• STC-15 has demonstrated durable clinical activity and tolerability to progress into a combination study with a checkpoint inhibitor
  • Collaboration enables Phase 1b/2 study with STORM’s lead product, STC-15 in combination with Coherus’s next generation PD-1 inhibitor, LOQTORZI® (toripalimab) in patients with NSCLC, HNSCC, melanoma, and endometrial cancer
  • Atif Abbas, M.D. joins as Chief Medical Officer

STORM Therapeutics Ltd. (STORM), the clinical stage company pioneering cellular reprogramming through RNA modifications to treat disease, today announced dosing of its first patient in a collaboration with Coherus BioSciences, Inc., commencing a Phase 1b/2 study evaluating STC-15, its first-in-class lead program, in combination with LOQTORZI (toripalimab-tpzi), the anti-PD-1 antibody, for the treatment of non-small cell lung cancer (NSCLC), head and neck squamous cell carcinoma (HNSCC), melanoma and endometrial cancer, and the appointment of Atif Abbas, M.D. as Chief Medical Officer.

Under the terms of the agreement with Coherus, a Phase 1b study will evaluate STC-15, a METTL3 inhibitor, in combination with LOQTORZI in a dose escalation study to determine the safety of the combination and recommended dose for STC-15. Further to this, the Phase 2 portion of the study will evaluate expansion cohorts in NSCLC, HNSCC, melanoma, and endometrial cancer, in up to 188 patients in the United States.During his two-decade career, Dr. Abbas has played key roles in immuno-oncology drug development, encompassing IND to NDA/BLA submissions, product launches and life cycle management. Atif received his medical degree from King Edward Medical University in Pakistan, with additional postdoctoral training at Yale University and Harvard Medical School. He has held roles of increasing responsibility in clinical development at Merck KGaA, Abbvie, Astellas and Boehringer Ingelheim, most recently as VP at Servier Pharmaceuticals.Jerry McMahon, Chief Executive Officer of STORM Therapeutics, said: “We are excited that the first patient is receiving treatment on our collaborative clinical study, evaluating the potential of STC-15 to enhance responses to immune checkpoint inhibitors. Our clinical data has demonstrated that STC-15 can achieve durable responses for patients who are refractory to immune checkpoint inhibitors, therefore combining it with LOQTORZI may further validate our hypothesis of treating cancer through cellular reprogramming and RNA modifications. We are thrilled that Atif has joined Storm as Chief Medical Officer to lead this effort, and to chart the development strategy for STC-15 with future studies.”

Under the terms of the clinical trial collaboration and supply agreement, Coherus will provide LOQTORZI to STORM, which will be the sponsor of the Phase 1b/2 clinical combination trial. STORM and Coherus each retain all commercial rights to their respective compounds, including as monotherapies or as combination therapies.

Final clinical results from a Phase 1 study of STC-15 in patients with advanced malignancies demonstrated that it is well tolerated and achieved tumor regressions at all dose levels evaluated, with an overall response rate of 9% and disease control rate of 67%. Pharmacokinetic simulations and safety data support advancing STC-15 into combination studies with checkpoint inhibitors, such as LOQTORZI.