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IND-enabling studies for eCD4-Ig as a long-acting recombinant protein therapeutic

US · IL NIH grant awarded #nih-1R43AI191927-01

Summary

This FastTrack SBIR grant supports preclinical Investigational New Drug (IND)-enabling studies for eCD4-Ig, a long-acting recombinant protein therapeutic for HIV, in preparation for a first-in-human Phase 1 clinical trial.

What they want

Phase I involves conducting in vitro assays (tissue cross-reactivity, immunotoxicity using human peripheral blood cells) required for IND application submission and holding a pre-IND meeting with the FDA. Phase II will conduct a definitive GLP toxicology study in macaques, assessing various parameters including leukocyte/lymphocyte populations, body weight, food consumption, clinical signs, clinical chemistries, coagulation, urinalysis, toxicokinetics, anti-drug antibodies (ADAs), histopathology, and safety pharmacology endpoints (cardiotoxicity, respiratory toxicity, CNS toxicity).
Deliverables
  • Results of in vitro tissue cross-reactivity assays
  • Results of in vitro immunotoxicity assays using human peripheral blood cells
  • Pre-IND meeting with the FDA
  • Definitive GLP toxicology study report in macaques
  • Data on leukocyte and lymphocyte populations, body weight, food consumption, clinical signs, clinical chemistries, coagulation, urinalysis, toxicokinetics, anti-drug antibodies (ADAs), and histopathology from macaque study
  • Data on cardiotoxicity, respiratory toxicity, and central nervous system (CNS) toxicity from macaque study
  • Submission of an Investigational New Drug (IND) application to the FDA
Technical requirements
  • IND-enabling studies
  • In vitro assays for tissue cross-reactivity and immunotoxicity
  • GLP toxicology study in macaques
  • Doses for toxicology study set to provide a 10x safety margin
  • eCD4-Ig protein with enhanced effector function through afucosylation

Market context

inferred from NAICS
Professional, Scientific & Technical Services
NAICS 541714
US market size
$2.0T
Typical award
$25K – $50M
Typical buyers
All federal civilianDoDStates
Commonly required
8(a)WOSBSDVOSBPE/PMP

Sector-level estimate — full code lookup not yet in catalog.

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