Oxford BioTherapeutics Announces Partner Boehringer Ingelheim Dosed First Patient in Phase 2 Trial with BI 764532 in Small Cell Lung Cancer and other Neuroendocrine Cancers

Oxford BioTherapeutics Announces Partner Boehringer Ingelheim Dosed First Patient in Phase 2 Trial with BI 764532 in Small Cell Lung Cancer and other Neuroendocrine Cancers

BI 764532 was discovered using OBT’s proprietary OGAP® platform, the world's largest, cancer specific, membrane protein library used to identify novel, high specific antigens for cancer targets

Oxford, UK, San Jose, Calif., 24^th 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 partner Boehringer Ingelheim dosed the first patient in a Phase 2 trial investigating BI 764532 (OBT620) for the treatment of small cell lung cancer (SCLC) and other neuroendocrine cancers.

The Phase 2 study, ‘DAREON™-5’ (NCT05882058) is an open-label, multi-centre, dose-selection study evaluating two doses of BI 764532 in patients with relapsed/refractory extensive-stage SCLC and other relapsed/refractory neuroendocrine carcinomas.

BI 764532 is an investigational T-Cell engager that might selectively redirect T cells (type of white blood cells called lymphocytes which help the immune system fight disease) towards the cancer cells expressing the DLL3 protein. DLL3 is minimally expressed in normal tissue but expressed in 80-85% of SCLC tumors, and approximately 77% of neuroendocrine carcinomas (NECs)¹ making DLL3 an ideal therapeutic target for these two indications of high unmet medical need.

Christian Rohlff, PhD, Chief Executive Officer of Oxford BioTherapeutics, said: “The start of this Phase 2 trial with BI 764532, the most advanced candidate with our partner Boehringer Ingelheim which was discovered using our proprietary OGAP® platform, is a major milestone for OBT. The progression to Phase 2 development and recent US FDA fast track designation, validates the power of our platform and discovery capabilities to identify targets that kick start the development of impactful therapeutics, particularly for patient populations with poor prognoses and a significant unmet need. Patients with neuroendocrine carcinomas, including small cell lung cancer, have a 5-year survival rate of approximately 13%. We hope that we can continue to make excellent progress with the other programs under the partnership to deliver life changing treatments for this patient population and other cancer patients in need of new treatments.”

“At Boehringer Ingelheim, we have a clear aspiration – to transform the lives of people with cancer by delivering meaningful advances, with the ultimate goal of curing a range of cancers. Making our ambition reality requires a diversity of minds. Therefore, partnerships like these are vital to address some of the most challenging, but potentially most impactful, areas of cancer research.” said Mike Akimov, Head of Medicine, Therapy Area Oncology, Boehringer Ingelheim.

BI 764532 was discovered using OBT’s proprietary OGAP® drug discovery platform and Boehringer Ingelheim’s longstanding expertise in oncology through a successful partnership initiated in 2013. The companies announced a second collaboration in 2020 which was further extended in May 2023.