Oxford Biotherapeutics Launches Phase Ib Clinical Trial for OBT076 in Patients With Advanced Solid Tumors, Initiating First Patient Dose With CPI Balstilimab in Europe
Wednesday, July 05, 2023
Oxford BioTherapeutics (OBT) has recently initiated a Phase 1b combination trial to evaluate its lead candidate, OBT076, in conjunction with Agenus' balstilimab, an anti-PD1 checkpoint inhibitor. The trial is being conducted at multiple centers in Europe, specifically in France, Belgium, and Greece, and aims to assess the effectiveness of the combination therapy in treating advanced solid tumors, including lung, gastric, and ovarian cancers.
The decision to extend OBT's US Phase I Clinical Trial for OBT076 is based on promising preliminary data presented at the American Association for Cancer Research (AACR) Annual Meeting in 2022. These data demonstrated nearly complete responses in two patients with low PDL1 expression who were treated with OBT076 followed by the CPI pembrolizumab. Immuno-blood profiling conducted during translational work on these patients indicated early signs of clinical activity and suggested a potential novel mechanism for immune system reactivation and tumor shrinkage.
In May 2022, OBT entered into a collaboration and supply agreement with Agenus Inc, an immuno-oncology company, to support this trial. The initiation of the European arm of the trial marks a significant milestone in the partnership between OBT and Agenus and signifies progress in the development of balstilimab with OBT076 as a potential therapy for advanced solid tumors.
Additionally, OBT has expanded its Phase 1b clinical trial to investigate the safety, tolerability, and pharmacokinetic profile of OBT076 as a monotherapy in Europe. This expansion is a continuation of the ongoing trial initiated in the US and has shown promising initial signs of clinical activity and a favorable tolerability profile for OBT076 as a standalone treatment.
The expanded cohorts will enroll approximately 150 patients with a range of solid tumors, including gastric, endometrial, ovarian, and non-small cell lung cancer. The trial will be conducted at sites in France, Belgium, Greece, and the US. The primary objectives of these cohorts are to gather additional data on the safety, tolerability, and anti-tumor activity of OBT076, both as a monotherapy and in combination with balstilimab.
Overall, these endeavors by OBT aim to provide a novel treatment option for patients with advanced solid tumors who have not responded to standard chemotherapy. The exploration of OBT076 and balstilimab in combination therapy represents a significant advancement in the field of immuno-oncology.
