Oxford BioTherapeutics Ltd. (“OBT”), a clinical stage oncology company developing antibody-based immuno-oncology therapies, has announced the initiation of the dose-escalation portion of its U.S. Phase I program for OBT076, a CD205 targeting antibody-drug conjugate (ADC), in patients with advanced solid tumours. Dose-escalation is the first part of the Phase I program that includes two U.S. expansion cohorts: high-risk HER2-/HR+ chemotherapy-failure breast cancer and a basket trial that will enrol patients with a variety of CD205-overexpressing advanced solid tumours.

Christian Rohlff, Ph.D., Chief Executive Officer of OBT announced. “Our Phase I program is designed to leverage results obtained by our European partner, Menarini, to initiate dose escalation at a level where tolerability has been established, which is expected to expedite completion of the dose escalation phase of the trial. In addition, OBT has developed a CLIA-certified patient selection assay that we developed in conjunction with OBT076, which will be highly beneficial in identifying patients with CD205-overexpressing tumours to enrol in the expansion phase of the trial and potentially in more advanced clinical trials.”

Abderrahim (Rahim) Fandi, M.D., Ph. D, Chief Medical Officer of OBT said, “Our U.S. clinical program is truly innovative because OBT076 can potentially reverse immune tolerance by simultaneously destroying tumour associated immune cells and the tumor itself. Safety data collected by Menarini enables us to more rapidly and effectively move toward the second portion of the program.

“HER2-/HR+ breast cancer is a common phenotype for which chemotherapy is generally effective,” said Gary Schwartz, M.D., Chief of Hematology/Oncology at NewYork-Presbyterian/Columbia University Irving Medical Center, Deputy Director of the Herbert Irving Comprehensive Cancer Centre, and investigator of the clinical trial. “However, more than 30% of these patients respond poorly to treatment and face limited treatment options. There is a high unmet need for an innovative drug that is effective in this subset of HER2-/HR+ patients. I look forward to seeing the results of this Phase I program.”

Solmaz Sahebjam, M.D., Director of the Clinical Research Unit  and leader of the Phase 1 Clinical Trial Program at Moffitt Cancer Centre, added, “The proposed mechanism of action of OBT076 provides for a unique new approach to treat CD205-positive solid tumours in areas of high unmet need by aiming to kill the tumour and re-engage the patient’s immune system at the same time in patients with breast, bladder, lung, ovarian and gastric cancers.

For further information please see the full release here.