Tracon Pharmaceuticals has started dosing patients in a Phase l/ll clinical trial evaluating TRC105 in combination with Afinitor (everolimus), a mammalian target of rapamycin (mTOR) inhibitor, and Femara (letrozole), an aromatase inhibitor, to treat patients with breast cancer prior to surgery.
TRC105 is a new, clinical stage antibody to endoglin, a protein overexpressed on proliferating endothelial cells that is essential for angiogenesis, the process of new blood vessel formation.
The antibody is currently being studied in multiple Phase ll clinical trials sponsored by Tracon or the National Cancer Institute, to treat solid tumour types in combination with VEGF inhibitors.
The Phase l/ll trial is an open-label, non-randomised, clinical trial of TRC105 in combination with Afinitor and Femara being conducted in neoadjuvant setting.
The trial is conducted in post-menopausal women with newly diagnosed local or locally advanced, potentially resectable, hormone-receptor positive and Her2-negative non-metastatic breast cancer.
Around 35 patients are expected to enrol in the trial at the University of Alabama-Birmingham, US, and top-line data is expected to be reported next year.
Tracon Pharmaceuticals president and CEO Dr Charles Theuer said: "Our collaborators at the University of Alabama-Birmingham have demonstrated in previous studies that the addition of anti-angiogenic therapy to hormonal therapy in the neoadjuvant setting resulted in the down-staging of a significant proportion of breast cancer patients, and could produce pathologic complete responses.
"The achievement of a pathologic complete response with neoadjuvant therapy in early-stage breast cancer is known to have a favourable impact on patient outcomes.
"As such, we look forward to assessing the ability of TRC105 to potentiate neoadjuvant treatment."
The company develops targeted therapies for cancer, ophthalmic and fibrotic diseases.
Its clinical-stage pipeline includes TRC105, an endoglin antibody that is being developed for the treatment of multiple cancers, DE-122, the ophthalmic formulation of TRC105 being developed in wet AMD through a collaboration with Santen Pharmaceutical Company and TRC102, a small molecule developed for the treatment of lung cancer and glioblastoma.