On June 25, 2024 Step Pharma, the global leader in CTPS1 inhibition for targeted cancer treatment, reported that its lead asset dencatistat (STP938), a first-in-class selective CTPS1 inhibitor, has cleared an investigational new drug (IND) application by the US Food and Drug Administration (FDA), enabling Step Pharma to progress dencatistat into a Phase 1 clinical trial for patients with solid tumours, anticipated to start in Q3 2024 (Press release, Step Pharma, JUN 25, 2024, View Source [SID1234644534]).
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The open label trial will evaluate the safety, tolerability and pharmacokinetics of dencatistat in adults living with advanced solid tumours, with a safety expansion in advanced CTPS2 null ovarian cancer. Selecting patients whose tumours have deleted CTPS2 represents a precision oncology approach that is expected to maximise the therapeutic potential of dencatistat. The trial will recruit patients with advanced cancer who have no other treatment options available.
Step Pharma is pioneering a novel class of oral drugs that specifically inhibit nucleotide synthesis and the enzyme cytidine triphosphate synthase 1 (CTPS1) in particular, which was originally identified as an essential gene for lymphocyte proliferation. By targeting CTPS1, Step Pharma has unlocked the ability to selectively target the de novo pyrimidine synthesis pathway in cancer cells. This groundbreaking approach is predicted to enable the highly selective treatment of both blood cancers and solid tumours.
Andrew Parker, Chief Executive Officer of Step Pharma, commented:
"The approval by the US FDA to initiate clinical evaluation of dencatistat in solid tumours is a significant milestone for Step Pharma as we continue to advance our lead candidate beyond blood cancers and into solid tumours, bringing us a step closer to a potentially paradigm-shifting treatment for patients. We look forward to starting the study in Q3 2024 and continuing our progress in driving a step change in the way we treat cancer, making a real difference to patients’ lives."
Further details of the planned Phase 1 trial can be found on clinicaltrials.gov under the identifier NCT06297525.