Recent Corporate and Clinical Developments:
Anticipated 2017 Milestones:
JACKSONVILLE, FLORIDA – May 31, 2017 – TapImmune, Inc. (NASDAQ: TPIV), a clinical-stage immuno-oncology company specializing in the development of immunotherapies targeting women’s cancers, today provided its first quarterly business update, following the company’s uplisting to The NASDAQ Capital Market in the fourth quarter 2016. A public conference call and live audio webcast is scheduled for today at 4:30 pm ET.
“TapImmune is entering a period where we expect to reach several substantive clinical milestones over the next 18 months,” said Dr. Glynn Wilson, Chairman and CEO of TapImmune. “By the end of 2017, we expect to have four active Phase 2 studies ongoing in multiple high-need cancers, including clinical studies sponsored by our top-tier partners, the Mayo Clinic and Memorial Sloan Kettering Cancer Center. Two of the planned Phase 2 studies are fully funded by approximately $17 million in U.S. Government grants to the Mayo Clinic, which continues to be a significant source of non-dilutive clinical funding. Based on the breadth of our pipeline, we believe TapImmune is the only immune-oncology company of our size that is poised to generate such substantial value through the continued development of our novel vaccine candidates. We look forward to advancing our extensive pipeline and to translating our anticipated clinical milestones in to multiple value inflection points for our shareholders.”
Dr. Wilson continued, “Adding to this position of clinical strength is our earlier stage PolyStart™ technology platform, which is designed to improve antigen expression compared to current vaccines. We continue to generate encouraging in vitro and in vivo data that demonstrate how PolyStart may be able to enhance the potency of virtually any expression-based vaccine. Once matured, we expect that TapImmune will benefit from multiple opportunities to leverage this next-generation technology, both to continue expanding our in-house oncology pipeline, as well as to out-license PolyStart to strategic partners developing vaccines for infectious disease. We plan to explore several ways to monetize this valuable and proprietary platform.”
Current Clinical Studies:
TPIV 200: Lead T-cell vaccine targeting folate receptor alpha
Planned Clinical Studies:
TPIV 200:
TPIV 100/110 T-cell vaccine targeting HER2/neu:
Conference Call and Webcast Information:
The company will host a conference call and live audio webcast on Wednesday, May 31, 2017, at 4:30 p.m. ET. Interested participants and investors may access the conference call by dialing either:
An audio webcast will be accessible via the News and Events section of the TapImmune website https://markertherapeutics.com/events/. An archive of the webcast and presentation will remain available for 90 days beginning at approximately 6:30 p.m. ET, on May 31, 2017.
JACKSONVILLE, FLORIDA – May 18, 2017 – TapImmune, Inc. (NASDAQ: TPIV), a clinical-stage immuno-oncology company specializing in the development of immunotherapies targeting women’s cancers, today announced that the Company will host a conference call and live audio webcast on Wednesday, May 31, 2017, at 4:30 p.m. ET, to provide a corporate and clinical update for the first quarter 2017.
Reserve Your Seat: Register Today
The event will be webcast live via the Internet on:
May 31, 2017
4:30 PM ET
Click here to register today, or visit https://markertherapeutics.com/register/.
Day-of Call-in Information:
To access the live conference call, dial:
To access the live audio webcast, visit the Events section of the TapImmune website https://markertherapeutics.com/events/. The webcast will also be archived for 90 days beginning at approximately 6:30 p.m. ET, on May 31, 2017.
JACKSONVILLE, FLORIDA – May 1, 2017 – TapImmune, Inc. (NASDAQ: TPIV), a clinical-stage immuno-oncology company specializing in the development of immunotherapies targeting women’s cancers, today announced it has engaged Richard Kenney, MD, FACP, in a consultant role as Medical Director for the Company. Dr. Kenney will manage TapImmune’s ongoing and planned clinical programs for its next-generation T-cell vaccine candidates, which currently include multiple Phase 2 trials in advanced breast and ovarian cancer.
Dr. Glynn Wilson, Chairman and CEO of TapImmune, stated, “We are delighted to have Dr. Kenney join us given his broad expertise and extensive experience in clinical operations in designing and implementing successful clinical development programs in immunotherapy, including those for DNA vaccines. We will benefit from his wealth of experience as we continue to advance our two current cancer vaccine candidates and our next generation DNA vector technology, PolyStart™, and position TapImmune as a leader in the immunotherapy of woman’s cancers. Today’s appointment marks an important transition in our overall corporate development program as we strategically focus on clinical operations now that our manufacturing operations and contracts are in place”.
