Roswell Park, Generate Biomedicines Launch Exclusive Clinical Trial of ‘Armored’ CAR T Therapy for Ovarian Cancer

Engineered with AI to optimize T-cell function in solid tumors, GB-5267 is the first next-generation cell therapy for ovarian cancer to enter clinical trials

First patient treated in new clinical trial underway at Roswell Park

Treatment is designed to avoid pre-infusion chemotherapy and its side effects

GB-5267 targets MUC16, a biomarker over-expressed in +80% of ovarian tumors

BUFFALO, N.Y. and SOMERVILLE, Mass., Oct. 01, 2026 (GLOBE NEWSWIRE) -- Roswell Park Comprehensive Cancer Center (“Roswell Park”) and Generate Biomedicines, Inc. (“Generate”) today announced that the first patient has been dosed in a first-in-human clinical trial evaluating GB-5267, an investigational, autologous IL-18 armored CAR T-cell therapy designed to overcome key barriers that have limited the success of cellular therapies in ovarian cancer and other solid tumors. GB-5267 targets the antigen MUC16, which is over-expressed by more than 80% of ovarian tumors and helps them grow, spread, and hide from the immune system. The trial is recruiting patients whose disease has returned after treatment or does not respond to platinum-based chemotherapy, the standard first-line treatment.

Led by Principal Investigator Emese Zsiros, MD, PhD, FACOG, Chair of Gynecologic Oncology at Roswell Park, the phase 1 clinical trial (NCT07489287) will evaluate the safety and tolerability of GB-5267.

Each patient’s T cells, immune cells capable of killing cancer cells, will be collected, genetically engineered, and expanded in Roswell Park’s GMP Engineering & Cell Manufacturing Facility before being returned to the patient to target an attack against the tumor.

While T-cell therapies have revolutionized the treatment of blood cancers, leading to long-term remission or even cure for many patients, solid tumors — cancers that grow in organs or tissue — have posed more of a challenge. That’s because the tumor’s microenvironment, a protective cocoon that surrounds it, prevents immune cells from entering the tumor or even being able to recognize it. But investigators believe they have found a way around that roadblock.

“We’re armoring the T cells with IL-18, a cytokine that will help protect them from the suppressive microenvironment of the solid tumor,” explains Marco Davila, MD, PhD, Senior Vice President and Associate Director for Translational Research at Roswell Park. Dr. Davila co-developed some of the first CAR T-cell therapies and has played a key role in refining them.

“Because ovarian cancer spreads through the peritoneal cavity, the CAR T-cell therapy will be delivered in two ways: intravenously and into the peritoneal cavity,” adds Dr. Zsiros. “This strategy is designed to concentrate the immune response where it is needed, without the toxicity of high-dose chemotherapy.”

GB-5267 was engineered by Generate with AI through the design and evaluation of CAR architectures at scale based on how T cells actually behave, rather than relying on binding affinity as a proxy for performance. GB-5267 was designed to optimize three interdependent functions required for CAR T-cell performance in solid tumors:

• Potency, the ability to kill MUC16-expressing tumor cells
• Proliferation, the ability to expand into a larger T-cell population
• Persistence, the ability to remain active over time in a suppressive tumor microenvironment
  

“Recognizing a tumor antigen is only one part of the challenge. In solid tumors, a CAR T cell that kills but does not expand or persist is a partial solution. GB-5267 was computationally designed with potency, proliferation, and persistence to maintain activity in a suppressive tumor microenvironment. Dosing the first patient begins the clinical test of whether that function-first approach behaves in patients as intended,” says Dinesh de Alwis, PhD, Senior Vice President and Head of Clinical Drug Development at Generate Biomedicines.

Unlike many CAR T-cell approaches, this study will not require lymphodepletion, which uses chemotherapy to reduce the patient’s original immune cells to provide more space for the new cells. That means patients will not be exposed to the side effects associated with chemotherapy.

Typically, ovarian cancer is treated with surgery followed by platinum-based chemotherapy. When the disease recurs, it often no longer responds to chemotherapy, at which point it is very difficult to treat, with few options. The five-year relative survival rate for the disease is only 51.6%.

“CAR T-cell therapy has transformed outcomes in blood cancers,” says Dr. Zsiros. “With this clinical trial, we are working to bring that progress to people with ovarian cancer.”

Research leading to this clinical trial was made possible in part by donations to the Roswell Park Alliance Foundation’s Igniting Cancer Breakthroughs campaign and through events like Ride for Roswell.

