LEXINGTON, Mass. / Oct 22, 2023 / Business Wire / Agenus Inc. (Nasdaq: AGEN), a leader in developing novel immunological agents to treat cancers, today announced first-time and updated data from its ongoing botensilimab/balstilimab (BOT/BAL) clinical programs in advanced colorectal cancer (CRC), neoadjuvant CRC, pancreatic cancer, non-small cell lung cancer (NSCLC), melanoma, and sarcoma. Members of the Agenus leadership team along with key opinion leaders will discuss these findings during a live webcast at 1:00 p.m. EDT (19:00 CEST) at a corporate event at the European Society for Medical Oncology 2023 Conference.
“These new and updated data underscore BOT’s broad effectiveness across several advanced solid tumors, demonstrating its potential beyond first-generation immunotherapies and current treatments,” said Dr. Steven O’Day, Chief Medical Officer. “BOT’s versatility, alone, in combination with BAL, or in combination with other standard of care therapies, in early and late-stage solid tumors, positions Agenus to transform cancer care, offering immense promise to patients.”
Key highlights across solid tumors include:
Extended Follow-up and Additional Data in Refractory MSS CRC Demonstrate Improved Responses and Durability
In 70 efficacy evaluable patients with MSS CRC and no active liver metastases:
Subsequent data from expanded cohorts and early signals from a 230 patient Phase 2 trial is consistent with the earlier cohort of 70 patients. Based on the totality of the evidence from the Phase 1 and Phase 2 trials, Agenus plans to submit its Biologics License Application (BLA) to the U.S. Food & Drug Administration (FDA) for BOT/BAL in patients with 2/3L+ MSS CRC in midyear 2024. Interactions with U.S. and EU regulatory agencies are ongoing.
Robust Clinical Outcomes in Neoadjuvant MSS CRC Underscore BOT/BAL’s Potential in Earlier-Stage Patients*
Compelling Activity from Dose-escalation Portion of Phase 2 BOT/Chemotherapy Combination in Advanced (2L) Pancreatic Cancer
Monotherapy Activity in CTLA-4 Relapsed/Refractory Advanced (2L+) Melanoma
Compelling Responses in Refractory NSCLC
Broad and Durable Activity in Advanced Sarcomas
Updated data was presented at ESMO 2023 from the Phase 1b study in 41 efficacy evaluable heavily pretreated advanced sarcoma patients, demonstrating durability with extended follow-up and additional activity in difficult-to-treat subtypes such as leiomyosarcoma.
Webcast Details
A live webcast will be held today at 19:00 – 21:00 CEST (1:00 p.m. – 3:00 p.m. EDT). To register for the webcast, please click here.
References:
*Investigator Sponsored Trial
**Investigator reported, subject to change.
About Botensilimab
Botensilimab is an investigational multifunctional anti-CTLA-4 immune activator (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 750 patients have been treated with botensilimab 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 Agenus
Agenus is a leading immuno-oncology company targeting cancer and infectious diseases with a comprehensive pipeline of immunological agents. The company’s mission is 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 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.
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 a 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 2022, 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.
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