UK-based oncology company Oxford BioTherapeutics has initiated a Phase Ib trial evaluating OBT-076 in patients with solid tumours at a European site.

The company dosed the first patient with its CD205 targeting antibody-drug conjugate (ADC).

The trial is investigating OBT-076 in combination with Agenus’ anti-PD1 checkpoint inhibitor (CPI) balstilimab. The combination trial will enrol patients who are CPI-naïve and resistant patients with advanced solid tumours, including lung, gastric and ovarian cancers.

Oxford BioTherapeutics announced its collaboration with Agenus in May 2022. Under the agreement, Oxford BioTherapeutics is sponsoring the trial and is responsible for operational execution while Agenus is providing drug supply and scientific support.

The combination study is an extension to Oxford BioTherapeutics’ Phase I clinical trial investigating OBT-076 at US-based sites. The first two parts of the trial are investigating OBT076 as a monotherapy, and in the final portion, patients receive OBT-076 in combination with a CPI.

The new trial is designed to build on preliminary data supporting the notion that OBT-076 is able to deliver immune priming in chemo-refractory, advanced cancer patients.

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In last year’s American Association of Cancer Research (AACR) Annual Meeting, Oxford BioTherapeutics presented data that showed evidence of near-complete responses in two patients with low PDL1 expression after a dosing regimen of two to five cycles of OBT-076 followed by one to two cycles of CPI pembrolizumab.

Monotherapy trial with OBT076

Alongside the combination trial expansion, Oxford BioTherapeutics is also extending the monotherapy cohorts into European sites.

Both monotherapy and combination expansions will enrol approximately 150 patients in France, Belgium, and Greece. Oxford BioTherapeutics is also adding new sites in the US.

The open-label, dose-finding trial (NCT04064359) is measuring the incidence of adverse events and the percentage of subjects with dose-limiting toxicities as primary endpoints.

Exploring other indications with OBT076

Earlier this year, Oxford BioTherapeutics entered a collaboration with France-based Groupe d’Oncologie Radiothérapie Tête Et Cou (GORTEC). Together they will investigate OBT-076 in patients with adenoid cystic carcinoma (ACC) of the head and neck.

The Phase Ib trial will be led by Dr Jean Bourhis, chief of radiation oncology at Lausanne University Hospital and chairman at GORTEC. It will enrol patients into 15 sites in France, Belgium, and Switzerland.

OBT-076 will be investigated as a monotherapy and in combination with Agenus’ balstilimab.

According to a recent GlobalData report, ADC cancer therapies are a key innovation area in immuno-oncology. The analysis ranked Oxford BioTherapeutics in third place for geographic reach, which refers to the number of different countries each relevant patent is registered in.