STORM Therapeutics has announced positive interim Phase I clinical data on its first-in-class clinical candidate STC-15, a METTL3 RNA methyltransferase inhibitor.
Findings from the study were presented at the ongoing American Society of Clinical Oncology (ASCO) Annual Meeting, which is taking place until June 4.
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STC-15 is an orally bioavailable, small molecule that inhibits METTL3, an RNA methyltransferase implicated in oncology and other diseases.
The Phase I study was designed to evaluate STC-15’s safety, pharmacokinetics, pharmacodynamics, target engagement, biomarkers related to mechanism, and anti-tumour efficacy in solid tumour patients.
STC-15 was well tolerated across its pharmacologically active dose range and treatment-emergent adverse events (TEAEs) were manageable, with common TEAEs such as rash and pruritus.
A key objective of the study, which enlisted a cohort of 33 patients across five dose escalation cohorts ranging from 60mg to 200mg and explored daily and thrice-weekly oral dosing regimens, was to establish a recommended Phase II dose escalation to support future clinical development.
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By GlobalDataRecommended Phase II doses were identified as between 60mg and 200mg three times per week.
Data also showed significant reductions in methylated polyA-RNA in blood samples from all cohorts, which STORM said demonstrated METTL3 target engagement and rapid pharmacodynamic effect.
In addition, further pharmacodynamic biomarker analysis indicated activation of interferon signalling and innate immune responses, as measured by RNA transcript analysis in blood cells from treated patients.
“These data signify great progress for STORM as we continue to develop our pipeline of RNA-modifying enzyme inhibitors,” said STORM CMO Josi Holz.
“We look forward to completing the current Phase I study and including the addition of checkpoint inhibitors.”
STORM said it expects the advancement of STC-15 into combination studies with checkpoint inhibitors to commence later this year.
Other companies that have presented cancer treatment clinical data at ASCO 2024 include Verastem Oncology, which reported positive initial results from an ongoing Phase I/II trial investigating kinase inhibitor avutometinib for the treatment of pancreatic cancer.
