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., and SOUTH SAN FRANCISCO, Calif. – April 5, 2023 – 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.

Media Contact

Carolyn Hawley
Evoke Canale
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Mike Mangone, Ph.D.

Mike has spent more than 15 years in strategic, operational and drug development roles in the biotech and life science space. Most recently, he was Vice President of Business Development and Operations at BridgeBio (BBIO) where he advanced two late-stage portfolio companies, Phoenix Tissue Repair and Origin Biosciences. At Origin, Mike managed operations through clinical development; oversaw FDA and EMA approvals; and directed corporate strategy for the launch of Nulibry, BridgeBio’s first commercial asset. Prior, Mike consulted for a wide range of biotech, pharma and private equity clients on projects spanning corporate, portfolio and commercial strategy, and business development in the oncology, inflammation and immunology, and autoimmunity disease spaces among other areas. Mike also spent time at Flagship Pioneering helping create early-stage platform companies centered on breakthrough science, such as Ring Therapeutics.

Mike is a scientist by training and developed small molecule inhibitors targeting key oncogenic and inflammatory pathways at the Center for Lymphoid Malignancy at Columbia University. He received his Ph.D. in Pathobiology working on cancer vaccine development at NYU School of Medicine and earned an A.B. in molecular biology from Princeton University.

Hirdesh Uppal, Ph.D.

Hirdesh possesses over two decades of drug development expertise, making significant contributions advancing medicines from discovery to regulatory approval. In his recent role as VP of Development Sciences at CytomX Inc., he managed a diverse portfolio encompassing antibodies, ADC’s, bispecifics, and cytokines. Prior to this, he served as VP of Development Sciences at Revolution Medicines Inc., concentrating on novel therapies targeting RAS-addicted cancers. At Medivation Inc., Hirdesh led Translational Medicine & Companion Diagnostics (CDx), involving the translational strategy & clinical development for enzalutamide (XTANDIâ), talazoparib (TALZENNAâ) and several other pipeline molecules. He invented & facilitated successful clinical biomarker work culminating in CDx development at partner firms. His earlier tenure at Genentech Inc. and F. Hoffmann-La Roche Ltd focused on development sciences and safety assessment where he provided leadership & strategic alignment of a safety biomarker, stem cell & biochemical-molecular toxicology investigative laboratory group. Hirdesh holds a Ph.D. in Pharmacology from the University of Pittsburgh School of Medicine, a Doctor of Veterinary Medicine degree, and a Master’s in Immunology from Punjab Agricultural University, India. Additionally, he has completed Executive Management programs at the Stanford Graduate School of Business, Harvard Business School, and The Wharton School.

Jeremy Barton, M.D.

Jeremy Barton, M.D. has over 31 years of experience in all phases of oncology drug development in the pharmaceutical industry in Switzerland, UK and currently in the US. He is now working as a self-employed consultant, advising biotech companies on strategic oncology drug development.

Most recent industry responsibilities in the US have included Chief Medical Officer roles at Biogen Idec, eFFECTOR Therapeutics and Mirati Therapeutics. He was also head of early Oncology Development at Pfizer (San Diego) for 5 years overseeing the transition of all Oncology compounds from research through IND to proof-of-concept studies.

After obtaining a Master’s Degree in Physiological Sciences from Oxford University and his medical degree at University College Hospital Medical School in London, he trained in Internal Medicine and Clinical Oncology in the United Kingdom and practiced for 11 years in the National Health Service.

Jeremy is Board Certified in Internal Medicine and Clinical Oncology, a Member of the Royal College of Physicians (U.K.), a Fellow of the Royal College of Radiologists (Clinical Oncology) and a Member of the Faculty of Pharmaceutical Medicine.