| Ticker | Status | Jurisdiction | Filing Date | CP Start | CP End | CP Loss | Deadline |
|---|
| Ticker | Case Name | Status | CP Start | CP End | Deadline | Settlement Amt |
|---|
| Ticker | Name | Date | Analyst Firm | Up/Down | Target ($) | Rating Change | Rating Current |
|---|
Preconditioning with lymphodepletion linked to stronger MAR-T cells response and suggests enhanced anti-tumor activity
Highest enrollment since study launch underscores momentum and signals a positive trial trajectory
Clinical data readout from Phase 1 APOLLO study expected later this year
HOUSTON, May 20, 2025 (GLOBE NEWSWIRE) -- 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 tumor indications, today reported scientific evidence from the Phase 1 APOLLO study demonstrating that lymphodepletion improves the expansion and persistence of MAR-T cells.
The Company's Phase 1 APOLLO study is investigating MT-601, a MAR-T cell product, in patients with lymphoma who have relapsed after anti-CD19 chimeric antigen receptor (CAR)-T cell therapy or for whom anti-CD19 CAR-T cell therapy is not an option. In December, the Company provided an update on the progress and clinical observations from the study, with a data cutoff date of September 10, 2024 (Press Release, December 19, 2024). This update included clinical data from 9 patients from 5 clinical sites in the United States. Infusion of MT-601 was well tolerated in all study participants with no dose limiting toxicities (DLTs), including immune-effector cell associated neurotoxicity syndrome (ICANS). Objective responses were achieved in 7 out of 9 patients (78%), with 4 patients demonstrating complete response (CR; 44.4%) as early as 4 weeks after infusion of MT-601.
The Company previously reported that study participants showed early objective responses with and without lymphodepletion. Today, Marker provides data demonstrating preliminary evidence that lymphodepletion supports the expansion and persistence of MT-601 in vivo. Using T Cell Receptor (TCR) sequencing as an immunomonitoring strategy, the Company has evidence suggesting that MT-601 MAR-T cell clones in the drug product expanded and persisted at significantly higher levels in patients receiving lymphodepletion compared to patients who did not undergo the conditioning regimen. Preliminary results from this observation have been posted on the Investor Relations section of the Marker website.
The Company believes that the enhanced in vivo expansion and persistence of MT-601 may positively influence the clinical anti-tumor activity of MT-601 in the ongoing APOLLO study. Similar correlations have been observed when using lymphodepletion with other T cell therapies, including CAR-T and tumor infiltrating lymphocyte (TIL) products. While these prior studies have shown that T cell therapies can be effective with and without lymphodepletion, the use of lymphodepletion was associated with improved clinical outcomes and an enhanced expansion and persistence of T cells (Rosenberg SA, J Natl Cancer Inst, 1994; Ramos CA et al, J Clin Oncol, 2020; Turtle CJ et al, Sci Transl Med, 2016).
Driven by encouraging early clinical data and a shifting competitive landscape, the Company today announced a marked increase in patient enrollment. In the first five months of 2025 alone, the Company enrolled and successfully manufactured product for more patients than in the entire year of 2024. This upward trend reflects growing momentum and is expected to meaningfully expand the magnitude of the clinical data set, which the Company plans to present later this year.
Posted In: MRKR
