Agenus to Present New BOT/BAL Data in Two Presentations at AACR 2025

Rhea-AI Summary

Agenus (Nasdaq: AGEN) has announced two upcoming presentations at the American Association for Cancer Research (AACR) Annual Meeting in Chicago (April 25-30, 2025), highlighting their neoadjuvant immunotherapy program with botensilimab and balstilimab (BOT/BAL).

The presentations include:

• An oral presentation of initial results from the NEOASIS trial studying BOT/BAL in MMR proficient and deficient early-stage cancers, presented by Dr. Myriam Chalabi from Netherlands Cancer Institute on April 28, 2025
• A poster presentation featuring new data from the Phase 1 study of BOT/BAL in treatment-refractory hepatocellular carcinoma (HCC), presented by Dr. Anthony El-Khoueiry from USC Norris Comprehensive Cancer Center on April 29, 2025

These presentations build upon previous BOT/BAL data from two independent studies (UNICORN and NEST) in colorectal cancer presented earlier at ASCO-GI.

• First oral presentation of BOT/BAL neoadjuvant results from the NEOASIS trial in MSI-H and MSS solid tumors
• New data from the treatment-refractory hepatocellular carcinoma (HCC) cohort of the BOT/BAL Phase 1 trial to be presented

LEXINGTON, Mass.--(BUSINESS WIRE)-- Agenus Inc. (Nasdaq: AGEN), a leader in immuno-oncology, today announced two upcoming presentations at the American Association for Cancer Research (AACR) Annual Meeting, taking place April 25–30, 2025 in Chicago, Illinois. The presentations continue to build momentum for Agenus’ neoadjuvant immunotherapy program with botensilimab and balstilimab (BOT/BAL), including an oral presentation of the initial results from the NEOASIS trial in solid tumors and a poster featuring new data from the advanced hepatocellular carcinoma (HCC) cohort of a Phase 1 study evaluating BOT/BAL in patients with advanced solid tumors. Data from two separate, independent studies of neoadjuvant treatment with BOT/BAL in colorectal cancer--UNICORN and NEST-- were presented earlier this year at ASCO-GI.

Oral Presentation Details:

Presentation Title: Neoadjuvant botensilimab plus balstilimab in MMR proficient and deficient early-stage cancers: First results of the pan-cancer NEOASIS study (NCT06279130)
Presenting Author: Myriam Chalabi, MD, Netherlands Cancer Institute
Session Title: Aiming for Cure: Adjuvant and Neoadjuvant Approaches
Session Date and Time: 4/28/2025; 2:30:00 - 4:30:00 PM CT
Abstract Presentation Number: CT130

Poster Presentation Details:

Presentation Title: Results from a phase 1 study of botensilimab and balstilimab in treatment refractory hepatocellular carcinoma (NCT03860272)
Presenting Author: Anthony El-Khoueiry, MD, USC Norris Comprehensive Cancer Center
Session Title: Late-Breaking Research: Clinical Research 3
Session Date and Time: 4/29/2025; 2:00 - 5:00 PM CT
Location: Poster Section 53
Poster Board Number: 9
Abstract Presentation Number: LB365

About Botensilimab (BOT)

Botensilimab 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 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 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.

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.

View source version on businesswire.com: https://www.businesswire.com/news/home/20250325174550/en/

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Source: Agenus Inc.

FAQ

What new data will Agenus (AGEN) present at AACR 2025?

Agenus will present initial results from the NEOASIS trial studying BOT/BAL in early-stage cancers and new data from a Phase 1 study in treatment-refractory hepatocellular carcinoma at AACR 2025 in Chicago.

When and where will the NEOASIS trial results for AGEN be presented?

The NEOASIS trial results will be presented orally on April 28, 2025, from 2:30-4:30 PM CT at the AACR Annual Meeting in Chicago.

What types of cancers are being studied in Agenus's NEOASIS trial?

The NEOASIS trial is studying BOT/BAL in MMR proficient and deficient early-stage cancers across multiple tumor types (pan-cancer study).

How does the new AGEN data build on previous BOT/BAL research?

The new presentations build upon previous BOT/BAL data from two independent studies (UNICORN and NEST) in colorectal cancer that were presented earlier at ASCO-GI.

What is the focus of AGEN's Phase 1 hepatocellular carcinoma study?

The Phase 1 study focuses on evaluating BOT/BAL combination therapy in treatment-refractory hepatocellular carcinoma patients.