AVI BioPharma, Inc., developer of RNA-based drugs, announced today that it has received expanded contract funding from the government for the development of the Investigational New Drug (IND) data package for its candidate drug AVI-7012, which is designed to treat Junin virus infection. The Junin virus, though rare, has a mortality rate of 20%-30%, and is considered a potential bioterrorism agent. The expanded funding of approximately $11.5 million comes from the DTRA (Defense Threat Reduction Agency) as part of their Transformational Medical Technologies Initiative (TMTI). To date, the Department of Defense has contracted with AVI for work of up to $45 million for the development of RNA-based drug candidates to treat Ebola, Marburg, and Junin virus infections.
AVI’s Sr. VP for Strategic Alliances, Dr. Patrick Iverson, commented on the funding extension. “AVI has recently been able to confirm the impressive and dose-related survival of drug-treated non-human primates in large dose titration studies for Ebola and Marburg virus infections, which were carried out in collaboration with the U.S. Army Medical Research Institute of Infectious Diseases (USAMRIID). Importantly, these studies allowed us to unequivocally demonstrate the sequence-specific nature of the protection afforded by our drug candidates.”
AVI has also received a “safe to proceed” allowance from the U.S. Food & Drug Administration for IND applications for clinical safety trials of its two lead products for treating Ebola and Marburg virus infections. It represents the first TMTI supported drug candidates targeting bioterrorism agents to receive FDA IND allowance. The company plans to conduct animal efficacy trials for potential approval of its drugs under the Animal Rule, as part of its continued collaboration with the USAMRIID. The current funding is an expansion of the original 2006 DTRA contract of $28 million.
AVI’s CFO, David Boyle, spoke of the contract expansion, “The expansion of the contract for our therapeutic programs in Junin, Ebola and Marburg viruses reflects the DoD’s continued support of our bio-defense program, which is developing a series of RNA-based anti-viral drugs. AVI’s ability to virtually double the value of the original contract is a powerful illustration of the performance of our drug candidates to date.”
AVI’s drugs for treating these viruses are novel analogs based on the company’s PMO antisense chemistry, in which anti-viral potency is enhanced by the addition of positively-charged components to the morpholino oligomer. AVI BioPharma is focused on the development of RNA-based drugs utilizing proprietary derivatives of its morpho-modified phosphorodiamidate oligomers (PMOs) that can be applied to a wide range of diseases and genetic disorders.