PeproMene Bio has submitted an investigational New Drug application to the FDA for PMB-101, a chimeric antigen receptor T-cell therapy (CAR-T), for the potential treatment of relapsed or refractory B cell acute lymphoblastic leukemia, according to a press release.

The CAR-T therapy is the first to target B cell-activating factor receptor (BAFF-R). 

City of Hope, who has licensed intellectual property relating to PMB-101 will conduct the first in-human phase 1 clinical trial. The trial will be a single-center, open-label study of safety and preliminary efficacy of BAFF-R-CAR T cells among patients with B-ALL who are ineligible or have failed CD19-targeted immunotherapy.  

“City of Hope is excited to leverage the numerous and very promising pre-clinical model outcomes of our investigational CAR-T project and to explore its effect in cancer patients for whom few treatments are currently available,” said Larry W. Kwak, MD, PhD, vice president and deputy director of City of Hope’s comprehensive cancer center. Kwak, along with Hong Qin, PhD, are inventors on the licensed intellectual property and Scientific Advisory Board members of PeproMene. 

In preclinical models, PMB-101 appeared to shrink tumors and prolong survival among CD19 resistant tumors.

“We look forward to collaborating closely with leading clinical investigators at City of Hope and the FDA to validate the safety of PMB-101 in humans in a controlled clinical setting,” Bryan HW Kim, CEO of PeproMene said in the release.