplant;
    • The patient who developed a partial response saw significant tumor debulking, with circulating blasts reduced from over 50% to 15%.
  • 2 additional patients who did not meet partial response criteria experienced disease stabilization enabling a 2-month delay to next-line therapy
    • Of these patients with disease stability, one patient was sufficiently stabilized to enable that patient to receive a second allogeneic stem cell transplant. The second transplant eliminated the patient’s MultiTAA T cells. This patient was given a second dose of MultiTAA T cells after initial disease relapse after the second transplant, but progressed to another line of therapy prior to any evaluable response assessment to the subsequent dose of MultiTAA T cells;
    • The other patient who had disease stability saw significant reduction in tumor burden, with a reduction in circulating blasts from 70% prior to infusion of MultiTAA T cells, to approximately 45% circulating blasts after MultiTAA therapy.
  • For patients in Arm B, overall survival ranged from 4 to 21 months after T cell infusions.

ALL Results

In addition to data from ongoing lymphoma and multiple myeloma trials, also presented in an oral presentation at the meeting were updated results from an ongoing study in ALL. Updates from this trial included:

  • Patients are now up to 28 months in CCR (Continued Complete Remission);
  • The only patient who has experienced relapse was a patient who displayed mixed donor/recipient chimerism after transplant, but remained in CCR for 6 months prior to relapse;
  • Patients that remain in CCR have been durable for between 4 to 28 months, with a median duration of 16 months.

“We are very excited about the results we are seeing in our early clinical trials. For patients with r/r AML, we believe that MultiTAA therapies may produce meaningful improvements in overall survival of patients who historically have had a dire prognostic outlook,” stated Mythili Koneru, Senior Vice President of Clinical Development at Marker Therapeutics. “In adjuvant settings for patients currently in remission, I believe our early clinical results suggest that we may be providing significant additional protection against relapse and disease recurrence.”

About Marker Therapeutics, Inc.
Marker Therapeutics, Inc. is a clinical-stage immuno-oncology company specializing in the development of next-generation T cell-based immunotherapies for the treatment of hematological malignancies and solid tumor indications. Marker’s cell therapy technology is based on the selective expansion of non-engineered, tumor-specific T cells that recognize tumor associated antigens (i.e. tumor targets) and kill tumor cells expressing those targets. Once infused into patients, this population of T cells attacks multiple tumor targets and acts to activate the patient’s immune system to produce broad spectrum anti-tumor activity. Because Marker does not genetically engineer its T cells, when compared to current engineered CAR-T and TCR-based approaches, its products (i) are significantly less expensive and easier to manufacture, (ii) appear to be markedly less toxic, and (iii) are associated with meaningful clinical benefit. As a result, Marker believes its portfolio of T cell therapies has a compelling therapeutic product profile, as compared to current gene-modified CAR-T and TCR-based therapies.

Marker is also advancing a number of innovative peptide- and gene-based immuno-therapeutics for the treatment of metastatic solid tumors, including the Folate Receptor Alpha program (TPIV200) for breast and ovarian cancers and the HER2/neu program (TPIV100/110) for breast cancer, currently in Phase II clinical trials. In parallel, we are developing a proprietary DNA expression technology named PolyStart™ that can enhance the ability of the immune system to recognize and destroy diseased cells.

For additional information, please call toll free at (904) 862-6490 or visit: markertherapeutics.com

To receive future press releases via email, please visit: https://markertherapeutics.com/email-alerts/

Follow us on Twitter @MRKRTherapeutic, or follow us on Facebook.

Forward-Looking Statement Disclaimer
This release contains forward-looking statements for purposes of the safe harbor provisions of the Private Securities Litigation Reform Act of 1995. Statements in this news release concerning the Company’s expectations, plans, business outlook or future performance, and any other statements concerning assumptions made or expectations as to any future events, conditions, performance or other matters, are “forward-looking statements”. Forward-looking statements include statements regarding our intentions, beliefs, projections, outlook, analyses or current expectations concerning, among other things: our research and development activities relating to our non-engineered multi-tumor antigen specific T cell therapies; our TPIV200 and TPIV100/110 programs and our PolyStart™ program; the effectiveness of these programs or the possible range of application and potential curative effects and safety in the treatment of diseases; and, the timing and success of our clinical trials, as well as multi-tumor antigen specific T cell clinical trials conducted by our collaborators. Forward-looking statements are by their nature subject to risks, uncertainties and other factors which could cause actual results to differ materially from those stated in such statements. Such risks, uncertainties and factors include, but are not limited to the risks set forth in the Company’s most recent Form 10-K, 10-Q and other SEC filings which are available through EDGAR at www.sec.gov. The Company assumes no obligation to update our forward-looking statements whether as a result of new information, future events or otherwise, after the date of this press release. .

Contacts
Marker Therapeutics, Inc.
Aaron Santos
(904) 862-6490
investor.relations@nullmarkertherapeutics.com

Solebury Trout
Brad Miles
(646) 513-3125
bmiles@nullsoleburytrout.com

– or –

Amy Bonanno
(914) 450-0349
abonanno@nullsoleburytrout.com

 

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