Umoja gets FDA approval to begin clinical trials of its trans­for­ma­tive in vivo gene therapy for cancer

At DCVC Bio we back world-leading science teams with ideas that are trans­forming medicine or food production and benefiting millions of patients and consumers. 

Umoja Biopharma has invented a new form of CAR‑T cancer immunotherapy that is more accessible on every dimension than conven­tional CAR‑T therapy. When we began to assemble Umoja with founding scientists, we shared the vision of the team: that we could have a future where we could coax our own immune systems to attack our cancers — for both solid and liquid tumors. 

Umoja has now invented the first way to engineer this ​“coaxing” without the need for extracting the patient’s cells or further damaging their existing immune systems. We want to again elevate the commitment and insight of Phil Low, Michael Jensen, Andy Scharenberg, Ryan Crisman, and the many others at Umoja who are set to transform the cost, effec­tive­ness, and access to oncology treatment.

Umoja announced last week that the FDA has cleared its Inves­ti­ga­tional New Drug application to study UB-VV111, an in vivo therapy designed to help people with hematologic cancers. That frees the company to begin recruiting patients for a Phase I clinical trial focusing on safety, dosing, and antitumor activity. The company will enroll patients who have large-B-cell lymphoma and chronic lymphocytic leukemia and have relapsed or haven’t responded to previous rounds of CAR‑T therapy.

Conven­tional CAR‑T treatment can be highly effective, but the procedure is complicated and expensive. It involves extracting some of a patient’s white blood cells and trans­fecting them in the lab with genes needed to produce a protein called a chimeric antigen receptor (CAR), which equips the cells to target and destroy cancer cells. It can take weeks to grow or ​“expand” the population of new cells, and before they can be transfused back into the bloodstream the patient must undergo lymphode­ple­tion — chemotherapy to kill their remaining white blood cells. The overall cost of treatment can range from $350,000 to $1 million or more per patient. Umoja’s innovation is a virus-inspired system that delivers the required genes to white blood cells in the body, bypassing the arduous and costly steps of extraction, expansion, lymphode­ple­tion, and transfusion.

“Physicians and patients have been waiting for something better” than conven­tional ex vivo CAR‑T therapy, says Umoja co-founder and CEO Andrew Scharenberg. As Umoja moves from the lab to the clinic, it’s finally bringing that wait to an end. 

Kiersten Stead and John Hamer are Managing Partners of DCVC Bio.