Latest news with #Agenus
Business Wire
3 days ago
- Business
- Business Wire
Agenus Presents New Data at ASCO Highlighting Botensilimab's Immune Activation in MSS Colorectal Cancer
LEXINGTON, Mass.--(BUSINESS WIRE)--Agenus Inc. (Nasdaq: AGEN), a leader in immuno-oncology, today presented new translational data at the 2025 American Society of Clinical Oncology (ASCO) Annual Meeting. The study demonstrates that botensilimab-based therapy induces a robust and persistent T cell immune response in microsatellite stable (MSS), or mismatch repair proficient (pMMR), metastatic colorectal cancer (mCRC)—a tumor type traditionally resistant to immunotherapy and representing approximately 85-95% of all colorectal cancers. T cells are key immune cells capable of recognizing and attacking cancer cells. Activating these typically 'cold' tumors and driving a strong T cell response suggests that botensilimab has the potential to overcome resistance and improve patient outcomes. The research was led by Dr. Gertjan Rasschaert of Leuven University Hospitals in collaboration with Agenus, KU Leuven, and Omniscope. This joint effort brings together global leaders in immuno-oncology and advanced immune profiling technologies. 'These data provide clinical evidence of botensilimab's unique ability to enhance T-cell priming, activation, and diversity—key mechanisms that help render 'cold,' poorly immunogenic MSS colorectal tumors visible to the immune system,' said Dr. Dhan Chand, PhD, Vice President of Research at Agenus. 'Our findings offer new insight into how patients with immunotherapy-resistant colorectal cancer are responding at the immune level and highlight botensilimab's potential to activate immune responses in tumors that have historically been unresponsive.' Data Highlights: Fast T cell priming and activation: T-cells begin activating within two weeks of starting botensilimab. Robustly expands and sustains T cell activity: Newly primed T cells persist and expand across treatment cycles, correlating with improved clinical responses. Immune activity detected before scans: Immune-profiling tests detect this activity even when standard imaging hasn't yet caught a response. Blood signals predict benefit: A quick blood draw can reveal early immune markers that help doctors identify who is most likely to respond and live longer. 'We're seeing — at the immune level — how botensilimab can help the body recognize and attack pMMR colorectal cancer, a form of the disease that has historically resisted immunotherapy and represents the vast majority of colorectal cancer cases,' said Dr. Steven O'Day, Chief Medical Officer at Agenus. 'By activating T cells and making these typically 'cold' tumors visible to the immune system, botensilimab is showing real promise in overcoming resistance and opening the door to better outcomes for patients who previously had limited options.' Presentation Details: The presentation will be available on the publications section of the Agenus website at on the date of the poster session. Presentation Title: Monitoring botensilimab and balstilimab induced T cell dynamics in refractory mismatch repair proficient metastatic colorectal cancer. Presenting Author: Poster Session: Gastrointestinal Cancer—Colorectal and Anal Session Date and Time: May 31 st, 2025; 9:00 AM-12:00 PM CDT Abstract Number: 3527 Poster Number: 196 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 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 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 2024, 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.
Yahoo
16-05-2025
- Business
- Yahoo
Agenus says expanded MSS mCRC cohort data to be presented at ESMO GI
Agenus (AGEN) announced new data from its ongoing Phase 1 trial evaluating botensilimab and balstilimab in patients with microsatellite stable metastatic colorectal cancer will be presented at the 2025 European Society for Medical Oncology Gastrointestinal Cancers Congress in Barcelona, Spain. A poster presentation will feature updated findings from an expanded cohort of 123 patients, incorporating additional participants and extended follow-up to further assess clinical activity of the combination, including durability of response and overall survival, the company noted. Quickly and easily unpack a company's performance with TipRanks' new KPI Data for smart investment decisions Receive undervalued, market resilient stocks straight to you inbox with TipRanks' Smart Value Newsletter Published first on TheFly – the ultimate source for real-time, market-moving breaking financial news. Try Now>> See the top stocks recommended by analysts >> Read More on AGEN: Disclaimer & DisclosureReport an Issue Biotech Alert: Searches spiking for these stocks today Agenus price target raised to $4 from $3 at Baird Agenus's Regulatory and Clinical Developments Prompt Neutral Stance Amid Uncertain FDA Pathway Agenus Inc. Reports Q1 2025 Progress and Financials Agenus Inc. Earnings Call: Optimism Amid Challenges Error in retrieving data Sign in to access your portfolio Error in retrieving data Error in retrieving data Error in retrieving data Error in retrieving data
Business Wire
15-05-2025
- Business
- Business Wire
Agenus Announces New Data from Expanded MSS Metastatic Colorectal Cancer Cohort to be Presented at ESMO GI 2025
LEXINGTON, Mass.--(BUSINESS WIRE)-- Agenus Inc. ('Agenus' or the Company') (NASDAQ: AGEN), a leader in immuno-oncology, today announced new data from its ongoing Phase 1 trial evaluating botensilimab and balstilimab (BOT/BAL) in patients with microsatellite stable (MSS) metastatic colorectal cancer (mCRC) at the 2025 European Society for Medical Oncology (ESMO) Gastrointestinal Cancers Congress in Barcelona, Spain. A poster presentation will feature updated findings from an expanded cohort of 123 patients, incorporating additional participants and extended follow-up to further assess clinical activity of the combination, including durability of response and overall survival (NCT03860272). Presentation Details: Presentation: Botensilimab plus balstilimab in an expanded cohort of 123 patients with metastatic microsatellite stable colorectal cancer and no active liver metastases Presenting Author: Dr. Benjamin Schlechter, Dana Farber Cancer Institute Poster Number: 8P 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 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 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 2024, 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.
