By Nathan Rubbelke, St. Louis Business Journal | March 17, 2022
St. Louis-based clinical-stage biotechnology startup Wugen, which has raised more than $200 million in venture funding, has launched a clinical trial for one of its cancer-fighting therapies.
Wugen said this week it has dosed the first patient in the initial phase of a clinical trial for its drug WU-CART-007. The trial is focused on studying the drug's treatment of relapsed or refractory (R/R) T-cell acute lymphoblastic leukemia (T-ALL)/lymphoblastic lymphoma (LBL). It comes as Wugen says the U.S. Food and Drug Administration has provided WU-CART-007 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.
Wugen said the first phase of its newly launched trial is “designed to characterize the safety and tolerability of a single dose” of WU-CART-007. The study’s second phase will analyze the drug’s preliminary anti-tumor activity. Wugen plans to enroll up to 44 patients as part of its multi-site clinical trial. One of Wugen’s sites for the clinical trial is Washington University School of Medicine.
Wugen President and CEO Dan Kemp called the start of the trial "a significant milestone as we continue to advance the first, off-the-shelf allogeneic CAR-T cell therapy for T-Cell malignancies in the United States into the clinic."
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. The 70-person company, headquartered at the BioGenerator Building in the Cortex district, in July 2021 announced it had raised $172 million in a Series B funding round to advance the development of its treatments. With the Series B round, Wugen's total capital raised from investors topped $200 million.
WU-CART-007 is the second drug that Wugen has advanced into clinical trials. Another one of its drug candidates, WU-NK-101, is in an ongoing clinical trial for acute myelogenous leukemia.