On March 17, 2022 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, reported financial results for the fiscal year ended December 31, 2021 (Press release, Marker Therapeutics, MAR 17, 2022, View Source [SID1234610338]).

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"In 2021, we completed enrollment of the first 20 patients in our Phase 2 AML trial investigating our lead product candidate, MT-401," said Peter L. Hoang, Marker’s President and Chief Executive Officer. "We also developed a new nine-day manufacturing process which increased the potency and antigen specificity and diversity of our products and significantly reduced the time it takes to manufacture our patient-specific T cell therapies. In February 2022, we reported initial results from the six-patient safety lead-in phase of the Phase 2 AML trial, which demonstrated that MT-401 was well-tolerated and satisfied the safety requirements with FDA. We expect to report topline data from the active disease group in the main phase of the Phase 2 trial next quarter. In addition, we look forward to expanding our pipeline beyond AML and expect to file INDs for lymphoma and pancreatic cancer by the end of the year."

PROGRAM UPDATES AND EXPECTED MILESTONES

Acute Myeloid Leukemia (AML)

MT-401

In February 2022, Marker announced the initial results of the safety lead-in stage of its Company-sponsored Phase 2 AML trial evaluating MT-401, Marker’s lead MultiTAA-specific T cell product candidate. Results from the safety lead-in demonstrate that MT-401 was well-tolerated, eliminated measurable residual disease (MRD) in one MRD positive patient and induced epitope spreading across multiple AML-associated antigens in that patient.
The safety lead-in satisfied safety requirements with the FDA and the main Phase 2 stage of the AML trial began enrolling in July 2021.
Enrollment of the first 20 patients of the Phase 2 AML trial was completed in Q4 2021.
Topline readout of Group 2 active disease is anticipated in Q2 2022.
Off-the-Shelf (MT-401-OTS)

Marker announced in February 2022 that it intends to expand its AML program with the development of MT-401-OTS, a scalable, off-the-shelf product candidate with the potential to match patients to treatment in under three days. Marker’s open Investigational New Drug application (IND) for MT-401 for the treatment of AML includes approval of an off-the-shelf program. The Company is in the process of developing a patient cell bank inventory and expects to dose the first patient with MT-401-OTS in 2023.
Additional Clinical Programs (MT-601)

Marker recently announced that the Company intends to file INDs for MT-601, Marker’s second MultiTAA-specific T cell product candidate, in lymphoma and pancreatic cancer in 2022. The Company expects to initiate these trials in 2023.
In January 2022, Marker announced that the U.S. Food and Drug Administration granted Orphan Drug designation to MT-601 for the treatment of pancreatic cancer.
BUSINESS UPDATES

On December 9, 2021, Marker announced the appointment of Katharine Knobil, M.D., to the Company’s Board of Directors.
Marker began manufacturing MT-401 for its Phase 2 AML trial at the Company’s cGMP manufacturing facility in the fourth quarter of 2021.
The Company developed and is implementing a new nine-day MultiTAA-specific T cell manufacturing process for its current Company-sponsored Phase 2 AML trial as well as future clinical trials using a patient-specific manufacturing approach. The new T cell manufacturing process is designed to improve potency, increase antigen specificity and diversity and significantly reduce manufacturing time.
FISCAL YEAR 2021 FINANCIAL RESULTS

Cash Position and Guidance: At December 31, 2021, Marker had cash, cash equivalents and restricted cash of $43.5 million. The Company believes that its existing cash, cash equivalents and restricted cash will fund its operating expenses and capital expenditure requirements into the first quarter of 2023.

R&D Expenses: Research and development expenses were $27.8 million for the year ended December 31, 2021, compared to $18.9 million for the year ended December 31, 2020.

G&A Expenses: General and administrative expenses were $12.9 million for the year ended December 31, 2021, compared to $10.5 million for the year ended December 31, 2020.

Net Loss: Marker reported a net loss of $41.9 million for the year ended December 31, 2021, compared to a net loss of $28.7 million for the year ended December 31, 2020.