NEW YORK – Nurix Therapeutics said on Tuesday that it has dosed its first gynecologic cancer patient in a Phase I clinical trial of DeTIL-0255, its modified autologous tumor-infiltrating lymphocyte (TIL) therapy.
The trial is enrolling patients with advanced ovarian, endometrial, and cervical cancer, and is designed to evaluate the safety and preliminary anti-tumor activity of DeTIL-0255. The therapy involves a one-time infusion of patient-derived TILs that the firm has "drug-enhanced" ex vivo using a Nurix-developed small-molecule CBL-B inhibitor, called NX-0255.
By combining patients' harvested TILs with NX-0255, Nurix has devised a way to inhibit the CBL-B ligase within patient-derived immune cells, reversing the ligase's negative effect on T-cell activation. In animal models of adoptive cell therapy, the firm said that DeTIL-0255 showed superior anti-tumor activity. The Phase I trial marks the first time that a targeted protein modulation has been combined with cell therapy, according to Robert Brown, executive VP of clinical development at Nurix.
"DeTIL-0255 is … designed to overcome the major limitations of current TIL therapy, which include T-cell exhaustion post expansion, suboptimal manufacturing success rates, and poor persistence of anti-tumor cells in the patient," Nurix Chief Cellular Therapy Officer Michael Lotze said in a statement.
The San Francisco-based firm will report a clinical update from the Phase I trial's initial safety portion during the second half of this year.