Marker Therapeutics, Inc.

Marker Therapeutics

A Major Leap Forward in Cell Therapy

We are a clinical-stage immuno-oncology company specializing in the development and commercialization of novel T cell-based immunotherapies and innovative peptide-based vaccines for the treatment of hematological malignancies and solid tumor indications. We developed our lead product candidates from our MultiTAA T cell technology, which is based on the selective expansion of non-engineered, tumor-specific T cells that recognize tumor-associated antigens, or TAAs, which are tumor targets, and then kill tumor cells expressing those targets. These T cells are designed to recognize multiple tumor targets to produce broad-spectrum anti-tumor activity. We are advancing two MultiTAA T cell pipelines: our autologous T cells for the treatment of lymphoma, multiple myeloma and selected solid tumors and our allogeneic T cells for the treatment of acute myeloid leukemia, or AML, and acute lymphoblastic leukemia, or ALL. Because we do not genetically engineer our MultiTAA therapies, we believe that our product candidates are easier and less expensive to manufacture, with reduced toxicities, than current engineered CAR-T and T cell receptor-based therapies, and may provide patients with meaningful clinical benefit. We are also developing innovative peptide-based immunotherapeutic vaccines for the treatment of metastatic solid tumors, as well as PolyStart™, a proprietary nucleic acid-based antigen expression technology designed to improve the ability of the immune system to recognize and destroy diseased cells.

We are pursuing post-transplant AML as the lead indication for our MultiTAA program. Our MultiTAA therapy was well tolerated in our recent Phase 1 clinical trial, with no drug-related serious adverse events. Eleven of the thirteen patients in the adjuvant disease setting dosed with our MultiTAA therapy after receiving an allogeneic stem cell transplant survived, ranging from 6 weeks to 2.5 years post-infusion as of March 2019, with nine of these patients in continuous complete remission. As of March 2019, the survival of the six patients with active disease ranged from 4 to 21 months, as compared to a historical survival rate of 4 months for patients who receive the standard of care post-transplant. We intend to submit an investigational new drug application to the United States Food and Drug Administration in the third quarter of 2019 to initiate a Phase 2 clinical trial in post-allogeneic hematopoietic stem cell transplant patients with AML in both the adjuvant and active disease setting.

We are also evaluating our MultiTAA therapy in a Phase 2 clinical trial for the treatment of breast cancer and in Phase 1 clinical trials for the treatment of ALL, lymphoma, multiple myeloma, pancreatic cancer, and sarcoma. As of March 2019, our MultiTAA therapy has been well tolerated in all clinical trials in hematological and solid tumor indications with no drug-related serious adverse events, including cytokine release syndrome or neurotoxicity. In our clinical trials in lymphoma, ALL and multiple myeloma, we observed that our MultiTAA therapies have shown the potential to mediate a meaningful anti-tumor effect, as well as significant in vivo expansion of T cells. We may initiate additional Phase 2 clinical trials in other indications in 2019 in addition to our planned Phase 2 trial in post-transplant AML patients. We plan to report additional interim data from an ongoing Phase 1/2 clinical trial in pancreatic cancer in the third quarter of 2019.

In addition to our MultiTAA therapies, we are developing peptide-based immunotherapeutic vaccines that are designed to precisely target breast and ovarian cancer cells, in contrast to standard therapies for the treatment of cancer that target both cancer cells and normal cells. We are currently evaluating TPIV100/110 for the treatment of breast cancers that overexpress human epidermal growth factor receptor 2 in a Phase 1b clinical trial and TPIV200 for the treatment of breast and ovarian cancers that overexpress folate receptor alpha in multiple Phase 2 clinical trials, including in ovarian cancer, for which we expect to report interim data in the fourth quarter of 2019, and triple negative breast cancer, for which we recently reported that 26 of the 27 patients evaluated for immunogenicity showed significant immune response to treatment as of March 2019. We believe that our peptide vaccines and our PolyStart™ technology, which is currently in preclinical development, can be used as both standalone therapies and as complementary therapies that enhance the efficacy of other immunotherapy approaches.

Future of T Cell Therapy