Latest news with #Agenus
Business Wire
07-07-2025
- Business
- Business Wire
Agenus' BOT/BAL Achieves 42% Two-Year Survival in Refractory MSS CRC, Advances Toward Registration with FDA Alignment on Phase 3
LEXINGTON, Mass.--(BUSINESS WIRE)--Agenus Inc. (Nasdaq: AGEN) a leader in immuno-oncology innovation, today announced that its botensilimab and balstilimab (BOT/BAL) combination achieved a two-year survival rate of 42% along with a now more mature 21-month median overall survival (OS) in an expanded cohort of 123 patients with microsatellite-stable (MSS) metastatic colorectal cancer (mCRC) without active liver metastases (NLM). Agenus also confirmed that it has reached agreement with the U.S. Food and Drug Administration (FDA) on the design of the global BATTMAN Phase 3 trial. The FDA waived the need for a BOT monotherapy arm, allowing for a simple two-arm study design. These new BOT/BAL data were reported at the 2025 ESMO Gastrointestinal Cancers Congress (ESMO-GI) in Barcelona, Spain, along with regulatory updates from its July 1, 2025 End-of-Phase 2 (EoP2) meeting with the U.S. Food and Drug Administration (FDA). 'Deep, durable responses and survival plateaus emerging at two years and beyond are rarely seen in microsatellite stable refractory colorectal cancer ...' said Dr. Steven O'Day, Chief Medical Officer at Agenus. ESMO‑GI Clinical Highlights The new data presented at ESMO-GI represent an approximate 40% increase in number of patients (n=123) compared to earlier reports published in Nature Medicine in 2024. The expanded dataset demonstrates continued durability of tumor responses and median overall survival approaching two years in an immunotherapy-resistant treatment setting. Among these 123 heavily pretreated MSS mCRC patients (third-line or later) treated with BOT/BAL, the confirmed objective response rate (ORR) was 20%, with a median duration of response (DOR) of 16.6 months. The disease control rate (DCR, responses plus stable disease) was 69%. Notably, median overall survival (OS) reached 20.9 months, with 42% of patients still alive at two years in this refractory population. Patients in fourth-line or later (n=37), having exhausted all standard therapies, saw similar benefits, with a ~19% ORR and 43% two-year survival. These findings are particularly meaningful in this refractory population for which best supportive care has been historically limited to roughly 5-8 months median overall survival. No new safety signals were observed. Immune-related side effects were manageable and no treatment-related deaths occurred. The combination was tolerated across dose levels. 'These results reinforce the consistency and durability of the botensilimab plus balstilimab combination in a population that has historically seen minimal benefit from immune checkpoint blockade,' said Dr. Benjamin Schlechter of Dana-Farber Cancer Institute, who presented the data. 'For patients with MSS colorectal cancer who have exhausted standard therapies, this combination is showing the kind of meaningful, long-lasting benefit we rarely see in this setting. It has the potential to fundamentally shift how we treat this disease.' 'Deep, durable responses and survival plateaus emerging at two years and beyond are rarely seen in microsatellite stable refractory colorectal cancer – they are usually only seen in highly immunogenic tumors,' said Dr. Steven O'Day, Chief Medical Officer of Agenus. 'These data reinforce the potential for a chemo‑free option in a population with limited alternatives.' FDA Meeting Outcomes Official minutes from the July 1, 2025 End-of-Phase 2 (EoP2) meeting reflect a meaningful shift in FDA alignment since July 2024, establishing two new areas of agreement: Contribution of components – FDA wrote that the current data 'appears to support' balstilimab's contribution to the combination's clinical activity and therefore a registrational Phase 3 trial may proceed without a BOT monotherapy arm. Phase 3 registrational trial – BATTMAN (CCTG CO.33): FDA and Agenus aligned on the core design of this global registration study for BOT/BAL. Agenus is incorporating the Agency's feedback and will initiate BATTMAN in Q4 2025. During the discussion on July 1, 2025, the FDA stated that it continues to recommend Agenus conduct a randomized controlled trial to support the approval of BOT/BAL