HHS awards $31.17M contract to EITR BIOLOGICS for antibody platform development, aiming to extend immunotherapy intervention windows

Contract Overview

Contract Amount: $31,170,391 ($31.2M)

Contractor: Eitr Biologics, Inc.

Awarding Agency: Department of Health and Human Services

Start Date: 2023-09-22

End Date: 2027-09-30

Contract Duration: 1,469 days

Daily Burn Rate: $21.2K/day

Competition Type: FULL AND OPEN COMPETITION

Number of Offers Received: 1

Pricing Type: COST PLUS FIXED FEE

Sector: R&D

Official Description: THE DEVELOPMENT OF A MULTIMODAL ANTIBODY PLATFORM TO EXTEND THE WINDOW OF IMMUNOTHERAPEUTIC INTERVENTION. THE OVERALL OBJECTIVE OF THE WORK OUTLINED IN THIS CONTRACT IS TO CRITICALLY EVALUATE THE UTILITY OF THE VHH AS A PLATFORM MCM TECHNOLOGY FOR VI

Place of Performance

Location: SAN DIEGO, SAN DIEGO County, CALIFORNIA, 92121

State: California Government Spending

Plain-Language Summary

Department of Health and Human Services obligated $31.2 million to EITR BIOLOGICS, INC. for work described as: THE DEVELOPMENT OF A MULTIMODAL ANTIBODY PLATFORM TO EXTEND THE WINDOW OF IMMUNOTHERAPEUTIC INTERVENTION. THE OVERALL OBJECTIVE OF THE WORK OUTLINED IN THIS CONTRACT IS TO CRITICALLY EVALUATE THE UTILITY OF THE VHH AS A PLATFORM MCM TECHNOLOGY FOR VI Key points: 1. Contract focuses on developing a multimodal antibody platform for therapeutic intervention. 2. The project aims to evaluate the utility of VHH as a platform MCM technology. 3. This contract supports research and development in biotechnology, specifically in antibody platforms. 4. The duration of the contract is approximately 4 years, indicating a significant research commitment. 5. The awardee, EITR BIOLOGICS, INC., is positioned to advance critical areas of biopharmaceutical research. 6. The contract type is Cost Plus Fixed Fee, suggesting flexibility for research and development.

Value Assessment

Rating: good

The contract value of $31.17 million over nearly 4 years for advanced biotechnology R&D appears reasonable. Benchmarking against similar contracts for platform development in immunotherapy is challenging due to the specialized nature of the technology. However, the Cost Plus Fixed Fee structure allows for adaptation during research, which can be cost-effective for novel scientific endeavors. The fixed fee component provides a baseline incentive for the contractor.

Cost Per Unit: N/A

Competition Analysis

Competition Level: full-and-open

The contract was awarded under full and open competition, indicating that multiple capable bidders had the opportunity to submit proposals. This competitive process is expected to drive innovation and ensure fair pricing. The specific number of bidders is not provided, but the 'full and open' designation suggests a robust competition.

Taxpayer Impact: Full and open competition generally benefits taxpayers by fostering a competitive environment that can lead to better value and more innovative solutions, potentially at a more optimized cost.

Public Impact

The primary beneficiaries are expected to be patients who could benefit from extended immunotherapy intervention windows. The services delivered involve the research and development of a novel antibody platform technology. The geographic impact is primarily within California, where EITR BIOLOGICS, INC. is located. Workforce implications include potential job creation in specialized biotechnology research and development roles.

Waste & Efficiency Indicators

Waste Risk Score: 50 / 10

Warning Flags

Potential for research to not yield desired outcomes within the projected timeline.
Reliance on a single contractor for a critical platform development could pose a risk if performance falters.

Positive Signals

Focus on a novel antibody platform technology addresses a critical need in extending immunotherapy.
The long-term nature of the contract (nearly 4 years) suggests a commitment to achieving significant research milestones.
Awarded through full and open competition, implying a vetted and competitive selection process.

Sector Analysis

This contract falls within the Biotechnology (except Nanobiotechnology) sector, a rapidly growing area focused on leveraging biological systems for therapeutic and diagnostic purposes. The market for immunotherapy platforms is expanding significantly, driven by advancements in understanding disease mechanisms and developing targeted treatments. Comparable spending in this sector often involves substantial R&D investments, with contracts ranging from millions to hundreds of millions of dollars depending on the stage and scope of development.

Small Business Impact

The data indicates that this contract was not set aside for small businesses, and there is no explicit mention of subcontracting goals for small businesses. Therefore, the direct impact on the small business ecosystem is likely minimal unless EITR BIOLOGICS, INC. voluntarily engages small businesses as subcontractors. Further analysis would be needed to determine any indirect effects or potential subcontracting opportunities.

Oversight & Accountability

Oversight for this contract would typically be managed by the Department of Health and Human Services, specifically the Office of Assistant Secretary for Preparedness and Response. Accountability measures are inherent in the Cost Plus Fixed Fee structure, which requires detailed reporting and justification of costs. Transparency is generally maintained through contract award databases and reporting requirements, though specific research progress details may be proprietary.

