"Data presented at ASCO GI highlight botensilimab and balstilimab’s potential to redefine colorectal cancer treatment, delivering remarkable outcomes in neoadjuvant MSS CRC," said Dr. Steven O’Day, Chief Medical Officer of Agenus. "These findings set the stage for pivotal studies intended to create a new standard of care for colon and rectal cancer patients by reducing reliance on chemotherapy, radiation, and surgery, while improving survival."
Data presented from two independent studies, UNICORN and NEST, collectively include more than 80 patients treated with BOT/BAL:
Dr. Filippo Pietrantonio, Department of Medical Oncology, Fondazione IRCCS Istituto Nazionale dei Tumori Milan comments on the UNICORN study stating, "These results further validate the transformative potential of botensilimab and balstilimab in colorectal cancer. The remarkable pathological response rates observed in both pMMR and dMMR tumors highlight the unique strength of this combination in addressing a critical unmet need and pave the way for non-operative management strategies."
First-Line and FOLFOX Rechallenged MSS CRC: Powerful Combination with Standard Therapies
Refractory MSS CRC: Consistent Results Across Phase 1 and 2 Studies
"The Phase 2 results highlight the unique and consistent activity of the botensilimab and balstilimab combination, demonstrating a compelling objective response rate in microsatellite stable metastatic colorectal cancer, a disease where responses to immunotherapy have historically been absent," said Dr. Marwan Fakih, Department of Medical Oncology and Therapeutics Research, City of Hope Comprehensive Cancer Center. "These findings underscore the potential of botensilimab and balstilimab combination treatment in addressing this critical unmet need, paving the way for further investigation."
Gastric Cancer
Future Development Plans
Agenus has developed registrational enabling trials in MSS CRC across neoadjuvant, first-line, and late-line settings. These trials will launch upon completion of strategic transactions. Upon the options being considered are, partnerships, licensing, or joint ventures. These initiatives aim to accelerate global access to BOT/BOL to deliver transformative patient outcomes and drive substantial value for stakeholders.
Botensilimab, balstilimab, and agenT-797 are investigational agents and are not approved for use as therapies in any jurisdiction worldwide.
For additional data and publications, visit agenusbio.com/publications.
About Agenus
Agenus is a leading immuno-oncology company targeting cancer with a comprehensive pipeline of immunological agents. The company was founded in 1994 with a mission to expand patient populations benefiting from cancer immunotherapy through combination approaches, using a broad repertoire of antibody therapeutics, adoptive cell therapies (through MiNK Therapeutics) and adjuvants (through SaponiQx). Agenus has robust end-to-end development capabilities, across commercial and clinical cGMP manufacturing facilities, research and discovery, and a global clinical operations footprint. Agenus is headquartered in Lexington, MA. For more information, visit www.agenusbio.com or @agenus_bio. Information that may be important to investors will be routinely posted on our website and social media channels.
About Botensilimab (BOT)
Botensilimab (BOT) is a human Fc enhanced CTLA-4 blocking antibody designed to boost both innate and adaptive anti-tumor immune responses. Its novel design leverages mechanisms of action to extend immunotherapy benefits to "cold" tumors which generally respond poorly to standard of care or are refractory to conventional PD-1/CTLA-4 therapies and investigational therapies. Botensilimab augments immune responses across a wide range of tumor types by priming and activating T cells, downregulating intratumoral regulatory T cells, activating myeloid cells and inducing long-term memory responses.
Approximately 1,100 patients have been treated with botensilimab and/or balstilimab in phase 1 and phase 2 clinical trials. Botensilimab alone, or in combination with Agenus’ investigational PD-1 antibody, balstilimab, has shown clinical responses across nine metastatic, late-line cancers. For more information about botensilimab trials, visit www.clinicaltrials.gov with the identifiers NCT03860272, NCT05608044, NCT05630183, and NCT05529316.
About Balstilimab (BAL)
Balstilimab is a novel, fully human monoclonal immunoglobulin G4 (IgG4) designed to block PD-1 (programmed cell death protein 1) from interacting with its ligands PD-L1 and PD-L2. It has been evaluated in >900 patients to date and has demonstrated clinical activity and a favorable tolerability profile in several tumor types.
About AgenT-797
AgenT-797 is an allogeneic invariant natural killer T (iNKT) cell therapy, leveraging a unique innate immune cell type that serves as a master regulator of both innate and adaptive immunity. iNKTs combine the cytotoxic capabilities of natural killer (NK) cells with the adaptive memory of T cells, enabling them to elicit a broad range of immune responses in a pathogen-agnostic manner.
AgenT-797 is a scalable, "off-the-shelf" cell therapy product, manufactured by MiNK Therapeutics in Lexington, MA, to deliver transformative treatment solutions to patients.
Forward-Looking Statements
This press release contains forward-looking statements that are made pursuant to the safe harbor provisions of the federal securities laws, including statements regarding its botensilimab and balstilimab programs, expected regulatory timelines and filings, and any other statements containing the words "may," "believes," "expects," "anticipates," "hopes," "intends," "plans," "forecasts," "estimates," "will," "establish," "potential," "superiority," "best in class," and similar expressions are intended to identify forward-looking statements. These forward-looking statements are subject to risks and uncertainties that could cause actual results to differ materially. These risks and uncertainties include, among others, the factors described under the Risk Factors section of our most recent Annual Report on Form 10-K for 2023, and subsequent Quarterly Reports on Form 10-Q filed with the Securities and Exchange Commission. Agenus cautions investors not to place considerable reliance on the forward-looking statements contained in this release. These statements speak only as of the date of this press release, and Agenus undertakes no obligation to update or revise the statements, other than to the extent required by law. All forward-looking statements are expressly qualified in their entirety by this cautionary statement.
1 Ros J et al. Front Oncol 2023;13:1112276; 2. André T et al. Am Soc Clin Oncol Educ Book 2022;42:1-9;
2 eClinicalMedicine, 2022
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