Strategic Partnership with BioNTech for PD-L1 VEGF Bispecific BNT327
BMS entered into a global strategic partnership with BioNTech to co-develop and commercialize BNT327, a potentially transformative PD-L1 VEGF bispecific therapy.
The collaboration aims to accelerate clinical trials, expedite time to market, and expand indications, with the goal of positioning BNT327 as a first or second to market in its class.
The partnership leverages BMS' expertise in immuno-oncology and BioNTech's innovation, with a focus on speed to market and broadening indications.
Initial clinical development is underway in small cell lung cancer, non-small cell lung cancer, and triple-negative breast cancer.
BD's Strategic Separation of Biosciences and Diagnostics Business
BD announced a definitive agreement to separate its Biosciences and Diagnostics business via a tax-efficient Reverse Morris Trust with Waters, expected to close around the end of Q1 2026.
The separation aims to unlock shareholder value and establish New BD as a pure-play medical technology company with over 90% consumable revenue, a strong innovation pipeline, and margin expansion.
Brooke Story has been appointed to lead the integration and separation management office, leveraging her experience as President of Diagnostics and her role in Edwards Critical Care integration.
The post-separation company is expected to benefit from enhanced capital allocation, including using at least half of the $4 billion cash from Waters for share buybacks, and will maintain a focus on margin expansion and innovation.
The transaction is progressing well, with the expected timeline and strategic benefits clearly articulated, positioning BD for long-term success.
Veracyte delivered approximately 25,500 Decipher tests in Q2, on track to exceed 100,000 tests annually, marking a significant milestone.
Decipher volume grew 28% year-over-year, with 13 consecutive quarters of over 25% growth, driven by strong execution and expanding clinical utility.
The metastatic prostate cancer test launch in June has generated increased physician interest, especially in high-risk NCCN patients, contributing to halo effects and future growth potential.
The company expects Decipher to maintain double-digit growth driven by market share gains, incidence growth, and expanding clinical evidence, including ongoing prospective trials and guideline updates.
Transition to Clinical-Stage Biotech with First Clinical Trials
AbCellera achieved a major milestone by receiving Health Canada authorization to initiate its first two clinical trials for ABCL635 and ABCL575.
Dosing has begun in the Phase I trial for ABCL635, targeting moderate to severe vasomotor symptoms, marking a shift from platform to clinical-stage biotech.
A second Phase I trial for ABCL575 was also initiated, with dosing expected to start shortly, expanding the company's clinical pipeline.
The company added a third program, ABCL688, into IND-enabling studies, indicating ongoing pipeline expansion and transition into more advanced clinical development.
Emi-Le Clinical Data Highlights and Tumor Response Rates
Mersana reported a 31% objective response rate (ORR) in evaluable patients with B7-H4 high tumor expression at ASCO 2025, with doses ranging from 38 to 67 mg/m².
In adenoid cystic carcinoma type 1 (ACC1), 4 confirmed responses and 1 unconfirmed response were observed among 9 evaluable patients, with a confirmed ORR of 56% after data cutoff.
The company emphasized Emi-Le's potential to address unmet needs in triple-negative breast cancer (TNBC) patients previously treated with topoisomerase 1 inhibitors, highlighting poor outcomes with current standard of care.
Data from the TNBC expansion cohort showed a 29% ORR in B7-H4 high patients, with median PFS of 16 weeks, suggesting promising efficacy beyond standard chemotherapy.
Mersana is progressing with dose expansion in TNBC, enrolling over 45 patients across two dosing regimens, with initial data expected in the second half of 2025.
The company believes the post-topo-1 TNBC opportunity is sizable, with Trodelvy expected to generate about $1 billion in 2025, and Emi-Le could serve as a subsequent line of therapy, especially as treatment landscapes evolve.