The Lundquist Institute (TLI) and its start-up company Vitalex Biosciences (Vitalex) are pleased to announce that the second-generation fungal vaccine candidate known as VXV01, which was developed using a proprietary TLI vaccine technology platform, is poised to move forward in development up to and including Phase 1 clinical evaluation — enabled by a major contract awarded to a collaboration consortium of Vitalex and Appili Therapeutics (TSX: APLI; OTCPink: APLIF).
The contract from the National Institutes of Health’s (NIH) National Institute of Allergy and Infectious Diseases (NIAID) is valued at up to US $40 million. It will support the development of VXV-01 from manufacturing and non-clinical studies through two Phase 1 clinical trials. This contract represents a significant milestone for The Lundquist Institute’s vaccine research program.
Key Highlights
- Vitalex has an exclusive option to license VXV-01 from TLI for commercial development.
- The contract, awarded by NIH/NIAID, provides up to US $40 million of non-dilutive funding to Vitalex and its collaborator Appili and for the comprehensive development of VXV-01.
- VXV-01 is built on the TLI (Therapeutic & Laboratory Immunology) technology platform developed at TLI, a second-generation approach containing two antigens designed to target invasive Candida infections with broader-spectrum cross-kingdom protection potential against Gram-negative healthcare-associated infections.
- With this funding, the program is positioned to begin manufacturing and other preparations necessary to initiate two Phase 1 clinical trials, which, when they occur, will mark a transition from preclinical research into the first stage of human testing.
- Advancing VXV-01 into development up to and including Phase 1 trials brings it one step closer to delivering a novel prophylactic solution for serious fungal infections, a major unmet need in infectious disease.
“Securing this contract is a pivotal moment for our team,” said Ashraf Ibrahim, PhD, Principal Investigator and VXV-01 program lead at TLI and CEO of Vitalex. “By putting VXV-01 into development through human trials, we are significantly increasing our chances of making this vaccine a reality. It is the culmination of years of work on our TLI technology platform and reflects our commitment to tackling high-impact infectious disease challenges.”
About VXV-01
VXV-01 is a dual-antigen fungal vaccine candidate designed to elicit robust immunity against key opportunistic and hospital-associated Candida and Gram-negative bacterial pathogens. Built at TLI and further developed by Vitalex, VXV-01 is engineered for strong immunogenicity, manufacturability and scalability. The move into Phase 1 human trials marks the transition from lab and animal model proof-of-concept to human safety and immunogenicity studies.
About Vitalex
Vitalex is a start-up company created to further the development of technologies discovered in the laboratory of its founder, Dr Ashraf S. Ibrahim, a senior investigator at TLI and a Professor at the David Geffen School of Medicine at UCLA. Vitalex has obtained >$10 million in non-dilutive funding from the NIAID to further the development of a dual antigen vaccine that targets hospital-acquired infections caused by multidrug-resistant Candida albicans, Candida auris, and Gram-negative bacteria, including those caused by Pseudomonas aeruginosa, Acinetobacter baumannii, and Klebsiella pneumoniae. Vitalex is also developing a humanized monoclonal antibody against mucormycosis, a lethal and rare fungal infection. For more information, visit www.vitalexbiosciences.com.
About Appili Therapeutics
Appili Therapeutics is a biopharmaceutical company that is purposefully built, portfolio-driven, and people-focused to fulfill its mission of solving life-threatening infections. By systematically identifying urgent infections with unmet needs, Appili’s goal is to strategically develop a pipeline of novel therapies to prevent deaths and improve lives. The Company is currently advancing a diverse range of anti-infectives, including an FDA-approved ready-made suspension of metronidazole for the treatment of antimicrobial-resistant infections, a vaccine candidate to prevent tularemia, a serious biological weapon threat, and a topical antiparasitic for the treatment of cutaneous leishmaniasis, a disfiguring disease. Led by a proven management team, Appili is at the center of the global fight against infection. For more information, visit www.AppiliTherapeutics.com.
This article contains forward-looking statements regarding the development of VXV-01, including its advancement into clinical trials, the benefits of the TLI technology platform, and the potential for VXV-01 to become a realized vaccine. Actual results may differ materially from those projected due to risks and uncertainties, including regulatory approval, clinical trial outcomes, manufacturing challenges, and funding uncertainties.