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12 November, 2025 |
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Max Gelman studied Pfizer and BioNTech’s respective investor presentations that showcased their PD-(L)1xVEGF bispecific plans. He finds that the race is more of a marathon than a sprint. Pivotal data are expected at the end of this decade, around the same time Keytruda goes off-patent in 2028. Check out Max’s birds-eye view of how the contest is shaping
up. |
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Reynald Castaneda |
Deputy Editor, Endpoints News
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by Max Gelman
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The competitive landscape for PD-(L)1xVEGF bispecifics is finally taking shape. For the last couple years, much of the attention has focused on Summit Therapeutics and its lead drug ivonescimab. Now, two other challengers are revving their engines, setting up a race that may shape the future of immuno-oncology. If successful, the companies could bring new
treatments to a plethora of cancer patients in the next decade. The biggest impact will likely be in areas like colorectal cancer, where PD-(L)1 checkpoint inhibitors are not widely used and some experts see untapped potential. But each bispecific will also be attempting to replace those PD-(L)1 drugs, like Merck’s $30-billion-a-year blockbuster Keytruda, in certain cancers where they’ve long been the standard. | |
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by Max Gelman
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Alkermes’ quest to develop a new narcolepsy drug became murkier on Wednesday following another Phase 2 readout. The company claimed success, noting the 18 mg high dose achieved a statistically
significant improvement in both primary endpoints after eight weeks. This 92-patient trial evaluated a drug called alixorexton in patients with narcolepsy type 2, which is typically less severe than narcolepsy type 1 but has more varied symptoms. (Alkermes presented Phase 2 data in the type 1 population earlier this year.) But Wednesday’s results were clouded by an analysis that
“precluded” researchers from determining whether the lowest dose of 10 mg reached statistical significance, executives said on a conference call. Alkermes adjusted p-values for all the data points “for multiplicity" — leading the trial's successful endpoints to approach the p<0.05 threshold, which means it is barely within what’s counted as statistically significant. | |
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by Lei Lei Wu
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Immatics is planning to advance two T cell receptor-based bispecific antibodies based on results reported Wednesday across Phase 1 trials. The company’s bispecific work
previously faced questions when Bristol Myers Squibb last year dropped its partnership on one of those drug candidates, known as IMA401. But Immatics moved forward with its bispecific plans. And with more data in hand, the biotech's shares IMTX rose 15% on Wednesday morning. The company is best known for its lead PRAME cell therapy called anzu-cel, which it is studying in several melanoma trials. On Wednesday, Immatics reported data on a bispecific antibody, called IMA402, that is also aimed at PRAME. It said 80 patients with various solid tumor cancers have received the experimental treatment at a wide range of doses. | |
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Beacon Biosignals co-founders Jarrett Revels (L) and Jacob Donoghue |
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by Lei Lei Wu
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Beacon Biosignals is seeking to build an expansive brain wave dataset to boost the study of new drugs and diagnostics for neurological diseases, and it now has $86 million in fresh funding to help reach its goals. The Boston company is home to a portable device that measures EEG data. Its Series B raise will go toward scaling up its partnerships with biopharma
companies and training AI to generate better biomarkers for neurological diseases. Drug development for neurological diseases has undergone a |
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