Appili Therapeutics Secures $40 Million NIAID Contract to Develop First-in-Class Fungal Vaccine VXV-01
Key Insights
Appili Therapeutics (search) and Vitalex Biosciences (search) received up to $40 million from NIAID (search) to develop VXV-01 (search), a novel dual-antigen vaccine targeting invasive fungal infections caused by Candida species.
The five-year contract will fund comprehensive development through Phase 1 clinical trials, addressing a critical unmet need as no fungal vaccines are currently approved for human use.
VXV-01 (search) targets a significant global health burden, with invasive fungal infections affecting 6.5 million people annually and causing approximately 3.8 million deaths worldwide.
Appili Therapeutics (search) Inc. and its partner Vitalex Biosciences (search) have secured a major funding milestone with the National Institute of Allergy and Infectious Diseases (NIAID (search)) awarding up to $40 million to advance development of VXV-01 (search), a novel vaccine designed to protect against invasive fungal infections. The five-year contract represents a significant investment in addressing one of medicine's most challenging infectious disease threats.
Contract Structure and Development Timeline
The NIAID (search) contract (number 75N93025C00033) consists of a 22-month base period totaling $3.6 million, with twelve additional option periods valued at approximately $36.3 million. Under the agreement, Appili will serve as the prime contractor, managing subcontractors performing technical tasks associated with product development. The funding is expected to support VXV-01 (search) development through Investigational New Drug (IND) submission and completion of Phase 1 clinical trials.
"VXV-01 (search) has the potential to significantly reduce serious invasive infections caused by Candida albicans, Candida auris, and other related healthcare-associated infections," said Don Cilla, Pharm.D., M.B.A., President and Chief Executive Officer of Appili. "We are excited to bring Appili's expertise in vaccine development and government contracting to our collaboration with the Vitalex team who have deep knowledge in this field of research to move their promising vaccine candidate forward."
Addressing Critical Unmet Medical Need
Recent global estimates indicate that invasive fungal infections affect nearly 6.5 million people annually and are associated with approximately 3.8 million deaths, with Candida species being a major cause of these infections. Despite this significant health burden, there are currently no fungal vaccines approved for use in humans.
VXV-01 (search) is a novel dual-antigen vaccine designed to target antigens present on the surface of broad-spectrum pathogenic fungi. This innovative approach has the potential to provide robust immunity against these challenging pathogens, representing a major advance in the prevention of serious fungal diseases.
"Vitalex's second generation VXV-01 (search) vaccine shows impressive protection against lethal invasive and mucosal Candida infections," said Dr. Ashraf S. Ibrahim, Ph.D., Chief Executive Officer of Vitalex. "The vaccine is expected to reduce mortality rates of lethal multidrug Candida infections and reduce occurrence of mucosal Candida infections such as recurrent yeast infections."
Clinical Significance and Treatment Landscape
The development of VXV-01 (search) addresses significant limitations in current treatment options for invasive fungal infections. "Invasive Candida infections are life-threatening, and the current standard of care drug treatments are not highly effective," said Dr Gary Nabors, Ph.D., Chief Development Officer at Appili and Principal Investigator on the contract. "The VXV-01 vaccine has the potential to reduce the suffering and death that is often seen in those vulnerable people who are at risk of acquiring severe Candida fungal infections."
The vaccine targets multiple Candida species, including the emerging multidrug-resistant Candida auris, which has become a significant concern in healthcare settings worldwide. Vitalex has previously obtained more than $10 million in non-dilutive funding from NIAID (search) to develop this dual antigen vaccine that targets hospital-acquired infections caused by multidrug resistant Candida albicans, Candida auris, and Gram-negative bacteria.
Strategic Partnership and Future Funding
Vitalex is the current owner of VXV-01 (search), and as a condition to advancing the program, Appili and Vitalex expect to enter into an agreement for the development of VXV-01. Vitalex is a start-up company created to further develop technologies discovered in the laboratory of its founder, Dr Ashraf S. Ibrahim, a senior investigator at The Lundquist Institute at Harbor-University of California at Los Angeles (UCLA) Medical Center and a Professor at the David Geffen School of Medicine at UCLA.
Beyond the awarded NIAID (search) contract, Appili has submitted four other funding proposals to the U.S. government representing a combined potential award value of up to $97 million. If awarded, these funds would support the advanced development of critical infectious disease products aligned with public health and biodefense priorities.
"Having successfully raised $34.9 million in prior government funds, Appili has built a strong track record in government contracting, and we are well-positioned to execute on innovative programs aligned with public health agencies," said Cilla. "Securing additional non-dilutive funding remains key to Appili's strategy, enabling us to advance high-priority infectious disease products while maximizing shareholder value."