Related Government Programs

Biotechnology Research and Development
Immunotherapy Development
Medical Countermeasures (MCM) Technology
Antibody Platform Development

Risk Flags

Research and Development Timeline Risk
Technological Feasibility Risk
Cost Overrun Potential (inherent in CPFF)

Frequently Asked Questions

What is this federal contract paying for?

Department of Health and Human Services awarded $31.2 million to EITR BIOLOGICS, INC.. THE DEVELOPMENT OF A MULTIMODAL ANTIBODY PLATFORM TO EXTEND THE WINDOW OF IMMUNOTHERAPEUTIC INTERVENTION. THE OVERALL OBJECTIVE OF THE WORK OUTLINED IN THIS CONTRACT IS TO CRITICALLY EVALUATE THE UTILITY OF THE VHH AS A PLATFORM MCM TECHNOLOGY FOR VI

Who is the contractor on this award?

The obligated recipient is EITR BIOLOGICS, 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 $31.2 million.

What is the period of performance?

Start: 2023-09-22. End: 2027-09-30.

What is the specific scientific innovation EITR BIOLOGICS, INC. aims to achieve with this multimodal antibody platform?

The contract aims to develop a multimodal antibody platform technology, specifically evaluating the utility of VHH (variable domain of heavy chain) as a platform for Medical Countermeasures (MCM). The core innovation lies in extending the 'window of immunotherapeutic intervention.' This suggests creating antibody-based therapies that can be administered later in the course of a disease or exposure, or that offer a broader range of therapeutic applications through their multimodal nature. The VHH format is known for its stability, small size, and potential for engineering multiple binding sites, making it a promising scaffold for developing versatile therapeutic agents.

How does the Cost Plus Fixed Fee (CPFF) contract structure influence the risk and reward for EITR BIOLOGICS, INC. and the government?

The Cost Plus Fixed Fee (CPFF) structure means EITR BIOLOGICS, INC. will be reimbursed for all allowable costs incurred during the research and development, plus a predetermined fixed fee. This structure is common for R&D contracts where the scope of work can evolve. For the contractor, it reduces financial risk as costs are covered, and the fixed fee provides a guaranteed profit margin. For the government, it offers flexibility to adapt the research direction as new findings emerge. However, it places a greater burden on government oversight to ensure costs are reasonable and allocable. The fixed fee incentivizes the contractor to complete the work efficiently to maximize their return on the fixed profit.

What are the potential long-term implications of developing a successful multimodal antibody platform for public health preparedness?

A successful multimodal antibody platform could significantly enhance public health preparedness by providing versatile and rapidly deployable therapeutic options against a range of threats, including emerging infectious diseases, bioweapons, or even complex chronic conditions. The 'extended window of intervention' implies that treatments could be effective even when administered later than current therapies, improving patient outcomes and reducing the burden on healthcare systems during outbreaks or emergencies. Furthermore, a platform approach allows for quicker adaptation and development of new MCMs compared to traditional methods, potentially shortening response times to novel threats.

What is the significance of the VHH format in the context of this antibody platform development?

The VHH format refers to the variable domain of heavy-chain-only antibodies, which are naturally occurring in camelids (like camels and llamas). These VHH fragments are significantly smaller than conventional antibodies, offering several advantages for therapeutic development. Their small size allows for better tissue penetration and potentially lower immunogenicity. They are also highly stable and can be engineered to bind to multiple targets simultaneously (multimodal), which is the core objective of this contract. This engineering capability is crucial for creating versatile platforms that can address complex diseases or multiple targets with a single therapeutic agent.

How does this contract align with the mission of the Office of Assistant Secretary for Preparedness and Response (ASPR)?

This contract directly aligns with the mission of ASPR, which is to lead the nation in preventing, preparing for, responding to, and recovering from public health emergencies. Developing advanced Medical Countermeasures (MCMs), such as a novel antibody platform that extends therapeutic intervention windows, is a key component of ASPR's strategy to ensure the U.S. is equipped to handle a wide range of health threats. By investing in cutting-edge biotechnology research, ASPR aims to bolster the nation's medical defenses and improve resilience against biological and chemical threats.

Industry Classification

NAICS: Professional, Scientific, and Technical Services › Scientific Research and Development Services › Research and Development in Biotechnology (except Nanobiotechnology)

Product/Service Code: SPECIAL INDUSTRY MACHINERY

Competition & Pricing

Extent Competed: FULL AND OPEN COMPETITION

Solicitation Procedures: NEGOTIATED PROPOSAL/QUOTE

Offers Received: 1

Pricing Type: COST PLUS FIXED FEE (U)

Evaluated Preference: NONE

Contractor Details

Address: 7090 MIRATECH DR STE 130, SAN DIEGO, CA, 92121

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

Financial Breakdown

Contract Ceiling: $315,662,884

Exercised Options: $31,170,391

Current Obligation: $31,170,391

Actual Outlays: $11,928,166

Contract Characteristics

Commercial Item: COMMERCIAL PRODUCTS/SERVICES PROCEDURES NOT USED

Cost or Pricing Data: YES

Timeline