HHS awards $20M contract for plasma gelsolin research to BioAegis Therapeutics to combat severe inflammation and infection

Contract Overview

Contract Amount: $20,000,000 ($20.0M)

Contractor: Bioaegis Therapeutics Inc

Awarding Agency: Department of Health and Human Services

Start Date: 2023-09-21

End Date: 2027-08-31

Contract Duration: 1,440 days

Daily Burn Rate: $13.9K/day

Competition Type: FULL AND OPEN COMPETITION

Number of Offers Received: 100

Pricing Type: FIRM FIXED PRICE

Sector: R&D

Official Description: BIOAEGIS: PLASMA GELSOLIN (PGSN), AN ABUNDANT, CIRCULATING PROTEIN MODULATES INFLAMMATION WHILE ALSO ENHANCING HOST DEFENSES BY STIMULATING THE UPTAKE AND KILLING OF PATHOGENS. CLINICAL STUDIES HAVE CONSISTENTLY SHOWN PGSN IS DEPLETED IN SEVERE I

Place of Performance

Location: MORRISTOWN, MORRIS County, NEW JERSEY, 07960

State: New Jersey Government Spending

Plain-Language Summary

Department of Health and Human Services obligated $20.0 million to BIOAEGIS THERAPEUTICS INC for work described as: BIOAEGIS: PLASMA GELSOLIN (PGSN), AN ABUNDANT, CIRCULATING PROTEIN MODULATES INFLAMMATION WHILE ALSO ENHANCING HOST DEFENSES BY STIMULATING THE UPTAKE AND KILLING OF PATHOGENS. CLINICAL STUDIES HAVE CONSISTENTLY SHOWN PGSN IS DEPLETED IN SEVERE I Key points: 1. Contract supports research into Plasma Gelsolin (PGSN) as a therapeutic agent for severe inflammation and infection. 2. The research aims to enhance host defenses by stimulating pathogen uptake and killing. 3. Clinical studies indicate PGSN depletion in severe inflammatory conditions, highlighting its potential therapeutic role. 4. The contract is a definitive contract with a firm fixed price, indicating clear cost expectations. 5. The awardee, BioAegis Therapeutics Inc., is positioned to advance this novel therapeutic approach. 6. The research aligns with the broader goal of improving preparedness for public health emergencies.

Value Assessment

Rating: good

The contract value of $20 million for a 4-year research and development effort appears reasonable given the scope of investigating a novel therapeutic agent. Benchmarking against similar R&D contracts in the life sciences sector would provide further context, but the firm fixed-price structure suggests a degree of cost control. The focus on a specific protein with demonstrated clinical relevance in inflammatory conditions supports the investment.

Cost Per Unit: N/A

Competition Analysis

Competition Level: full-and-open

The contract was awarded under full and open competition, suggesting that multiple vendors had the opportunity to bid. This process is designed to foster a competitive environment, potentially leading to better pricing and innovative solutions. The number of bidders (100) indicates significant interest and a robust competitive landscape for this type of research.

Taxpayer Impact: Full and open competition generally benefits taxpayers by driving down costs and encouraging the most capable contractors to participate, ensuring federal funds are used efficiently.

Public Impact

The primary beneficiaries are patients suffering from severe inflammatory conditions and infections, who may eventually benefit from new therapeutic options. The services delivered involve advanced research and development in the physical, engineering, and life sciences. The geographic impact is primarily centered in New Jersey, where BioAegis Therapeutics Inc. is located, but the research has national public health implications. The contract supports a specialized workforce in biotechnology and pharmaceutical research.

Waste & Efficiency Indicators

Waste Risk Score: 50 / 10

Warning Flags

Potential for long development timelines typical of pharmaceutical R&D.
Uncertainty in translating research findings into a marketable therapeutic.
Dependence on continued funding for subsequent research and clinical trial phases.

Positive Signals

Focus on a well-researched protein (PGSN) with existing clinical data.
Awardee has a specific focus on this therapeutic area.
Firm fixed-price contract provides cost certainty for this phase of research.

Sector Analysis

This contract falls within the Biotechnology and Pharmaceutical R&D sector, a critical area for public health preparedness and medical innovation. The market for novel therapeutics targeting inflammation and infection is substantial, driven by unmet medical needs and the threat of emerging infectious diseases. Comparable spending benchmarks would likely be found within NIH and BARDA funding for early-stage drug development and advanced research.

Small Business Impact

The contract was awarded through full and open competition and does not appear to have a specific small business set-aside. However, the large contract value may present subcontracting opportunities for specialized services or research components that could benefit small businesses within the life sciences ecosystem.

Oversight & Accountability

Oversight for this contract will likely be managed by the Office of Assistant Secretary for Preparedness and Response (ASPR) within HHS. Accountability measures are embedded in the definitive contract structure with defined deliverables and milestones. Transparency is facilitated through the federal contract database, and any specific Inspector General jurisdiction would be determined by HHS policies.

Related Government Programs

National Institutes of Health (NIH) Research Grants
Biomedical Advanced Research and Development Authority (BARDA) Contracts
Department of Defense (DoD) Medical Research Programs

Risk Flags

Research and Development Risk
Clinical Efficacy Uncertainty
Regulatory Approval Pathway
Long Development Timelines

Frequently Asked Questions

What is this federal contract paying for?

