BVX-0918A / BioVaxys, Procare Health - LARVOL DELTA

BioVaxys and Procare Health Agree to Termination of USA Distribution Agreement for Papilocare (PRNewswire) - "BioVaxys Technology Corp.,,announced today that as part of BioVaxys' efforts to refocus on immunotherapeutics, Biovaxys and Procare Health ('Procare') have jointly and amicably agreed to terminate the US Distribution Agreement for Papilocare and Immunocaps....The partnership between BioVaxys and Procare for the EU clinical development of BioVaxys' ovarian cancer vaccine BVX-0918 will continue and remains unchanged."

Licensing / partnership • Gynecologic Cancers • Oncology • Ovarian Cancer • Solid Tumor

BIOVAXYS ANNOUNCES SALE OF TAET SOFTWARE CO (PRNewswire) - "We are pleased to monetize our investment in TAET Software Corp.; exiting this medical software business will allow BioVaxys to refocus on its core business objectives of distributing OTC women's healthcare products in the USA and advancing towards the launch of the planned Phase I trial for BVX-0918, our therapeutic ovarian cancer vaccine."

New P1 trial • Gynecologic Cancers • Oncology • Ovarian Cancer • Solid Tumor

BioVaxys Announces Successful Test-Run Production of its Bi-Haptenized Ovarian Cancer Vaccine (PRNewswire) - "BioVaxys Technology Corp....is pleased to announce the successful sterile and bacteria-free test-run production of BVX-0918, the Company's bi-haptenized autologous ovarian cancer vaccine. The complete manufacturing of BVX-0918 from a cancer patient's ovarian tumor now validates the production protocols that had been in development over the past few months for the successful extraction of tumor cells, the cryo-packaging and cryo-preservation of tumor cells, identification of ovarian cancer cells as the components of the vaccine using specially developed monoclonal antibodies and flow cytometry, sterility processes, and development of the process for double haptenization of the ovarian tumor cells used in the vaccine."

Commercial • Gynecologic Cancers • Oncology • Ovarian Cancer • Solid Tumor

Clinical Study Collaborator HCL Sends First Surgically Excised Ovarian Cancer Tumors to BioVaxys for BVX-0918 Vaccine Process Development (Canada Newswire) - "BioVaxys Technology Corp...announced today that its clinical study collaborator Hospices Civils de Lyon in France ('HCL') has surgically excised the first ovarian cancer tumors from cancer patients to be used by BioVaxys for process development and manufacturing 'dry runs' of BVX-0918, a major step leading to the completion of Good Manufacturing Process ('GMP') production of the Company's ovarian cancer vaccine....BioVaxys recently entered collaborations with HCL and Deaconess Research Institute in the United States to provide the Company with surgically debulked tumors from Stage III/Stage IV ovarian cancer patients."

Clinical • Licensing / partnership • Gynecologic Cancers • Oncology • Ovarian Cancer • Solid Tumor

BioVaxys Confirms First Clinical Site and Principal Investigators for Ovarian Cancer Vaccine Trial and Enters into Second Tumor Cell Supply Agreement (Canada Newswire) - "BioVaxys Technology Corp...announced today that Hospices Civils de Lyon, France...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. 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...BioVaxys is preparing to file a Clinical Trial Application ('CTA') with the European Medicines Agency ('EMA') later in 2022."

European regulatory • Licensing / partnership • New P1 trial • Gynecologic Cancers • Oncology • Ovarian Cancer • Solid Tumor

International Patent Application Filed for Cervical Cancer Vaccine (PRNewswire) - "BioVaxys Technology Corp....announced today that it has continued to expand the patent coverage for its cancer vaccine platform by filing an international patent application through the Patent Cooperation Treaty ('PCT') for broad geographic market coverage outside the US for cervical cancer. BioVaxys has an agreement with Procare Health of Barcelona, Spain ('Procare') for clinical co-development of the Company's autologous bihaptenized cervical cancer vaccine for the EU market, in addition jointly conducting the upcoming EU Phase I clinical study of BVX-0918 in ovarian cancer."

Licensing / partnership • New P1 trial • Patent • Cervical Cancer • Gynecologic Cancers • Oncology • Ovarian Cancer • Solid Tumor

BioVaxys Cancer Vaccine Manufacturing Partner Bio Elpida Reaches Bioproduction Milestone (PRNewswire) - "BioVaxys Technology...has reached major milestones in the development of the bioproduction process for BVX-0918A, BioVaxys' ovarian cancer vaccine and is beginning the next phase of manufacturing process development....BVX-0918A is headed for a planned Phase I clinical trial in Spain early next year with BioVaxys' EU commercial partner Procare Health Iberia."

