BMS-986158

At its R&D day on Thursday, Bristol Myers Squibb revealed that it intends to double its registrational pipeline from six to 12 new assets over the next 18 months. The company also indicated that cell therapy and targeted protein degradation platforms will take centre stage, offering the potential to expand treatment options across several therapeutic areas."We are seeing the impact of our focused efforts to strengthen our R&D engine and pipeline as we've executed against our priorities over the past four years," said Giovanni Caforio, who is set to retire from the role in November. "We are well-positioned to deliver more medicines to patients even faster in the future," he added.The pipeline update comes as Bristol Myers Squibb faces pressure from declining demand for Revlimid (lenalidomide) and Eliquis (apixaban), which face generic competition. The latter, which is partnered with Pfizer, also recently landed on the list of 10 drugs that will be subject to the first-ever price negotiations by the US Medicare programme.Three cell therapies that target immune disorders, cancerCandidates seen advancing include the CD19-directed NEX-T cell therapy BMS-986353, which Bristol Myers Squibb said it intends to move into clinical trials for immunologic diseases such as severe refractory systemic lupus erythematosus (SLE). BMS-986353 expresses the same CD19-specific CAR construct as Breyanzi (lisocabtagene maraleucel), but with a "differentiated safety profile" and enhanced manufacturing process, the company noted. Data from a Phase I trial in SLE is anticipated in 2024.Two other assets – the CAR-T BMS-986393, which is a potential first cell therapy targeting GPRC5D, and the BCMAxCD3 T-cell engager alnuctumab – are advancing into registrational testing for relapsed/refractory multiple myeloma, the latter in Phase III. The protein degrader golcadomide is also moving into Phase III next year for first-line large B-cell lymphoma.Meanwhile, a first asset from Bristol Myers Squibb's ligand-directed protein degradation platform, an androgen receptor degrader, is moving into pivotal studies in metastatic castration-resistant prostate cancer, while the BET inhibitor BMS-986158 for myelofibrosis is awaiting proof-of-concept data early next year.These would add to a batch of six candidates already in registrational trials, including the ROS1 inhibitor repotrectinib, which is currently under priority review at the FDA for non-small-cell lung cancer (NSCLC), with a decision date set for November 27. Protein degraders iberdomide and mezigdomide are both in registrational trials for second-line-plus multiple myeloma, with first data expected in 2026.The company is also developing the anti-IL-13 asset cendakimab for eosinophilic esophagitis, and milvexian in secondary stroke prevention, acute coronary syndrome and atrial fibrillation in collaboration with Johnson & Johnson. Meanwhile, Bristol Myers Squibb on Thursday also outlined Phase III trials for its LPA1 antagonist BMS-986278 in idiopathic pulmonary fibrosis and progressive pulmonary fibrosis that will evaluate both the 60mg and 120mg doses of the drug. 

Registrational assets expected to double from six to 12 over next 18 months Cell Therapy and Targeted Protein Degradation platforms offer potential to expand treatment options across multiple therapeutic areas Enhanced approach to R&D expected to drive top-tier productivity PRINCETON, N.J.--(BUSINESS WIRE)-- Bristol Myers Squibb Company (NYSE: BMY) is today holding a Research and Development (R&D) Day in New York to discuss the company’s R&D strategy and capabilities and to provide insight into its robust pipeline supporting long-term sustainable growth. Members of the company’s leadership team will also highlight its differentiated research platforms and enhanced R&D framework, which are expected to drive top-tier productivity that delivers high quality early-stage candidates and meaningfully accelerates R&D timelines. “We are seeing the impact of our focused efforts to strengthen our R&D engine and pipeline as we’ve executed against our priorities over the past four years,” said Giovanni Caforio, M.D., board chair and CEO, Bristol Myers Squibb. “By combining the best assets, capabilities and platforms within our company, we are well-positioned to deliver more medicines to patients even faster in the future.” “Science and innovation derived from research and development are critical to the continued success of our company and represent the core of Bristol Myers Squibb’s vision to transform patients’ lives,” said Chris Boerner, Ph.D., executive vice president and chief operating officer, Bristol Myers Squibb. “We are further enhancing our R&D engine to strengthen scientific leadership, accelerate our promising pipeline and drive increased productivity. This work is a key enabler of our goal of delivering long-term sustainable growth and ensuring we help more patients prevail over serious diseases.” Strengthening Scientific Leadership and Advancing Promising Pipeline The company expects to double the number of registrational assets over the next 18 months from six to 12. Key pipeline updates for the newly anticipated registrational assets include: CD19-directed NEX T cell therapy BMS-986353, expanding into clinical trials for immunologic diseases, including severe, refractory systemic lupus erythematosus. Potential first cell therapy targeting GPRC5D, our CAR T BMS-986393, starting a registrational trial in relapsed/refractory multiple myeloma (RRMM). BCMA x CD3 T-cell engager, alnuctumab, advancing into a Phase 3 trial for RRMM. Potential first-in-class protein degrader, golcadomide, progressing into a Phase 3 trial in first-line large B-cell lymphoma. The first asset from BMS’ novel ligand-directed protein