Oxford BioTherapeutics has dosed the first subject in a Phase Ib clinical trial of its lead antibody-drug conjugate (ADC) candidate, OBT076, to treat adenoid cystic carcinoma (ACC) of the head and neck.

Sponsored by the European oncology and radiotherapy consortium Groupe d’Oncologie Radiothérapie Tête Et Cou (GORTEC), the trial will enrol patients with recurrent or metastatic ACC at 15 study centres in France, Belgium and Switzerland.

The study is designed to evaluate OBT076 both as a monotherapy and along with Agenus‘ balstilimab.

OBT076 acts on the CD205 receptor on tumour cells and specific immune suppressive cells in high-risk cancer patients.

It has a dual mechanism of action to treat ACC, an aggressive cancer type which represents 2% of head and neck cancers and around 20% of salivary gland malignancies.

In addition to this trial, OBT076 is being assessed in Phase I trials in the US and Europe for various advanced solid tumour indications, such as endometrial, gastric, ovarian, and non-small cell lung cancer (NSCLC).

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These studies are investigating OBT076 alone and together with a checkpoint inhibitor (CPI) to treat tumours.

Preliminary findings indicated signs of clinical activity for OBT076.

Furthermore, following two to five cycles of OBT076 and one to two CPI treatment cycles led to near-complete responses in two chemo-refractory patients with low programmed cell death ligand 1 (PD-L1) expression.

Oxford BioTherapeutics CEO Christian Rohlff said: “The start of this Phase Ib trial investigating our lead asset OBT076 in adenoid cystic carcinoma 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 an immune primer to boost the effectiveness of CPI immunotherapies, particularly in patients with advanced and/or refractory tumours and those with low PD-L1 expression.”