Botensilimab/Balstilimab Data in Neoadjuvant Colorectal Cancer Selected for ASCO-GI 2024

Agenus Inc. (“Agenus”) (Nasdaq: AGEN), a leader in discovering and developing novel immunological agents to treat various cancers, today announced that data from an investigator sponsored trial (IST) evaluating botensilimab (BOT, multifunctional CTLA-4 immune activator) in combination with balstilimab (BAL, PD-1 antibody) in neoadjuvant colorectal cancer (CRC) will be presented at the upcoming ASCO-GI Meeting, to be held January 18 – 20, 2024 in San Francisco, CA. The IST is led by Pashtoon Kasi, M.D., who was recruited to Weill Cornell Medicine as an associate professor of medicine and is a member of its Sandra and Edward Meyer Cancer Center. Dr. Kasi is also an oncologist at NewYork Presbyterian/Weill Cornell Medical Center.

Presentation Details:

Abstract Title: Neoadjuvant botensilimab plus balstilimab in resectable mismatch repair proficient and deficient colorectal cancer: NEST-1 clinical trial (NCT05571293)

Abstract Number: 117

Presenting Author: Pashtoon Kasi, M.D., M.S., Director of Colon Cancer Research at Weill Cornell Medicine/NewYork Presbyterian Hospital, and Director of Liquid Biopsy Research, Englander Institute of Precision Medicine, Sarah and Edward Meyer Center

Session: Poster Session C: Cancers of the Colon, Rectum, and Anus

Presentation Date and Time: 1/20/2024, 6:30am – 7:55am EST

Complete abstracts will be released on Tuesday, January 16, 2024 at 5:00pm EST. Data presented at the conference will be available to view in the publications section of the Agenus website (https://agenusbio.com/publications) following the ASCO-GI Meeting.

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 relating to the use of botensilimab and balstilimab, for instance, statements regarding therapeutic benefit and efficacy, mechanism of action (including validation of mechanism of action), potency, durability, and safety profile (including the absence of specific toxicities) of the Company’s therapeutic candidates; 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 Quarterly Report on Form 10-Q or Annual Report on Form 10-K 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.

View source version on businesswire.com: https://www.businesswire.com/news/home/20231220565677/en/