On May 18, 2022 BioVaxys Technology Corp. (CSE: BIOV; FRA: 5LB; OTCQB: BVAXF) ("BioVaxys" or "Company"), reported that Hospices Civils de Lyon, France ("HCL") has agreed to serve as a clinical study site for the Phase I study of BVX-0918, the Company’s autologous haptenized tumor cell vaccine for late-stage ovarian cancer (Press release, BioVaxys Technology, MAY 18, 2022, View Source [SID1234614858]). HCL has further agreed to supply BioVaxys with surgically debulked tumors from Stage III/Stage IV ovarian cancer patients undergoing treatment at the hospital to permit the Company to perform manufacturing tests. BioVaxys, together with its EU partner, ProCare Health of Barcelona, Spain, is preparing for a Phase I clinical study with BVX-0918 later this year.

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HCL is a public hospital and France’s second University Hospital Center, and a premier site for clinical studies in the EU. Hospices Civils de Lyon is at the heart of the healthcare ecosystem of Greater Lyon, one of the major biotechnology and healthcare markets in Europe.

BioVaxys and Procare personnel will collaborate with Dr Pierre Adrien Bolze, MD, PhD, and Pr. Benoît You, MD, PhD, of HCL who are planned Clinical Investigators for the Phase I study of BVX-0918.

BioVaxys is preparing to file a Clinical Trial Application ("CTA") with the European Medicines Agency ("EMA") later in 2022. Access to surgically removed ovarian cancer tumor cells is a critical step enabling BioVaxys to validate the manufacturing process for BVX-0918. BioVaxys recently entered a similar collaboration with 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, a requirement for the planned CTA with the EMA.

HCL has pre-screened the first patient for tumor collection, with patient enrollment for surgical debulking planned for next week.

Dr. You stated, "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. 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." Professor You is a medical oncologist and head of the Phase 1 trial unit oncology group (Centre d’Investigation des Thérapeutiques en Oncologie et Hématologie de Lyon), certified by French National Cancer Institute.

"We are very happy to partner with Biovaxys to contribute to the development of innovative therapeutic strategies for our ovarian cancer patients," stated Pierre Adrien Bolze, MD, PhD, Professor of Gynecological Obstetrics at HCL. "Our department is certified by the European Society of Gynaecological Oncology for ovarian cancer surgery, and has an extensive track record in gynecology oncology studies."

"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," says Kenneth Kovan, President and Chief Operating Officer of BioVaxys. Ovarian cancer ranks fifth for cancer-related death in women. About 75% of ovarian cancers are diagnosed at late stage of the disease, when the peritoneum is involved (stage III) or disease has spread to other organs (stage IV). The standard of care for late-stage ovarian cancer relies on a medical-and-surgical treatment associating a platinum-based chemotherapy and a surgical debulking of the tumor mass meant to be complete with no post-operative residual lesion.

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.