Exciting News: Oxford BioTherapeutics’ Partner, Boehringer Ingelheim, Earns Fast Track Designation from U.S. FDA for Promising Cancer Treatment

Oxford BioTherapeutics (OBT), a clinical-stage oncology company specializing in immuno-oncology and Antibody Drug Conjugate (ADC)-based therapies, has announced that the U.S. Food and Drug Administration (FDA) has granted Fast Track designation to BI 764532. This designation is for the treatment of extensive stage small cell lung cancer (ES-SCLC) in patients whose disease has progressed after at least two prior lines of treatment, including platinum-based chemotherapy.

It also applies to advanced or metastatic extrapulmonary neuroendocrine carcinomas (epNEC) in patients whose disease has progressed after at least one prior line of treatment, including platinum-based chemotherapy.

BI 764532 is an investigational DLL3/CD3 IgG-like T-cell engager developed by Boehringer Ingelheim for the treatment of SCLC and other neuroendocrine tumors. The development of BI 764532 was made possible through a partnership initiated in 2013, leveraging OBT’s proprietary OGAP® drug discovery platform for identifying the DLL3 antigen and Boehringer Ingelheim’s extensive expertise in oncology and biotherapeutic development.

Encouraging data from the Phase I first-in-human dose-escalation trial were presented at the American Society of Clinical Oncology (ASCO) 2023 Annual Meeting. These Phase I results demonstrated a clinically acceptable safety profile and early efficacy in patients with DLL3-positive ES-SCLC and epNECs.

Christian Rohlff, CEO of OBT, expressed excitement about the accelerated clinical development of BI 764532 and the impact of the partnership on patients with aggressive cancers like ES-SCLC and epNECs. The FDA’s Fast Track designation is intended to expedite the development and review of drugs aimed at treating serious or life-threatening diseases with unmet medical needs.

About Oxford BioTherapeutics

Oxford BioTherapeutics (OBT) is a clinical-stage oncology company with a diverse pipeline of pioneering immuno-oncology (IO) and antibody-drug conjugate (ADC) therapies. These therapies are designed to address unmet medical needs in the field of cancer therapeutics.

OBT’s portfolio includes bispecific antibodies, Chimeric Antigen Receptor T Cell (CAR-T) therapies, Antibody Drug Conjugates (ADCs), and Antibody-Dependent Cell-Mediated Cytotoxicity (ADCC) therapeutics.

OBT’s first clinical program, OBT076, commenced expansion in a U.S. clinical trial in 2021. This program targets patients with advanced or refractory solid tumors, including gastric, bladder, ovarian, and lung cancers characterized by the overexpression of CD205.

The company’s research indicates that the presence of immunosuppressive cells within tumors is associated with unfavorable outcomes, including lower progression-free and overall survival, suggesting that these cells contribute to cancer progression in multiple indications.

The foundation of OBT’s innovation lies in its proprietary OGAP® target discovery platform, which is built on one of the world’s largest proprietary cancer membrane proteomic databases. This database contains information on over 5,000 cancer cell proteins, providing a unique and highly qualified resource for identifying oncology targets. Currently, three OBT programs based on this platform are in clinical development across the United States and Europe.

OBT’s IO discovery process offers valuable insights into the cancer-immune cell synapse, leading to the identification of novel IO monoclonal antibodies and bispecific antibody candidates for cancer therapy.

The company has a strong track record of forming strategic partnerships, including collaborations with Boehringer Ingelheim, ImmunoGen, and Kite Pharma, among others. OBT’s management team and board boast extensive experience in the development of IO and antibody-based therapies, further strengthening the company’s position as a leader in the field of oncology research and therapeutics.

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