Policy & Regulation
PeproMene Bio submits US FDA Investigational New Drug application to study PMB-101
29 October 2020 -

United States-based PeproMene Bio Inc has submitted an Investigational New Drug (IND) application to the United States Food and Drug Administration (FDA) to study a novel chimeric antigen receptor (CAR) T cell therapy, PMB-101, it was reported on Wednesday.

PMB-101 is claimed to be the first CAR T cell therapy targeting the B cell-activating factor receptor (BAFF-R) on cancerous cells intended to treat refractory or relapsed B cell acute lymphoblastic leukaemia (r/r B-ALL).

An independent research and treatment centre for cancer, diabetes and other life-threatening diseases, City of Hope, has licensed intellectual property relating to PMB-101 under a Licensing and Collaboration agreement with PeproMene. It will also conduct the proposed first in-human, Phase one clinical trial.

The proposed trial is a single-centre, open-label trial to assess the safety and preliminary efficacy of BAFF-R-CAR T cells in cancer patients with r/r/ B-ALL who are ineligible for or have failed CD19-targeted immunotherapy in the United States. The product is a novel CAR T cell therapy which has indicated synergistic activity in CD-19 resistant or relapsed animal models in preclinical trials.