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Marker Therapeutics notes expanded CDMO after Kincellis formation

September 22, 2026 8:03 AM

Marker Therapeutics, Inc. (NASDAQ: MRKR) highlighted the expanded manufacturing capabilities supporting its lead program, MT-601 (neldaleucel), following the combination of its existing manufacturing partner, Cellipont Bioservices, with Kincell Bio to form Kincellis Advanced Therapies.

Kincellis was formed on Sept. 17, 2026, creating a U.S.-based contract development and manufacturing organization with approximately 140,000 square feet of development and manufacturing infrastructure and 16 operational, qualified GMP manufacturing suites across three U.S. locations in Gainesville, Florida; Research Triangle Park, North Carolina; and The Woodlands, Texas.

Marker previously selected Cellipont Bioservices as its manufacturing partner for MT-601 to support continued clinical development and potential pivotal-stage and commercial manufacturing requirements.

"The combination creates a stronger manufacturing partner, and we look forward to continuing our work with the team as MT-601 advances into its next stage of clinical development," said Juan Vera, MD, President and Chief Executive Officer of Marker Therapeutics.

MT-601 is currently being investigated in the Phase 1 APOLLO study (NCT05798897) in patients with lymphoma who have relapsed after anti-CD19 CAR-T cell therapy or are not candidates for it. Marker previously reported a 66% objective response rate among 12 patients with Non-Hodgkin Lymphoma in the dose-escalation portion of the study, with 50% achieving complete remission.

Darren Head, Chief Executive Officer of Kincellis Advanced Therapies, said the combined organization would provide continuity of support while adding broader resources and manufacturing capacity as the MT-601 program advances.

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