For information about this ongoing and currently enrolling Phase 1 study or other clinical trials at Roswell Park, please call 1-800-ROSWELL (1-800-767-9355) or email ASKRoswell@RoswellPark.org.

About Roswell Park
From the world’s first chemotherapy research to the PSA prostate cancer biomarker, Roswell Park Comprehensive Cancer Center generates innovations that shape how cancer is detected, treated and prevented worldwide. The Roswell Park team of 4,000+ makes compassionate, patient-centered cancer care and services accessible across New York State and beyond. Rated “Exceptional” by the National Cancer Institute, Roswell Park, founded in 1898, was one of the first NCI-designated comprehensive cancer centers in the country and remains the only one in Upstate New York. To learn more about Roswell Park Comprehensive Cancer Center and the Roswell Park Care Network, visit www.roswellpark.org, call 1-800-ROSWELL (1-800-767-9355) or email ASKRoswell@RoswellPark.org.
About GB-5267
GB-5267 is an investigational, autologous IL-18-armored CAR T-cell therapy engineered by Generate with AI for the treatment of solid tumors, initially focused on platinum-resistant ovarian cancer. The program applies a function-first design approach intended to optimize potency, proliferation, and persistence, three CAR T-cell behaviors relevant to activity in solid tumors. GB-5267 is being evaluated in a first-in-human phase 1 clinical trial (NCT07489287) led by Roswell Park Comprehensive Cancer Center.

About Generate Biomedicines Inc.
Generate (NASDAQ: GENB) is a clinical-stage generative biology company founded at the intersection of machine learning, biological engineering, and medicine, advancing a new era of programmable biology to engineer better drug candidates for patients, faster. The Generate Platform integrates computational design with large-scale biological experimentation, enabling the creation of novel, optimized therapeutics that address historically undruggable and hard-to-drug targets, as well as known targets in new and more effective ways. The platform has enabled the generation of a broad pipeline across multiple therapeutic areas and protein-based modalities, addressing health challenges out of reach of traditional approaches. Founded in 2018, Generate is leading a fundamental shift from drug discovery to drug generation. Learn more at www.generatebiomedicines.com or follow us on X, LinkedIn, and YouTube.

Cautionary Note Regarding Forward-Looking Statements
This news release contains “forward-looking statements” within the meaning of the Private Securities Litigation Reform Act of 1995. All statements contained in this news release that do not relate to matters of historical fact should be considered forward-looking statements, including, without limitation, statements regarding Generate’s expectations relating to the advancement of GB-5267; the initiation, design, conduct, timing, progress, and results of its Phase 1 clinical trial; the potential safety, tolerability, and therapeutic benefits of GB-5267; and the expected benefits and potential of The Generate Platform. In some cases, forward-looking statements can be identified by terms such as “may,” “will,” “should,” “would,” “expect,” “plan,” “anticipate,” “could,” “intend,” “target,” “project,” “believe,” “estimate,” “predict,” “potential,” or “continue,” or the negative of these terms or other similar expressions.

These forward-looking statements are based on management’s current expectations and beliefs and are subject to a number of risks, uncertainties, and assumptions that could cause actual results to differ materially from those described in the forward-looking statements, including, but not limited to, risks and uncertainties related to Generate’s ability to successfully develop and obtain regulatory approval for its drug candidates; the initiation, design, progress, timing, and results of preclinical studies and clinical trials; Generate’s ability to obtain, maintain, and enforce intellectual property protection; Generate’s dependence on third parties for the manufacture and development of its drug candidates; the impact of competitive products and technologies; Generate’s ability to replicate results from earlier preclinical studies or clinical trials in current or future clinical trials; Generate’s ability to demonstrate that its drug candidates are safe and effective for their proposed indications; Generate’s ability to obtain additional capital to fund its operations; and general economic, industry, and market conditions.

Additional information on these and other risks and uncertainties that could affect Generate’s business, financial condition, and results of operations is included in Generate’s filings with the Securities and Exchange Commission, including its Quarterly Reports. The forward-looking statements in this news release are made as of the date hereof, and Generate undertakes no obligation to update any forward-looking statements to reflect events or circumstances after the date of this news release, except as required by applicable law.

Roswell Park Media Contact
Jane Rose
Jane.rose@roswellpark.org
716-845-4919

Generate Media Contact
Megan McLaughlin
pr@generatebiomedicines.com