Wugen, the St. Louis-based, clinical-stage biotechnology startup that has raised more than $200 million in venture funding, has dosed the first patient in a clinical trial for one of its cancer-fighting drug candidates.
The company said this week it has started the first phase of human trials for its drug WU-NK-101 to study its safety and tolerability for patients with relapsed or refractory acute myelogenous leukemia (AML). That comes as Wugen also said the U.S. Food and Drug Administration has provided WU-NK-101 with its Orphan Drug Designation, which is given to drugs treating rare diseases and provides Wugen with marketing exclusivity, tax credits and other benefits designed to accelerate the drug’s development.
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. Wugen in July 2021 announced it had raised $172 million in a Series B funding round to advance the development of its treatments. It counts St. Louis-based investors as financial supporters, including RiverVest Venture Partners, BioGenerator and Lightchain Capital.
Wugen said this week in a news release that WU-NK-101 is its “lead memory natural killer cell therapy product and is comprised of cells optimized for anti-cancer function.”
“Today’s news represents a significant milestone for Wugen, as WU-NK-101 is the first therapeutic candidate from our memory NK cell platform to enter the clinic,” said Kumar Srinivasan, Ph.D., president and CEO of Wugen, in a statement. “Beginning in AML, where there remains a high unmet need for new therapeutic options, our goal is to deploy our memory NK cell platform to deliver next-generation, best-in-class allogeneic memory NK cell therapies to transform cancer care, including treatment of solid tumors.”
While Wugen’s clinical trial is focused on AML, the startup said preclinical studies for WU-NK-101 “suggest efficacy in solid tumors alone or in combination with monoclonal antibodies.” The startup said plans to begin studies of WU-NK-101 for sold tumors in combination with the drug cetuximab, a monoclonal antibody treatment for certain cancers.
In addition to WU-NK-101, Wugen in March 2022 initiated clinical trials for another drug candidate, WU-CART-007, to study its treatment of relapsed or refractory T-cell acute lymphoblastic leukemia/lymphoblastic lymphoma.
Wugen, which has operations in San Diego and St. Louis, last year opened a new 18,000-square-foot headquarters at 4260 Forest Park Ave. in the Central West End’s Cortex innovation district.
