Vesigenurtacel-L: Phase I/II amended

Heat Biologics amended a U.S. Phase I/II trial of HS-410 to add an open-label arm to the Phase II portion evaluating the compound as a monotherapy in an additional 25 patients. The double-blind Phase II portion is enrolling about 75 patients who have undergone transurethral resection of bladder tumor to receive placebo or 1*106 and 1*107 cells/dose HS-410 weekly given in combination with bacillus Calmette-Guerin (BCG) for 6 weeks, then alone for 6 additional weeks followed by 3 courses of the combination weekly for 3 weeks at 3, 6 and 12 months after starting therapy.

The open-label Phase I portion enrolled 10 patients to receive BCG for 5-6 weeks, followed by 1*106 cells/dose HS-410 weekly for 12 weeks and then monthly for 3 months. Heat said the decision to add the arm occurred after observing a vaccine-induced immune response in the Phase I portion (see BioCentury, Feb. 16). ...