Latest news with #Botensilimab
Business Wire
4 days ago
- Business
- Business Wire
Agenus and Noetik Enter Collaboration to Develop AI-Enabled Predictive Biomarkers for BOT/BAL Using Foundation Models of Virtual Cell Biology
LEXINGTON, Mass. & SAN FRANCISCO--(BUSINESS WIRE)--Agenus Inc. (Nasdaq: AGEN), a leader in immuno-oncology innovation, and Noetik, a leader in AI-driven spatial and multimodal biology, today announced a research collaboration to develop predictive biomarkers of response to Agenus' lead clinical stage immuno-oncology (IO) combination, botensilimab (BOT, multifunctional Fc-enhanced anti-CTLA-4) and balstilimab (BAL, anti-PD-1). The collaboration harnesses Noetik's proprietary virtual cell foundation models and large-scale, multimodal tumor data to uncover novel insights into the biology of tumor immunology. Together, the teams will deploy Noetik's first-in-class foundation models directly on clinical results with the aim to enrich clinical efficacy. We are excited to deploy Noetik's virtual cell foundation models on Agenus' rich clinical data to uncover biomarkers that can enrich patient therapeutic response, improve trial outcomes, and ultimately deliver more precise therapies. Share Central to this collaboration is Noetik's OCTO virtual cell model, a 1.5 billion parameter foundation model trained on one of the largest proprietary multimodal spatial datasets. This dataset brings together spatial proteomics, spatial transcriptomics, H&E pathology, DNA genotyping, and clinical metadata from nearly 200 million tumor and immune cells collected from thousands of patients with cancers such as colorectal cancer, non-small cell lung cancer, ovarian cancers, and sarcomas. By integrating these diverse data types, Noetik's foundation models provide a systems-level view of the tumor microenvironment in real patients, unlocking novel insights into cancer biology that can drive more precise therapeutic discovery and development. Botensilimab, alone or in combination with BAL, has been evaluated in more than 1,200 patients across nine tumor types, including colorectal cancer, NSCLC, and sarcomas. By targeting complementary immune pathways, the BOT/BAL combination has shown deep and durable clinical responses—even in tumors considered immunotherapy 'cold' or resistant to prior IO treatment. The regimen has generated growing recognition within the medical community, supported by compelling data presented in both late-line and neoadjuvant settings, multiple peer-reviewed publications, and presentations at more than a dozen major medical congresses over the past three years. The collaboration aims to uncover clear, actionable biomarkers that can help predict which patients are most likely to respond to BOT/BAL treatment. Using OCTO virtual cell models to simulate how tumors behave in the body, Noetik will analyze complex biological data from multiple cancer types. The goal is to identify patterns that can predict treatment outcomes and help classify patient groups who may benefit most. Agenus will have exclusive rights to apply these insights in its drug development and commercialization efforts. 'Enhancing clinical efficacy is the most important problem in developing new medicines, and exactly what we've trained our foundation models to do. We are excited to deploy Noetik's virtual cell foundation models on Agenus' rich clinical data to uncover biomarkers that can enrich patient therapeutic response, improve trial outcomes, and ultimately deliver more precise therapies,' said Ron Alfa, M.D., Ph.D., CEO & Co-Founder, Noetik. 'At Agenus, we are committed to transforming cancer care through scientific innovation and next-generation immunotherapies. This collaboration with Noetik enables us to harness cutting-edge AI to better understand patient biology and tailor treatments more precisely,' said Dr. Garo Armen, Chairman and CEO of Agenus. 'By integrating Noetik's virtual cell models with our expansive BOT/BAL clinical dataset, we have the potential to accelerate the identification of predictive biomarkers, enhance the success of our pivotal trials, and ultimately improve outcomes for patients who currently have limited or no treatment options.' This collaboration reflects a growing momentum in oncology toward model-driven trial design and AI-enabled precision medicine—an area increasingly prioritized by the FDA under the guidance of the current U.S. administration as central to advancing more equitable, effective cancer care. By applying these technologies to real patient data, the goal is to accelerate the delivery of more personalized treatments, improve outcomes, and expand access to therapies for patients who need them most. About Noetik Noetik is an AI-native biotechnology company using machine learning to increase clinical success rates for precision cancer therapies. By training AI models directly on human patient data, the company bridges the gap between drug development and human biology. Noetik's proprietary platforms, OCTO and Perturb-map, leverage the power of virtual cell models trained on massive multimodal data to identify therapeutic targets with unprecedented precision. Founded by biotech and AI veterans from Recursion Pharmaceuticals, Genentech, and the Parker Institute for Cancer Immunotherapy, Noetik is based in San Francisco, CA. To learn more about Noetik, visit 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 on social @agenus_bio. Information that may be important to investors will be routinely posted on our website and social media channels. 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. Botensilimab alone, or in combination with Agenus' investigational PD-1 antibody, balstilimab, has shown clinical responses across nine metastatic, late-line cancers. Approximately 1,100 patients have been treated across the botensilimab/balstilimab program in phase 1 and phase 2 clinical trials. 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. 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.
