BioVaxys Technology Corp said it has entered into an agreement with the Deaconess Research Institute (DRI) to supply it with surgically debulked tumors from Stage III/Stage IV ovarian cancer patients undergoing treatment at Deaconess Health System.
The company noted that Evansville, Indiana-based DRI, is the clinical studies arm of Deaconess, a premier regional provider of health care services in the United States. Access to ovarian cancer tumor cells is a critical step enabling it to validate the manufacturing process for BVX-0918, its autologous haptenized tumor cell vaccine for late-stage ovarian cancer, it added.
The standard of care for late-stage ovarian cancer often involves surgically debulking of the tumor mass, BioVaxys explained. The debulked tumor cells will be used to test and validate the tumor collection protocol, cryopackaging, cryopreservation, and supply chain logistics for BVX-0918 bioproduction.
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Following shipment to France-based bioproduction partner BioElpida, BioVaxys said the tumor cells will 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, a requirement for the planned Clinical Trial Application with the European Medicines Agency. BioVaxys, together with its EU partner, ProCare Health of Barcelona, Spain, is preparing to launch a Phase I clinical study for BVX-0918 later this year.
BioVaxys noted that BioElpida has developed various tests and validation procedures needed to support GMP manufacturing, such as sterility testing for transport, hapten fixation, and cryopreservation solutions, as well as antibody generation, bioburden screening of the haptens, and endotoxin assays.
It said access to debulked tumor means that BioElpida can begin the final stages of the vaccine production protocol and GMP validation. BioVaxys and BioElpida have also designed and fabricated a specialized shipping package which would cryopreserve the tumor sample while in transit from any hospital site to the BioElpida site.
"Having complied with the regulatory oversight involved in obtaining waste tumor samples, BioVaxys is now able to provide BioElpida with the materials required for finalizing the vaccine production protocol and performing process validation in the lead up to our planned CTA submission to the European regulator,” BioVaxys president and chief operating officer Kenneth Kovan said in a statement.
BioVaxys said its 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" patient's immune system to recognize and make target proteins more "visible" as foreign, thereby stimulating a T-cell mediated immune response.
It said its 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, the company added.
BioVaxys noted that a first-generation single-hapten vaccine invented by its co-founder and chief medical officer Dr 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.
These studies were conducted under an FDA-reviewed investigational new drug (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. It said the results were encouraging: in 24 patients, the median overall survival was 25.4 months with a range of 4.5-57.4 months; eight patients survived for more than two years.
BioVaxys said it has enhanced the first-generation approach by utilizing two haptens (bi-haptenization), which it said it believes will yield superior results.
Based in Vancouver, BioVaxys has a significant advantage over many other companies looking at cancer therapies in that it already has extensive promising clinical data for its cancer vaccines.
Contact the author at stephen.gunnion@proactiveinvestors.com