Appili Therapeutics Announces Issuance of Patent for ATI-1701 Biodefense Vaccine Candidate to Protect Against Tularemia and Provides Update on Bridge Loan

Appili Therapeutics Inc. (TSX:APLI; OTCQB: APLIF) (the “Company” or “Appili”), a biopharmaceutical company focused on drug development for infectious diseases and biodefense, today announced that the United States Patent and Trademark Office (“USPTO”) has published patent claims for ATI-1701 under the U.S. Application No. 16/982,322 filed on September 18, 2020 and titled “A Method for Lyophilizing Live Vaccine Strains of Francisella Tularensis”. The patent covers the composition and preparation methods for the vaccine through 2039.

This patent was issued to our partners, the National Research Council of Canada (“NRC”) and protects against the unauthorized use of methods claimed to lyophilize Francisella tularensis strains, including Appili’s proprietary live vaccine strain ATI-1701. Appili licensed the biodefense vaccine candidate ATI-1701 from NRC in December 2017. The license agreement with NRC grants Appili exclusive worldwide rights to develop and commercialize ATI-1701. The new patent protects additional manufacturing methods for the final drug product.

“This patent protects an improvement in the method of lyophilizing F. tularensis live vaccine strains, such as the Ft ∆clpB mutant (ATI-1701). The patent also protects a special media which preserves the viability of the vaccine in a manner which is clinically useful and allows long-term storage,” said Don Cilla, Pharm.D., M.B.A., President and Chief Executive Officer of Appili Therapeutics. “This patent strengthens ATI-1701’s position and the new methods are expected to allow Appili to further develop a valuable vaccine that is urgently needed on the market.”

Appili’s development program ATI-1701, for the prevention of tularemia, has received awards totaling US$14 million from the U.S. Air Force Academy (“USAFA”). This year, as ATI-1701 early-stage development activities and regulatory activities progressed, the Company successfully completed a knowledge transfer and executed a technology transfer to the Phase 1 Contract Manufacturing Organization (“CMO”). Appili expects the ATI-1701 CMO to successfully produce engineering batches and GMP batches in 2024.

Additionally, Appili was granted a pre-IND meeting with the FDA to discuss ATI-1701’s regulatory, CMC, toxicology, and Phase 1 strategies and expects to receive feedback in early 2024. The goal of the ATI-1701 program is to evaluate the immunogenicity, efficacy, and safety of the ATI-1701 vaccine and ultimately submit a Biological License Application.