Biontech SE and Bristol Myers Squibb Co. are teaming up to develop Biontech’s bispecific antibody targeting PD-L1 and VEGF-A, BNT-327, in a deal possibly worth over $11 billion. The companies will split development costs and potential profits for the drug that’s being tested as a treatment for first-line extensive stage small-cell lung cancer, non-small-cell lung cancer and triple-negative breast cancer. Biontech will receive $1.5 billion up front and $2 billion total in anniversary payments through 2028, and is also eligible for $7.6 billion in undisclosed development, regulatory and commercial milestone payments.

Redemption for Lyra as second phase III rhinosinusitis trial hits goal

Shares of Lyra Therapeutics Inc. were up by more than 400% at midday on data from its second phase III trial testing drug-device candidate LYR-210 in patients with chronic rhinosinusitis, with statistical significance on primary and key secondary endpoints. It’s a turnaround for the firm, which reported a miss in the first phase III study a year ago, and Lyra execs said they plan to meet with the U.S. FDA in the second half of 2025 to discuss a potential regulatory pathway. Created with a bioabsorbable mesh scaffold, LYR-210 is designed for local delivery of the corticosteroid mometasone furoate over a six-month period, with the aim of offering patients an option beyond systemic steroid and topical intranasal treatments.

Sanofi buying Blueprint and its TKI BLU-808 for $9.5B

Sanofi SA is to acquire Blueprint Medicines Inc. in a $9.5 billion deal that will give the French pharma ownership of a marketed rare disease immunotherapy heading toward blockbuster status, a follow-on product in phase II/III, and a phase II clinical program relevant to a number of autoimmune diseases. The agreed offer price of $129 per share, valuing Cambridge, Mass-based Blueprint (NASDAQ:BPMC) at $9.1 billion, is a 27% premium to the closing price on May 30 and 34% more than the average price over the past 30 days. The balance of $400 million will come in the form of contingent value rights against clinical and regulatory milestones for BLU-808, an oral selective inhibitor of the wild-type KIT tyrosine kinase receptor (TKI), which plays a central role in the mast cell activation that drives a broad range of inflammatory diseases.

ASCO 2025: Pancreatic cancer treatment progressing beyond chemotherapy

Multiple companies presented clinical trial data at the 61st American Society of Clinical Oncology (ASCO) Annual Meeting showing their drugs and devices helped patients with pancreatic cancer live longer or improved response rates. In the Panova-3 phase III study of patients with unresectable, locally advanced pancreatic adenocarcinoma, Novocure Ltd. showed that adding treatment with its tumor treating fields device to a chemotherapy regimen of gemcitabine and nab-paclitaxel improved overall survival by 2 months compared to the chemotherapy regimen alone. Likewise, Actuate Therapeutics Inc. showed its glycogen synthase kinase-3 beta inhibitor, elraglusib, when added to gemcitabine and nab-paclitaxel, improved overall survival by 2.9 months compared to the chemotherapy regimen alone in its Actuate-1801 phase II study of patients with metastatic pancreatic ductal adenocarcinoma. And Biolinerx Ltd. showed that its CXCR4 inhibitor motixafortide plus the PD-1 inhibitor Libtayo (cemiplimab, Regeneron Pharmaceuticals Inc.), gemcitabine and nab-paclitaxel produced an overall response rate of 64% compared to the historical rate of 23% for gemcitabine and nab-paclitaxel in its Chemo4metpanc phase II study of first-line treatment of pancreatic cancer.

ASCO 2025: Protagonist-Takeda, Novartis post phase III wins

More phase III data coursed through the annual American Society of Clinical Oncology conference on Sunday as Protagonist Therapeutics Inc. and Takeda Pharmaceutical Co. Ltd. led the charge with positive results for its potential blockbuster rusfertide in treating a rare leukemia. Also, Novartis AG released positive results at the massive conference from a new subgroup analysis of its phase III Natalee study of Kisqali (ribociclib) combined with endocrine therapy in treating stage II and III hormone receptor-positive/human epidermal growth factor receptor 2-negative (HR+/HER2-) early breast cancer for those at high risk of recurrence across age and menopausal status.