New P1 trial • Gynecologic Cancers • Oncology • Ovarian Cancer

BioVaxys And Bioproduction Partner Bio Elpida Begin Construction Of GMP Facility To Produce Clinical Supply For Planned Ovarian Cancer Vaccine Study (Canada Newswire) - "BioVaxys Technology Corp...is pleased to announce that its bioproduction partner Bio Elpida of Lyon, France, has initiated construction of a new Good Manufacturing Practice ('GMP') clean room facility needed for producing clinical supply of BVX-0918A, BioVaxys' ovarian cancer vaccine candidate. The design, construction and qualification of the new facility will be dedicated to autologous cancer vaccine production for BioVaxys, allowing for ovarian tumor biopsy reception and treatment within a short time frame. The GMP clean room facility is planned to be completed by the end of this year."

Clinical • Gynecologic Cancers • Oncology • Ovarian Cancer

Biovaxys Strengthens Internal Expertise With Appointment Of Scientific Advisor For Ovarian Cancer Vaccine Clinical Program And Papilocare Marketing (PRNewswire) - "BioVaxys Technology Corp...is pleased to announce that Charles J. Dunton, MD, has joined BioVaxys as an Advisor to help provide additional scientific support for BVX-0918A, the Company's ovarian cancer vaccine candidate...'Dr. Dunton's clinical experience makes him ideally suited to bring additional strategic guidance to BioVaxys as we advance BVX-0918A, our ovarian cancer vaccine candidate, into a EU clinical study...'"

Clinical • Gynecologic Cancers • Oncology • Ovarian Cancer

BioVaxys And BioElpida Sign Definitive Exclusive Agreement To Begin Ovarian Cancer Vaccine Bioproduction (PRNewswire) - "BioVaxys Technology Corp...announced...that it has signed the definitive exclusive bioproduction agreement ('Agreement') with BioElpida S.A.S. ('BioElpida') of Lyon, France, to begin the clinical-grade bioproduction and aseptic packaging for BXV-0918A, BioVaxys' vaccine candidate for Stage III/Stage IV ovarian cancer. BioVaxys and BioElpida executed a Term Sheet in February outlining the commercial relationship, with todays definitive Agreement focusing on the GMP facility build-out in Lyon, and technical aspects of the bioproduction protocol such as process design and validation, quality control and quality assurance steps, batch test runs, stability testing, and aseptic fill. BioVaxys expects to be able to prepare its regulatory submission for a EU Phase I study of BVX-0918A in Stage III/Stage IV ovarian cancer near the end of this year, with vaccine supply for the planned clinical study available early May 2022."

European regulatory • Licensing / partnership • New P1 trial • Gynecologic Cancers • Oncology • Ovarian Cancer

BioVaxys and BioElpida Sign Term Sheet for Clinical Grade BVX-0918A Bio-production (PRNewswire) - "BioVaxys Technology Corp...announced...that it has signed a Term Sheet ('Term Sheet') with BioElpida S.A.S. ('BioElpida') of Lyon, France, to collaborate on the build-out for the clinical-grade manufacturing process and aseptic packaging for BXV-0918A, BioVaxys' vaccine for Stage III/Stage IV ovarian cancer. Completion of the GMP-grade bioproduction process development is planned for later this year, with the EU Phase I/II clinical trial slated for early 2022, pending European Medicines Agency ('EMEA') approval....Completion of the GMP-grade bioproduction process development is planned for later this year, with the EU Phase I/II clinical trial slated for early 2022, pending European Medicines Agency ('EMEA') approval."

Licensing / partnership • New P1/2 trial • Gynecologic Cancers • Oncology • Ovarian Cancer

BioVaxys and Procare Health Announce Broad Co-Development, Joint Commercialization and Marketing Collaboration for Cancer and Viral Vaccines (PRNewswire) - "Under the terms of the agreement, which was executed on February 9th, 2021, the companies will jointly conduct a Phase I Clinical Study of BVX-0918A in Spain, BioVaxys' autologous haptenized protein vaccine for late-stage ovarian cancer....Clinical data from the Spanish Phase I study will be used by BioVaxys to support its planned IND for BVX-0918A in the US next year, as well as for all other global markets."

IND • Licensing / partnership • Gynecologic Cancers • Oncology • Ovarian Cancer

"$LMNGF BioVaxys and BioElpida Sign Term Sheet for Clinical Grade BVX-0918A Bio-production https://t.co/OQ7eNeJdW5" (@otcdynamics)

Clinical