Streamlining Delivery Modalities for Biologic Therapeutics to Improve Patient Outcomes

Efforts to develop novel biologic therapeutics have provided critical resources to enable warfighter readiness and counter existing and emerging biothreats; however, current delivery modalities limit biologics' efficacy and rapid deployment. The goal of DARPA's new Hermes program is to overcome the challenges associated with broad, intracellular delivery of biologics to diverse cell and tissue types by developing new delivery modalities that provide systemic distribution with limited negative side effects.

Unlike traditional small molecule pharmaceuticals, biologics are large, complex molecules that can be exceptionally effective, but are challenging to administer and deliver in sufficient quantities to requisite cell and tissue types throughout the body. In addition, the immune system's response leads to the swift elimination of these large molecules, reducing their local concentrations and therapeutic efficacy.

Next generation, flexible delivery platforms developed during the Hermes program should offer unprecedented efficiency with minimal toxicity and immunogenicity. Developing new delivery technologies that expand access to multiple cell and tissue types concurrently, along with accommodating the increasing complexity of therapeutic cargo, is critical to strengthen and augment biosecurity preparedness.

"To effectively prepare for the emergence of any biological threat, the Hermes program seeks to develop a versatile threat-agnostic system capable of delivering diverse classes of therapeutic cargo to broad cell and tissue types to protect the warfighter," said Shannon Greene, Hermes program manager for DARPA.

"I encourage researchers from academia and industry -- including small and large biotech and pharmaceutical companies - to explore this opportunity. Technologies developed in the Hermes program could have a significant impact by protecting the warfighter from the emerging threat landscape, as well as developing capabilities with broader benefits to patient outcomes."

Previous DARPA efforts such as the Pandemic Prevention Platform and the PRemptive Expression of Protective Alleles and Response Elements programs resulted in the development of highly efficacious monoclonal antibodies and novel protein-based therapeutics, respectively, against viral, bacterial, and chemical threat agents. In addition, these programs advanced the state of the art of nucleic acid-based delivery modalities, an area in which further fundamental research and development is required.

The 30-month Hermes program is structured in two sequential phases of increasing technical complexity. Phase I will focus on developing the delivery platform screening pipeline, optimization of lead candidates, and evaluating delivery efficiency of chosen therapeutic cargo. Phase II will focus on adapting platforms to deliver a government-defined therapeutic cargo to demonstrate platform flexibility. Performers will conduct a capability demonstration at the end of each phase.

A special notice with details on the April 8 Industry Day, as well as a draft broad agency announcement, are available on SAM.gov.

New to DARPA? Resources are available to help navigate the Industry Day and proposal process via DARPAConnect. Registration is required to access the learning tools through this free, comprehensive resource on doing business with DARPA. The curriculum includes a module on Making the Most of a DARPA Proposers Day.

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