in the metastatic setting and the demonstrated magnitude of treatment effect 'does not appear to meet the standard of reasonably likely to predict benefit.' Agenus and key experts in oncology and immunotherapy, including those present in the FDA meeting—strongly believe that the BOT/BAL data meets the standard of Subpart E given the magnitude, durability, and urgent unmet need in this patient population. Jennifer Buell, Ph.D., Executive Chairwoman of Agenus, commented: 'FDA's acknowledgement of balstilimab's role and its constructive guidance on the Phase 3 trial mark a pivotal step forward. We have incorporated the Agency's input and are moving swiftly to launch BATTMAN, while continuing to mature our existing dataset. Guided by Commissioner Makary's commitment to accelerate promising therapies, we intend to use every expedited pathway—Fast Track, Real-Time Oncology Review, the new Commissioner's National Priority Voucher Program, and other accelerated mechanisms—to bring this chemo-free option to patients who have exhausted all other treatments.' Clinical Urgency 'Colorectal cancer is rising fastest in people under 50 and is projected to become the leading cause of cancer death in that age group by 2030,' said Richard Goldberg, M.D., Chief Development Officer, Agenus. 'Given the dismal five‑to‑eight‑month median survival with current late‑line therapies, making BOT/BAL available quickly is not just prudent—it is imperative.' 2H2025 Catalysts Launch Global Registrational Trial (BATTMAN): Initiate BATTMAN in 4Q2025; rapidly accrue trial designed to confirm OS benefit and registration. Advancing Earlier-Line CRC: Ongoing data of BOT/BAL in 1L and neoadjuvant MSS CRC will inform upcoming discussions with regulatory agencies on potential pathways for expanded development. Global Clinical Infrastructure: Advancing collaboration with Zydus and other strategic partners to support rapid global enrollment, high-quality data generation, and future regional access. Upcoming Data Presentations: Updated data of BOT/BAL in CRC and other tumors to be presented at major oncology congresses in Q4 2025, reinforcing the combinations activity across solid cancers. Regulatory Engagement & Expedited Pathways: Ongoing collaboration with Dr. Makary, the FDA, and senior U.S. government stakeholders to pursue expedited regulatory mechanisms, including Accelerated Approval, the Commissioner's National Priority Voucher Program, and Real-Time Oncology Review to address the current cancer crisis. Agenus' Commitment to Patient Access Agenus is committed to making our investigational medicines available to patients with cancer. Our goal is to provide access to our investigational medicines at the appropriate time and in the correct manner for patients. You can find information on access on our website at and apply. About the C-800-01 Phase 1 Study The C-800-01 Phase 1, open-label, multicenter trial (NCT03860272) evaluated botensilimab alone or in combination with balstilimab across multiple solid tumors, including an expansion cohort in microsatellite stable metastatic colorectal cancer. In the MSS CRC cohort, patients received botensilimab (1 or 2 mg/kg every six weeks) plus balstilimab (3 mg/kg every two weeks) for up to two years. The study enrolled heavily pretreated patients, including those with no active liver metastases, and assessed safety, objective response rate, progression-free survival, and overall survival. No maximum tolerated dose was reached, and the safety profile was manageable across dose levels. The trial also included exploratory biomarker analyses to inform potential predictors of response. Preliminary findings from this study in refractory MSS CRC were published in Nature Medicine in September 2024. About Agenus Agenus is a leading immuno-oncology company targeting cancer with a comprehensive pipeline of immune-driven therapies. Founded in 1994, the company's mission is to expand the patient populations benefiting from cancer immunotherapy through innovative combination approaches. Agenus' portfolio includes a broad repertoire of antibody therapeutics, adoptive cell therapies (via its affiliate MiNK Therapeutics), and adjuvants (via SaponiQx). The company has end-to-end capabilities spanning research, discovery, and GMP manufacturing, and it has a global clinical development