The multi-centre, open-label, first-in-human Phase I study has been designed for systematically evaluating STC-15’s safety, pharmacokinetics, pharmacodynamics, target engagement, biomarkers related to mechanism, and anti-tumour efficacy in solid tumour patients.
It will assess multiple ascending daily oral doses of STC-15 in Q3W treatment cycles, with dose levels determined by a modified Fibonacci algorithm.
Nearly 40 to 60 participants are expected to be enrolled in the study.
STC-15 is an orally bioavailable, small molecule that inhibits METTL3, an RNA methyltransferase which is implicated in oncology and other diseases.
It is said to be the first molecule specifically targeting an RNA methyltransferase enzyme to enter clinical development.
The company stated that STC-15’s preclinical activity was shown through direct cytotoxic and anti-cancer immune response mechanisms in solid tumour and leukaemia models.
In addition, the clinical candidate had shown to inhibit tumour growth through anti-cancer immune responses such as changes in interferon signalling and synergy with T cell checkpoint blockade.
STORM Therapeutics CEO Dr Jerry McMahon 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 tumours.
“We anticipate presenting results from our Phase I study in 2023.”