Evaxion reports durable responses; Novartis halts kidney trial; AstraZeneca signs AI deal

Evaxion reports sustained cancer vaccine responses at three years: Denmark’s Evaxion said all six patients in a Phase 2 extension maintained their responses without tumor progression after three years. The advanced melanoma patients received personalized peptide vaccine EVX-01 alone during the third year, following two years alongside Keytruda. The original 16-patient trial reported a 75% response rate with 25% of patients obtaining a complete response. The durability signal is encouraging, but the extension included only six of the 12 responders. Further findings will be presented at ESMO on October 24. Evaxion’s shares jumped 21.6% on Monday following the company’s announcement.

Novartis stops the next stage of its Fabhalta kidney trial: The Swiss pharma group will not proceed to the second part of a Phase 2 study testing Fabhalta in lupus nephritis, an autoimmune complication that damages the kidneys. The company told Fierce Pharma the decision reflected strategic considerations and was not driven by interim efficacy or safety findings. Future development will depend on data from the completed first part. Fabhalta already has approvals in other kidney diseases, while Novartis continues to pursue lupus nephritis through a late-stage study of its antibody ianalumab.

AstraZeneca pays $40 million upfront for an insitro AI partnership: The UK-based drugmaker will work with U.S. biotech insitro to discover targets and develop treatments for metabolic dysfunction-associated steatohepatitis, an inflammatory liver disease, and cardiomyopathies, which affect heart muscle. Insitro will combine human and cellular data through its Virtual Human AI platform, advancing selected targets toward development candidates. AstraZeneca receives exclusive worldwide rights to selected programs and will lead clinical development. Insitro could receive approximately $1.46 billion in additional development and commercial milestones, plus royalties, depending on future progress.

Verdiva drops its GLP-1 switching trial: The U.K. biotech has terminated a Phase 2 study testing whether its weekly oral GLP-1 candidate VRB-101 could maintain weight loss after patients switched from injectable drugs. The trial enrolled eight of a planned 120 participants before ending in September. Verdiva told Fierce Biotech it had refined development plans in response to market changes. The company, which launched with a $410 million Series A in 2025, continues to develop VRB-101 as a standalone treatment and assess its potential alongside its amylin portfolio.

Modus pauses enrollment after a serious adverse event: Sweden’s Modus Therapeutics voluntarily paused recruitment in the second part of its Phase 2a sevuparin study in chronic kidney disease with anemia. A patient’s serious adverse event was reported as a suspected unexpected serious adverse reaction, meaning a link to treatment cannot be excluded but has not been established. The pause was not ordered by regulators, and no other patient was receiving treatment at the time. Modus now expects proof-of-concept results in the first quarter of 2027, rather than around year-end. The stock lost almost half of its value following the announcement.

Sanofi selects its first development candidate from Recursion: The French big pharma has exercised an option on an oral immunology candidate discovered through its collaboration with US-based Recursion, triggering a $10 million milestone payment. The molecule targets two proteins implicated in inflammatory disease, although the targets and intended indication were not disclosed. Sanofi will fund and lead further development, with Phase 1 testing planned for 2027. The selection marks progress from AI-assisted discovery toward clinical testing, but human validation remains ahead. Recursion could receive more than $300 million in additional program milestones, plus royalties.