degradation platform, androgen receptor degrader, moving into pivotal studies in metastatic castration-resistant prostate cancer. Potential best-in-class BET inhibitor, BMS-986158, for myelofibrosis expecting proof-of-concept data. This complements six assets already in registrational trials: Repotrectinib, a potential best-in-class ROS1 inhibitor with a U.S. FDA PDUFA goal date of November 27, 2023. Iberdomide and mezigdomide, protein degraders in registrational trials with first data expected in 2026. Cendakimab, an anti-IL-13 asset in eosinophilic esophagitis. BMS-986278, our first-in-class LPA1 antagonist, with potential to become the new standard of care in idiopathic pulmonary fibrosis and progressive pulmonary fibrosis. Today, the company outlined Phase 3 trials in each disease that will evaluate both 60mg and 120mg doses of this potentially important medicine for patients. Milvexian in secondary stroke prevention, acute coronary syndrome and atrial fibrillation, in collaboration with Janssen Pharmaceuticals Inc., one of the Janssen Pharmaceutical Companies of Johnson & Johnson. In addition to its growing registrational portfolio, the company has more than 25 indication expansion opportunities on the horizon and nine, high-potential early assets expected to advance in the pipeline. Taken together, this leads to increased depth across the company’s therapeutic areas, including oncology, hematology, immunology, cardiovascular and a growing presence in neuroscience. “The work we’re undertaking to accelerate our clinical pipeline and extend scientific leadership across therapeutic areas make it an incredibly exciting time to be a part of this company and our R&D organization,” said Samit Hirawat, M.D., executive vice president and chief medical officer, Drug Development, Bristol Myers Squibb. “Our integrated approach to R&D will allow us to maximize innovation and get more medicines to more patients faster.” Differentiated Research Platforms Support Long-Term Growth The company is uniquely positioned with differentiated research platforms including Cell Therapy and Targeted Protein Degradation supporting its innovative work across therapeutic areas. Building on our leadership in Cell Therapy BMS is the only company with two cell therapies approved against two distinct targets, exhibiting growing leadership in the space with strong positioning at the center of the innovation ecosystem. The company is expanding manufacturing capacity, exploring innovative technologies such as dual-targeting CARs and allogenic approaches, advancing multiple next-generation assets including new targets. BMS is also rapidly expanding into immunology, including lupus and multiple sclerosis. Expanding to new targets with Targeted Protein Degradation The company has a strong legacy in the protein degradation field and has been advancing its pipeline with an expansive library of assets spanning molecular glues, ligand-directed degraders and antibody drug conjugates. With three assets in registrational trials, four others in the clinic and more than 15 being studied pre-clinically, this growing platform has potential across several diseases, and is positioned to deliver approximately four investigational new drugs (INDs) each year. Enhancing R&D Productivity and Bringing Treatments to Patients Faster The company is undertaking efforts to further increase and sustain the productivity of its R&D engine, enabling an approach to research and development that will allow it to identify higher-quality candidates with increased probability of making it to market. Moving forward, BMS is focused on three objectives for establishing and sustaining top-tier R&D productivity: Driving toward approximately 10 INDs per year. Increasing success rates from first-in-human to approval to approximately 20%. Reducing research and drug development timelines to achieve a median of 6.5 years from first-in-human to approval. “Bristol Myers Squibb is committed to harnessing our integrated R&D approach to deliver high-quality assets with an increased chance of success based on a deep understanding of causal human biology,” said Robert Plenge, M.D., Ph.D., executive vice president and chief research officer. “Our research strategy will enable us to increase the number and quality of potentially transformational early-stage candidates, leveraging our differentiated research platforms, and accelerate the path from proof-of-concept to regulatory approval.” R&D Day takes place at 9 a.m. ET today and will be available via live webcast here. About Bristol Myers Squibb Company Bristol Myers Squibb is a global biopharmaceutical company whose mission is to discover, develop, and deliver innovative medicines that help patients prevail over serious diseases. For more information about Bristol Myers Squibb, visit us at BMS.com or follow us on LinkedIn, Twitter, YouTube, Facebook, and Instagram. Cautionary Statement Regarding Forward-Looking Statements This press release contains statements about Bristol-Myers Squibb Company’s (the “Company”) future financial results, plans and strategy, business development strategy, anticipated clinical trials, results and regulatory approvals that constitute forward-looking statements for purposes of the safe harbor provisions under the Private Securities Litigation Reform Act of 1995. These statements may be identified by the fact they use words such as “should,” “could,” “expect,” “anticipate,” “estimate,” “target,” “may,” “project,” “guidance,” “intend,” “plan,” “believe,” “will” and other words and terms of similar meaning and expression in connection with any discussion of future operating or financial performance, although not all forward-looking statements contain such terms. 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