Oxford BioTherapeutics Receives IND Clearance for OBT076

Oxford BioTherapeutics has received US Investigational New Drug (IND) clearance from the US Food and Drug Administration (FDA) for OBT076, an experimental antibody drug conjugate (ADC) for the treatment of women with high risk HER2 negative breast cancer, as well as other solid tumors expressing this target antigen including gastric, lung, bladder and ovarian cancer. The phase I study will be performed at a number of clinical centrs across the United States.

"With our highly experienced expert investigators, we hope to bring this new innovative treatment option to this high unmet medical need patient population with high risk Her2 negative breast cancer", said OBT's Chief Medical Officer, Dr Rahim A Fandi. "We also aim to develop OBT076 for other solid tumors expressing the target antigen. OBT076/MEN1309 has already been shown to be well tolerated in an on-going phase 1 trial conducted in Europe under the sponsorship of Menarini Ricerche. OBT076/MEN1309 is an ADC drug, which is designed to target CD205 positive tumors and to reverse immune tolerance in patients with high risk breast cancer and other solid and liquid tumors. This is a great achievement by OBT's team."

"The FDA's acceptance of the IND for OBT076 is an important milestone in OBT's US product development strategy. We plan to conduct studies in the US that will extend the potential of this first-in-class molecule, beyond the cancer indications currently under evaluation in the Menarini Ricerche sponsored European trial, under the name MEN1309, to patients with other cancer types with a clear need for better treatment options," OBT Chief Executive Officer, Dr. Christian Rohlff said. "OBT076 is expected to play a key role in OBT delivering on its commitment to help patients with cancer, in particular those with high risk breast cancer. The start of this trial will herald an exciting start to 2019 for OBT."

OBT076, is an antibody drug conjugate (ADC) comprising a fully human antibody targeting CD205, coupled to the DM4 toxin from Immunogen. OBT076 is being developed for a number of CD205 driven tumors including Her2 negative breast cancer, gastric cancer, triple-negative metastatic breast cancer, bladder cancer and pancreatic cancers as well as Non-Hodgkin Lymphoma (NHL). Infiltration of primary localized breast tumors by pDC correlates with an adverse outcome, suggesting their contribution in the progression of breast cancer and several other solid and liquid cancers. CD205 is overexpressed in subsets of Her2 negative breast cancer, triple negative breast cancer, gastric cancer, lung cancer, bladder cancer, pancreatic cancer, ovarian cancer and multiple liquid cancers including DLBCL.

OBT076 is currently also being tested in a multi-center first-in-human clinical study under the name MEN1309 in major European oncology centers in Italy, Spain, Belgium and the UK in triple negative breast cancer (TNBC), pancreatic, and bladder cancers, as well as diffuse large B-cell lymphoma (DLBCL) under the sponsorship of Menarini Ricerche via a strategic alliance with OBT. The European first in human trial is successfully progressing the dose escalation phase that commenced by enrolling patients with solid tumors and has recently extended the enrolment to patients with NHL. The subsequent expansion cohorts' phase of this European trial will aim to identify the recommended phase II dose in specific sold tumor indications as well as NHL.

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