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

WILMINGTON, Del.--(BUSINESS WIRE)--Synnovation Therapeutics, a precision medicine company focused on the discovery and development of best-in-class targeted medicines, today 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. SNV4818 is a potentially best-in-class pan-mutant-selective PI3Kα inhibitor that may effectively cover kinase (H), helical domain (E), and other PI3Kα mutations clinically. This marks the second Synnovation program to enter the clinic in just over three years since company formation. Synnovation’s lead candidate and potentially best-in-class PARP1 selective program, SNV1521, entered a Phase I trial in January of 2024.

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.

“We are excited to initiate the clinical development of our second potential best-in-class program, both of which were discovered at Synnovation,” said Kevin O’Hayer, M.D., Ph.D., Senior Vice President, Head of Clinical Development at Synnovation. “SNV4818 has the potential to address a significant unmet need for a large population of patients with breast cancer and multiple other tumor types.”

The potential of the PI3Kα inhibitor class has been limited by a lack of selectivity against wild type PI3Kα. First generation PI3Kα-isoform specific inhibitors are limited by significant toxicities due to wild type PI3Kα inhibition, including stomatitis, hyperglycemia and rash. A pan-mutant selective, wild-type-sparing, inhibitor enables a wider therapeutic index leading to greater target inhibition which may improve clinical efficacy while decreasing toxicity, unlocking significant potential for this therapeutic class.

SNV4818 is a potentially best-in-class, highly potent pan-mutant PI3Kα inhibitor with excellent selectivity against wild type PI3Kα. This selectivity may allow for broad spectrum PI3Kα mutation coverage including targeting both H1047X and E545/542X classes of driver mutations in breast cancer and other solid tumor indications.

About Synnovation Therapeutics

Synnovation is dedicated to the discovery and development of best-in-class therapeutics that can improve the lives of patients. Leveraging our deep expertise in biology and a world class medicinal chemistry team, we are building a diverse pipeline of novel small molecule targeted therapies. Our mission is to efficiently advance these agents into clinical trials with the goal of transforming care through patient-focused precision medicine. Synnovation’s other clinical stage program, SNV1521, is a potentially best-in-class potent, selective and CNS penetrant PARP1 inhibitor currently in Phase I. For more information, please visit www.synnovationtx.com.