In-Kind Investment by Procare into BVX-0918A Clinical Study in EU. Co-Dev of Vaccines for Cervical Cancer & HPV Right of 1st Refusal US Marketing of Papilocare

VANCOUVER, BRITISH COLUMBIA, CANADA, February 11, 2021 /EINPresswire.com/ -- BioVaxys Technology Corp. (CSE: BIOV, FRA:5LB, OTC:LMNGF) (“BioVaxys”), the world leader in haptenized protein vaccines for antiviral and cancer applications and Procare Health Iberia, S.L., of Barcelona, Spain (“Procare Health”), a leading privately held European pharmaceutical company, announced today that they have entered into a broad-collaboration for the co-development, joint commercialization, and marketing of vaccines for ovarian cancer, cervical cancer, and human papilloma virus (“HPV”), and the right of first refusal for marketing by BioVaxys in the United States of Procare Health’s vaginal gel product, PapilocareTM, the world’s first and only product to prevent and treat HPV-dependent cervical lesions. Left untreated, HPV infection generally leads to cervical cancer (World Health Organization, HPV and Cervical Cancer, 11 November 2020).
Under the terms of the agreement, 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. BioVaxys will be responsible for the core technology and vaccine production, with Procare Health overseeing and making an in-kind investment in the clinical program and regulatory planning, CRO management, patient/clinical center recruitment, marketing, and opinion leader management. Both companies have agreed to equally share costs associated with engaging a European clinical research organization to conduct the study. In return, Procare Health will have exclusive rights to market and distribute BVX-0918A in the European Union and the United Kingdom. Clinical data from the Spanish Phase I study will be used by BioVaxys to support its planned IND for BVX-0918A in the US and for all other global markets.
TMBioVaxys President and COO Ken Kovan said “This co-development gives BioVaxys access to Procare Health’s clinical development and regulatory expertise, and its marketing & sales presence in Europe.” Kovan added “The relationship with Procare Health will give access to key gynecological oncology opinion leaders for patient access, clinical trial recruitment, and a relationship that post-approval will drive vaccine sales. Having a strong EU opinion leader network will also be invaluable for our planned US launch of the vaccine.”
Yann Gaslain, CEO of Procare Health stated, “We are thrilled to start working on the collaboration with BioVaxys as it brings a new hope in the field of gynecological cancer. We have been working for 8 years in the area of cervical cancer and HPV, investigating to understand how the immune response of the host could be stimulated to help defend versus HPV infection and persistency, and we believe that the new haptenized cell platform technology can bring a valid answer to this unmet therapeutical need, mainly when high grade lesions of the cervix or even cervical carcinoma have been characterized. ̈
Javier Cortés, MD, Specialist in Gynecology and Cytology for the international Academy of Cytology (Chicago, USA) stated, “I believe that the planned clinical trial in Phase I is of a very high interest based on my experience in oncology for more than 30 years. The immunotherapy is a line of treatment with very active investigation and promising early results in some cancers (lungs, melanoma and ovarian). That is why, every single line of investigation well based and with consistent criteria of quality in the design of the investigation should be very well received and encouraged.”
Leveraging the recent proven ability of its haptenized viral antigen vaccine platform in stimulating a 96.4% positive immune response and powerful ‘memory’ T-cell activation against SARS-CoV-2, BioVaxys will use the platform’s flexibility to swap in viral antigens for Human Papilloma Virus, with the intent to develop a treatment for adults who are already infected with HPV. There are vaccines to protect against getting HPV, but none to treat someone who already has HPV.
James Passin, CEO of BioVaxys, stated, “We are honored to partner with Procare Health, a market leader in gynecological oncology and women’s health in the EU; this transformative collaboration leverages all of the innovative work of Dr. David Berd in the field in oncology and novel vaccine development, as well as our recent success with the preclinical development of a viable haptenized viral protein vaccine for Covid-19. We look forward to using our proprietary haptenized vaccine technology to address urgent and large market deficiencies in the area of women’s health and to potentially generate a new and material revenue stream for our company.”
1. WHO. https://www.who.int/news-room/fact-sheets/detail/sexually-transmitted-infections-(stis)
About BioVaxys Technology Corp.
BioVaxys Technology Corp. is a British Columbia-registered, early stage biotechnology company that is developing viral and oncology vaccine platforms, as well as immuno-diagnostics. The Company is advancing a SARS-CoV-2 vaccine based on its haptenized viral protein technology, and is planning a clinical trial of its haptenized autologous cell vaccine that will initially be developed for ovarian cancer. Also in development is a diagnostic for evaluating the presence or absence of a T-cell immune response to SARS-CoV-2, the virus that causes COVID-19. BioVaxys has two issued US patents and a patent pending for its cancer vaccine, and two pending patent applications for its SARS-CoV-2 vaccine and diagnostic technologies.
About Procare Health
Procare Health is a multinational EU biotechnology company based in Barcelona (Spain) founded in 2012 as a result of the spin-off of executives and employees of Procter & Gamble Pharmaceuticals, focused primarily to bring innovative solutions in women ́s health, with a special interest into unmet therapeutical needs. Procare Health invests every year circa 25% of its investments budget into R&D, fundamental research on Cervix clinical trials to bring clinical evidence of its main products in the market. Procare Health develops, investigates and commercializes its own products into more than 50 countries in the world, focusing on EU, in women ́s genital tract diseases. Procare Health vision is to become a women ́s health leader in Europe.
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James Passin, CEO
BioVaxys
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