Department of Health and Human Services awarded $20.0 million to BIOAEGIS THERAPEUTICS INC. BIOAEGIS: PLASMA GELSOLIN (PGSN), AN ABUNDANT, CIRCULATING PROTEIN MODULATES INFLAMMATION WHILE ALSO ENHANCING HOST DEFENSES BY STIMULATING THE UPTAKE AND KILLING OF PATHOGENS. CLINICAL STUDIES HAVE CONSISTENTLY SHOWN PGSN IS DEPLETED IN SEVERE I

Who is the contractor on this award?

The obligated recipient is BIOAEGIS THERAPEUTICS INC.

Which agency awarded this contract?

Awarding agency: Department of Health and Human Services (Office of Assistant Secretary for Preparedness and Response).

What is the total obligated amount?

The obligated amount is $20.0 million.

What is the period of performance?

Start: 2023-09-21. End: 2027-08-31.

What is the specific scientific rationale for focusing on Plasma Gelsolin (PGSN) for treating severe inflammation and infection?

The scientific rationale stems from consistent clinical observations that Plasma Gelsolin (PGSN) levels are significantly depleted in patients experiencing severe inflammatory conditions, such as sepsis and acute respiratory distress syndrome. PGSN is a naturally occurring protein that plays a crucial role in regulating inflammation and enhancing the innate immune system's ability to clear pathogens. It acts by severing actin filaments, which are released from damaged cells and can exacerbate inflammation and tissue damage. By replenishing or modulating PGSN, researchers aim to dampen excessive inflammatory responses, reduce tissue injury, and improve the body's capacity to eliminate infectious agents. This contract supports further investigation into the mechanisms of PGSN and its therapeutic potential in preclinical and potentially early clinical settings.

How does the $20 million contract value compare to typical R&D investments in similar therapeutic areas?

The $20 million contract value for a 4-year research and development effort in a novel therapeutic area like Plasma Gelsolin (PGSN) is within a reasonable range for early-stage biomedical research. Federal agencies like HHS, NIH, and BARDA often award contracts and grants of this magnitude for preclinical studies, mechanism of action research, and initial safety assessments. For comparison, early-phase drug development contracts can range from a few million dollars for specific studies to tens or even hundreds of millions for more advanced clinical trials and manufacturing scale-up. Given that this contract appears to focus on further characterizing PGSN's therapeutic potential and underlying science, $20 million over four years represents a significant but not unusually large investment for advancing a promising candidate.

What are the primary risks associated with this research and development contract?

The primary risks associated with this R&D contract are inherent to the nature of drug development. Firstly, there is a significant scientific risk: the research may not yield the expected results, or PGSN may prove ineffective or unsafe in further studies. Secondly, there is a regulatory risk, as any potential therapeutic derived from this research would need to navigate complex and lengthy FDA approval processes. Thirdly, there is a commercialization risk; even if successful, bringing a new drug to market requires substantial additional investment and faces market competition. Finally, there is a timeline risk, as R&D projects, especially in the life sciences, are prone to delays due to unforeseen scientific challenges or experimental setbacks.

What does the 'definitive contract' type imply for the project's execution and oversight?

A definitive contract is a contract that has been fully negotiated and finalized, specifying all terms and conditions, including price, delivery schedule, and scope of work. For this project, it implies that the initial negotiation phase is complete, and BioAegis Therapeutics Inc. has a clear understanding of its obligations and the government's expectations. This contract type provides a stable framework for the 4-year research period. Oversight will focus on monitoring progress against defined milestones, ensuring adherence to the research plan, and verifying the quality of deliverables. While it offers stability, the firm fixed-price nature means that cost overruns beyond the agreed amount would typically be borne by the contractor, incentivizing efficient project management.

How does this contract align with broader HHS and national public health preparedness goals?

This contract directly aligns with the Department of Health and Human Services' (HHS) mission, particularly the goals of the Office of Assistant Secretary for Preparedness and Response (ASPR). ASPR focuses on preparing the nation for public health emergencies, including those caused by infectious diseases and biological threats. Research into novel therapeutics that can combat severe inflammation and enhance host defenses against pathogens is a critical component of preparedness. By investing in the understanding and potential development of Plasma Gelsolin, HHS is supporting the creation of new medical countermeasures that could be vital in mitigating the impact of future pandemics or bioterrorism events. This proactive research contributes to building a more resilient public health infrastructure.

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: BASIC RESEARCH

Offers Received: 100

Pricing Type: FIRM FIXED PRICE (J)

Evaluated Preference: NONE

Contractor Details

Address: 6 E COVE LN, MORRISTOWN, NJ, 07960

Business Categories: Category Business, Corporate Entity Not Tax Exempt, Not Designated a Small Business, Special Designations, U.S.-Owned Business

Financial Breakdown

Contract Ceiling: $20,000,000

Exercised Options: $20,000,000

Current Obligation: $20,000,000

Actual Outlays: $14,931,922

Contract Characteristics

Commercial Item: COMMERCIAL PRODUCTS/SERVICES PROCEDURES NOT USED

Cost or Pricing Data: NO

Timeline