Candidate is first molecule targeting an RNA methyltransferase enzyme to enter development
Storm – a company focusing on the development of novel small molecule therapies targeting RNA modifying enzymes (RMEs) for oncology and other diseases – has announced that its first patient has been dosed with STC-15.
The candidate is an orally bioavailable METTL3 inhibitor and the first molecule specifically targeting an RNA methyltransferase enzyme to enter clinical development. The phase 1 study is a multiple ascending dose escalation trial aiming to enrol 40-60 patients to determine safety, pharmacokinetics, engagement, biomarkers related to mechanism and anti-tumour efficacy in patients with solid tumours.
Prior to the research, activity was demonstrated with STC-15 through direct cytotoxic and anti-cancer immune response mechanisms in both solid tumour and leukaemia models. The data indicated enhanced interferon signalling and synergy with T-cell checkpoint blockade as a pivotal STC-15 action. This ultimately resulted in anti-cancer immunity and tumour regression in rodent models.
Josefin-Beate Holz, chief medical officer at Storm, commented: “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 ground-breaking milestone for the drug class and we are looking forward to receiving the emerging data from the study.”
Dr Jerry McMahon, chief executive officer of Storm, added: “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,” he concluded.