Novartis signs a $3 billion deal to acquire Synnovation Therapeutics’ PI3Kα inhibitor SNV4818, a Phase 1/2 therapy targeting PIK3CA-mutant HR+/HER2- breast cancer and other solid tumors.
Written By: Marka Sheshi PharmD
Reviewed By: Pharmacally Editorial Team
Novartis has entered into an agreement to acquire the investigational PI3Kα inhibitor SNV4818 from Synnovation Therapeutics, a biotechnology company based in San Diego, California, USA, strengthening its pipeline of targeted therapies for breast cancer and other solid tumors.
The deal includes the acquisition of Pikavation Therapeutics, a wholly owned subsidiary of Synnovation that holds a portfolio of next-generation pan-mutant selective PI3Kα inhibitor programs. SNV4818, the lead asset, is currently being evaluated in a Phase 1/2 clinical study in patients with advanced solid tumors, including HR-positive/HER2-negative breast cancer.
The investigational oral therapy, SNV4818, is currently in a Phase 1/2 clinical study (NCT06736704). It is designed to selectively target mutated PI3Kα enzymes that drive tumor growth while sparing the normal (wild-type) PI3Kα found in healthy cells. This mutant-selective approach aims to address a key limitation of currently available PI3K inhibitors, which often inhibit both mutant and normal enzymes, leading to tolerability issues that limit long-term treatment.
Mutations in the PIK3CA gene occur in approximately 40% of HR+/HER2- breast cancer cases and are associated with poorer disease outcomes. By focusing specifically on the mutated enzyme, SNV4818 may enable more sustained pathway inhibition, improved tolerability, and greater flexibility for use in combination with endocrine therapies and CDK inhibitors earlier in treatment.
“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. He noted that SNV4818 applies mutant-selective chemistry designed to more precisely target tumor biology while sparing normal cells, potentially enabling more durable benefit for patients through precision medicine.
Preclinical studies have demonstrated strong activity of SNV4818 against common PIK3CA mutations and high selectivity over the normal PI3Kα enzyme. Clinical evaluation is ongoing to determine its safety and efficacy in patients with breast cancer and other solid tumors.
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 wholly owned subsidiary of Synnovation that houses the company’s portfolio of pan-mutant selective PI3Kα inhibitor programs, including SNV4818.
The transaction is expected to close in the first half of 2026, subject to customary closing conditions and regulatory approvals.
References
Novartis. Novartis agrees to acquire a pan-mutant-selective PI3Kα inhibitor, strengthening its breast cancer pipeline. 2026. Available from: https://www.novartis.com/news/media-releases/novartis-agrees-acquire-pan-mutant-selective-pi3ka-inhibitor-strengthening-its-breast-cancer-pipeline
ClinicalTrials.gov. Study of SNV4818 in advanced solid tumors (Phase I/II), Clinical Trial ID NCT06736704, https://clinicaltrials.gov/study/NCT06736704
About the Writer
Marka Sheshi | Doctor of Pharmacy
Driven by a deep commitment to clinical excellence, research integrity, and impactful medical writing. With a strong foundation in pharmacotherapy and patient safety, specializes in transforming complex scientific evidence into authoritative, publication-ready content. Passionate about advancing healthcare through precise, evidence-based communication that informs practice, strengthens research visibility, and improves patient outcomes.