RAE346 / Novartis - LARVOL DELTA

Novartis today announced that it 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. (Novartis Press Release) - "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 programs, including SNV4818. The transaction is expected to close in H1 2026, subject to the satisfaction or waiver of customary closing conditions, including regulatory approvals."

M&A • HER2 Negative Breast Cancer • Hormone Receptor Positive Breast Cancer • Solid Tumor

SNV4818 in Participants With Advanced Solid Tumors (clinicaltrials.gov) - P1/2 | N=320 | Recruiting | Sponsor: Pikavation Therapeutics, Inc. | Phase classification: P1 ➔ P1/2 | N=140 ➔ 320 | Trial completion date: Dec 2026 ➔ Jun 2027 | Trial primary completion date: Oct 2026 ➔ Apr 2027

Enrollment change • Monotherapy • Phase classification • Trial completion date • Trial primary completion date • Oncology • Solid Tumor • PIK3CA

Synnovation Therapeutics Announces Second Program to Enter the Clinic: First Patient Dosed in Phase I Trial with SNV4818, a Potential Best-In-Class Pan-Mutant-Selective PI3Kα Inhibitor for the Treatment of Solid Tumors (Businesswire) - "Synnovation Therapeutics...announced that the first patient has been dosed in a Phase I trial evaluating SNV4818 as a monotherapy and in combination with fulvestrant, in patients with breast cancer and other solid tumors. The SNV4818 Phase I trial, which is being led by Timothy Yap, M.D., Ph.D., Professor of Investigational Cancer Therapeutics at the University of Texas MD Anderson Cancer Center, is designed to evaluate the safety, tolerability and preliminary efficacy of SNV4818 as a monotherapy in tumor agnostic patients with PI3Kα activating mutations as well as in combination with fulvestrant in HR+/HER2- advanced breast cancer patients."

Trial status • HER2 Negative Breast Cancer • Hormone Receptor Positive Breast Cancer • Solid Tumor

SNV4818 in Participants with Advanced Solid Tumors (clinicaltrials.gov) - P1 | N=140 | Recruiting | Sponsor: Synnovation Therapeutics, Inc. | Not yet recruiting ➔ Recruiting

Enrollment open • Monotherapy • Oncology • Solid Tumor

SNV4818 in Participants with Advanced Solid Tumors (clinicaltrials.gov) - P1 | N=140 | Not yet recruiting | Sponsor: Synnovation Therapeutics, Inc.

Combination therapy • Metastases • Monotherapy • New P1 trial • Oncology • Solid Tumor

Synnovation Therapeutics Launches with $102 Million to Advance Clinical-Stage Pipeline of Precision Therapies Targeting Highly Validated Disease Pathways (Businesswire) - "Synnovation Therapeutics...launched today with a $102 million Series A. The financing was led by Third Rock Ventures with participation from Nextech, Lilly Asia Ventures, Sirona Capital and Cormorant Asset Management....Proceeds will fund the advancement of the company’s clinical and preclinical pipeline, including SNV1521 and SNV4818, as well as additional programs....The company is initiating a Phase I study and anticipates dosing its first patient in the coming weeks."

Financing • New P1 trial • Oncology