Oslo (Norway), 31 May 2021 – PCI Biotech (OSE: PCIB), a cancer focused biopharmaceutical company, today announces that the U.S. Patent and Trademark Office (USPTO) has informed the company that a new US patent will be granted early June 2021. The US patent covers the use of fimaVacc in combination with immune checkpoint inhibitors (ICIs).

The use of ICIs has revolutionised cancer immunotherapy, as this class of drugs may induce long-lasting effects in those patients responding to treatment. Unfortunately, most patients do not respond to ICI therapy and different treatment combination strategies are explored with the aim to increase the number of patients responding. Combining ICIs with therapeutic cancer vaccines that induce relevant immune responses against the tumour cells is regarded as one of the most promising strategies. The patent that soon will be granted in the US covers the use of PCI Biotech’s fimaVacc vaccination technology in combination with important classes of ICIs and an important type of immunological adjuvants (a class of so-called Toll like receptor agonists).

“Increasing the response rates to ICI’s is one of the pharma industry’s main priorities in cancer and therapeutic cancer vaccination is a rational approach to this aim. The fimaVacc technology has delivered encouraging immune responses in early phase clinical trials and this US patent provides relevant intellectual property for the further development of this technology.“ said Dr. Per Walday, CEO of PCI Biotech.

As part of PCI Biotech’s strategy for applying the PCI technology for therapeutic cancer vaccines, several global patent applications were filed in 2013-2016. Today’s announced US patent secure protection until 2036 and this patent application is still pending in Europe and key Asian markets.

About fimaVacc
This novel vaccine technology applies a unique mode of action, triggered endosomal release of antigens or antigen-encoding nucleic acids, to enhance immune responses essential for therapeutic cancer vaccines as well as for several types of vaccines against viral and parasitic infections. fimaVacc works in synergy with several other state-of-the-art vaccination technologies, and is especially effective in combination with some types of TLR agonists. The fimaVacc programme aims to enhance the cellular immune responses that are important for the therapeutic and prophylactic effect of vaccines, and the fimaVacc technology has proven excellent preclinical efficacy with protein- and peptide-based vaccines. The technology has shown particularly strong CD8 T-cell immune responses, which are important for therapeutic vaccination, as well as enhanced helper (CD4) T-cell and antibody responses.

PCI Biotech successfully translated the vaccination technology into humans through a Phase I study in healthy volunteers that was completed in May 2019. The study covered more than 90 subjects and established the tolerability of