HHS awards $113M contract to Abviro LLC for Dengue MAB Phase 2 trial
Contract Overview
Contract Amount: $11,335,102 ($11.3M)
Contractor: Abviro LLC
Awarding Agency: Department of Health and Human Services
Start Date: 2023-09-25
End Date: 2026-12-31
Contract Duration: 1,193 days
Daily Burn Rate: $9.5K/day
Competition Type: FULL AND OPEN COMPETITION
Number of Offers Received: 31
Pricing Type: COST PLUS FIXED FEE
Sector: R&D
Official Description: TO CONDUCT A PHASE 2 DENGUE HUMAN CHALLENGE CLINICAL TRIAL OF ABVIRO ANTI-DENGUE MONOCLONAL ANTIBODY (MAB) AV-1.
Place of Performance
Location: BETHESDA, MONTGOMERY County, MARYLAND, 20814
State: Maryland Government Spending
Plain-Language Summary
Department of Health and Human Services obligated $11.3 million to ABVIRO LLC for work described as: TO CONDUCT A PHASE 2 DENGUE HUMAN CHALLENGE CLINICAL TRIAL OF ABVIRO ANTI-DENGUE MONOCLONAL ANTIBODY (MAB) AV-1. Key points: 1. Contract focuses on a novel monoclonal antibody for Dengue. 2. Competition was full and open, suggesting market availability. 3. Risk is moderate, tied to clinical trial success and MAB efficacy. 4. Sector is R&D, specifically life sciences, with high innovation potential.
Value Assessment
Rating: good
The contract value of $113.4M for a Phase 2 clinical trial appears reasonable given the complexity and duration. Benchmarking against similar early-stage biotech clinical trial contracts would provide a more precise assessment.
Cost Per Unit: N/A
Competition Analysis
Competition Level: full-and-open
The 'FULL AND OPEN COMPETITION' indicates a robust price discovery process. This method allows multiple qualified vendors to bid, driving competitive pricing and potentially better value for the government.
Taxpayer Impact: Taxpayer funds are being used for critical research into a significant public health threat, with competition aiming to ensure efficient allocation.
Public Impact
Potential for a new treatment against Dengue fever, a widespread disease. Advancement of biotechnology research and development within the US. Investment in public health preparedness and response capabilities.
Waste & Efficiency Indicators
Waste Risk Score: 50 / 10
Warning Flags
- Clinical trial success is not guaranteed.
- Regulatory approval pathway for new drugs can be lengthy and uncertain.
Positive Signals
- Addresses a significant unmet medical need.
- Utilizes a competitive bidding process.
- Supports innovative medical research.
Sector Analysis
This contract falls within the Research and Development in the Physical, Engineering, and Life Sciences sector. Spending in this area is crucial for innovation but carries inherent risks associated with scientific discovery and market adoption.
Small Business Impact
The contract was awarded to Abviro LLC, a specific company. Analysis of whether small businesses were involved as subcontractors or if opportunities were missed requires further investigation.
Oversight & Accountability
The contract is managed by the National Institutes of Health, a reputable agency with established oversight mechanisms for research grants and contracts. Monitoring progress and adherence to trial protocols will be key.
Related Government Programs
- Research and Development in the Physical, Engineering, and Life Sciences (except Nanotechnology and Biotechnology)
- Department of Health and Human Services Contracting
- National Institutes of Health Programs
Risk Flags
- Potential for MAB ineffectiveness against all Dengue serotypes.
- Uncertainty in achieving regulatory approval.
- Long-term efficacy and safety profile unknown.
- Dependence on successful patient recruitment and trial execution.
Tags
research-and-development-in-the-physical, department-of-health-and-human-services, md, definitive-contract, 10m-plus
Frequently Asked Questions
What is this federal contract paying for?
Department of Health and Human Services awarded $11.3 million to ABVIRO LLC. TO CONDUCT A PHASE 2 DENGUE HUMAN CHALLENGE CLINICAL TRIAL OF ABVIRO ANTI-DENGUE MONOCLONAL ANTIBODY (MAB) AV-1.
Who is the contractor on this award?
The obligated recipient is ABVIRO LLC.
Which agency awarded this contract?
Awarding agency: Department of Health and Human Services (National Institutes of Health).
What is the total obligated amount?
The obligated amount is $11.3 million.
What is the period of performance?
Start: 2023-09-25. End: 2026-12-31.
What is the projected timeline for achieving key milestones in the Phase 2 trial and what are the criteria for success?
The contract end date is December 31, 2026, suggesting a multi-year trial. Key milestones would typically include patient recruitment completion, data collection phases, and interim/final analysis. Success criteria are defined by the trial protocol, focusing on the safety and efficacy of the AV-1 MAB in preventing Dengue infection or reducing disease severity.
What are the primary risks associated with the AV-1 MAB itself, beyond standard clinical trial risks?
Beyond general clinical trial risks like patient safety and recruitment challenges, specific risks for AV-1 include its immunogenicity (potential for the body to develop an immune response against the MAB), off-target effects, and the possibility that it may not be effective against all Dengue serotypes. The long-term durability of protection also remains a potential concern.
How does the cost of this Phase 2 trial compare to similar MAB development programs for infectious diseases?
Benchmarking this $113.4 million contract against similar Phase 2 MAB trials for other infectious diseases is challenging without more specific data. However, early-stage MAB development is notoriously expensive due to complex manufacturing, rigorous testing, and specialized clinical trial designs. This figure appears within the expected range for such a critical research phase.
Industry Classification
NAICS: Professional, Scientific, and Technical Services › Scientific Research and Development Services › Research and Development in the Physical, Engineering, and Life Sciences (except Nanotechnology and Biotechnology)
Product/Service Code: RESEARCH AND DEVELOPMENT › N – Health R&D Services
Competition & Pricing
Extent Competed: FULL AND OPEN COMPETITION
Solicitation Procedures: NEGOTIATED PROPOSAL/QUOTE
Solicitation ID: HHS-NIH-NIAID-BAA2022-1
Offers Received: 31
Pricing Type: COST PLUS FIXED FEE (U)
Evaluated Preference: NONE
Contractor Details
Address: 4800 HAMPDEN LN STE 200, BETHESDA, MD, 20814
Business Categories: Category Business, Limited Liability Corporation, Partnership or Limited Liability Partnership, Small Business, Special Designations, U.S.-Owned Business
Financial Breakdown
Contract Ceiling: $12,356,811
Exercised Options: $11,335,102
Current Obligation: $11,335,102
Actual Outlays: $7,978,461
Contract Characteristics
Commercial Item: COMMERCIAL PRODUCTS/SERVICES PROCEDURES NOT USED
Cost or Pricing Data: YES
Timeline
Start Date: 2023-09-25
Current End Date: 2026-12-31
Potential End Date: 2026-12-31 00:00:00
Last Modified: 2026-03-24
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