Cancer
The discontinued CAR T therapy bbT369 came to Regeneron when the pharma bought all of 2seventy bio’s pipeline assets for $5 million upfront in January 2024.
The antibody-drug conjugate, withdrawn from the market by GSK in 2022 after failing a confirmatory study, was approved Thursday by the FDA for previously treated patients with multiple myeloma. This is despite a negative advisory committee vote in July.
The deal focuses on ICT01, a monoclonal antibody being tested in acute myeloid leukemia. ImCheck is also developing assets in infectious disease and other oncology indications.
Pfizer, Merck, AstraZeneca and Bristol Myers Squibb were among the many biopharmas showing off novel cancer modalities at ESMO, with antibody-drug conjugates, bispecific antibodies and kinase inhibitors demonstrating encouraging efficacy and safety for various cancers.
For $1.2 billion upfront and up to $10.2 billion in milestones, Takeda will gain access to a bispecific antibody fusion protein targeting both the PD-1 and IL-2 pathways, among other assets.
Novo Nordisk’s leadership gets another shake-up as President Trump promises to significantly slash prices for its GLP-1 drugs; Summit/Akeso, Exelixis and more present new data at ESMO 2025; Replimune pops as FDA accepts resubmitted BLA; FDA names first winners of Commissioner’s National Priority Voucher program; and more.
With data from the Phase III STELLAR-303 study in the books, Exelixis is plotting a 2025 regulatory application for zanzalintinib.
In May, Summit released early data from the Phase III HARMONi study showing that while the PD-1/VEGF inhibitor resulted in significant progression-free survival improvements, it fell short of the overall survival bar.
To tailor cancer therapies to individual patients, Moderna, BioNTech and other companies are rethinking how they optimize manufacturing schedules and resources.
Last month, investors’ hopes were dashed as Replimune suggested alignment had not yet been reached with the FDA on RP1’s future. Now, the regulator has accepted a refiled application after all.
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