Oxford, UK and San Jose, Calif. – Oxford BioTherapeutics (‘OBT’), a clinical stage oncology company with a pipeline of immuno-oncology and antibody-drug conjugate (ADC)-based therapies, today announces that the first patient has been dosed in a Phase 1b trial investigating OBT’s lead candidate, OBT076, in patients with Adenoid Cystic Carcinoma (ACC) of the head and neck. This Phase 1b trial is being sponsored by Groupe d’Oncologie Radiothérapie Tête Et Cou (GORTEC), an established, internationally renowned European oncology and radiotherapy consortium specializing in clinical and laboratory research specifically for the benefit of head and neck cancer patients.
OBT076, is an innovative ADC with a potential dual mechanism of action in treating patients with ACC, a rare, aggressive type of cancer which represents 2% of head and neck cancers and about 20% of salivary gland malignancies. OBT076 targets the CD205 receptor on tumor cells as well as certain immune suppressive cells in high-risk cancer patients. The CD205 receptor is highly overexpressed in solid and liquid tumors with high unmet need, including gastric, lung and ovarian cancer.
Led by Professor Jean Bourhis, MD, PhD, Chief of Radiation Oncology at Lausanne University Hospital & Chairman at GORTEC, the trial (NCT05930951) will be carried out in patients with recurrent or metastatic ACC of the head and neck from an anticipated 15 study sites across the GORTEC network in France, Belgium and Switzerland. It will investigate OBT076 both as a monotherapy and in combination with balstilimab, a PD-1 blocking antibody, accessed through a clinical collaboration agreement from Agenus.
Prof Bourhis commented: “Recurrent or metastatic adenoid cystic carcinoma (ACC) is an orphan disease since there is no established and validated treatment that could significantly improve the patients’ outcome. With such an unmet clinical need, OBT076 is opening new avenues and creating a major interest among GORTEC investigators since it is targeting the CD205 protein which is overexpressed in a large proportion of ACCs, a much higher proportion compared to other types of solid tumors.”
Christian Rohlff, PhD, Chief Executive Officer of Oxford BioTherapeutics, said: “The start of this Phase 1b trial investigating our lead asset OBT076 in Adenoid Cystic Carcinoma (ACC) is a major milestone for OBT. We look forward to demonstrating the potential value of OBT076, with the hope to provide meaningful benefit for ACC patients. Additionally, it will contribute to the expanding pool of data affirming the potential of OBT076, both as an ADC monotherapy and as 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.”
OBT076 is also 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.
OBT076 was discovered using OBT’s proprietary OGAP® platform, and is the world’s largest cancer specific, membrane protein library used to identify novel, high specific antigens for cancer targets.
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About GORTEC
GORTEC (Head and Neck Oncology and Radiotherapy Group) was created in 1999 with the aim of running clinical and/or laboratory studies in the field of head and neck oncology towards improving care, and promoting research, for the benefit of patients. It is currently one of the most prominent cooperative groups in this field and its multidisciplinary network consists of >100 cancer treatment centers in France, Switzerland, Belgium, Germany and Spain and represents around 500 investigators in the field of head and neck cancer.
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 lead 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.
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Dr Christian Rohlff, CEO
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Sylvie Berrebi, Sandi Greenwood, Erica Hollingsworth
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