The Defense Advanced Research Projects Agency’s Biological Technologies Office (BTO) is hosting a Proposers Day in advance of a planned Broad Agency Announcement (BAA) for the INTERfering and Co-Evolving Prevention and Therapy (INTERCEPT) program.
The goal of the INTERCEPT program is to explore and develop a new therapeutic platform to outpace fast-evolving viral pathogens, based upon virus-based therapeutic particles that interfere with viral infection and co-evolve with viral targets.
Current preventive and therapeutic platforms including vaccines and anti-virals are designed to treat viral pathogens in their circulating state or at the time of diagnosis. However, pathogens mutate and evolve over time, becoming resistant to static therapies.
The INTERCEPT program builds upon previously reported naturally occurring Defective Interfering Particles (DIPs), viral-derived particles with partially deleted genomes that lack essential genes for replication enzymes and capsid proteins. DIPs rely on the wildtype parent virus to replicate and mobilize, and consume critical wildtype resources, thus interfering with the infection process.
Performers within the INTERCEPT program will aim to engineer and optimize therapeutic versions of DIPs as Therapeutic Interfering Particles (TIPs) to stoichiometrically outcompete the parent virus for viral proteins, in the process reducing viral load within a patient and attenuating viral transmission. Preliminary modeling studies suggest that the viral chassis of TIPs will enable them to co-evolve and keep pace with the viral pathogen as it mutates, thereby addressing the ongoing challenges of viral escape and therapeutic obsolescence.
The INTERCEPT program aims to explore and demonstrate the potential of TIPs for use as therapeutic and preventive platforms for the long-term control, at the individual and the population levels, of a broad range of fast-evolving viruses.
To explore the TIP concept as a therapeutic platform that can keep pace with fast-evolving pathogens, INTERCEPT will address four fundamental questions:
Safety & Efficacy: Can TIPs be built that are safe and out-compete the pathogen?
Co-evolution capability: Can TIPs safely evolve and keep pace with evolving pathogens to control an infection long-term?
Efficacy across populations: Can TIPs provide population-wide protection and infectious disease control?
Generalizability: Can the TIP concept be extended across multiple viruses and for multiple acute and chronic infectious diseases?
DARPA anticipates that INTERCEPT will encompass a four-year program organized in two phases of 2 years duration each. During the Phase 1 period, performer teams will establish proof of concept of TIPs safety, broad range efficacy, and initial TIP-pathogen co-evolution using in vitro and in vivo models of viral infection, as well as mathematical models of TIP-pathogen-host dynamics. Phase 2 period will focus on the validation of long-term TIP safety and efficacy, long-term co-evolution studies, and TIP co-transmission dynamics for population-scale disease control.
The Proposers Day will be held on Friday, April 29, 2016 (UPDATE: the event has been rescheduled and will now take place April 28) in Arlington, VA. A webcast of the meeting will be broadcast for those who would like to participate remotely. Advance registration is required for both the physical meeting and the webcast. Registrants will have the opportunity to participate in an oral presentation that can be scheduled upon registration. Registration closes on Friday, April 22, 2016.