BioVaxys Technology announced that its Lyon, France-based bioproduction partner, BioElpida, has completed the creation of multiple OVCAR-3 cell banks as the next step in the GMP manufacturing process development for BVX-0918, BioVaxys' vaccine for treatment of platinum-resistant ovarian cancer.
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The OVCAR-3 cell line is mandatory for creating the identity assays that will have to be performed on every batch of ovarian cancer vaccine. This assay is required by regulatory bodies in the EU and United States.
The cell line is derived from a human ovarian adenocarcinoma, established from a patient refractory to cisplatin, a chemotherapeutic agent used in late-stage ovarian cancer. Patients whose tumors are innately cisplatin-resistant at the time of initial treatment generally have poor prognosis, which is the patient population target for BVX-0918.
BioVaxys recently entered collaborations with Hospices Civils de Lyon in France and Deaconess Research Institute in the United States to provide the Company with surgically debulked tumors from Stage III/Stage IV ovarian cancer patients.
Tumor samples from both hospitals are being used to validate the tumor collection protocol, cryopackaging, cryopreservation, and supply chain logistics for BVX-0918 bioproduction for prospective patients in the US and EU.
Tumor samples from HCL will also be used for process testing and manufacturing "dry runs" of BVX-0918, a major step leading to the completion of Good Manufacturing Process ("GMP") production.
BioVaxys' vaccine platform is based on the established immunological concept that modifying surface proteins---whether they are viral or tumor---with haptens makes them more visible to the immune system.
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' cancer vaccines are created by extracting a patient's own (autologous) cancer cells, chemically linking with a hapten, and re-injecting them into the patient to induce an immune response to proteins which are otherwise not immunogenic.
Haptenization is a well-known and well-studied immunotherapeutic approach to cancer immunotherapy and has been clinically evaluated in both regional and disseminated metastatic tumors.
A first generation single-hapten vaccine invented by BioVaxys Co-Founder and Chief Medical Officer David Berd, MD, achieved positive immunological and clinical results in Phase I and Phase II human trials in over 600 patients with different tumor types, as well as having no observed toxicity in years of clinical study.
These studies were conducted under an FDA-reviewed IND. A first generation autologous, haptenized vaccine was also tested by Dr. Berd in women with advanced ovarian cancer who had ceased to respond to conventional chemotherapy.
The results were encouraging: In 24 patients, the median overall survival was 25.4 months with a range of 4.5-57.4 months; 8 patients survived for more than 2 years. BioVaxys has enhanced the first-generation approach by utilizing two haptens ("bi-haptenization"), which the Company believes will yield superior results. ■