On June 23, 2020 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 that the United States Adopted Names (USAN) Council has approved "zelenoleucel" as the nonproprietary (generic) name for MT-401, a multi-tumor-associated antigen (MultiTAA)-specific T cell product candidate for the treatment of patients with acute myeloid leukemia (AML) following allogeneic stem cell transplant in both adjuvant and active disease settings (Press release, TapImmune, JUN 23, 2020, View Source [SID1234561389]).
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"The USAN approval of zelenoleucel as the generic name for MT-401 is another step forward for continued advancement of our therapy," said Peter L. Hoang, President & CEO of Marker Therapeutics. "MT-401, which received Orphan Drug designation from the U.S. FDA in April, has shown clinical benefit in patients with acute myeloid leukemia post stem cell transplant in an investigator-sponsored trial. We are excited about the continued clinical development of zelenoleucel and look forward to initiating our Company-sponsored Phase 2 study in patients with AML following transplant."
About USAN
The United States Adopted Names (USAN) Council is responsible for selecting simple, informative and unique nonproprietary (generic) drug names. The USAN Council establishes logical nomenclature classifications based on pharmacological and/or chemical relationships. In addition to one member-at-large and a Food and Drug Administration (FDA) liaison, the council consists of one representative from each of the following: The American Medical Association, United States Pharmacopeia (USP) and the American Pharmacists Association.
About MultiTAA-Specific T Cell Therapy
Marker’s Multi-Tumor-Associated Antigen Targeted (MultiTAA) platform is a novel, non-genetically modified cell therapy approach that selectively expands tumor-specific T cells from a patient’s blood capable of recognizing a broad range of tumor antigens. In early clinical trials, the multi-antigen approach has been well-tolerated and shown to enhance tumor destroying capability of T cells. It is one of the first therapies to consistently demonstrate epitope-spreading – inducing the patient’s own T cells to expand, potentially contributing to a lasting anti-tumor effect. Unlike other cell therapies which require pre-conditioning regimens and hospitalization, MultiTAA-specific T cells are designed to be administered in an outpatient setting.