Marker Therapeutics collaborates with Cellipont for MT-601 manufacturing, enhancing clinical supply for lymphoma therapy trials.
Quiver AI Summary
Marker Therapeutics, Inc. has announced a collaboration with Cellipont Bioservices to support the cGMP manufacturing of MT-601, its lead Multi-Antigen Recognizing (MAR)-T cell therapy, currently in Phase 1 trials for lymphoma patients. The collaboration aims to enhance clinical supply and prepare for a pivotal trial, following promising early results from the ongoing APOLLO study where 78% of participants showed objective responses. Cellipont will provide technology transfer and manufacturing services to ensure the scale-up of MT-601, positioning both companies to advance towards commercial readiness. This partnership is intended to address significant unmet needs in lymphoma treatment and reflects each company’s commitment to advancing next-generation immunotherapies.
Potential Positives
- Marker Therapeutics announced a significant collaboration with Cellipont Bioservices for cGMP manufacturing of their lead therapy, MT-601, which is crucial for scaling up production for clinical trials.
- The partnership aims to accelerate the clinical supply and prepare for a potential pivotal trial, highlighting Marker Therapeutics' commitment to addressing unmet needs in the treatment of lymphoma.
- Favorable clinical data from the ongoing APOLLO study, with a reported 78% objective response rate, supports the potential of MT-601, enhancing investor and stakeholder confidence in the therapy's efficacy.
Potential Negatives
- The press release primarily focuses on a collaboration with Cellipont Bioservices, which may imply a reliance on external partners for critical manufacturing capabilities, potentially raising concerns about the company's independence and operational control.
- The mention of forward-looking statements emphasizes uncertainty regarding the efficacy and outcomes of clinical trials, suggesting that there may be significant risks associated with the development and commercialization of their therapies.
- While the clinical data reported is favorable, it is based on a small sample size (7 out of 9 participants), which may not be robust enough to ensure confidence in the broader efficacy and safety of MT-601.
FAQ
What is the purpose of Marker Therapeutics' collaboration with Cellipont Bioservices?
The collaboration aims to enhance the cGMP manufacturing of MT-601, Marker’s lead MAR-T cell therapy, for clinical trials.
What is MT-601 being investigated for?
MT-601 is being investigated in the Phase 1 APOLLO study for patients with lymphoma who relapsed after CAR-T therapy.
What were the results of the MT-601 study?
Preliminary results showed a favorable safety profile with 78% objective responses, including a 44.4% complete response rate.
What facilities does Cellipont Bioservices provide?
Cellipont offers a state-of-the-art facility with modular cleanrooms and integrated QC labs for high-quality cell therapy production.
How does Marker Therapeutics plan to improve patient outcomes?
Marker Therapeutics focuses on developing novel T cell therapies while preserving financial resources and ensuring operational excellence.
Disclaimer: This is an AI-generated summary of a press release distributed by GlobeNewswire. The model used to summarize this release may make mistakes. See the full release here.
$MRKR Insider Trading Activity
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Full Release
HOUSTON, June 17, 2025 (GLOBE NEWSWIRE) -- 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, today announced 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.
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.”
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.
To receive future press releases via email, please visit: https://www.markertherapeutics.com/email-alerts .
About Cellipont Bioservices
Cellipont Bioservices is a premier Contract Development and Manufacturing Organization (CDMO) specializing in the advancement of cell therapies. With a team of industry-leading experts, Cellipont is at the forefront of cell therapy development and manufacturing, offering comprehensive solutions from process development, analytical services, to large-scale commercial manufacturing. Our purpose-built facility, combined with our cutting-edge technology and commitment to quality enable us to support our clients in delivering life-changing cell therapies to patients worldwide. Cellipont Bioservices is dedicated to excellence in all aspects of our operations, ensuring that we not only meet but exceed the expectations of our clients and the communities we serve. To learn more, visit
www.cellipont.com
and follow us on
LinkedIn
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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- antigen recognizing T cell therapies; the manufacturing capabilities of our CDMO partners; 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 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.
Marker Therapeutics
Investor and Media Contact
Marker Therapeutics, Inc.
+1 (713) 400-6400
[email protected]
Cellipont Bioservices
Media Contact
Edwin Beale
CCO
[email protected]
