The U.S Food and Drug Administration (FDA) has granted Investigational New Drug (IND) clearance for OBT076, an experimental antibody-drug conjugate or ADC being developed by  Oxford BioTherapeutics 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.

A Phase I study, to be performed at a number of leading clinical centers across the United States, will be initiated in the near future.

OBT076 includes a fully human antibody targeting CD205, which is overexpressed in subsets of Her2 negative cancers, coupled to the DM4, a potent microtubule-targeted compounds that inhibit proliferation of cells at mitosis. [1]

In addition to HER2 negative breast cancer, the investigational agent is being developed for a number of other CD205 driven  cancers such as gastric cancer, triple-negative metastatic breast cancer, bladder cancer and pancreatic cancers as well as Non-Hodgkin Lymphoma (NHL). [2] and several other solid and liquid cancers.

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Unmet medical need
“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, Rahim A Fandi, MD, Ph.D.

“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 I 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,” Fandi added.

Important milestone
“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,”  noted Christian Rohlff, Ph.D., OBT Chief Executive Officer,

“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,” Rohlff concluded.

[1] Maytansine. ADC Review | J. Antibody-drug Conjugates. Online. Last accessed December 21, 2018
[2] Treilleux I, Blay JY, Bendriss-Vermare N, Ray-Coquard I, Bachelot T, Guastalla JP, Bremond A, et al. Dendritic cell infiltration and prognosis of early stage breast cancer. Clin Cancer Res. 2004 Nov 15;10(22):7466-74.

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