Umoja Biopharma has the FDA’s green light to dose the first patient with what it believes could be a more readily accessible CAR-T therapy.
The company has plans to launch a Phase 1 trial this year for UB-VV111, its experimental in vivo gene therapy for blood cancer. Unlike ex vivo CAR-Ts on the market, in vivo treatments wouldn’t require the costly and time-consuming process of collecting cells, engineering them, and then delivering them back to the patient. Umoja’s VivoVec platform instead seeks to help the body make its own cancer-killing CAR-T cells.
David Fontana“Every step of the CAR-T process today loses patients to the burdens and complexity — patients that will lose out on the oftentimes curative potential of CAR-Ts,” Umoja COO David Fontana told Endpoints News. “We view those losses along the treatment journey ultimately as efficacy failures for the CAR-T industry. We are motivated to simplify all of this with our VivoVec-driven in vivo approach.”
AbbVie took interest in the idea earlier this year when it agreed to pay an undisclosed upfront and equity investment plus up to $1.44 billion in milestones for an option to license UB-VV111 and develop other in vivo CAR-Ts with Umoja.
Pharmaceutical companies large and small are developing in vivo cell therapies, including Moderna, Capstan Therapeutics, Myeloid Therapeutics and Interius BioTherapeutics, which got clearance to launch an in-human trial in Australia earlier this month. Umoja’s trial will enroll patients with relapsed or refractory large B cell lymphoma and chronic lymphocytic leukemia.
“We hope there is a paradigm shift in the management of blood cancer patients, where CAR-T cells can truly be used in a broader patient population,” Fontana said. “No apheresis. No months wait to secure a manufacturing slot and have a patient’s cell manufactured. No cost and complexity of the ex vivo process today.”