On September 14, 2023 Bristol Myers Squibb (NYSE: BMY) reported that it is 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 (Press release, Bristol-Myers Squibb, SEP 14, 2023, View Source [SID1234635160]).
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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.