footprint. Agenus is headquartered in Lexington, MA. For more information, visit or follow @agenus_bio on social media. Important information for investors will be routinely posted on the company's website and social channels. About Botensilimab (BOT) Botensilimab (AGEN1181) is a novel, multifunctional, Fc-enhanced CTLA-4 antibody engineered to boost both innate and adaptive anti-tumor immune responses. Its unique design aims to overcome the limitations of first-generation CTLA-4 inhibitors (like ipilimumab) and extend immunotherapy benefits to 'cold' tumors that typically respond poorly or not at all to standard immune checkpoint blockade. Botensilimab's Fc-enhanced structure allows it to robustly engage activating Fc receptors on key immune cells, thereby priming and activating T cells, depleting immunosuppressive regulatory T cells in the tumor microenvironment, activating myeloid cells, and inducing long-term immune memory. Through these mechanisms, botensilimab has demonstrated the ability to ignite immune responses across a range of solid tumors, including those resistant to conventional PD-1 or CTLA-4 therapies. To date, approximately 1,200 patients have been treated with botensilimab and/or balstilimab in Phase 1 and 2 trials. Botensilimab alone or in combination with Agenus' investigational PD-1 antibody balstilimab has shown clinical responses in nine different metastatic cancers in late-line settings. For more information on ongoing botensilimab trials, please visit About Balstilimab (BAL) Balstilimab (AGEN2034) is a novel, fully human monoclonal IgG4 antibody that blocks PD-1 (programmed cell death-1) from interacting with its ligands PD-L1 and PD-L2. By inhibiting the PD-1 checkpoint pathway, balstilimab aims to restore T-cell activity against tumors. It has been evaluated in over 900 patients to date and has demonstrated clinical activity with a favorable tolerability profile in several tumor types. Balstilimab is being studied both as a monotherapy and in combination with other agents (such as botensilimab) to expand its therapeutic impact. 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 the botensilimab and balstilimab clinical programs, expected trial initiations and regulatory plans, and the potential benefits of the combination therapy. Words such as 'may,' 'believes,' 'expects,' 'anticipates,' 'hopes,' 'intends,' 'plans,' 'forecasts,' 'estimates,' 'will,' 'potential,' 'game-changing,' 'curative,' and similar expressions are intended to identify forward-looking statements. These statements are subject to risks and uncertainties that could cause actual results to differ materially from current expectations. Factors that could cause actual results to differ include, but are not limited to, those described under the 'Risk Factors' section of Agenus' most recent Annual Report on Form 10-K for 2024 and subsequent Quarterly Reports on Form 10-Q filed with the SEC. Agenus cautions investors not to place undue reliance on forward-looking statements in this release, which speak only as of the date of this announcement. The company undertakes no obligation to update or revise these statements, except as required by law. All forward-looking statements are expressly qualified in their entirety by this cautionary statement.
Business Wire
10-06-2025
- Business
- Business Wire
Agenus Announces Virtual Annual Shareholders Meeting
LEXINGTON, Mass.--(BUSINESS WIRE)--Agenus Inc. ('Agenus') (NASDAQ: AGEN), a leader in immuno-oncology innovation, today announced that its Annual Shareholders Meeting will begin at 10:30 a.m. ET on June 17, 2025, and will be conducted in a virtual format only. Registration for attendees will start at 10:15 a.m. ET. To participate in the Annual Shareholders Meeting, shareholders should visit and enter the 16-digit control number found in their proxy materials. Guests may also access the Annual Shareholders Meeting, but in listen-only mode. No control number is required for guests. Webcast Information: Time: 10:30 a.m. ET A live webcast and replay will be accessible on the Company's website at and at Voting Information: Shareholders of Agenus as of the April 24th, 2025, record date can vote. Alliance Advisors, Agenus's proxy solicitor, can assist shareholders with voting at 844-202-6561 or AGEN@ 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.
