Step Pharma closes $41M round to take enzyme targeting lead program into early-stage trial for T cell malignancies
24 Mar 2021
Cell TherapyFast Track
The search for better T and B cell therapies have absorbed billions in R&D funds from some of the biggest drugmakers in the world. A French biotech thinks it could have a hyper-focused approach to T and B cell malignancies, and it’s taking home a decent-sized check to race to the clinic.
Step Pharma has bagged $41.5 million in funding to take its lead CTPS1 inhibitor into clinical trials for T cell malignancies by the first quarter of 2022, the French biotech said Wednesday.
The company’s science was based on the work of French immunologist Alain Fischer, who identified a genetic connection between the CTP synthase 1 enzyme and the inability of normal B and T cells to proliferate in patients. The company was initially seeded in 2015, and current CEO Andrew Parker stepped in about 18 months ago to help drive the company into Phase I studies. Step believes its focus on the CTPS1 enzyme can offer a hyper-targeted approach to spur T cells and B cells to target aggressive tumors.
“The genetics told us that if you block CTP synthase 1, you’ve got this very specific effect on T and B cells,” Parker said. “That’s what really gives this a very targeted approach to inhibit proliferation of B cells and T cells and spare other cell types.”
The initial Phase I, scheduled to enroll in the EU given the company’s established presence in France, will operate as a five-arm “basket study,” Parker said, with three arms focusing on T cell hematologic malignancies and two arms focusing on B cell conditions. If any arm shows clinical promise, the biotech plans to expand enrollment up to 35 patients in Phase II proof-of concept studies.
In T cell lymphomas, Step believes a 35-patients study in the Phase II setting could be enough for a breakthrough designation and fast track, Parker said. Meanwhile, the B cell arms would likely require Phase III studies as they would apply to third-line-or-later patients.
With the EU equivalent of an IND set for early 2022 — in the January or February range, by Parker’s count — Step is planning to expand its small team of five to around 10 as it enters the clinic.
The round was co-led by new investors Hadean Ventures and Sunstone Life Science Ventures, which joined existing investors Kurma Partners, Pontifax and Bpifrance, which reinvested through its Innovative Biotherapies and Rare Diseases fund and InnoBio 2 fund.
As part of the financing, Jacob L. Moresco from Sunstone Life Science Ventures and Walter Stockinger from Hadean Ventures will join the board.
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