- Early clinical-stage biotechnology company developing viral and oncology vaccine platforms
- Advancing a SARS-CoV-2 vaccine based on its haptenized viral protein technology
- Ramping up for a Phase I study in the EU early next year for its ovarian cancer vaccine
- Preparing for a combined Phase I/II trial in the US for CoviDTH
What BioVaxys Technology does:
Based in Vancouver, 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 tumor cell vaccine used in combination with anti-PD1 and anti-PDL-1 checkpoint inhibitors 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 coronavirus (COVID-19).
BioVaxys has two issued US patents and multiple US and international patent applications related to its cancer vaccine, for its viral vaccine platform, including its SARS-CoV-2 (COVID-19) vaccine, and diagnostic technologies.
How is it doing:
BioVaxys announced on July 22, 2021, that it is advancing CoviDTH, its disposable point-of-care diagnostic tool, towards clinical trials. That’s after the US Food and Drug Administration provided the necessary guidance for the company to prepare an Investigational New Drug (IND) application for the CoviDTH as a diagnostic for evaluating T-cell immune response to SARS-CoV-2.
The FDA, in its official written response to BioVaxys' request for a pre-IND Type B review of CoviDTH, found the chemistry, manufacturing and controls, and other elements of the clinical development program proposed by BioVaxys to be acceptable and provided guidance and feedback supportive of the company's clinical development plans.
In addition, the company said the FDA indicated that animal toxicity studies for CoviDTH were not required and that it could start its clinical development program with a combined Phase I/II study.
Based on FDA feedback, BioVaxys said it is beginning the preparation of an IND application to support a combined Phase I/II safety, dosing, and efficacy study.
To support the development of CoviDTH, the company revealed on August 3 that well-known immunologist Dr Yvelise Barrios has joined the company as a scientific adviser. Dr Barrios, a specialist in clinical immunology at Spain’s Hospital Universitario de Canarias, in Tenerife, is an authority in the clinical use of delayed-type hypersensitivity (DTH), the mechanism behind CoviDTH as an immuno-diagnostic tool.
In June this year, the Clinical Immunology and Vaccines journals both published the results of two clinical studies led by Dr Barrios and her colleagues on the use of the DTH reaction to measure cellular immune responses to SARS-CoV-2 in patients after infection; and in individuals vaccinated with the Pfizer (NYSE:PFE) mRNA vaccine.
BioVaxys noted that the studies in people by Dr Barrios and her colleagues are “the first publications” of the results obtained using the “classical DTH response to the SARS-CoV-2 s-spike protein (s protein) to assess T cell immune responses” in vaccinated individuals.
It said the clinical trial proved that an affordable and simple test, which is substantially equivalent to CoviDTH, is effective and safe, and can answer basic immunogenicity questions in large-scale populations.
There is mounting evidence that an antibody-mediated and T cell-mediated immune response is required for protection against SARS-CoV-2. According to the company, T cell-mediated immunity is a “more reliable correlate of vaccine protection” than antibody titers in seniors, strongly supporting the need for a determination of T cell response in COVID-19 vaccine design and population screening.
BioVaxys Chief Operating Officer Kenneth Kovan said the results of Dr Barrios' studies back the idea that the company’s planned Phase I/II US study will likewise find "CoviDTH to be effective and safe in humans.”
Meanwhile, in a July 7 interview with Proactive, CEO James Passin said the company is preparing for a Phase 1 compassionate trial in the European Union next year of its ovarian cancer vaccine candidate, BXV-0918A, which will be conducted by Procare Health Iberia, a large pharma and biotechnology company based in Spain.
The two companies have entered a broad collaboration for the co-development, joint commercialization, and marketing of BioVaxys’ vaccines for ovarian cancer, cervical cancer, and human papillomavirus (HPV), and the right of first refusal for marketing by BioVaxys in the US of Procare Health’s cervical gel product, Papilocare, the world’s first and only product to prevent and treat HPV-dependent cervical lesions. If approved by the FDA, Passin said BioVaxys could introduce Papilocare to the US as early as next year.
In return, Procare Health will have exclusive rights to market and distribute BVX-0918A in the EU and the UK. 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.
On the financing front, the company closed the second and final tranche of a non-brokered private placement of its units on July 28, raising total gross proceeds of about $1.18 million. Including the first tranche, which completed on July 14, it raised total aggregate gross proceeds of $2.02 million.
The net proceeds of the placement will be used to advance its research and development programs and for working capital.
Inflection points:
- Preparing an IND application for the CoviDTH as a diagnostic tool
- Phase 1 trial for ovarian cancer candidate to take place in early 2022
- Right of first refusal to market Papilocare in the US
What the boss says:
“(Papilocare) will put us on the map because we will no longer be just a pre-revenue, development-stage company but a revenue-generating biotechnology company,” CEO James Passin told Proactive in the July 7 interview.
“Behind that, we have our pipeline addressing cervical cancer. We will go after other cancers, and we're going to go after other viruses. We have a very robust technology platform with a significant pedigree and historic investment, and our mission and our job is really to take it all the way through commercialization.”
Contact the author at stephen.gunnion@proactiveinvestors.com
