A phase 1 placebo-controlled dose-escalation safety and pharmacokinetic study of in-007, a nebulized, pan-sars ACE2-decoy therapeutic for pandemic preparedness

Active Definitive Contract Awarded

Contract number
HT942525CE039
Awardee
Awarding agency
Obligated
$3,175,643

Award facts

Opportunity
  • HT942524SJWMR Solicitation number
Contract value 100% obligated
$3,175,643.00 Current and potential, with all options
Completion date 49% complete
Current and potential, with all options
NAICS code
541715 Research and Development in the Physical, Engineering, and Life Sciences (except Nanotechnology and Biotechnology)
PSC
AN13 Health R&D Services; Health Care Services; Experimental Development
Set-aside
No set-aside
Competition
Full and Open Competition · 44 offers Basic Research
Pricing
Fixed Price Level of Effort
Place of performance
Morrisville, NC, USA
Research
SBIR Program Phase III Action
Legislative mandates

Award details come from SAM.gov/FPDS.

About this award

The Defense Health Agency awarded a $3.18M fixed-price level of effort contract to Inhalon Biopharma, Inc., a clinical-stage biopharmaceutical company based in Morrisville, North Carolina, for a Phase I placebo-controlled dose-escalation safety and pharmacokinetic study of IN-007, a nebulized pan-SARS ACE2-decoy therapeutic. This Small Business Innovation Research (SBIR) Program Phase III action supports pandemic preparedness initiatives by advancing an innovative inhaled treatment platform that leverages human ACE2 receptor decoys to neutralize respiratory pathogens. The contract, awarded on September 22, 2025, carries no set-aside designation and is scheduled for completion by December 31, 2027, with all work to be performed at the contractor's Morrisville facilities.

IN-007 represents Inhalon's specialized approach to respiratory disease therapeutics through direct pulmonary administration via handheld nebulizers, enabling broad-spectrum protection against pandemic pathogens. The study will evaluate the safety profile and pharmacokinetic properties of the nebulized therapeutic in human subjects, supporting regulatory pathway advancement toward clinical deployment. This contract builds upon Inhalon's existing federal partnerships, including previous Defense Health Agency contracts and multiple National Institute of Allergy and Infectious Diseases grants totaling approximately $3M, collectively positioning the company as a key contributor to the federal government's pandemic preparedness and respiratory infection treatment capabilities.

Quick answers

Who was awarded contract HT942525CE039?

HT942525CE039 was awarded to Inhalon Biopharma, Inc. by Defense Health Agency (Department of Defense) on September 22, 2025.

How much is contract HT942525CE039 worth?

The government has obligated $3,175,643 on HT942525CE039.

Was contract HT942525CE039 competed?

The extent of competition for HT942525CE039 was full and open competition. The government received 44 offers.

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