Agenus Announces Five Presentations at ASCO GI Highlighting BOT/BAL Activity Across Colorectal and Gastric Cancers

Rhea-AI Summary

Agenus (NASDAQ: AGEN) announced five presentations featuring botensilimab (BOT) plus balstilimab (BAL) at the upcoming ASCO GI Symposium (January 23-25, 2025). The presentations will showcase BOT/BAL's activity across three distinct colorectal cancer settings: late-line metastatic, first-line, and neoadjuvant treatment.

The studies demonstrate BOT/BAL's consistent activity in microsatellite stable (MSS) colorectal cancer, which represents over 80% of CRC cases with treatment options, as well as microsatellite instability-high (MSI-H) CRC. An additional presentation will feature BOT/BAL and invariant natural killer T cells (iNKTs) in refractory gastric cancer patients.

Positive

• Multiple clinical trials across different treatment settings showing potential versatility of BOT/BAL therapy
• Targeting MSS colorectal cancer, which represents 80% of CRC cases with treatment options
• Expanding into multiple treatment lines (first-line, late-line, neoadjuvant) potentially broadening market opportunity

Negative

• All data are preliminary or in-progress, with full results pending
• Efficacy and safety data not yet disclosed in the press release

Insights

Medical Research Analyst

Future conference presentations without current data releases are typically considered not impactful for immediate stock movement or investment decisions. However, this case warrants attention due to its comprehensive clinical program scope. The presentations will cover BOT/BAL's performance across multiple treatment settings for colorectal cancer, particularly in MSS CRC which represents over 80% of cases and has treatment options. The breadth of data spanning first-line, late-line metastatic and neoadjuvant settings, along with gastric cancer applications, suggests significant potential market opportunities. While specific data points aren't available until January 21st, 2025, the multiple presentation acceptances at a major oncology conference indicate promising clinical progress.

Market Research Analyst

The strategic positioning of BOT/BAL across multiple treatment lines could significantly expand Agenus's market opportunity in colorectal cancer. With MSS CRC representing the majority of cases and having treatment options, successful trial outcomes could position Agenus to address a substantial unmet medical need. The inclusion of studies in both early-stage (neoadjuvant) and late-stage settings suggests a comprehensive commercialization strategy. However, without actual data being presented yet, investors should maintain measured expectations until the detailed results are available at the conference.

Presentations will showcase new data reinforcing BOT/BAL’s potential across different lines of treatment in colorectal cancer, including the neoadjuvant setting

LEXINGTON, Mass.--(BUSINESS WIRE)-- Agenus Inc. (Nasdaq: AGEN), a leader in immuno-oncology, today announced five presentations featuring botensilimab (BOT, an Fc-enhanced anti-CTLA-4 antibody) plus balstilimab (BAL, an anti-PD-1 antibody) at the upcoming American Society of Clinical Oncology Gastrointestinal Cancers (ASCO GI) Symposium. The conference will take place on January 23-25, 2025, in San Francisco, California.

The presentations will showcase BOT/BAL's activity across three distinct colorectal cancer settings—late-line metastatic, first-line, and neoadjuvant treatment. The studies demonstrate BOT/BAL’s consistent activity in microsatellite stable (MSS) colorectal cancer (CRC), which accounts for over 80% of CRC cases and has limited treatment options, as well as its efficacy in microsatellite instability-high (MSI-H) CRC. Additionally, one presentation will feature BOT/BAL and invariant natural killer T cells (iNKTs) in patients with refractory gastric cancer.

“These presentations will highlight BOT/BAL’s potential to benefit patients across colorectal cancer treatment settings, including the neoadjuvant, late-line, and first-line settings,” said Dr. Garo Armen, Chairman and CEO of Agenus. “We aim to transform outcomes at every stage of disease and deliver renewed hope for patients worldwide.”

Presentation Details

Abstract Title: Preliminary results from a randomized, open-label, phase 2 study of botensilimab (BOT) with or without balstilimab (BAL) in refractory microsatellite stable metastatic colorectal cancer with no liver metastases (MSS mCRC NLM)*
Abstract Number: 23
Presenting Author: Dr. Marwan Fakih
Session: Rapid Oral Abstract Session C: Cancers of the Colon, Rectum, and Anus
Session Date and Time: 1/25/2025, 9:15 AM-10:00 AM PST

Abstract Title: Preoperative botensilimab (BOT) with or without balstilimab (BAL) for patients with resectable locally advanced pMMR or dMMR colon cancer: Results from the UNICORN trial by GONO
Abstract Number: 158
Presenting Author: Dr. Filippo Ghelardi
Session: Poster Session C: Cancers of the Colon, Rectum, and Anus
Session Date and Time: 1/25/2025, 7:00 AM-7:55 AM PST

Abstract Title: A phase II study of agenT-797 (invariant natural killer T-cells), botensilimab (Fc-enhanced CTLA-4 inhibitor) and balstilimab (anti-PD-1) in patients with advanced, refractory gastroesophageal adenocarcinoma
Abstract Number: TPS515
Presenting Author: Dr. Samuel Cytryn
Session: Trials in Progress Poster Session A: Cancers of the Esophagus and Stomach and Other Gastrointestinal Cancers
Session Date and Time: 1/23/2025, 11:30 AM-1:00 PM PST

Abstract Title: Neoadjuvant botensilimab (BOT) plus balstilimab (BAL) in resectable mismatch repair proficient (pMMR) and deficient (dMMR) colorectal cancer (CRC): NEST clinical trial update
Abstract Number: 207
Presenting Author: Dr. Erika Hissong
Session: Poster Session C: Cancers of the Colon, Rectum, and Anus
Session Date and Time: 1/25/2025, 7:00 AM-7:55 AM PST

Abstract Title: A phase 1 trial of folinic acid, fluorouracil, oxaliplatin, bevacizumab, botensilimab, balstilimab (FOLFOX-3B) in microsatellite stable metastatic colorectal cancer.
Abstract Number: 180
Presenting Author: Dr. Marwan Fakih
Session: Poster Session C: Cancers of the Colon, Rectum, and Anus
Session Date and Time: 1/25/2025, 7:00 AM-7:55 AM PST

Complete abstracts will be released at 5:00 PM ET on January 21^st, 2025. 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.

*Agenus Sponsored Study

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.

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/20241218514510/en/

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Source: Agenus Inc.

FAQ

What are the key presentations for Agenus (AGEN) at ASCO GI 2025?

Agenus will present five studies featuring BOT/BAL therapy across different colorectal cancer settings (late-line metastatic, first-line, and neoadjuvant) and gastric cancer at ASCO GI from January 23-25, 2025.

What types of cancer does Agenus (AGEN) BOT/BAL therapy target?

BOT/BAL therapy targets microsatellite stable (MSS) colorectal cancer, which represents over 80% of CRC cases, microsatellite instability-high (MSI-H) CRC, and refractory gastric cancer.

When will the ASCO GI 2025 abstracts for Agenus (AGEN) be released?

The complete abstracts will be released at 5:00 PM ET on January 21st, 2025.

What is the UNICORN trial investigating for Agenus (AGEN)?

The UNICORN trial is investigating preoperative BOT with or without BAL for patients with resectable locally advanced pMMR or dMMR colon cancer.