Umoja Biopharma, Inc., an immuno-oncology company pioneering off-the-shelf, integrated therapeutics that reprogram immune cells in vivo for patients with solid and hematologic malignancies, announced today the Seattle Children’s activation of the Phase 1 ENLIGHTen clinical trial in patients with osteosarcoma to assess the safety and tolerability of autologous “universal” CAR T cells when administered with UB-TT170, the Company’s proprietary small molecule fluorescein tag. This follows the recent clearance of its Investigational New Drug (IND) application by the U.S. Food and Drug Administration (FDA) for UB-TT170. The trial is being conducted in partnership with Seattle Children’s Therapeutics, a venture at Seattle Children’s, bringing cutting edge, curative technologies and therapies to defeat pediatric cancer and other diseases that impact children.

“We are excited to receive IND clearance of our first TumorTag product candidate UB-TT170,” said Andy Scharenberg, M.D., co-founder and Chief Executive Officer of Umoja Biopharma. “The ability to target solid tumors with CAR T technology remains a large barrier for patients with cancer. Our TumorTag technology is intended to overcome treatment limitations due to antigen heterogeneity of tumors and the restrictive solid tumor microenvironment with the goal to provide better treatment outcomes for patients. This marks a great start for Umoja’s three integrated core programs, the TumorTag, VivoVec, and RACR/TagCAR platforms, to meaningfully advance the cancer immunotherapy field.”

The ENLIGHTen trial (NCT05312411) is an open-label Phase 1 feasibility and safety study of fluorescein-specific CAR T cells in combination with folate-fluorescein (UB-TT170) for patients with refractory/recurrent osteogenic sarcoma. All patients in the trial will be administered autologous CAR T cells engineered to express an anti-fluorescein chimeric antigen receptor that were developed by Seattle Children’s Therapeutics and will be manufactured in their Cure Factory Good Manufacturing Practices facility. Following that, each patient will receive escalating doses of Umoja’s UB-TT170 TumorTag molecules, followed by fixed dosing. The primary endpoint is safety (adverse events tracking) with secondary endpoints focused on the ability to manufacture anti-fluorescein CAR T cells. The trial will only be open at Seattle Children’s and the age range for enrollment is people aged 15-30 years old.

Find out more in the press release.