Yahoo
10-06-2025
- Business
- Yahoo
Agenus Announces Virtual Annual Shareholders Meeting
LEXINGTON, Mass., June 10, 2025--(BUSINESS WIRE)--Agenus Inc. ("Agenus") (NASDAQ: AGEN), a leader in immuno-oncology innovation, today announced that its Annual Shareholders Meeting will begin at 10:30 a.m. ET on June 17, 2025, and will be conducted in a virtual format only. Registration for attendees will start at 10:15 a.m. ET. To participate in the Annual Shareholders Meeting, shareholders should visit and enter the 16-digit control number found in their proxy materials. Guests may also access the Annual Shareholders Meeting, but in listen-only mode. No control number is required for guests. Webcast Information: Date: Tuesday, June 17, 2025 Time: 10:30 a.m. ET A live webcast and replay will be accessible on the Company's website at and at Voting Information: Shareholders of Agenus as of the April 24th, 2025, record date can vote. Alliance Advisors, Agenus's proxy solicitor, can assist shareholders with voting at 844-202-6561 or AGEN@ 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. View source version on Contacts Investors 917-362-1370investor@ Media 781-674-4422communications@
Yahoo
04-06-2025
- Business
- Yahoo
Agenus and Zydus sign agreements for botensilimab and balstilimab
Agenus has signed $141m partnership agreements with Zydus Lifesciences and its subsidiaries to enhance clinical developments and advance manufacturing globally while expanding patient access to botensilimab and balstilimab (BOT/BAL). The agreement includes an exchange of Agenus' biologics chemistry, manufacturing and controls facilities in Emeryville and Berkeley in the US state of California for $75m upfront. Agenus will receive up to an extra $50m in contingent payments obtained by production orders for BOT/BAL. Zydus plans to launch a BioCDMO [contract development and manufacturing organisation] business using these facilities as its flagship US sites provide biologics contract manufacturing services to biopharmaceutical companies across the globe. Agenus will be Zydus' inaugural BioCDMO customer as a result of an exclusive manufacturing agreement for BOT/BAL. This ensures that the combination regimen's biologics licence application (BLA) and launch readiness needs are met effectively. Agenus will give Zydus an exclusive licence for the development and commercialisation of BOT and BAL in Sri Lanka and India. This move benefits Zydus' established regional presence and infrastructure. In return, it will pay a 5% royalty to Agenus on net sales within those countries. Zydus will also make an equity investment in Agenus through the purchase of 2.1 million common stock shares at $7.50 per share. This $16m in gross proceeds will be used by Agenus for working capital purposes and for accelerating ongoing clinical development, registration and potential commercialisation related to BOT/BAL. Agenus CEO Dr Garo Armen stated: 'With a trade agreement between the US and India seemingly imminent, there is a renewed sense of confidence by trading partners in both countries in the future of Indian-American relations. 'There is also a growing recognition by both countries of the need for the US to ensure that biopharma supply chains are secure. We are working with Zydus to accelerate future clinical trials for BOT/BAL and eventually its global footprint in oncology therapeutics. This agreement is an expression of confidence in the future of Agenus and in the regulatory environment of the US.' By combining Agenus' research capabilities with Zydus' manufacturing strength globally, along with operational expertise, the partnership will help advancements in cancer immunotherapy in India and internationally. "Agenus and Zydus sign agreements for botensilimab and balstilimab" was originally created and published by Pharmaceutical Technology, a GlobalData owned brand. The information on this site has been included in good faith for general informational purposes only. It is not intended to amount to advice on which you should rely, and we give no representation, warranty or guarantee, whether express or implied as to its accuracy or completeness. You must obtain professional or specialist advice before taking, or refraining from, any action on the basis of the content on our site. 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
Mint
04-06-2025
- Business
- Mint
Zydus to Enter Global Biologics CDMO Business Plans
