PBI owns or has licensed key intellectual property for its specific biologic product candidates as well as its adjuvant and delivery technology platforms. These interleaved patents provide robust protection for the PBI combination products as outlined below:
(1) DNA vaccines (plasmid vector): PBI designed pBI-11 DNA to include E6 and E7 genes of both HPV16 and HPV18. PBI has been granted a US patent covering this technology. PBI is filing addition applications cover calreticulin fusions of the same viral antigens.
(2) TA-HPV: The patents covering TA-HPV have expired but the know-how is proprietary. A possible patent application for this new formulation is being evaluated, and this technology is combined with PBI’s patented priming vaccine. The method of administration is a heterologous local immunization. This unique immunization schedule has received a methodology patent from USPTO (US10512683) which expires in 2037.
(3) TriGrid electroporation technology: The TriGrid technology is protected by a broad international patent portfoilio that protects key functional, safety, and usability features that ensure effective administration across heterogenous patient populations with minimal operator training. Importantly, for products utilize the TriGrid technology as the means for delivery, the device IP provides an additional layer of proprietary protection for the combination product.
(4) We plan seeking a breakthrough designation for CIN2/3. We will also seek an orphan designation for the treatment of VIN/VaIN/AIN with PVX4, and HPV+ cancers with PVX7 which will potentially provide a 7-year market exclusivity post approval, fast tracking in future FDA reviews, waiver or reduction of new drug application fees, and tax benefits to the company.