Press Releases

HOUSTON, Sept. 22, 2026 (GLOBE NEWSWIRE) -- 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, today highlighted 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.

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.

About Marker Therapeutics, Inc.
Marker Therapeutics, Inc. is a Houston, TX-based clinical-stage immuno-oncology company specializing in the development of next-generation T cell-based immunotherapies for the treatment of hematological malignancies and solid tumors. The Company was founded at Baylor College of Medicine, and clinical trials that enrolled more than 200 patients across various hematological and solid tumor indications showed that the Company’s autologous and allogeneic MAR-T cell products were well tolerated and demonstrated durable clinical responses. Marker’s goal is to introduce novel T cell therapies to the market and improve patient outcomes. To achieve these objectives, the Company prioritizes the preservation of financial resources and focuses on operational excellence. Marker’s unique T cell platform is strengthened by non-dilutive funding from U.S. state and federal agencies supporting cancer research, including the National Cancer Institute of National Institutes of Health, U.S. Department of War, the FDA Orphan Drug program and the Cancer Prevention Research Institute of Texas (CPRIT).

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About Kincellis Advanced Therapies
Kincellis Advanced Therapies is a U.S.-based contract development and manufacturing organization supporting advanced-therapy developers from early-stage CMC, process and analytical development through clinical supply, pivotal-stage programs and commercial supply. With facilities in Gainesville, Florida; Research Triangle Park, North Carolina; and The Woodlands, Texas, Kincellis combines broad technical expertise with flexible, scalable GMP infrastructure across autologous and allogeneic therapies, including but not limited to CAR-T, Tregs, CAR-NK, MSCs, dendritic cell vaccines, exosomes, iPSCs & synthetic mRNA.

Forward-Looking Statements
This release contains forward-looking statements for purposes of the safe harbor provisions of the Private Securities Litigation Reform Act of 1995. Statements in this news release concerning the Company’s expectations, plans, business outlook or future performance, and any other statements concerning assumptions made or expectations as to any future events, conditions, performance or other matters, are “forward-looking statements.” Forward-looking statements include statements regarding our intentions, beliefs, projections, outlook, analyses or current expectations concerning, among other things: our research, development and regulatory activities and expectations relating to our non-engineered multi-tumor antigen specific T cell therapies; the effectiveness of these programs or the possible range of application and potential curative effects and safety in the treatment of diseases; and the timing, conduct, interim results announcements and outcomes of our clinical trials of our product candidates, including neldaleucel (MT-601) for the treatment of patients with lymphoma. Forward-looking statements are by their nature subject to risks, uncertainties and other factors which could cause actual results to differ materially from those stated in such statements. Such risks, uncertainties and factors include, but are not limited to the risks set forth in the Company’s most recent Form 10-K, 10-Q and other SEC filings which are available through EDGAR at WWW.SEC.GOV. The Company assumes no obligation to update its forward-looking statements whether as a result of new information, future events or otherwise, after the date of this press release except as may be required by law.

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Marker Therapeutics, Inc.
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