Welcome to this week’s edition of the Life Sciences Voice Top Five Newsletter, your go-to source for the latest breakthroughs in the life sciences industry! This time, we’re looking at the successful phase 3 results from Moderna’s influenza vaccine candidate trial, Argenex’s and Unnatural’s $1.5 billion deal, BerGenBio and Oncoinvent’s merger, and more! Stay informed and inspired by the innovations driving life sciences forward.
Moderna’s mRNA-1010 Flu Vaccine Shows Higher Efficacy in Phase 3 Trial
Moderna’s mRNA-1010 influenza vaccine candidate demonstrated 26.6% greater efficacy than a licensed standard-dose flu vaccine in a phase 3 trial of 40,805 participants aged 50 and older across 11 countries. Efficacy by strain included 29.6% for A/H1N1, 22.2% for A/H3N2, and 29.1% for B/Victoria. The vaccine showed 27.4% efficacy in adults 65 and older. Safety results were consistent with prior data, with mild adverse reactions. These findings follow earlier improvements over GSK’s Fluarix and align with Moderna’s goal of a flu-COVID combination vaccine. No updated launch timeline was announced, though regulatory discussions are ongoing.
Argenx and UNP Partner on Macrocyclic Peptide Drug Development
Argenx has formed a collaboration with Unnatural Products (UNP) to develop macrocyclic peptides for difficult biological targets, with the agreement including up to $1.5 billion in potential payments tied to milestones and option fees. UNP will lead early-stage research using its proprietary discovery platform, while Argenx holds the option to advance selected candidates through clinical development and commercialization. Disease targets remain undisclosed. UNP is also eligible for royalties and will receive a strategic equity investment from Argenx. The platform aims to address limitations in macrocyclic drug development, an area gaining renewed pharmaceutical interest despite historic technical challenges.
BerGenBio to Merge with Oncoinvent Following Bemcentinib Setback
BerGenBio will merge with Oslo-based Oncoinvent after discontinuing its lead oncology drug, bemcentinib, due to unsatisfactory phase 2 trial results in non-small cell lung cancer. Under the merger, Oncoinvent shareholders will own 75% and BerGenBio shareholders 25% of the new entity, which will operate as Oncoinvent and focus on its lead radiopharmaceutical candidate, Radspherin. The deal values Oncoinvent at 195.6 million kroner and BerGenBio at 65 million kroner. Radspherin, in a phase 2 trial for peritoneal cancer, will receive 45 million kroner in additional funding, with a 130 million kroner rights offering planned to extend development into 2027.
Atai and Beckley Merge Following Positive Phase 2b Results for Psychedelic Depression Treatment
Atai Life Sciences will merge with Beckley Psytech after Beckley’s intranasal psychedelic candidate, BPL-003, showed significant antidepressant effects in a Phase 2b trial for treatment-resistant depression. The trial tested 8 mg and 12 mg doses of mebufotenin (5-MeO-DMT) in 193 patients, with both doses achieving statistically significant MADRS score reductions by Day 29. Improvements appeared within one day and persisted for eight weeks. No serious safety issues were reported. The merged entity, Atai Beckley, will focus on short-duration psychedelic therapies. The merger follows a broader trend of renewed clinical interest in regulated psychedelic-based mental health treatments.
Amgen’s Bemarituzumab Shows Survival Benefit in Phase 3 Gastric Cancer Trial
Amgen reported that its monoclonal antibody bemarituzumab, combined with chemotherapy, achieved a statistically significant improvement in overall survival for patients with advanced gastric or gastroesophageal junction cancer in the phase 3 Fortitude-101 trial. The study involved 547 patients across 37 countries with FGFR2b-overexpressing, non-HER2-positive tumors. Specific survival data were not disclosed. Adverse events included visual impairment, corneal issues, anemia, and nausea, with ocular events more frequent and severe in the bemarituzumab group. Zai Lab, which holds regional rights, plans to submit the therapy for regulatory review in China. Additional trial results will be presented later in 2024.
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