Novartis has entered into an agreement with Synnovation Therapeutics to acquire SNV4818, a pan-mutant?selective PI3Kα inhibitor, exploring a next-generation approach for the treatment of patients with HR+/HER2- breast cancer and potentially other solid tumour indications.

Under the terms of the agreement, Novartis will pay USD 2 billion upfront and up to USD 1 billion in milestone payments to Synnovation Therapeutics, LLC to acquire Pikavation Therapeutics, Inc., a wholly-owned subsidiary of Synnovation that holds a portfolio of pan-mutant selective PI3Kα inhibitor programmes, including SNV4818. The transaction is expected to close in H1 2026, subject to the satisfaction or waiver of customary closing conditions, including regulatory approvals.

 “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. SNV4818 applies new mutant?selective chemistry to more precisely target tumour 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,” said Shreeram Aradhye, MD, President of Development, Novartis.

SNV4818 is an oral drug currently being evaluated in a phase-I/II study for breast cancer and other advanced solid tumours. The biology of mutated PI3Kα in HR+/HER2- breast cancer is well-understood, with approximately 40 percent of HR+/HER2- breast cancer patients potentially facing worse disease prognosis due to the presence of PIK3CA mutations in their tumours. The programme is aligned with the Novartis commitment to develop treatments that improve the lives of patients with breast cancer. It fits naturally alongside CDK inhibitors as well as endocrine (hormonal) therapies as part of a potential combination regimen.

The drug is designed to target the mutated PI3Kα enzyme found in cancer cells while sparing the wild-type (normal) PI3Kα in healthy cells. Available PI3Kα inhibitors block both mutant and wild-type PI3Kα, leading to tolerability challenges that make it difficult to keep patients on treatment. By focusing on the mutated form in tumours, SNV4818 aims to reduce unwanted side effects, support more consistent dosing, and make it easier to combine with hormonal therapy and other treatments earlier in care. Pre-clinical studies show strong activity against common PIK3CA mutations and clear selectivity over the normal enzyme, with clinical evaluation ongoing.