Defyrus’ collaboration with NIAID’s OBRA involves the funding and prosecution of the full range of IND-enabling Therapeutic Development Services that include: planning, prosecuting and analysis of in vivo safety, biodistribution and toxicology studies for DEF201. To date, the pilot and principle safety studies have been completed at SRI International (Palo Alto, CA) under NIAID contract.
Under a Non-clinical Evaluation Agreement signed March 12, 2009 and then extended March 4, 2011, Defyrus is collaborating with NIAID’s DMID group to comprehensively evaluate the in vivo efficacy of both DEF201 and Aderon™ against a wide variety of biodefence and public health viral pathogens. Under the terms of the agreement, Defyrus provides DEF201 to various NIAID contractors who evaluate it for efficacy in well characterized animal models of human disease. To date, Defyrus has completed over 55 in vivo studies in various animal species providing a wealth of efficacy and safety data on seven viral families. These promising results have been published jointly with Defyrus and NIAID’s contractors at the Institute for Antiviral Research, Utah State University in various scientific publications (see publications section). This efficacy data informs the upcoming IND filing for DEF201.
Under a Collaborative Research and Development Agreement signed, March 11, 2011 with the Virology Division of USAMRIID, Defyrus is investigating a series of in vivo efficacy studies with Aderon™ as a potential prophylactic against Togaviruses in combination with various DoD vaccines. The initial results of this collaboration were presented at the 10th Annual ASM Biodefense and Emerging Disease Research Meeting in Washington, DC.
Under a Collaborative Research Agreement, signed March 29, 2010, Defyrus and the Special Pathogens Branch of PHAC have evaluated the efficacy of our drug candidates for the treatment of severe hemorrhagic fever diseases such as Ebola or Lassa Fever viruses These studies have provided IND-enabling efficacy results illustrating excellent survival data in multiple animal models of Ebola infection (Zaire strain). ZMAb is advancing toward clinical evaluations under the direction of LeafBio (see Products page).
Under a Memorandum of Understanding signed September 19, 2008 and a Collaborative Research Agreement signed June 1, 2009, DRDC funds and prosecutes the evaluation of DEF201 against various Alphaviruses (e.g. Eastern Equine Encephalitis) at DRDC’s facilities. Earlier pioneering work with DEF201 against Western Equine Encephalitis conducted at DRDC has been published (Wu et al, 2007 Virology 369: 206-213).
Defyrus’ collaboration with NUHS involves funding from Defence Innovative Research Programme (Defence Research and Technology Office; DIRP grant approved Nov 16, 2011) to conduct in vivo efficacy of DEF201 against Dengue, Chikungunya and Enterovirus 71 (EV-71) at the Yong Loo Lin School of Medicine, Singapore.