Dr. Kenney commented, “I am delighted to assist TapImmune during this exciting time of growth as the company advances two of its T-cell vaccine candidates though multiple Phase 1b/2 and Phase 2 clinical trials. Each of these novel vaccines are designed to address significant unmet needs for women with ovarian and breast cancer, where recurrence is high and prognosis can be very poor. Having led the development of multiple vaccine programs and immunotherapies for cancer and infectious disease, I am eager to utilize my experience to drive successful clinical programs for TapImmune in collaboration with the Company’s top-tier clinical partners.”
TapImmune anticipates achieving several clinical milestones in 2017, including long-term survival and immunogenicity data from its completed Phase 1 clinical study of its TPIV 200 cancer vaccine, which is expected to be available in the third quarter of this year. The Company also expects to report interim results from two of its ongoing Phase 2 studies of TPIV 200 in the fourth quarter of 2017, in platinum-resistant ovarian cancer and triple-negative breast cancer. Finally, TapImmune expects to initiate two additional Phase 1b/2 clinical studies for its TPIV 100/110 vaccine in HER2/neu+ breast cancer and HER2/neu+ ductal carcinoma in situ (DCIS).
Dr. Kenney currently serves as President of ClinReg Biologics, LLC. Prior to this role, Dr. Kenney served as Principal Medical Advisor and Chief Medical Officer of Immune Design Corp, where he established and led the clinical development, pharmacovigilance and regulatory affairs groups to advance the development and commercialization of the company’s cancer prime-boost immunotherapeutic and vaccines. Previously, Dr. Kenney served as Chief Medical Officer of Crucell Holland, BV, where he directed clinical development of a broad platform of vaccines. He also served as Senior Vice President, Clinical Development for Vical Incorporated, where he led the clinical development of DNA vaccines for cancer immunotherapy and infectious diseases. Dr. Kenney held key positions in vaccine development at GSK Biologicals from 2005 to 2009, most recently as Senior Director of Global Clinical R&D, Vaccines for Viral Diseases. He earned his M.D. degree at Harvard Medical School, completed his residency in Internal Medicine at Duke University Medical Center, and a fellowship in Infectious Diseases at the National Institute of Allergy and Infectious Diseases.
April 28, 2017, Jacksonville, FL,, TapImmune Inc. (NASDAQ: TPIV), a clinical-stage immuno-oncology company specializing in the development of innovative peptide and gene-based immunotherapeutics and vaccines for the treatment of cancer and metastatic disease, has announced that on April 27, 2017, Dr. John Bonfiglio resigned as Chief Operating Officer, President and director of TapImmune Inc. to pursue other opportunities.
Speaking for the Board of Directors, Chairman and CEO of TapImmune Dr. Glynn Wilson stated, “We have been fortunate to have John serve the Company initially as a consultant and subsequently as an officer and director. During John’s tenure as part of our management team, the Company successfully optimized and scaled up GMP manufacturing operations, allowing us to enter multiple Phase 2 clinical studies and to be listed on Nasdaq Capital Markets. As the company transitions into a focus on later stages of clinical development, I want to thank John and wish him the best in his future endeavors.”
Dr. Bonfiglio stated “I am pleased to have had the opportunity to support TapImmune and its clinical programs. I remain optimistic about the Company’s future and the prospects for its next-generation vaccine technologies.”
In connection with Dr. Bonfiglio’s resignation, the size of the Board was reduced from seven members to six members. Dr. Wilson, was appointed to serve as the Company’s President due to the vacancy created by Dr. Bonfiglio’s resignation.
JACKSONVILLE, FLORIDA – March 29, 2017 – TapImmune Inc. (NASDAQ: TPIV), a leading clinical-stage immuno-oncology company with ongoing clinical trials in ovarian and breast cancer, today announced that the Company will host a conference call and live audio webcast on Thursday, April 5, 2018, at 4:30 p.m. ET, to provide a corporate and clinical update for the fourth quarter and year end 2017.
Reserve Your Seat: Register Today
The event will be webcast live via the Internet on:
April 5, 2018
4:30 PM ET
Click here to register today, or visit https://markertherapeutics.com/register/.
Day-of Call-in Information:
To access the live conference call on April 5, 2018, at 4:30pm ET you may use:
(855) 238-2333 (U.S.)
(412) 317-5215 (International)
To access the live audio webcast, visit the Events section of the TapImmune website: https://markertherapeutics.com/events. The webcast will also be archived for 90 days beginning at approximately 6:30 p.m. ET, on April 5, 2018.
JACKSONVILLE, FLORIDA – March 22, 2017 – TapImmune, Inc. (NASDAQ: TPIV), a clinical-stage immuno-oncology company specializing in the development of innovative peptide and gene-based immunotherapeutics for the treatment of cancer and metastatic disease, today announced that it will participate in two upcoming Investor and Industry conferences.
