FDA grants Fast Track Designation to Boehringer Ingleheim antitumor agent, BI 764532, partnered with Oxford BioTherapeutics
BI 764532 is a novel, investigational DLL3/CD3 IgG-like T-cell engager designed to redirect T cells toward DLL3 protein expressed by cancer cells. In preclinical trials, the agent showed robust antitumor activity against DLL3-positive cells and xenograft models. In October 2023, the FDA granted a fast track designation to BI 764532 as an option for patients with extensive-stage small cel lung cancer (ES-SCLC) that has progressed after at least 2 prior lines of treatment, including platinum-based chemotherapy, and for patients with advanced or metastatic extrapulmonary neuroendocrine carcinoma (epNEC) whose disease has progressed following at least 1 prior line of treatment including platinum-based chemotherapy.
BI 764532 was evaluated as part of a phase 1 trial (NCT04429087) among patients with DLL3-positive SCLC and NEC. Findings from the study were presented at the 2023 American Society of Clinical Oncology (ASCO) Annual Meeting.
The discovery of BI 764532 was enabled through a successful partnership between Oxford BioTherapeutics and Boehringer Ingelheim, initiated in 2013, leveraging OBT’s proprietary OGAP® drug discovery platform for identification of the DLL3 antigen and Boehringer Ingelheim’s longstanding expertise in oncology and development of biotherapeutics