Novartis has entered into an agreement with Synnovation Therapeutics LLC 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 tumor indications.

Under the terms of the agreement, Novartis will pay $2 billion upfront and up to $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 programs, including SNV4818.

SNV4818 is an oral drug currently being evaluated in a Phase 1/2 study for breast cancer and other advanced solid tumors. It 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 tumors, 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. Preclinical studies show strong activity against common PIK3CA mutations and clear selectivity over the normal enzyme, with clinical evaluation ongoing.

“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, M.D., 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.”

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