Botensilimab

Study to evaluate safety and anti-tumoral activity of anti-FcgRIIB antibody BI-1607 with anti-CTLA-4: ipilimumab, in combination with MSD's (Merck & Co., Inc., Rahway, NJ, USA)( anti-PD-1 therapy, KEYTRUDA® (pembrolizumab); initial data expected in H2 2025Data from Phase 1 study in combination with trastuzumab previously demonstrated BI-1607 is safe, well tolerated and achieves full receptor occupancy during the treatment interval at several dose levels; preclinical data show BI-1607 enables lower anti-CTLA-4 dosing with improved survivalClinical supply agreement for KEYTRUDA® in place with MSDLUND, SE / ACCESSWIRE / December 12, 2024 / BioInvent International AB ("BioInvent") (Nasdaq Stockholm:BINV), a biotech company focused on the discovery and development of novel and first-in-class immune-modulatory antibodies for cancer immunotherapy, today announces it has enrolled the first patient in the Phase1b/2a study evaluating the safety and anti-tumoral activity of its second FcyRIIB-blocking antibody BI-1607 in combination with ipilimumab and KEYTRUDA® (pembrolizumab) in patients with unresectable or metastatic melanoma.The study will incorporate four cohorts in which two different dose levels of BI-1607 will be tested with two different dose levels of the CTLA-4 antibody ipilimumab, 3 mg/kg, approved for the treatment of melanoma, and the lower dose 1 mg/kg, in combination with a 200 mg flat dose of pembrolizumab in patients with unresectable or metastatic melanoma previously treated with anti-PD-1/L1.Approximately 35 patients will be enrolled in 10 to 12 sites located in the UK, Germany and Spain with first data expected in H2 2025. In July 2024, BioInvent signed a clinical supply agreement with MSD International Business GmbH, a subsidiary of Merck & Co., Inc., Rahway, NJ, USA to provide KEYTRUDA for use in the study."The early data delivered so far by our BI-1607 program have been highly promising and we are very pleased to be advancing the asset's development with this new study," said Martin Welschof, Chief Executive Officer of BioInvent. "We have shown BI-1607 to be safe and well tolerated with signs of early clinical activity in Phase 1 evaluation in combination with trastuzumab. Additionally, our preclinical data also indicate that a regimen including BI-1607 could allow the use of lower doses of ipilimumab, potentially achieving increased tolerability and higher efficacy. We are looking forward to exploring the huge potential of this combination further and preliminary data from the study expected next year."BI-1607 is an engineered antibody that can be viewed as a platform to enhance efficacy and overcome resistance to existing cancer treatments, such as targeted monoclonal antibodies and immune checkpoint inhibitors. In December 2023, BioInvent presented first clinical data from the Phase 1 dose escalation study evaluating BI-1607 in combination with trastuzumab in subjects with HER2+ advanced solid tumors. The data demonstrated that the treatment was well tolerated, and no serious adverse events related to BI-1607 were observed. Stabilization of the disease was observed in 7 patients. Previously in 2021, BioInvent announced preclinical proof-of-concept data showing the ability of BI-1607 to overcome resistance to CTLA-4-based therapy.KEYTRUDA® is a registered trademark of Merck Sharp & Dohme LLC, a subsidiary of Merck & Co., Inc., Rahway, NJ, USA.About BioInventBioInvent International AB (Nasdaq Stockholm: BINV) is a clinical-stage biotech company that discovers and develops novel and first-in-class immuno-modulatory antibodies for cancer therapy, with currently five drug candidates in six ongoing clinical programs in Phase 1/2 trials for the treatment of hematological cancer and solid tumors. The Company's validated, proprietary F.I.R.S.T™ technology platform identifies both targets and the antibodies that bind to them, generating many promising new immune-modulatory candidates to fuel the Company's own clinical development pipeline and providing licensing and partnering opportunities.The Company generates revenues from research collaborations and license agreements with multiple top-tier pharmaceutical companies, as well as from producing antibodies for third parties in the Company's fully integrated manufacturing unit. More information is available at www.bioinvent.com . Follow us on the social media platform X: @BioInvent.For further information, please contact:Cecilia Hofvander, VP Investor RelationsPhone: +46 (0)46 286 85 50Email: [email protected]BioInvent International AB (publ)Co. Reg. No. Org nr: 556537-7263Visiting address: Ideongatan 1Mailing address: 223 70 LUNDPhone: +46 (0)46 286 85 50www.bioinvent.comThe press release contains statements about the future, consisting of subjective assumptions and forecasts for future scenarios. Predictions for the future only apply as the date they are made and are, by their very nature, in the same way as research and development work in the biotech segment, associated with risk and uncertainty. With this in mind, the actual outcome may deviate significantly from the scenarios described in this press release.AttachmentsBioInvent announces first patient enrolled in Phase 1b/2a study of BI-1607 in combination with ipilimumab and KEYTRUDA (pembrolizumab) in patients with unresectable or metastatic melanomaSOURCE: BioInvent International

LEXINGTON, Mass.--( BUSINESS WIRE )--Agenus Inc., a leader in immuno-oncology, today announced further details of its strategic realignment aimed at streamlining operations, strengthening its financial position, and prioritizing the advancement of its most impactful programs as it prepares for 2025. Reductions are designed to reduce cash burn to $100 million in FY 2025. This initiative follows the successful closing of a $22 million mortgage secured by key real estate assets, providing the company with enhanced operational flexibility during this pivotal period. Key Measures Include: Focusing on BOT/BAL : Agenus will concentrate its resources on its lead botensilimab/balstilimab (BOT/BAL) program, which has demonstrated robust clinical activity in microsatellite stable colorectal cancer (MSS CRC), non-small cell lung cancer (NSCLC), pancreatic cancer, sarcoma, and other difficult-to-treat cancers. Reducing Costs : The company will implement significant cost-cutting measures, including staff reductions and operational adjustments, targeting a 60% reduction in annual expenditures and a cash burn of $100 million for FY 2025. Optimizing Expert Manufacturing Capabilities : Agenus plans to transition its biologics CMC capabilities to a fee-for-service model, unlocking new revenue opportunities. This initiative is intended to be supported by external funding. “These adjustments are necessary to position Agenus for success in a challenging biotech environment,” said Dr. Garo Armen, Chairman and CEO of Agenus. “We remain committed to advancing BOT/BAL for patients with cancers that have limited or no treatment options.” BOT/BAL continues to demonstrate potential across multiple cancer types, particularly MSS CRC, a cancer historically unresponsive to existing treatments. Agenus is advancing BOT/BAL through clinical development and preparing for global regulatory submissions. Supporting Employees Agenus is grateful to the contributions of all our team members and will be providing support and assistance to affected employees to help with their transitions, reflecting the company’s appreciation for their contributions. 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 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.