5 October 2023
US FDA Fast Track designation granted to BI 764532 for the treatment of extensive stage small cell lung cancer
Oxford BioTherapeutics Announces Partner Boehringer Ingelheim Received U.S. FDA Fast Track Designation for BI 764532 for the Treatment of Extensive Stage Small Cell Lung Cancer and Extrapulmonary Neuroendocrine Cancers
BI 764532 is an investigational T-cell engager that redirects T cells towards cancer cells expressing the DLL3 protein
DLL3 was discovered using OBT’s proprietary OGAP® drug discovery platform
Fast Track designation accelerates BI 764532’s path to U.S. FDA submission
Oxford, UK, San Jose, Calif., 3rd October 2023 – Oxford BioTherapeutics (OBT), a clinical stage oncology company with a pipeline of immuno-oncology and Antibody Drug Conjugate (ADC)-based therapies, today announces that the U.S. Food and Drug Administration (FDA) has granted Fast Track designation to BI 764532 for the treatment of extensive stage small cell lung cancer (ES-SCLC) whose disease has progressed following at least two prior lines of treatment including platinum-based chemotherapy, and of advanced or metastatic extrapulmonary neuroendocrine carcinomas (epNEC) whose disease has progressed following at least one prior line of treatment including platinum-based chemotherapy.
BI 764532 is an investigational DLL3/CD3 IgG-like T-cell engager for treatment of patients with SCLC and other neuroendocrine tumors that is being developed by Boehringer Ingelheim. The discovery of BI 764532 was enabled through a successful partnership 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.
Encouraging data were presented from the Phase I first-in-human dose-escalation trial at the American Society of Clinical Oncology (ASCO) 2023 Annual Meeting. These Phase I data demonstrated a clinically acceptable safety profile and early efficacy in patients with DLL3-positive ES-SCLC and epNECs.
Christian Rohlff, Chief Executive Officer of OBT, commented: “We are delighted about the accelerated clinical development of BI 764532, for which the DLL3 antigen was discovered using ourOGAP® technology platform. This is tremendously exciting for OBT, as it shows the real impact this partnership has for patients in need. Receiving an ES-SCLC or epNEC diagnosis can be life changing and there is an urgent, unmet need for additional targeted immunotherapeutics to ensure that individuals impacted by these aggressive cancers get the care they need.”
FDA’s Fast Track designation is designed to facilitate the development and expedite the review of new drugs that are intended to treat serious or life-threatening diseases and that demonstrate the potential to address unmet medical needs.