STORM Therapeutics doses first patient with oral METTL3 targeting drug in a solid tumor Phase 1 study 

STORM Therapeutics Ltd. (STORM), the biotechnology company discovering and developing novel small molecule therapies targeting RNA modifying enzymes (RMEs) for oncology and other diseases, today announces that the first patient has been dosed with STC-15, the Company’s first-in-class clinical candidate.

An orally bioavailable, highly selective METTL3 inhibitor, STC-15 is the first molecule specifically targeting an RNA methyltransferase enzyme to enter clinical development. This Phase 1 study is a multiple ascending dose escalation trial aiming to enroll 40-60 patients to measure safety, pharmacokinetics, target engagement, biomarkers related to mechanism, and anti-tumor efficacy in patients with solid tumors. Details of the study can be found on clinicaltrials.gov under the identifier NCT05584111.

Preclinical activity was demonstrated with STC-15 through direct cytotoxic and anti-cancer immune response mechanisms in solid tumor and leukemia models. Data indicated enhanced interferon signalling and synergy with T cell checkpoint blockade as an important mechanism of action of STC-15 resulting in tumor regression and anti-cancer immunity in rodent models.

Dr Jerry McMahon, CEO of STORM Therapeutics, said:

“This is a major milestone for STORM as we enter clinical development with our lead candidate STC-15 and continue progressing a pipeline targeting RNA modifying enzymes beyond METTL3. We intend to exhibit preclinical data related to STC-15 at future medical conferences this year as we execute our Phase 1 study in patients with solid tumors. We anticipate presenting results from our Phase 1 study in 2023.”

Josefin-Beate Holz, MD, CMO of STORM Therapeutics, added:

“I am delighted with the successful initiation of STORM’s first candidate into the clinic from our innovative and proprietary pipeline. Clinical development allows us to establish meaningful clinical benefit with RNA modifying enzyme inhibitors in cancer patients. This first trial is a groundbreaking milestone for the drug class and we are looking forward to receiving the emerging data from the study.”

Justin Moser, MD, Associate Clinical Investigator of HonorHealth, the first clinical site to recruit patients to the STC-15 study, commented:

“Our goal at HonorHealth Research Institute is to offer tomorrow’s potential cures to our patients, today. We are excited about our collaboration with STORM which allows us to offer STC-15 and other cutting-edge, first-in-class treatment options to our patients.”