New Jersey, United States & Ahmedabad, Gujarat, India – Business Wire India Zydus Lifesciences Ltd. (including its subsidiaries/affiliates, hereafter referred to as 'Zydus) today announced its entry into the global biologics contract development and manufacturing organization (CDMO) business through its plan to acquire Agenus Inc.'s (Nasdaq: AGEN) U.S.-based biologics CMC facilities. This acquisition marks Zydus' strategic investment in U.S.-based manufacturing for biologics thereby adding a sustainable growth driver for the group. Agenus Inc. is a clinical-stage immuno-oncology company committed to developing immune therapies that effectively combat cancer. Under the terms of the agreement, Zydus will acquire two state-of-the-art biologics manufacturing facilities from Agenus in Emeryville and Berkeley, California (US) for an upfront consideration of US$75 million and contingent payment of US$50 million to be paid over three years subject to achievement of certain revenue milestone. This acquisition provides Zydus immediate access to advanced biologics manufacturing capabilities and establishes a key presence in California, a leading global biotechnology hub. This strategic move enables Zydus to leverage supply chain dynamics and a favourable geopolitical environment to expand its reach in the U.S. and globally. With this acquisition Zydus will now become a one stop solution provider across the entire development spectrum of biologics, right from pre-clinical to toxicology studies, clinical development and now CDMO business will operate as an independent entity and will house the acquired manufacturing capabilities. The facilities come with an experienced professional team with strong capabilities and requisite industry expertise to deliver high-quality biologics development and manufacturing services to global biotech and pharmaceutical companies. As a part of transaction Zydus will become an exclusive contract manufacturer for Agenus and will provide manufacturing services for clinical and commercial supply of two identified Phase-3 ready immuno-oncology products, Botensilimab (BOT) and Balstilimab (BAL). Zydus will also have first right of negotiation to manufacture any of the future pipeline products developed by Agenus. Zydus intends to further expand the team and help create new jobs in the region and contribute to the local on the development, Dr. Sharvil Patel, Managing Director, Zydus Lifesciences Ltd. said, "The acquisition will give Zydus a strategic foothold in the U.S. for biologics manufacturing in the global hub for biotech innovation, California. It will enhance our ability to partner with innovation-centric entities, advancing new products and prioritizing patient-centric solutions. This move strengthens our long-term biologics vision and positions us to better serve the evolving needs of the global biopharmaceutical industry." The global biologics CDMO market is experiencing significant growth, driven by the increasing complexity of therapies, the rise of biologics in clinical pipelines, and a growing number of emerging biotech companies lacking internal manufacturing capabilities. According to the Global Biologics CDMO Market Size is expected to be worth around US$ 84.9 Billion by 2034, growing at a CAGR of 15.7% between 2025 to 2034. As demand surges for reliable, agile, and scalable partners, Zydus' entry into this space positions it to tap into significant long-term growth opportunities and support innovation across the global biopharmaceutical landscape. About Zydus Zydus Lifesciences Ltd. with an overarching purpose of empowering people with freedom to live healthier and more fulfilled lives, is an innovative, global lifesciences company that discovers, develops, manufactures, and markets a broad range of healthcare therapies. The group employs 27,000 people worldwide, including 1,400 scientists engaged in R&D, and is driven by its mission to unlock new possibilities in lifesciences through quality healthcare solutions that impact lives. The group aspires to transform lives through path-breaking discoveries. Over the last decade, Zydus has introduced several innovative, first-in-class products in the market for treating unmet healthcare needs with vaccines, therapeutics, biologicals and biosimilars. For more details visit: About Agenus Agenus Inc. is a clinical-stage immuno-oncology company committed to developing immune therapies that effectively combat cancer. Leveraging proprietary scientific platforms, the company's pipeline includes multiple checkpoint antibody candidates, vaccines, and cell therapies. Headquartered in Lexington, MA, Agenus operates globally, driving innovations to bring better cancer treatments to patients. For more details visit: Forward-Looking Statements: This press release contains forward-looking statements. Such forward-looking statements are subject to risks and uncertainties that could cause actual results to differ materially from those projected. These risks and uncertainties include, but are not limited to, the successful integration of the acquired business, market conditions, and other factors. Sujatha Rajesh (Media Relations), Zydus Lifesciences Limited, +91-9974051180 Arvind Bothra (Investor Relations), Zydus Lifesciences Limited, +91-7045656895
