Advance the development of PAAG17G (drug product: MIIST305), a once daily, orally administered, GUT-restricted drug, to reduce mortality and morbidity arising from acute exposure to ionizing…

Active Definitive Contract Awarded Last action

Contract number
75A50124C00047
Awardee
Awarding agency
Obligated
$18,828,663

Award facts

Opportunity
Contract value 15% obligated
  • $18,828,663.00 Current, with exercised options
  • $121,533,645.00 Potential, with all options
Completion date 29% complete
  • Current, with exercised options
  • Potential, with all options
Contracting staff
Set-aside
No set-aside
Competition
Full and Open Competition · 1 offer Negotiated Proposal / Quote
Pricing
Cost Plus Fixed Fee
Place of performance
Claremont, CA 91711, USA
Legislative mandates

Award details come from SAM.gov/FPDS.

Transactions

Action Obligated Date
Supplemental Agreement for work within scope P00005 · Update the POP for clin 0001 due to FDA feedback on the development program and shifts in the scientific understanding as the program has progressed, update COA… $0
Supplemental Agreement for work within scope P00004 · Supplemental funding for clin 0001; update the POP for clins 0001 - 0007; update the SOW and milestone table $1,891,200
Supplemental Agreement for work within scope P00003 · NCE for clin 0001 to end on 10/30/2025; update for title to add chief executive officer (CEO) for laura saward; update POC for cpars, and update of far… $0
Supplemental Agreement for work within scope P00002 $0
Supplemental Agreement for work within scope P00001 $0
Original award $16,937,463

About this award

The Office of the Assistant Secretary for Preparedness and Response awarded a $121.5 million cost-plus-fixed-fee definitive contract to Synedgen, Inc. for advancement of PAAG17G (MIIST305), an orally administered, gut-restricted drug to reduce mortality and morbidity from acute ionizing radiation exposure, specifically gastrointestinal injury, on September 30, 2024.

Place of performance is Claremont, CA. The contract updates the period of performance for CLIN 0001 based on FDA feedback and shifts in scientific understanding as the program has progressed, updates the cost-of-achievement threshold, and refreshes FAR and HHSAR clauses to align with current executive orders and regulations. The ultimate completion date is December 22, 2031.

Synedgen is a small business specializing in regenerative medicine, wound healing, and advanced pharmaceutical research and development. The originating BARDA solicitation, posted September 26, 2023, sought advanced research and development proposals for medical countermeasures against CBRN threats, pandemic influenza, and emerging infectious diseases, with multiple awards of various values and contract types anticipated across twelve areas of interest. This award was made under no set-aside designation.

Description

Advance the development of PAAG17G (drug product: MIIST305), a once daily, orally administered, GUT-restricted drug, to reduce mortality and morbidity arising from acute exposure to ionizing radiation, specifically gastrointestinal (GI) injury (GI-AR

Quick answers

Who was awarded contract 75A50124C00047?

75A50124C00047 was awarded to Synedgen, Inc. by Office of the Assistant Secretary for Preparedness and Response (Department of Health and Human Services) on September 30, 2024.

How much is contract 75A50124C00047 worth?

The government has obligated $18,828,663 on 75A50124C00047. Its potential value, with all options, is $121,533,645.

Was contract 75A50124C00047 competed?

The extent of competition for 75A50124C00047 was full and open competition. The government received 1 offer.

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