On November 14, 2024 Marker Therapeutics, Inc. (Nasdaq: MRKR), a clinical-stage immuno-oncology company focusing on developing next-generation T cell-based immunotherapies for the treatment of hematological malignancies and solid tumors, reported corporate updates and financial results for the third quarter ended September 30, 2024 (Press release, Marker Therapeutics, NOV 14, 2024, View Source [SID1234648404]).

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"As we approach the end of 2024, we continue to build momentum across our clinical and corporate programs," said Juan Vera, M.D., President and Chief Executive Officer of Marker Therapeutics. "During the third quarter, we made significant progress in our ongoing Phase 1 APOLLO study investigating MT-601 in patients with lymphoma who have relapsed after anti-CD19 chimeric antigen receptor (CAR)-T cell therapy or where CAR-T cells are not an option. Enrollment is ongoing and we expect to be able to report preliminary safety and efficacy data by the end of this year. We, along with our study investigators, have been encouraged by the promising activity shown in this platform and look forward to continuing assessments from the trial."

"We also recently strengthened our financial position with the receipt of two, $2 million Small Business Innovation Research (SBIR) grants from the National Institutes of Health (NIH). The non-dilutive funding will be used to support further development of MT-601 in patients with non-Hodgkin’s lymphoma who have relapsed following anti-CD19 CAR-T cell therapy, as well as assist in funding the clinical investigation of MT-601 in pancreatic cancer. We continue to make meaningful progress and remain focused on execution as we move our programs through the clinical trials," added Dr. Vera.

PROGRAM UPDATES & EXPECTED MILESTONES

MT-601 (Lymphoma)

- Marker’s lead program is investigating MT-601 in the nationwide multicenter Phase 1 APOLLO study (clinicaltrials.gov identifier: NCT05798897) in patients with lymphoma who have relapsed after anti-CD19 CAR-T cell therapy or where CAR-T cells are not an option.

- The Company previously reported that one of the Principal Investigators presented preliminary safety and efficacy with sustained objective responses observed in three study participants treated at City of Hope National Medical Center (Press Release, April 8, 2024). Treatment was well tolerated among all study participants with no observation of severe adverse effects such as immune effector cell associated neurotoxicity syndrome (ICANS).

- All study participants continue to be observed for long-term treatment effects and durability of response.

- The Company is enrolling additional study participants in the Phase 1 APOLLO trial and expects to provide an update on safety and durability during the fourth quarter of 2024.

- Marker Therapeutics was awarded a $2 million grant from NIH Small Business Innovation Research Program (SBIR) to support the clinical investigation of MT-601 in patients with lymphoma who have relapsed following anti-CD19 CAR-T cell therapy (Press Release, August 12, 2024).

MT-601 (Pancreatic)

- The Company was awarded a $2 million grant from NIH Small Business Innovation Research (SBIR) Program to support the clinical investigation of MT-601 in patients with metastatic pancreatic cancer.

- The Company expects to start the clinical program of MT-601 in patients with metastatic pancreatic cancer in 2025.

MT-401-OTS (Acute Myeloid Leukemia or Myelodysplastic Syndrome)

- The Company previously secured non-dilutive funding to support the clinical investigation of MT-401-OTS in patients with Acute Myeloid Leukemia (AML) or Myelodysplastic Syndrome (MDS) and anticipates clinical program initiation during the first half of 2025.

THIRD QUARTER 2024 FINANCIAL HIGHLIGHTS

Cash Position and Guidance: At September 30, 2024, Marker had cash and cash equivalents of $9 million. The Company believes that its existing cash and cash equivalents will fund its operating expenses into October 2025. This estimate is subject to the Company’s ability to effectively manage its costs and utilize drawdowns of available grant funds.

R&D Expenses: Research and development expenses were $3.5 million for the quarter ended September 30, 2024, compared to $2.0 million for the quarter ended September 30, 2023 as a result of our increased clinical trial activity in the quarter.

G&A Expenses: General and administrative expenses were $0.9 million for the quarter ended September 30, 2024, compared to $1.4 million for the quarter ended September 30, 2023 reflecting the savings from the reorganization that was completed in late 2023.

Net Loss: Marker reported a net loss from continuing operations of $2.3 million for the quarter ended September 30, 2024, compared to $3.0 million for the quarter ended September 30, 2023.

About multiTAA-specific T cells

The multi-tumor associated antigen (multiTAA)-specific T cell platform is a novel, non-genetically modified cell therapy approach that selectively expands tumor-specific T cells from a patient’s/donor’s blood capable of recognizing a broad range of tumor antigens. Unlike other T cell therapies, multiTAA-specific T cells allow the recognition of hundreds of different epitopes within up to six tumor-specific antigens, thereby reducing the possibility of tumor escape. Since multiTAA-specific T cells are not genetically engineered, Marker believes that its product candidates will be easier and less expensive to manufacture, with an improved safety profile, compared to current engineered T cell approaches, and may provide patients with meaningful clinical benefits.