On September 22, 2026 Marker Therapeutics, Inc. (Nasdaq: MRKR), a clinical-stage immuno-oncology company developing multi-antigen recognizing (MAR)-T cell therapies for the treatment of hematologic malignancies and solid tumors, reported the expanded infrastructure, technical expertise and manufacturing capabilities supporting its lead program, MT-601 (neldaleucel), following the combination of Cellipont Bioservices and Kincell Bio to form Kincellis Advanced Therapies.

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

Kincellis was formed through the combination of Cellipont Bioservices and Kincell Bio, creating a U.S.-based contract development and manufacturing organization (CDMO) focused on cell therapies and other advanced modalities. Announced on September 17, 2026, the combination created a larger advanced-therapies CDMO with approximately 140,000 square feet of development and manufacturing infrastructure and 16 operational, qualified GMP manufacturing suites across three U.S. locations. The combined organization also brings together broader scientific and technical expertise, an expanded manufacturing network and additional financial resources to support programs from clinical development through commercial supply.

Marker believes these expanded capabilities further strengthen and de-risk the manufacturing foundation for MT-601 as the program advances toward later-stage clinical development.

"We congratulate the Cellipont and Kincell teams on the formation of Kincellis Advanced Therapies," said Juan Vera, MD, President and Chief Executive Officer of Marker Therapeutics. "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."

MT-601 (neldaleucel) is currently investigated in the Company’s Phase 1 APOLLO study (clinicaltrials.gov identifier: NCT05798897) in patients with lymphoma who have relapsed after anti-CD19 chimeric antigen receptor (CAR)-T cells or are not candidates for anti-CD19 CAR-T cell therapies. Marker previously reported a favorable safety profile and encouraging clinical activity from the dose-escalation portion of the study demonstrating a 66% objective response rate among 12 patients with Non-Hodgkin Lymphoma (NHL), with 50% achieving complete remission (Press Release, August 26, 2025).

"Establishing a robust and scalable manufacturing platform is an important component of advancing MT-601 through late-stage clinical development," Dr. Vera continued. "Kincellis’ expanded U.S. footprint, advanced cell therapy expertise and capabilities spanning clinical development through potential commercial supply align well with our long-term strategy and the evolving manufacturing needs of the MT-601 program."

"We are proud to continue supporting Marker and the advancement of MT-601," said Darren Head, Chief Executive Officer of Kincellis Advanced Therapies. "Marker will continue to work with the team that understands its program, now supported by the broader expertise, resources and manufacturing network of Kincellis. This combination allows us to provide continuity today while preparing to support Marker’s evolving needs as the program advances."

About Neldaleucel (MT-601)
The Company’s lead product, MT-601, is a multi-antigen recognizing (MAR) T cell product that utilizes a 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 patients with lymphoma who have relapsed after or are not candidates for 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 neldaleucel (MT-601) in participants with relapsed or refractory lymphoma. The primary objective of the exploratory Phase 1 clinical trial is to evaluate the optimum dose, safety, and preliminary efficacy of neldaleucel in participants with various lymphoma subtypes. The APOLLO study is supported by the National Cancer Institute of the National Institutes of Health (Award Number R44CA291521) and the U.S. Department of War (formerly U.S. Department of Defense).

About MAR-T cells
The multi-antigen recognizing (MAR) T cell platform (formerly multiTAA-specific T cells) 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. Unlike other T cell therapies, MAR-T cells allow the recognition of hundreds of different epitopes within up to six tumor-specific antigens, thereby reducing the possibility of tumor escape. Since MAR-T cells are not genetically engineered, Marker believes that its product candidates will be easier and less expensive to manufacture, with an improved safety profile compared to current engineered T cell approaches and may provide patients with meaningful clinical benefits.

(Press release, Marker Therapeutics, SEP 22, 2026, View Source [SID1234671019])