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., 24th 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. *** *Further information can be found in the article ‘Transforming cancer care through targeted immunotherapy for DLL3-positive carcinomas’ on Boehringer Ingelheim’s website. About Oxford BioTherapeutics Oxford BioTherapeutics (OBT) is a clinical stage oncology company with a pipeline of first-in-class immuno-oncology (IO) and antibody-drug conjugate (ADC) based therapies designed to fulfil major unmet patient needs in cancer therapeutics. These include bispecific, Chimeric Antigen Receptor T Cell (CAR-T), Antibody Drug Conjugate (ADC) and Antibody Dependent Cell-mediated Cytotoxicity (ADCC) therapeutics. OBT’s first clinical program, OBT076, initiated expansion in a US Clinical Trial in 2021 in patients with advanced or refractory solid tumors, including gastric, bladder, ovarian and lung cancer, where CD205 is overexpressed.
Infiltration of tumors by immunosuppressive cells correlates with adverse outcomes (lower progression free and overall survival), suggesting that this process contributes to the progression of several cancers. OBT’s proprietary OGAP® target discovery platform is based on one of the world’s largest proprietary cancer membrane proteomic databases, with data on over 5,000 cancer cell proteins providing unique, highly qualified oncology targets, of which three programs are in clinical development in the US and Europe. OBT’s IO discovery process provides unique insights into the cancer-immune cell synapse and has identified several novel IO monoclonal and bispecific antibody candidates for cancer therapies.
OBT’s pipeline and development capabilities have been validated through multiple strategic partnerships including with Boehringer Ingelheim, ImmunoGen and our cell therapy research collaboration with Kite Pharma as well as other world leaders in antibody development (such as Amgen, WuXi, Medarex (BMS), Alere (Abbott) and BioWa). OBT has a strong oncology focused management team and board with significant experience in developing IO and antibody-based therapies.