On June 17, 2025 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, reported a collaboration with Cellipont Bioservices, a leading cell therapy Contract Development and Manufacturing Organization (CDMO), for current good manufacturing practice (cGMP) manufacturing of MT-601, Marker’s lead Multi-Antigen Recognizing (MAR)-T cell therapy (Press release, Marker Therapeutics, JUN 17, 2025, View Source [SID1234653950]).
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MT-601 is currently being investigated in the Phase 1 APOLLO study in patients with lymphoma who relapsed after anti-CD19 chimeric antigen receptor (CAR)-T cell therapy or for whom anti-CD19 CAR-T cell therapy is not an option (clinicaltrials.gov identifier: NCT05798897). Marker previously reported a favorable safety profile and objective responses in 7 out of 9 study participants (78%), with 4 participants demonstrating complete response (44.4%) as early as 4 weeks after infusion of MT-601 (Press Release, December 19, 2024).
Under the agreement, Cellipont will provide technology transfer and cGMP manufacturing services to support the scale-up and production of MT-601 for Marker’s APOLLO study. The collaboration between Marker and Cellipont is designed to accelerate clinical supply and lay the foundation for a potential pivotal trial and commercial readiness.
"This exciting collaboration with Cellipont is a critical step forward as we prepare for a potential pivotal trial of MT-601 in patients with diffuse large B-cell lymphoma (DLBCL) who have relapsed after or are ineligible for anti-CD19 CAR-T cell therapy", commented Dr. Juan Vera, President and CEO of Marker Therapeutics. "The promising clinical data we have observed in the ongoing APOLLO study reinforce our commitment to advancing MT-601 to address an important area of unmet need. We sought a manufacturing partner with the capabilities to support not only mid-to-late-stage clinical development but also future commercial production, and we believe Cellipont is well positioned to support us as we advance our program through the next stages."
Cellipont provides end-to-end development and manufacturing services for advanced therapies, including CAR-T, and tumor-infiltrating lymphocytes (TILs). Its 76,000-square-foot state-of-the-art facility in The Woodlands, Texas, features modular cleanrooms, integrated QC labs, and advanced closed processing systems designed to accelerate and scale high-quality cell therapy production. With deep scientific expertise and its integrated approach, we believe Cellipont can help advance therapies from early development to commercial readiness.
Darren Head, CEO of Cellipont Bioservices, stated "We are proud to support Marker Therapeutics in advancing MT-601, a compelling MAR-T cell therapy that is anticipated to address a major need in the cell therapy space. Our team is dedicated to enabling the success of next-generation immunotherapies, and Marker’s platform exemplifies the innovation and translational potential that defines the future of cancer treatment. This partnership reflects our shared focus on quality, agility, and impact for patients."