On September 11, 2023 Marker Therapeutics, Inc. (Nasdaq: MRKR) is 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, reported the preliminary results of the first participant treated with MT-601, its multi-tumor associated antigen (multiTAA)-specific T cell product targeting 6 TAAs, in the Phase 1 multicenter APOLLO clinical trial (Press release, Marker Therapeutics, SEP 11, 2023, View Source [SID1234635070]). The APOLLO trial is investigating the safety and efficacy of MT-601 for the treatment of patients with lymphoma who have either failed or are ineligible to receive anti-CD19 CAR T cell therapy.
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This first APOLLO study participant had diffuse large B cell lymphoma (DLBCL) and was enrolled into the Phase 1 dose escalation stage of the trial (Press Release, June 12, 2023) after failing 4 prior lines of therapy, including anti-CD19 CAR T cell therapy.
After relapse following anti-CD19 CAR T cell therapy, the participant was treated with 2 doses of MT-601 at the 200 million cell dose level without prior lymphodepletion. MT-601 treatment was well tolerated with no reports of higher than Grade 1 treatment-related adverse events. The tolerability at this initial dose level is consistent with the favorable clinical safety profile and tolerability previously reported for other multiTAA-specific T cell products. Eight weeks after the 2nd infusion of MT-601, the participant demonstrated complete metabolic response based on PET-CT scans.
Marker previously reported non-clinical proof-of-concept data that showed that MT-601 has the potential to eliminate lymphoma cells that are resistant to anti-CD19 CAR T cells, highlighting the therapeutic potential of MT-601 in vitro (Press Release, May 31, 2023).
"We are delighted to announce that the first study participant treated in the APOLLO trial achieved a complete response after treatment with MT-601," said Monic Stuart, M.D., Chief Medical Officer of Marker Therapeutics. "This is a significant initial step forward in our Phase 1 clinical trial and highlights the potential benefit of MT-601 in patients who have relapsed after anti-CD19 CAR T cell therapy. The patient will remain under close observation as we continue to monitor long-term treatment effects and the durability of response."
"The complete response we have observed in this CAR T relapsed patient with lymphoma marks a remarkable milestone for Marker and our technology," said Juan F. Vera, M.D., President and Chief Executive Officer of Marker Therapeutics. "Our APOLLO trial is an important area for MT-601 assessment, as up to 60% of patients treated with anti-CD19 CAR T therapies relapse within one year. While a complete response in our first patient treated with MT-601 is certainly encouraging, the focus of the APOLLO study is to continue to treat and evaluate additional participants in this Phase 1 study."
About MT-601
MT-601 utilizes a novel non-genetically modified approach that specifically targets six different tumor antigens upregulated in lymphoma cells (Survivin, PRAME, WT-1, NY-ESO-1, SSX-2, MAGEA-4). Marker is currently investigating MT-601 in the Company-sponsored Phase 1 APOLLO trial (clinicaltrials.gov identifier: NCT05798897) for the treatment of lymphoma patients who are relapsed/refractory after or ineligible to anti-CD19 CAR T cell therapies.
About APOLLO
The APOLLO trial (clinicaltrials.gov Identifier: NCT05798897) is a Phase 1, multicenter, open-label study designed to evaluate the safety and efficacy of MT-601 in participants with relapsed or refractory lymphoma who either received anti-CD19 chimeric antigen receptor (CAR) T cell therapy or are ineligible for anti-CD19 CAR T cell therapy. The primary objective of this exploratory Phase 1 clinical trial is to evaluate the optimum dose, safety, and preliminary efficacy of MT-601 in participants with various lymphoma subtypes. Under the APOLLO trial, eight clinical sites across the United States will cumulatively enroll up to approximately 30 participants during the dose escalation phase.
About multiTAA-specific T cells
The multi-tumor associated antigen (multiTAA)-specific T cell platform is a novel, non-genetically modified cell therapy approach that selectively expands tumor-specific T cells from a patient’s/donor’s blood capable of recognizing a broad range of tumor antigens. Clinical trials that enrolled more than 180 patients with various hematological malignancies and solid tumors showed that autologous and allogeneic multiTAA-specific T cell products were well tolerated and demonstrated durable clinical responses, and consistent epitope spreading. The latter is typically not observed with other T cell therapies and enables the potential contribution to a lasting anti-tumor effect.