BioVaxys Technology Corp announced that its clinical study collaborator Hospices Civils de Lyon (HCL) in France has surgically excised the first ovarian cancer tumors from patients for use in the production of the company’s ovarian cancer vaccine, BVX-0918.
The tumors will be used for process development and manufacturing "dry runs" of the vaccine, which is a major step leading to the completion of Good Manufacturing Process (GMP) production.
BioVaxys recently entered collaborations with HCL and Deaconess Research Institute in the US to obtain surgically debulked tumors from Stage 3/Stage 4 ovarian cancer patients. Tumor samples from both hospitals are being used by BioVaxys' Lyon-based manufacturing partner, BioElpida, in order to validate the tumor collection protocol, cryopackaging, cryopreservation and supply chain logistics for BVX-0918 bioproduction for prospective patients in the US and European Union, the company said.
READ: BioVaxys says bio-manufacturing partner BioElpida completes next phase of BVX-0918 production for EU Clinical study
Donors of ovarian cancer tumors are required to sign a patient consent form, and the tumor extraction, storage and shipping logistics follow a strict, regulated protocol, the company noted.
BVX-0918 produced from the removed tumor cells will be screened using the identity assays derived from the OVCAR-3 cell line recently completed by BioElpida. The identity assay will be performed on every batch of the autologous ovarian cancer vaccine, and it is mandatory for regulators in both the US and EU.
“The production of BVX-0918 is a process that built on the prior successful execution of sequential steps, such as the bioproduction technology transfer to BioElpida, development of validation procedures needed to support GMP manufacturing, sterility testing for transport, hapten fixation, cryopreservation methods, antibody generation, bioburden screening, endotoxin assays, and most recently, the development of the identity assays from the OVCAR-3 cell line,” COO Kenneth Kovan said in a statement.
“With the surgically excised tumors we can now begin the final stages of the vaccine production protocol and GMP validation."
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.
The company’s 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 that 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, noted the company.
A first-generation single-hapten vaccine invented by BioVaxys co-founder and Chief Medical Officer David Berd, 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.
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