St. Louis biotechnology startup Wugen, which has raised more than $200 million in venture funding as it develops cancer-fighting drugs, has received two key regulatory designations it says will “expedite” evaluation of one of its treatments.
The clinical-stage company said last week it has been given the U.S. Food and Drug Administration’s Regenerative Medicine Advanced Therapy (RMAT) and European Medicines Agency’s PRIME designations. Both agencies say their respective designations are meant to provide regulatory support for treatments being developed for “unmet medical needs.”
Wugen has received the designations for WU-CART-007, a drug candidate in clinical trials for treating relapsed or refractory T-cell acute lymphoblastic leukemia/lymphoblastic lymphoma.
Founded in 2018, Wugen is developing “off the shelf” cell therapies to treat various cancers. The startup was created via technology licensed from Washington University and is developing so-called natural killer (NK) and T-cell therapies. In addition to WU-CART-007, Wugen is developing drug candidate WU-NK-101 to treat acute myelogenous leukemia.
Wugen Chief Medical Officer Jan Davidson said the RMAT and PRIME designations are “recognition by the regulators that this product is important” and include a commitment of assistance from the respective agencies.
“The regulatory agents after it’s awarded dedicate their time to work hand in hand with the biotech company to try to develop this and get this to market quickly for patients,” Davidson said.
The European Medicines Agency says its PRIME designation includes “enhanced interaction and early dialogue” with drug developers to gain approval for treatments. Likewise, the FDA’s RMAT designation allows for “early interactions” with the FDA as a company navigates the U.S. regulatory process.
Wugen CEO Kumar Srinivasan said in a news release the company plans to provide WU-CART-007 to patients “as soon as possible.” On June 14, the startup, at the European Hematology Association 2024 Hybrid Congress in Madrid, Spain, plans to present phase 2 clinical trial data “showing safety and anti-leukemic activity,” it said. Davidson said next steps in the drug’s development will be to launch a so-called pivotal trial that will provide data seeking approval of the drug. Wugen hopes to begin that trial by year’s end, Davidson said.
Wugen, which raised $172 million from investors in 2021 as part of a Series B financing, counts St. Louis-based investors as financial supporters, including RiverVest Venture Partners, BioGenerator and Lightchain Capital. Wugen, which has its headquarters at 4260 Forest Park Ave. in the Cortex innovation district in the Central West End, has 74 employees.
