Step Pharma, which works on CTPS1 inhibition for the targeted treatment of cancer, has announced its lead asset STP938 has cleared both an Investigational New Drug (IND) application by the Food and Drug Administration (FDA), and a clinical trial application (CTA) by the UK’s Medicines and Healthcare products Regulatory Agency (MHRA).
This means Step Pharma can progress STP938, its first-in-class, selective CTPS1 inhibitor into the clinic in the US and UK.
STP938 has now entered an open label, first-in-human, phase 1/2 study to evaluate the safety, tolerability, pharmacokinetics, and preliminary efficacy of STP938 in adult subjects with relapsed/refractory B cell and T cell lymphomas.
Patients with such cancers currently face high relapse rates from existing treatments.
Selective treatment of cancers
The French company is pioneering a novel class of oral drugs that specifically inhibits nucleotide synthesis and the enzyme cytidine triphosphate synthase 1 (CTPS1) in particular, originally identified as an essential gene for lymphocyte proliferation.
By targeting CTPS1, Step Pharma said it has unlocked the ability to selectively target the de novo pyrimidine synthesis pathway in cancer cells. This approach should enable the highly selective treatment of both blood cancers and solid tumors.
Andrew Parker, CEO of Step Pharma, said: “Our unique approach to cancer treatment has the potential to yield a novel targeted cancer therapy that can form the backbone of both blood and solid tumor cancer treatment regimens. We are delighted to have moved STP938 into the clinic for hard-to-treat lymphomas with the ultimate goal of improving the lives of millions of cancer patients.”
Brian Schwartz, chief medical officer of Step Pharma, added: “The clinical trial approvals by both the US FDA and UK MHRA are a significant milestone for Step Pharma and our highly differentiated lead candidate STP938, as we become a clinical-stage company and move at speed to bring this first-in-class treatment to cancer patients with high unmet medical needs.”
Step Pharma will initially investigate STP938 in blood cancers, with a focus on T cell lymphomas, where there has been no improvement in five-year survival rates for more than 20 years. However, as studies have shown that all cancer cells require CTPS1 for DNA synthesis, STP938 could be a key component of a multitude of cancer treatment regimens.
Step Pharma
Step Pharma was founded in 2014 by Kurma Partners, the Imagine Institute and Sygnature Discovery, based on the scientific discoveries of Alain Fischer and Sylvain Latour.
Step Pharma is based in Saint-Genis-Pouilly, France, and is supported by a syndicate of investors led by Kurma Partners and including Bpifrance (Fonds Biothérapies Innovantes et Maladies Rares and InnoBio2 Fund), Pontifax, Hadean Ventures, Sunstone Life Science Ventures, Inserm Transfert Initiative, Idinvest, Sygnature Discovery and the Imagine Institute.