Simcha Therapeutics Announces Clinical Trial Collaboration with Merck to Evaluate ST-067 in Combination with KEYTRUDA® (Pembrolizumab) in Patients with Various Solid Tumors

Dr. Emmett Schmidt, Merck Vice President of Early Oncology Development, to Join the Simcha Scientific Advisory Board

NEW HAVEN, Conn. & SOUTH SAN FRANCISCO, Calif.--(BUSINESS WIRE)--Simcha Therapeutics (“Simcha”), a clinical-stage immunobiology company pioneering first-in-class cytokine treatments in cancer, today announced a clinical trial collaboration with Merck (known as MSD outside the US and Canada) to evaluate clinical safety and benefits of ST-067, Simcha’s decoy resistant IL-18 agent, in combination with Merck's anti-PD-1 therapy, KEYTRUDA^® (pembrolizumab), in patients with solid tumors. In conjunction with this collaboration, Dr. Emmett Schmidt, vice president of early oncology development for Merck, will join Simcha’s scientific advisory board.

"ST-067, with its ability to stimulate both adaptive and innate immunity, has potential in a broad range of tumor types, and preclinical experiments combining ST-067 with immuno-oncology agents such as Keytruda have generated encouraging results,” said Sanuj Ravindran, M.D., CEO of Simcha Therapeutics. “I’m excited to work with Dr. Schmidt, and we are eager to leverage Merck’s expertise to evaluate the clinical benefits of ST-067 in combination with Keytruda in hopes of bringing transformational medicines for cancer patients.”

“I am delighted to join the Scientific Advisory Board at Simcha,” commented Dr. Schmidt. “I look forward to directly contributing to the development of agents with the potential to benefit patients receiving Keytruda in combination with emerging combination agents.”

KEYTRUDA is a registered trademark of Merck Sharp & Dohme LLC, a subsidiary of Merck & Co., Inc., Rahway, NJ, USA.

About ST-067

ST-067 is the first “decoy-resistant” variant of IL-18, designed to be impervious to the decoy receptor IL-18BP, which blocks IL-18 from interacting with its receptor, thereby blocking the cytokine’s immunostimulatory activity. ST-067 has been shown in preclinical studies to maintain strong immune stimulation in the tumor microenvironment and is currently in Phase 1a/2 clinical development as a monotherapy in solid tumors. Additional clinical studies of ST-067 as both a monotherapy and in combination with other therapies such as Keytruda (pembrolizumab) are planned.

About Simcha Therapeutics

Simcha Therapeutics is a clinical-stage immunobiology company pioneering the development of first-in-class engineered cytokine therapeutics with transformational promise for patients. The company is built on a foundation of scientific rigor to overcome biological challenges in clinically translatable pathways, exemplified by the first decoy-resistant interleukin-18 (IL-18). By unlocking the potential of IL-18, Simcha is developing its lead program (ST-067) as monotherapy and in combination with potentially several other anticancer agents. ST-067 is currently being studied in a Phase 1a/2 clinical trial, in patients with solid tumors and who have progressed on other immunotherapeutic agents. Simcha is seeking to explore additional modalities for IL-18-based therapeutics and capture the full potential of this potentially transformational cytokine. For more information, please visit www.simchatherapeutics.com.