Oxford BioTherapeutics announces Phase 1b trial in collaboration with GORTEC to investigate OBT076 in Adenoid Cystic Carcinoma (ACC) of the head and neck

Oxford BioTherapeutics announces Phase 1b trial in collaboration with GORTEC to investigate OBT076 in Adenoid Cystic Carcinoma (ACC) of the head and neck

• Trial will investigate OBT076 as monotherapy and in sequence with balstilimab
• CD205, OBT076’s target antigen, is overexpressed in ~ 80 % of ACC tumor biopsy samples
• Recurrent or metastatic ACC patients currently face poor prognosis and very few treatment options

Oxford, UK and San Jose, Calif., 19 April 2023 - Oxford BioTherapeutics Ltd. (OBT), a clinical stage oncology company with a pipeline of immuno-oncology and antibody-drug conjugate (ADC)-based therapies, announces it has entered into a collaboration with Groupe d'Oncologie Radiothérapie Tête Et Cou (GORTEC), an established, internationally renowned, European oncology and radiotherapy consortium specialising in clinical and laboratory research specifically for the benefit of head and neck cancer patients, to undertake a new Phase 1b trial investigating OBT’s lead asset, OBT076, in patients with Adenoid Cystic Carcinoma (ACC).

ACC is a rare, aggressive type of cancer which represents 2% of head and neck cancers and about 20% of salivary gland malignancies. Patients with ACC typically have a poor prognosis with a high risk of recurrence and metastasis. The Median survival of patients with ACC and distant metastasis is less than three years. There are no effective and/or standardized treatments available to date, beyond surgery and radiotherapy, for ACC cancer patients.

OBT has observed the drug receptor CD205, a unique characteristic for this disease, in at least 80% of ACC patients. CD205 is the target for OBT’s innovative ADC, OBT076, suggesting that OBT076 may have high therapeutic potential in this type of cancer.

Led by Professor Jean Bourhis, MD, PhD, Chief of Radiation Oncology at Lausanne University Hospital & Chairman at GORTEC, the trial will be carried out in patients with recurrent or metastatic ACC of the head and neck across the GORTEC network in France, Belgium and Switzerland, from an anticipated 15 study sites. It will investigate OBT076 both as a monotherapy and in combination with Agenus Inc. proprietary checkpoint inhibitor (CPI), balstilimab. Balstilimab is a PD-1 blocking antibody that has been studied in over 750 patients and is currently in clinical development in multiple solid tumor indications.

Prof. Jean Bourhis, said: “OBT076’s ability to target a highly prevalent receptor in ACC, and the potential to work in combination with checkpoint inhibitor therapies make it an interesting prospect as we continue seeking effective treatment options for patients with ACC. We are looking forward to leveraging our network for the trial and learning more about the drug’s potential in this rare indication with very limited treatment options.”

OBT076 is currently being evaluated in Phase 1 clinical trials in the US and Europe across several advanced solid tumor indications, including gastric, endometrial, ovarian and non-small cell lung (NSCLC) cancer. Trial arms are investigating OBT076 both as a monotherapy and in combination with a CPI in these tumors. In preliminary data, OBT076 showed signs of clinical activity as a single agent and in combination with a CPI, including near complete responses after 2-5 cycles of OBT076 and 1-2 cycles of a CPI, in two chemo-refractory patients with low PD-L1 expression.

Christian Rohlff, PhD, Chief Executive Officer of Oxford BioTherapeutics, added: “We are excited to be collaborating with GORTEC to investigate OBT076 in another key indication where CD205 expression appears to be a driving factor. This collaboration will allow OBT to work in partnership with a number of world renowned experts in the field of head and neck cancer, who have a strong track record of conducting multiple, globally significant clinical trials in this field. We are hopeful that this trial will provide evidence to develop better treatment options for ACC patients while simultaneously adding to the growing body of data supporting OBT076’s potential both as an ADC monotherapy and as an immune primer to boost the effectiveness of CPI immunotherapies, particularly in patients with advanced and/or refractory tumors and those with low PD-L1 expression. As ACC is an orphan disease, should OBT076 be found to be effective, the regulatory process could be expedited via fast-track approval, given the high unmet medical need for this patient population.”