On November 10, 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 third quarter ended September 30, 2022 (Press release, Marker Therapeutics, NOV 10, 2022, View Source [SID1234623824]).

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"This quarter we reached a major milestone in treating the first six patients in our Phase 2 AML trial with T cells derived from our new manufacturing process, which are designed for increased potency against tumor antigens," said Peter L. Hoang, Marker’s President and Chief Executive Officer. "We are also pleased to receive a grant from the FDA Orphan Products program to support the Phase 2 treatment arm evaluating MT-401 in patients with minimal residual disease. We believe the MRD-positive patient population represents a significant opportunity for MT-401 as we continue to dose more patients in the trial and measure long-term response."

PROGRAM UPDATES AND EXPECTED MILESTONES

Acute Myeloid Leukemia (MT-401)

In September 2022, Marker announced that it had been awarded a $2 million grant from the U.S. Food and Drug Administration (FDA) Orphan Products Grants program to support the Phase 2 ARTEMIS trial of the company’s lead multi-tumor-associated antigen (MultiTAA) T cell product candidate, MT-401, in patients with post-transplant AML. The FDA grant will support the Company’s treatment arm evaluating MT-401 in patients with post-transplant AML with minimal residual disease. MT-401 was granted Orphan Drug Designation for the treatment of patients with AML following allogeneic stem cell transplant in 2020.
The Company has treated all six patients in Cohorts 4 and 5 using MT-401 manufactured with Marker’s new T cell manufacturing process. The new manufacturing process is designed to produce a more potent product with increased antigen specificity and diversity and a reduction in manufacturing time. To date, all six patients have completed dose-limiting toxicity (DLT) periods with no DLTs reported. The Company expects to announce an efficacy analysis from the six patients in Cohorts 4 and 5 by year-end.
Marker remains on track to dose the first patient in 2023 with MT-401-OTS, a scalable, off-the-shelf product candidate with the potential to match patients to treatment in under three days. The Company is in the process of developing a patient cell bank inventory.
Lymphoma (MT-601)

In August 2022, Marker announced that the U.S. FDA cleared the Company’s Investigational New Drug Application (IND) for a Phase 1 study of MT-601, a multiTAA-specific T cell product targeting six antigens, for the treatment of patients with relapsed/refractory non-Hodgkin lymphoma who have failed or are ineligible to receive anti-CD19 CAR T cell treatment.
The Company expects some sites to open before the end of the year and to enroll the first patient in the Phase 1 trial in Q1 of 2023.
Pancreatic Cancer (MT-601)

The Company intends to initiate a Phase 1 multicenter study of MT-601 administered in combination with front-line chemotherapy to patients with locally advanced unresectable or metastatic pancreatic cancer in 2023.
THIRD QUARTER 2022 FINANCIAL RESULTS

Cash Position and Guidance: At September 30, 2022, Marker had cash and cash equivalents of $18.1 million.
Revenues: For the quarter ended September 30, 2022, Marker recorded $1.0 million of grant income and $2.95 million of related party service revenue.
R&D Expenses: Research and development expenses were $7.3 million for the quarter ended September 30, 2022, compared to $6.8 million for the quarter ended September 30, 2021.
G&A Expenses: General and administrative expenses were $3.7 million for the quarter ended September 30, 2022, compared to $3.2 million for the quarter ended September 30, 2021.
Net Loss: Marker reported a net loss of $6.9 million for the quarter ended September 30, 2022, compared to a net loss of $12.4 million for the quarter ended September 30, 2021.