White House budget proposal would cut FDA, slash NIH budgets

The Trump administration released its budget proposal for fiscal year 2026, a document that is likely to receive mixed reviews on Capitol Hill as Congress ramps up its appropriations work. The U.S. FDA’s total spending numbers would fall by more than $271 million under this proposal while the National Institutes of Health would be chopped by $18 billion (roughly 40%), both of which are sure to spark a loud and strident opposition from stakeholders outside the halls of Congress.

ASCO 2025: Regeneron, Merck-Gilead drugs drop disease, death rates

New and positive phase III cancer data for two monoclonal antibodies from two pharma giants opened the second day of the American Society of Clinical Oncology conference this past weekend. Merck & Co. Inc. heralded the latest results for Keytruda (pembrolizumab) in locally advanced or metastatic triple-negative breast cancer as a potentially new frontline standard of care. Keytruda plus Gilead Sciences Inc.’s TROP2 antibody-drug conjugate Trodelvy (sacituzumab govitecan-hziy) reduced the risk of disease progression or death by 35% vs Keytruda plus chemotherapy as a first-line treatment for unresectable disease. Also, Regeneron Pharmaceuticals Inc.’s study of Libtayo (cemiplimab) hit its primary endpoint with a 68% reduction in reducing disease recurrence or death in treating high-risk cutaneous squamous cell carcinoma after surgery.

China clears Mabwell’s Mailisheng injection to treat neutropenia

Mabwell (Shanghai) Bioscience Co. Ltd. on May 30 gained Chinese approval of Mailisheng (albipagrastim alfa; 8MW-0511) as a subcutaneous (SC) injection to treat febrile neutropenia induced by myelosuppressive anticancer treatment, such as radiotherapy and chemotherapy. Mailisheng is a recombinant human serum albumin-human granulocyte colony-stimulating factor (G-CSF) fusion protein (rHSA-hG-CSF) expressed by Pichia pastoris. The SC injection was developed by Mabwell’s wholly owned subsidiary, Jiangsu T-mab Biopharma Co. Ltd. Clearance from China’s National Medical Products Administration makes Mailisheng Mabwell’s first commercialized innovative drug.

BARDA’s $375M to Shionogi for COVID-19 tops early list of 2025 grants

From January to April 2025, biopharma grants totaled $782.07 million across 110 transactions. The largest grant, after the termination of Moderna Inc.’s $590 million award from the Biomedical Advanced Research and Development Authority (BARDA), was BARDA’s award of $375 million in funding to Shionogi and Co. Ltd. to develop its S-892216 against COVID-19 infection.

Aimedbio’s ₩50B pre-IPO round to fuel new cancer missile ADCs

Samsung Medical Center spinoff Aimedbio Inc. announced raising ₩51.1 billion (US$37.15 million) in pre-IPO funding to advance its portfolio of clinical and preclinical antibody-drug conjugate (ADC) candidates. The pre-IPO round had one new investor, Mirae Asset Securities Co. Ltd., and was joined by existing investors Intervest Co. Ltd., DS Asset Management, Samsung Life Public Welfare Foundation and SMB Investment Partners Corp. The financing, announced June 2, pushes the total raised by the Seoul, South Korea-based company to ₩113.5 billion, a company spokesperson confirmed to BioWorld.

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Agenus, Avadel, Beam, Biocryst, Biolinerx, Biovaxys, Bluebird, Coherus, Diakonos, Enterome, Faron, GC, Genentech, Medicus, Merck, Naya, Novo Nordisk, Pioneer, Pfizer, Regeneron, Revelation, Roche, Ryvu, Sumitomo, Summit, Trisalus, Vima, Zymeworks