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
Indian Express
03-06-2025
- Business
- Indian Express
Zydus announces plan to acquire US manufacturing units of Agenus Inc
Zydus Lifesciences on Tuesday announced its plan to acquire Agenus Inc's US-based biologics CMC (Chemistry, Manufacturing, and Control) facilities, marking the Gujarat-based firm's entry into the global biologics contract development and manufacturing organisation (CDMO) business. Agenus Inc. is a clinical-stage immuno-oncology company developing immune therapies, which effectively combat cancer. Zydus, in a statement, said it is set to acquire two biologics manufacturing facilities, located in Emeryville and Berkeley, California, for an upfront consideration of USD 75 million and contingent payment of USD 50 million to be paid over three years, 'subject to achievement of certain revenue milestones'. With this acquisition, Zydus claims it will become a one-stop solution provider across the entire development spectrum of biologics, right from preclinical to toxicology studies, clinical development and now manufacturing. Zydus's CDMO business will operate as an independent entity and will house the acquired manufacturing capabilities, according to the statement. Further, Zydus will also 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). In addition, Zydus will have the first right of negotiation to manufacture any of the future pipeline products developed by Agenus, the statement further read. Dr Sharvil Patel, Managing Director (MD) of Zydus Lifesciences, said, 'The acquisition will give Zydus a strategic foothold in the US 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 prioritising 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.'
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Business Standard
03-06-2025
- Business
- Business Standard
Zydus enters biologics CDMO market with $125 million acquisitions
Zydus Lifesciences has announced its entry into the global biologics contract development and manufacturing organisation (CDMO) market with a planned acquisition of two manufacturing facilities from US-based Agenus for up to $125 million (around ₹1,070 crore). Under the agreement, Zydus will acquire Agenus' biologics facilities in Emeryville and Berkeley, California, for an upfront payment of $75 million (₹642 crore). It will come with an additional $50 million (₹428 crore) payable over three years, contingent upon achieving certain revenue milestones. The acquisition gives Zydus immediate biologics manufacturing capabilities and a base in California, considered a major hub for biotechnology in the US. The company said the acquired facilities would allow it to offer end-to-end services from pre-clinical development through largescale commercial manufacturing. The CDMO business will be housed under a new independent entity. As part of the transaction, Zydus will also become the exclusive contract manufacturer for two of Agenus' late-stage immuno-oncology candidates, Botensilimab and Balstilimab. It will hold the first right of negotiation for future pipeline products. The acquired facilities include an experienced professional team, which Zydus plans to expand. The company said it expects to create additional jobs and contribute to the local economy of California. Sharvil Patel, managing director, Zydus Lifesciences, said, 'The acquisition will give Zydus a strategic foothold in the US and enhance our ability to partner with innovation-centric entities, advancing new products and prioritising patient-centric solutions. This move strengthens our long-term biologics vision and positions us to better serve the needs of the global biopharmaceutical industry.' According to estimates cited by Zydus, the global biologics CDMO market is projected to grow at a compound annual growth rate (CAGR) of 15.7 per cent between 2025 and 2034, reaching around $84.9 billion by 2034. The market's growth is being driven by increasing complexity of therapies, a shift towards biologics, and limited manufacturing infrastructure among small biotech companies.
The Hindu
03-06-2025
- Business
- The Hindu
Zydus to acquire 2 biologics manufacturing units in U.S. from Agenus for $125 million
Zydus Lifesciences plans to acquire Nasdaq-listed clinical-stage immuno-oncology firm Agenus's two biologics manufacturing facilities in California, U.S. for $125 million to enter the global biologics contract development and manufacturing organization (CDMO) business. The move enables it to leverage supply chain dynamics and a favourable geopolitical environment to expand reach in the U.S. and globally. The facilities in Emeryville and Berkeley will be acquired for an upfront consideration of $75 million and contingent payment of $50 million, to be paid over three years subject to achievement of certain revenue milestone. Zydus said the acquisition, through a subsidiary, will provide access to advanced biologics manufacturing capabilities and establish a key presence in the leading global biotechnology hub of California. Also as a part of the transaction Zydus will become an exclusive contract manufacturer for Agenus and 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. Create jobs, spur local economy With the acquisition Zydus will become a one stop solution provider across the entire development spectrum of biologics, from pre-clinical to toxicology studies, clinical development to manufacturing. Zydus said it intends to further expand the team and help create new jobs in the region and contribute to the local economy. Zydus' CDMO business will operate as an independent entity and will house the acquired manufacturing capabilities. '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,' MD Sharvil Patel said. In a parallel development, Zydus Lifesciences has entered into a definitive agreement with Agenus Inc. to secure exclusive commercial rights for India and Sri Lanka for BOT and BAL.
