On March 9, 2021 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 a corporate update and reported financial results for the fiscal year ended December 31, 2020 (Press release, Marker Therapeutics, MAR 9, 2021, View Source [SID1234576352]).
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"We are proud of our Company’s continued progress, which has positioned us for a busy and productive year ahead," said Peter L. Hoang, President & CEO of Marker Therapeutics. "Recently, we dosed the first patient in the safety lead-in portion of our Phase 2 trial in post-transplant acute myeloid leukemia (AML). In the fourth quarter, we completed construction of a new in-house cGMP manufacturing facility in Houston, which we anticipate will be fully operational in the first half of this year. We also continue to optimize the MT-401 cell therapy manufacturing process, which we believe could result in an increase in the number of T cells available for patient administration, superior T cell phenotype and antigen specificity, and the potential for improved patient outcomes."
RECENT PROGRAM UPDATES
MT-401: Multi-Antigen Targeted (MultiTAA)-Specific T Cell Product Candidate for AML
Phase 2 AML Trial
In March 2021, Marker dosed the first patient in the safety lead-in portion of its Phase 2 trial in AML. The safety lead-in is expected to enroll a total of six patients: three of which will be treated with MT-401 manufactured with a legacy reagent, and the remaining three to be treated with MT-401 manufactured with a new reagent from an alternate supplier.
To date, Marker has activated seven clinical sites and is in the start-up phase with additional clinical sites to enroll patients for the safety lead-in portion of the AML trial. The Company has also received commitments from additional clinical sites to participate in the Phase 2 AML trial following the safety lead-in phase and anticipates activating a total of approximately 20 sites.
Manufacturing and Process Improvements
Marker continues to streamline and simplify the MT-401 manufacturing process. The technical improvements include a 50% reduction in manufacturing time, a 90%+ reduction in the number of required operator interventions, and significant improvement in the consistency and reproducibility of the manufacturing process, while yielding a significant increase in the number of T cells available for patient administration. The Company believes the new process could yield a measurably improved product, with superior T cell phenotype and antigen specificity as compared to the original process. The new process improvements have been updated in the CMC section of the IND and will be used for all patients in the Marker AML Phase 2 clinical trial.
BUSINESS UPDATES
The Company completed the construction and qualification of its cGMP manufacturing facility in Houston, TX, located near the George Bush Intercontinental Airport. The facility will allow production of MultiTAA-specific T cell products according to U.S. FDA guidelines and is designed to be scalable using modular processes. The facility will be used to support the manufacture of study drug for Marker’s Phase 2 AML trial (MT-401) and for future hematological and solid tumor trials, in addition to the potential commercialization of any approved products. The Company has initiated the technology transfer process and expects the facility to be fully operational in the first half of 2021.
FISCAL YEAR 2020 FINANCIAL RESULTS
Cash Position and Guidance: At December 31, 2020, Marker had cash and cash equivalents of $21.4 million. The Company raised $6.2 million through the previously executed $30 million common stock purchase agreement with Aspire Capital Fund, LLC. The remaining $23.8 million available to Marker from Aspire Capital, along with current cash available, funds operations into Q1 2022.
R&D Expenses: Research and development expenses were $18.9 million for the year ended December 31, 2020, compared to $12.8 million for the year ended December 31, 2019.
G&A Expenses: General and administrative expenses were $10.5 million for the year ended December 31, 2020, compared to $10.0 million for the year ended December 31, 2019.
Net Loss: Marker reported a net loss of $28.7 million for the year ended December 31, 2020, compared to a net loss of $21.4 million for the year ended December 31, 2019.