Dr. Glynn Wilson, Chairman and CEO of TapImmune, will provide an overview of the company’s business, clinical pipeline and partnering opportunities for its proprietary PolyStart technology platform during his presentation at the 5th Annual Cancer Biopartnering & Investment Forum hosted by Sachs Associates in New York, NY. Additionally, Dr. Wilson will serve as a panelist during the conference’s “Cancer Vaccines: Immuno-Priming and Tumor Antigens” panel discussion.
Concurrently, Dr. John Bonfiglio, President and Chief Operating Officer of TapImmune, will provide an overview of the company’s unique approach during a presentation titled “Synthesis, Purification and Formulation of a New T Cell Vaccine Using 5 Novel Proteins,” during the S2 Oligonucleotide & Peptide Therapeutics Boston Conference in Boston, MA.
Event:
Sachs’ 5th Annual Cancer Biopartnering & Investment Forum
Date: Tuesday, March 28, 2017
Times: Company presentation: 10:35 am (Eastern Time)
Cancer vaccine panel discussion: 2:00 pm (Eastern Time)
Location: The New York Academy of Sciences, New York, NY
Event:
S2 Oligonucleotide & Peptide Therapeutics Boston Conference
Date: Wednesday, March 29, 2017
Time: 1:30 pm (Eastern Time)
Location: Royal Sonesta Boston, Cambridge, MA
The presentation of the Sachs’ 5th Annual Cancer Biopartnering & Investment Forum will be webcast live and will remain available as an archive following the presentation. To access the webcast, please visit the events page section of the TapImmune website at https://markertherapeutics.com/events/.
SECOND TAPIMMUNE T-CELL VACCINE CANDIDATE TO BE TESTED IN A DOD-FUNDED STUDY
JACKSONVILLE, FLORIDA – March 14, 2017 – TapImmune, Inc. (NASDAQ: TPIV), a clinical-stage immuno-oncology company specializing in the development of innovative peptide and gene-based immunotherapeutics for the treatment of cancer and metastatic disease, today announced that its collaborators at the Mayo Clinic, recently received a $3.7 million grant from the U.S. Department of Defense (DoD) to conduct a Phase 2 clinical study on TapImmune’s HER2/neu-targeted T-cell vaccine that will enroll women diagnosed with an early form of breast cancer called ductal carcinoma in situ (DCIS). If successful, TapImmune’s vaccine may replace standard surgery and chemotherapy, and potentially could become part of a routine immunization schedule for preventing breast cancer in healthy women.
“This is our second T-cell vaccine candidate to be tested in a DoD-funded Phase 2 study to the Mayo Clinic, and it marks our expansion into a second breast cancer indication,” said Dr. Glynn Wilson, chairman and CEO of TapImmune. “In addition to ongoing and planned Phase 2 studies of our lead TPIV 200 vaccine for treating triple-negative breast cancer, this new study of our HER2neu vaccine in DCIS has the potential to validate our novel approach to establishing lasting immunity against breast cancer and precancerous lesions. Her2neu is overexpressed in about 30% of all breast cancer patients amounting to approximately 220,00 patients per year. We look forward to the advancement of this fully funded study, as it further broadens our robust clinical pipeline, which also includes two additional Phase 2 trials for treating ovarian cancer.”
The study is expected to begin in 2017 and will be led by Keith Knutson, Ph.D., Director of the Discovery and Translational Labs Cancer Research Program at Mayo Clinic’s Florida campus. It is expected to enroll 40-45 women with DCIS, who will receive the vaccine six weeks prior to standard surgical resection. The vaccine has already been shown to stimulate production of T-cells directed against breast cancer cells that overexpress the oncogene HER2 in a completed Phase 1 study.
TapImmune has licensed the HER2neu vaccine technology that will be used in this study and has the worldwide exclusive rights to commercialize the technology. TapImmune will be funded for providing the manufactured product for this trial.
Dr. Knutson added, “DCIS is a significant health problem, accounting for about 20% of U.S. cases of breast cancer. We ultimately want to eliminate ductal carcinoma in situ, which means preventing disfiguring surgeries and toxic therapies in the 60,000 women who receive this diagnosis every year in the U.S.”
Recent Corporate and Clinical Developments:
JACKSONVILLE, FLORIDA – March 14, 2017 – TapImmune, Inc. (NASDAQ: TPIV), a clinical-stage immuno-oncology company specializing in the development of innovative peptide and gene-based immunotherapeutics for the treatment of cancer and metastatic disease, today provided its first quarterly business update, following the company’s uplisting to The NASDAQ Capital Market in the fourth quarter 2016. A public conference call and live audio webcast is scheduled for today at 4:30 pm ET.
