A candidate is the 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, and biomarkers related to the mechanism and anti-tumour efficacy in patients with solid tumours.
Before 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 benefits 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 tumours. We anticipate presenting results from our phase 1 study in 2023,” he concluded.
