Botensilimab

iStock, Wirestock Cancer cocktails pairing Moderna’s mRNA-4359 with Merck’s Keytruda and Marengo’s invikafusp alfa with Gilead Sciences’ Trodelvy showed promising results, while a complex combination by Agenus and MiNK Therapeutics failed to elicit an overall response. Combinations continue to be a primary focus in cancer drug development, as researchers seek out therapeutic cocktails that target tumor cells with optimum efficiency while also mitigating side effects and potential drug resistance. Indeed, the next wave of combo therapies was on display at the American Association for Cancer Research’s annual meeting in San Diego last week. Companies including Moderna, Marengo Therapeutics and Akeso presented new data at AACR showcasing new uses for existing combinations, as well as blends of experimental therapies with tried-and-true treatments like chemotherapy and more recently approved drugs. A combination approach is “very, very important,” Zhen Su, a physician-scientist and CEO of Marengo, told BioSpace , pointing as an example to the “transformative care” now available to patients with certain types of lung cancer and multiple myeloma thanks to high-powered drug combos. “For frontline cancer, the treatment’s oftentimes a combination therapy because tumors are not easy to tackle, and sometimes you need a multi-modality approach to really hit tumors from different angles,” Su said. Such combos might include a chemotherapy or antibody-drug conjugate (ADC) that can give a tumor “a big hit from the get-go,” he said, alongside an immunotherapy capable of activating cancer-fighting T cells. When experimental meets approved At AACR, Marengo shared initial data from a Phase 2 study of invikafusp alfa, an investigational dual T cell agonist, in combination with Gilead Sciences’ ADC Trodelvy, which is FDA-approved for certain forms of heavily pretreated breast cancer. Of 10 patients with heavily pretreated metastatic breast cancer, two had confirmed complete responses to the combo, two had confirmed partial responses and six saw their disease remain stable. The drug cocktail is one of the first to combine a precision immunotherapy with a precision ADC, Su said, bringing “two of the most potent modalities into a tumor and [lighting] up a fire in their cancer.” The results so far, he continued, are a sign of “the next frontier,” an exciting new phase in the industry after his nearly three decades as a drug developer. Marengo plans to continue expanding the trial and, “if we continue to see the benefits we’re seeing,” will potentially seek FDA Fast Track designation for the combo in breast cancer before moving into a pivotal trial. Invikafusp alfa already holds the designation as a monotherapy in advanced colorectal cancer. Also unveiling combo data at AACR last week was Moderna, specifically, early results from a Phase 2 trial of its investigational antigen therapy mRNA-4359 in combination with Merck’s blockbuster immunotherapy Keytruda as a first-line treatment for locally advanced and metastatic melanoma. As of Dec. 1, 2025, two of 12 patients achieved a complete response, while eight had a partial response, for an overall response rate of 83%. Cancer AACR 2026: Moderna, Revolution, Zymeworks and BeOne showcase new data Moderna, Revolution Medicines and Zymeworks record wins in melanoma, lung and breast cancers, while BeOne swings and misses at head and neck cancer. April 21, 2026 · 4 min read · Tristan Manalac Read more There are several reasons for mRNA-4359’s promise in melanoma, David Berman, Moderna’s recently appointed chief development officer, told BioSpace via email. For one, he said, “this is a novel dual mechanism therapy where we activate T cells to kill cancer cells and recalibrate the tumor microenvironment to a more immune favorable state.” Berman also pointed to the benefits shown in a study of the combo among patients previously treated with immune checkpoint inhibitors and in late-stage data “from another company using a similar approach.” Following Monday’s AACR presentation, in a video posted to Moderna’s website, Berman called the early trial results “quite intriguing,” while noting that “it’s hard to tease apart” the contributions of each component of the drug cocktail. Therefore, the next steps will be to determine if, in the larger cohort of patients who have progressed on checkpoint inhibitors, there is sufficient reason to believe that mRNA-4359 is bringing additional activity, he said. Those data should arrive “over the next year.” In a Monday note to investors, Leerink Partners said that while the patient sample is very small, the 83% ORR “represents a promising signal,” though the analysts cautioned that it is “unlikely to garner meaningful investor enthusiasm.” Hits and misses Another promising drug is a combination of Akeso’s PD-1/CTLA-4 bispecific antibody cadonilimab with chemotherapy. The Chinese biotech is evaluating the combo in the Phase 2 Compassion-26 study as a first-line treatment for advanced cases of pancreatic ductal adenocarcinoma, the most common form of pancreatic cancer. Data presented at AACR showed an objective response rate of just under 34% and disease control rate of 96.4% among 56 patients. The drug combination appeared to be especially effective in patients with locally advanced disease, with a median overall survival rate of more than 23 months and median progression-free survival of 11.1 months, compared to 10.5 months and 7.2 months, respectively, among those with metastatic disease. “The efficacy of cadonilimab in hard-to-treat tumors is driven by its innovative molecular design and novel mechanism of action,” a company spokesperson told BioSpace via email. “It harnesses the therapeutic benefits of both PD-1 and CTLA-4 pathways while overcoming the traditional efficacy and safety limitations of each target.” This translates into breakthrough clinical value, the spokesperson continued. “For example, it addresses