Oxford BioTherapeutics (OBT), an oncology-focused clinical-stage firm specializing in immuno-oncology and Antibody Drug Conjugate (ADC) treatments, revealed that the U.S. FDA has accorded Fast Track status to BI 764532.
This designation is for the therapy of extensive stage small cell lung cancer (ES-SCLC) that has advanced after undergoing a minimum of two previous treatments, including platinum-based chemotherapy, and for advanced or metastatic extrapulmonary neuroendocrine carcinomas (epNEC) that progressed after at least one platinum-based chemotherapy treatment.
BI 764532 is an investigational DLL3/CD3 IgG-like T-cell engager intended for patients with SCLC and other neuroendocrine malignancies and is being developed by Boehringer Ingelheim.
Promising results from the Phase I first-in-human dose-escalation trial indicated an acceptable safety profile and initial effectiveness in patients with DLL3-positive ES-SCLC and epNECs.
Christian Rohlff, OBT’s CEO, expressed enthusiasm over the swift clinical progression of BI 764532, a development enabled by OBT’s proprietary OGAP® technology, which identified the DLL3 antigen. He highlighted the significance of this advancement for OBT, emphasizing its tangible benefits for patients requiring care.
Source: 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.
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