“I’m proud to say that the substantive clinical progress we achieved in 2016 has continued into the early part of 2017, and we now have multiple Phase 2 clinical studies either enrolling patients or preparing to commence in our target areas of breast and ovarian cancer,” said Dr. Glynn Wilson, Chairman and CEO of TapImmune. “We are unique among biotech companies of our size to be advancing such a deep mid-stage pipeline in collaboration with top-tier industry and clinical leaders. We believe this is a testament to the strength of our next generation T-cell cancer vaccine technology and the significant potential value of our lead clinical stage vaccine candidates. We expect continued clinical progress to be the primary value driver for TapImmune and we look forward to reaching several upcoming catalysts as our current and planned studies advance.”
Dr. Wilson continued, “In parallel, we’ve enhanced our efforts to position the company for significant near term growth. We successfully scaled our manufacturing and developed final drug formulations as we advance our pipeline and look toward potential commercialization of our vaccines. We also optimized our capital structure and balance sheet by eliminating $29 million in derivative liability through the exercise and restructuring of our outstanding warrants, raising $9 million through this and other equity financings. We did this to enable our successful late-2016 up-listing of TapImmune stock to The NASDAQ Capital Market, which provides a pathway toward increased stock liquidity and access to long-term institutional investors. With this enhanced infrastructure, our goal is to continue along this strong trajectory and build shareholder value through execution on our clinical and strategic initiatives.”
Conference Call and Webcast Information:
The company will host a conference call and live audio webcast on Tuesday, March 14, 2017, at 4:30 p.m. ET. Interested participants and investors may access the conference call by dialing either:
An audio webcast will be accessible via the New and Events section of the TapImmune website https://markertherapeutics.com/events/. An archive of the webcast and presentation will remain available for 90 days beginning at approximately 6:30 p.m. ET, on March 14, 2017.
Pipeline Update:
TPIV 200: Lead T-Cell vaccine targeting folate receptor alpha
TPIV 110: T-Cell vaccine targeting HER2/neu
PolyStart™ protein expression platform
Financial Highlights:
At the time of uplisting to The Nasdaq Capital Markets TapImmune raised $9 million, which gives the company sufficient cash to execute its programs this year.
JACKSONVILLE, FLORIDA – March 8, 2017 – TapImmune, Inc. (NASDAQ: TPIV), a clinical-stage immuno-oncology company specializing in the development of innovative peptide and gene-based immunotherapeutics for the treatment of cancer and metastatic disease, today announced that the Company will host a conference call and live audio webcast on Tuesday, March 14, 2017, at 4:30 p.m. ET, to provide a corporate and clinical update for the fourth quarter and year end 2016.
Reserve Your Seat: Register Today
The event will be webcast live via the Internet on:
March 14, 2017
4:30 PM ET
Click here to register today, or visit https://markertherapeutics.com/register/.
Day-of Call-in Information:
To access the live conference call on March 14, 2017, at 4:30pm ET you may use:
To access the live audio webcast, visit the Events section of the TapImmune website https://markertherapeutics.com/events/. The webcast will also be archived for 90 days beginning at approximately 6:30 p.m. ET, on March 14, 2017.
JACKSONVILLE, FLORIDA – February 15, 2017 – TapImmune, Inc. (NASDAQ: TPIV), a clinical-stage immuno-oncology company specializing in the development of innovative peptide and gene-based immunotherapeutics for the treatment of cancer and metastatic disease, today announced its lead cancer vaccine candidate, TPIV 200, received a positive recommendation from an independent Data Safety Monitoring Board (DSMB) to continue dosing triple-negative breast cancer (TNBC) patients in an ongoing Phase 2 clinical trial.
The planned safety review was performed when enrollment had reached 25 percent benchmark (20/80 patients). The four-arm trial is designed to test the safety, dosing level and optimal treatment regimen of TPIV 200, the company’s novel five-peptide vaccine designed to elicit a long-lasting adaptive immune response against TNBC cells, involving both “helper” and “killer” T-cells. The study tests two vaccine dose levels with and without cyclophosphamide priming of the immune system and will monitor for sustained immune response and relapse-free survival for three years. TapImmune will be enrolling the remaining patients at 12 clinical centers in the U.S. with enrollment completion targeted for the end of 2017.
“Successful completion of this safety review represents yet another clinical milestone achieved for TPIV 200,” said Dr. Glynn Wilson, chairman and CEO of TapImmune. “This is now our second TPIV 200 clinical study to complete a successful interim safety review allowing the continuation of recruitment according to the protocol. Our Phase 2 clinical trial in platinum-resistant ovarian cancer at Memorial Sloan Kettering Cancer Center, in combination with Astra-Zeneca’s durvalumab, had previously passed its initial safety review and this study has now recruited over 50 percent of total patients. We have two additional Phase 2 trials now enrolling or about to enroll ovarian and triple-negative breast cancer patients, and continue to believe TPIV 200 will have a significant impact in the cancer immunotherapy space. We look forward to bringing this product to these ovarian and breast cancer patients in need of advanced therapy in the most expeditious manner possible.”