the toxicity challenges that have historically limited the use of CTLA-4 agents and improves response in PD-L1 low/negative populations where PD-1/L1 inhibitors often underperform.” With these attributes, Akeso’s spokesperson added, “cadonilimab is well-positioned as a backbone agent to combine with novel therapies.” Cell therapy Agenus cancer cocktail records 0% response rate, missing midstage goal An investigational cocktail was tied to a 0% overall response rate in patients with gastroesophageal cancer, but developers Agenus and MiNK Therapeutics aren’t giving up on the program just yet. April 20, 2026 · 2 min read · Gabrielle Masson Read more Less successful, meanwhile, were results from a Phase 2 study of Agenus’ experimental immunotherapies botensilimab and balstilimab plus MiNK Therapeutics’ allogeneic cell therapy agenT-797, alongside the approved VEGFR2 antagonist Cyramza and chemotherapy. The cocktail elicited a 0% response rate among the study’s 15 eligible gastroesophageal adenocarcinoma patients. Despite missing the study’s primary endpoint, Agenus remained optimistic, suggesting in an April 17 press release that the secondary factors of durability and survival may in fact “be the most clinically relevant endpoints” among the study’s particular population. The combo was tied to a 73% stable disease rate, while three patients experienced overall survival of more than 20 months. .responsive-container { display: flex; flex-wrap: wrap; border: 1px solid #ededed; font-family: Helvetica, Arial, Sans-Serif; padding: 20px 20px 10px 20px; } .column-left { flex: 1; max-width: 45%; padding: 20px 20px 10px 20px; } .column-right { flex: 2; padding: 20px 20px 10px 20px; } @media (max-width: 768px) { .column-left, .column-right { max-width: 100%; flex: 100%; padding: 10px 0; } } Subscribe to ClinicaSpace! Clinical trial results, research news, the latest in cancer, cell and gene therapy hbspt.forms.create({ region: "na1", portalId: "4413123", formId: "674f4dc0-7371-4190-86cc-e1afd00b08ea", onFormSubmitted: function($form, data) { window.dataLayer = window.dataLayer || []; window.dataLayer.push({ 'event': 'GTMevent', 'event_name': 'newsletter_sign_up' }); } });

Four abstracts accepted across melanoma, colorectal cancer, and translational research LEXINGTON, Mass.--(BUSINESS WIRE)--Agenus Inc. (Nasdaq: AGEN), a leader in immuno-oncology innovation, today announced that four abstracts highlighting botensilimab (BOT), alone or in combination with balstilimab (BAL), have been accepted for presentation at the 2026 American Society of Clinical Oncology (ASCO) Annual Meeting, taking place May 29–June 2, 2026, in Chicago, Illinois. The accepted abstracts reflect continued progress of Agenus’ botensilimab and balstilimab immunotherapy program across colorectal cancer, melanoma, and translational research. They include the first presentation of Phase 2 clinical data for BOT with or without BAL in advanced cutaneous melanoma refractory or resistant to anti–PD-(L)1 therapy, with or without prior CTLA-4 inhibition, as well as a translational biomarker abstract evaluating an artificial intelligence foundation model in solid tumors and two trials-in-progress posters in colorectal cancer. “Our presence at ASCO reflects strong momentum across the botensilimab and balstilimab program. From the first Phase 2 melanoma presentation to important colorectal cancer trial updates and innovative translational biomarker research, these presentations underscore our focus on delivering new immunotherapy options to patients who need them most,” said Garo H. Armen, PhD, Chairman and CEO of Agenus. Presentation Details: Abstract Title: Botensilimab (BOT) ± balstilimab (BAL) in patients (pts) with advanced cutaneous melanoma (cMEL) refractory/resistant (R/R) to anti–PD-(L)1 ± CTLA-4: A phase 2 trial Abstract No.: 9543 Presenter: Michael Atkins MD; Georgetown Lombardi Comprehensive Cancer Center, Georgetown University Medical Center Session Title: Poster Session – Melanoma/Skin Cancers Location: Hall A – Posters and Exhibits Poster Board: 259 Date/Time: May 31, 2026, 9:00 AM–12:00 PM CDT Abstract Title: Artificial intelligence (AI) foundation model as a predictor of efficacy of next-generation checkpoint inhibition with botensilimab (BOT) + balstilimab (BAL) in solid tumors using pretreatment H&E images Abstract No.: 2535 Presenter: Ryan Dalton, Noetik Session Title: Poster Session – Developmental Therapeutics—Immunotherapy Location: Hall A – Posters and Exhibits Poster Board: 325 Date/Time: May 30, 2026, 1:30 PM–4:30 PM CDT Abstract Title: The CO.33/BATTMAN trial: A phase 3 randomized study of botensilimab + balstilimab versus best supportive care in chemo refractory unresectable colorectal adenocarcinoma that is not dMMR/MSI-H Abstract No.: TPS3676 Presenter: Jonathan Loree MD; BC Cancer; Canadian Cancer Trials Group, Queen’s University Session Title: Poster Session – Gastrointestinal Cancer—Colorectal and Anal Location: Hall A – Posters and Exhibits Poster Board: 441a Date/Time: May 30, 2026, 9:00 AM–12:00 PM CDT Abstract Title: Phase 2 study of adjuvant botensilimab in combination with balstilimab in patients with microsatellite-stable colorectal cancer and persistent circulating tumor DNA following surgery and chemotherapy Abstract No.: TPS3689 Presenter: Neil Segal, MD; Memorial Sloan Kettering Cancer Center Session Title: Poster Session – Gastrointestinal Cancer—Colorectal and Anal Location: Hall A – Posters and Exhibits Poster Board: 447b Date/Time: May 30, 2026, 9:00 AM–12:00 PM CDT 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. 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 multifunctional anti-CTLA-4 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 1,200 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. 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 more than 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 2025, 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.