Washington Post
12-05-2025
- Business
- Washington Post
Agenus: Q1 Earnings Snapshot
LEXINGTON, Mass. — LEXINGTON, Mass. — Agenus Inc. (AGEN) on Monday reported a loss of $26.4 million in its first quarter. The Lexington, Massachusetts-based company said it had a loss of $1.03 per share. The results surpassed Wall Street expectations. The average estimate of three analysts surveyed by Zacks Investment Research was for a loss of $1.61 per share.
National Post
12-05-2025
- Business
- National Post
Agenus Reports Q1 2025 Financial Results and Key Business Updates
Article content Article content LEXINGTON, Mass. — Agenus Inc. ('Agenus' or the 'Company') (NASDAQ: AGEN), a leader in immuno-oncology, today reported financial and operational results for the first quarter of 2025, and shared key clinical and strategic milestones supporting the advancement of its botensilimab (BOT) and balstilimab (BAL) program. Article content 'The growing strength of our BOT/BAL data across multiple hard-to-treat cancers reinforces our conviction in its transformative potential and fuels our unwavering commitment to delivering this combination to patients,' said Garo Armen, Ph.D., Chairman and CEO of Agenus. 'With expanded datasets, key leadership appointments, and the FDA's renewed focus on accelerating cures and meaningful treatments, Agenus is entering a pivotal phase—advancing toward regulatory engagement with financial discipline and a sharp focus on bringing innovative immunotherapies to individuals living with cancer.' Article content BOT/BAL continues to demonstrate robust and durable responses across microsatellite stable (MSS) 'cold tumors' where current immuno-oncology treatments have historically failed. At American Association for Cancer Research (AACR) Annual Meeting in Chicago, Illinois, new data highlighted the activity and safety profile in both multiple mismatch repair–proficient (pMMR/MSS) and mismatch repair–deficient (dMMR/MSI-H) solid tumors in neoadjuvant and later line treatment settings. Notably, new data from the investigator-sponsored pan-cancer NEOASIS study—now the third clinical study evaluating BOT/BAL in the neoadjuvant setting—were presented. These initial results from the safety run-in portion indicate that BOT/BAL can induce pathological responses in patients with solid tumors beyond CRC, including TNBC and sarcomas. No dose-limiting toxicities were observed, and all patients proceeded to their scheduled surgery. 100 percent of dMMR CRC patients given a higher dose of BOT/BAL achieved pCR. New data from the HCC cohort of the ongoing Phase 1 study were also presented. The HCC cohort comprised of patients with difficult-to-treat disease who had progressed following standard treatments, including approved immunotherapies. The durable responses and disease control in heavily pretreated HCC patients highlight the strength and differentiation of the BOT/BAL combination. Data on late stage pan tumor activity to be presented at an upcoming key cancer conference. Article content Dr. Richard Goldberg, an internationally recognized leader in GI cancer treatment and research, stepped out of early retirement to join Agenus as Chief Development Officer to support the advancement of BOT/BAL for patients. Dr. Goldberg will lead the company's efforts as it prepares to re-engage global regulatory authorities with expanded data and longer-term follow-up in metastatic CRC. Article content New Efficiencies: Article content Agenus is on track to reduce its annualized operating cash burn below $50 million starting in the second half of 2025, supported by recent cost optimization measures enabling the company to direct resources toward ensuring the potential of BOT/BAL is realized. The company is in final stages of an important collaboration which will result in substantial cash infusion. Article content Agenus ended the first quarter 2025 with a consolidated cash balance of $18.5 million compared to $40.4 million on December 31, 2024. Cash used in operations for the first quarter ended March 31, 2025 was $25.6 million, reduced from $38.2 million for same period in 2024. Article content For the first quarter ended March 31, 2025, Agenus recognized revenue of $24.1 million and incurred a net loss of $26.4 million, or $1.03 per share. For the first quarter ended March 31, 2024, Agenus recognized revenue of $28.0 million and incurred a net loss of $63.5 million or $3.04 per share. Revenue primarily includes non-cash royalty revenue. Article content Conference Call Article content Date: Monday, May 12th, at 8:30 a.m. ET To access dial-in numbers, please register here. Conference ID: 73242 Article content Webcast Article content About Botensilimab (BOT) Article content 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. Article content 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 with the identifiers NCT03860272, NCT05608044, NCT05630183, and NCT05529316. Article content About Balstilimab (BAL) Article content 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. Article content 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 or @agenus_bio. Information that may be important to investors will be routinely posted on our website and social media channels. Article content 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 2024, 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. Article content Article content Article content Article content Contacts Article content Article content Article content
