BioVaxys Technology Corp has confirmed its first clinical site for its Phase I ovarian cancer vaccine trial.
The study on BVX-0918, the company's autologous haptenized tumor cell vaccine for late-stage ovarian cancer, will take place at Hospices Civils de Lyon (HCL) in France, according to a company statement.
HCL has also agreed to supply BioVaxys with surgically debulked tumors from Stage III/Stage IV ovarian cancer patients undergoing treatment at the hospital to allow the company to perform manufacturing tests.
READ: BioVaxys files to expand international cervical cancer vaccine patent protection
The study will be led by Drs Pierre Adrien Bolze and Benoit You as planned clinical investigators.
"There is an unmet medical need for innovative approaches, based on vaccines and immunotherapies drugs, in ovarian cancer, as a way of improving the prognosis of patients. It has been defined as a priority for our institution,” Benoit You said in a statement.
“This collaboration with BioVaxys is a great opportunity for developing a vaccine that would then be assessed in a first-in-human trial in our early phase trial unit."
Pierre Bolze told BioVaxys shareholders that the department is certified by the European Society of Gynaecological Oncology for ovarian cancer surgery, and has an extensive track record in gynecology oncology studies.
"We are very happy to partner with BioVaxys to contribute to the development of innovative therapeutic strategies for our ovarian cancer patients," Bolze added.
The BioVaxys vaccine platform is based on the established immunological concept that modifying surface proteins with haptens makes them more visible to the immune system. According to BioVaxys, this process of haptenization "teaches" a patient's immune system to recognize and make target proteins more "visible" as foreign, thereby stimulating a T-cell mediated immune response.
"BioVaxys is honored to be working with Dr Bolze and Dr You on the Phase I study of BVX-0918. They are leaders in gynecological oncology, and have led an extensive range of clinical studies," COO Kenneth Kovan said.
A first generation single-hapten vaccine achieved encouraging results in early trials. BioVaxys said it has enhanced the first-generation approach by utilizing two haptens, which it believes will yield superior results.
Contact Angela at angela@proactiveinvestors.com
Follow her on Twitter @AHarmantas