Curative Biotechnology, Inc. (OTC: CUBT) announced that the Company has reached agreement with Mid-Atlantic BioTherapeutics (MABT) to broaden its previously announced license of IMT504, a novel patented immunotherapy and adjuvant, to include the development of a next generation COVID-19 vaccine. The Company will initially develop the vaccine to address the kidney failure patient population. This new license, utilizing IMT504 as an adjuvant on top of a proprietary protein vaccine, adds a second infectious disease program to the Curative Biotech product development portfolio which also includes a reformulation of Metformin licensed from the National Eye Institute at National Institutes of Health (NIH) to treat degenerative eye diseases; and a novel monoclonal antibody/drug combination to treat brain cancer licensed from the National Cancer Institute at NIH.
“It is becoming increasingly clear that the initial COVID-19 vaccines developed are not working for everyone. There are highly vulnerable people, such as those patients with kidney failure who require kidney transplantation or dialysis, who are being left behind. We need targeted vaccines for this immunocompromised patient group,” said Curative Biotech Chairman & President Paul Michaels.
Curative Biotech and Mid-Atlantic BioTherapeutics have agreed to develop a next generation COVID-19 vaccine targeted to meet the needs of this vulnerable population. A consequence of kidney failure in general is the loss of a robust immunologic response to infections, including COVID-19. This means that kidney failure patients may get a more severe version of COVID-19 that could lead to a greater chance of hospitalization or even death.
Dr. David Horn, CEO of Mid-Atlantic BioTherapeutics, added: “It is well known that kidney transplant recipients have impaired responses to mRNA COVID-19 vaccines. Recent data from France reveals that, even after 4 vaccine shots, many kidney transplant recipients have poor responses. In addition, kidney failure patients on dialysis do not initially respond as well to current vaccines and rapidly lose measurable antibodies when compared to the general population.”
As previously announced, Curative Biotech has acquired the worldwide rights for the development of IMT504 to treat symptomatic rabies. Curative Biotech and MABT are already working together to develop IMT504 to treat patients whose disease has advanced to a stage where the virus has migrated to the brain, causing lethal rabies encephalitis. There are currently no treatment options for these patients. IMT504 has already been granted orphan drug designation in the US for the treatment of rabies, which may provide significant benefits including tax credits, market exclusivity and the waiver of certain FDA fees. Rabies is one of only a limited number of diseases which qualify for the FDA Tropical Disease Priority Review Voucher (PRV) Program that is granted to sponsors of approved tropical disease product applications that meet certain criteria. Once the sponsor obtains a PRV, the voucher can be used to obtain priority review designation for a subsequent application that does not itself qualify for priority review as described in the guidance, and it can be sold to another party.
Chairman Michaels concluded, “We are excited to begin work on this additional program and expect to announce additional important management resources at Curative Biotech to supplement the clinical development team.”