Oxford BioTherapeutics Initiates Dose-Escalation Portion of U.S. Phase I Clinical Trial for OBT076 in Patients with Advanced Solid Tumors

Dose-escalation starting at a dose based on results from a European study sponsored by partner, Menarini Ricerche.

Phase I program includes two U.S. expansion cohorts: (1) High risk cohort of HER2 negative, Hormone receptor positive (HER2-/HR+) chemotherapy-failure breast cancer; and (2) a basket trial in multiple pretreated solid tumors.

Oxford, UK and San Jose, Calif., January 9 2020 – Oxford BioTherapeutics Ltd. (“OBT”), a clinical stage oncology company developing antibody-based immuno-oncology therapies emerging from the Company’s proprietary target discovery platform, today 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 tumors. 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 enroll patients with a variety of CD205-overexpressing advanced solid tumors. Dosing in the study will initiate near anticipated therapeutic dose levels based on results from the Company’s European development partner, Menarini Ricerche (“Menarini”).

“OBT076 binds to a novel target, CD205, identified by our OGAP® target discovery platform, that is highly expressed on the surface of both cancer cells and tumor-associated immunosuppressive cells such as in HER2-/HR+ breast cancer,” said Christian Rohlff, Ph.D., Chief Executive Officer of OBT. “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 tumors to enroll 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 tumor 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, where we will target high risk HER2-/HR+ chemotherapy-failure breast cancer patients, which call for new treatment approaches due to limited existing treatment options and more rapid disease progression.”

The dose-escalation phase of the clinical trial is an open-label, multicenter study that will investigate the safety, tolerability and pharmacokinetic profile of OBT076 in patients with advanced or refractory solid tumors. The expansion cohorts in HER2-/HR+ breast cancer and the basket trial will begin once a maximum tolerated dose has been established in the dose escalation phase.

“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 Center, Professor of Oncology at Columbia University Vagelos College of Physicians and Surgeons, 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 Center, added, “The proposed mechanism of action of OBT076 provides for a unique new approach to treat CD205-positive solid tumors in areas of high unmet need by aiming to kill the tumor and re-engage the patient’s immune system at the same time in patients with breast, bladder, lung, ovarian and gastric cancers. The totality of results from this phase 1 trial should provide us with significant information on this new mechanism, and the team at Moffitt Cancer Center is excited to make a contribution to this valuable effort.”