Global pharma giant Novartis has announced a landmark agreement with Synnovation Therapeutics to acquire a next-gen breast cancer drug.

 

SNV4818, the oral drug, is pan-mutant–selective PI3Kα inhibitor aimed at treating HR+/HER2- breast cancer and potentially other solid tumors.

 

Approximately 40% of HR+/HER2- patients carry PIK3CA mutations, which can worsen prognosis. Novartis says the program complements existing CDK inhibitors and hormonal therapies, positioning it as a potential cornerstone of combination treatment regimens.

 

“While mutated PI3Kα is a well‑established driver in HR+/HER2‑ breast cancer, there remains a challenge in achieving effective pathway inhibition with a tolerable therapeutic profile,” said Shreeram Aradhye, President of Development at Novartis. 

 

“SNV4818 applies new mutant‑selective chemistry to more precisely target tumor biology while sparing normal cells. This approach has the potential to translate proven biology into improved tolerability and more durable benefit for patients through precision medicine.”

 

Unlike existing PI3Kα inhibitors, which target both mutant and wild-type enzymes and can trigger dose-limiting side effects, SNV4818 is designed to selectively attack cancerous cells while sparing healthy tissue. Preclinical studies show strong activity against common PIK3CA mutations, supporting consistent dosing and combination with hormonal therapy earlier in treatment.

 

Under the terms of the agreement, Novartis will pay $2 billion upfront and up to $1 billion in milestone payments to acquire Pikavation Therapeutics, Inc., a Synnovation subsidiary holding the SNV4818 portfolio. The transaction is expected to close in the first half of 2026, pending customary regulatory approvals.