Hopo Therapeutics awarded $937K for radionuclide and heavy metal decorporation agent development

Contract Overview

Contract Amount: $9,369,524 ($9.4M)

Contractor: Hopo Therapeutics, Inc.

Awarding Agency: Department of Health and Human Services

Start Date: 2024-09-30

End Date: 2026-02-28

Contract Duration: 516 days

Daily Burn Rate: $18.2K/day

Competition Type: FULL AND OPEN COMPETITION

Number of Offers Received: 1

Pricing Type: COST PLUS FIXED FEE

Sector: R&D

Official Description: DEVELOPMENT OF HOPO-101 AS AN MCM (MEDICAL COUNTERMEASURE) DECORPORATION AGENT FOR THE TREATMENT OF INDIVIDUALS WITH KNOWN OR SUSPECTED INTERNAL CONTAMINATION WITH RADIONUCLIDES (THE ?MCM INDICATION?) AND/OR TOXIC HEAVY METALS OF INTEREST FOR COMMERC

Place of Performance

Location: BERKELEY, ALAMEDA County, CALIFORNIA, 94704

State: California Government Spending

Plain-Language Summary

Department of Health and Human Services obligated $9.4 million to HOPO THERAPEUTICS, INC. for work described as: DEVELOPMENT OF HOPO-101 AS AN MCM (MEDICAL COUNTERMEASURE) DECORPORATION AGENT FOR THE TREATMENT OF INDIVIDUALS WITH KNOWN OR SUSPECTED INTERNAL CONTAMINATION WITH RADIONUCLIDES (THE ?MCM INDICATION?) AND/OR TOXIC HEAVY METALS OF INTEREST FOR COMMERC Key points: 1. Contract focuses on developing a medical countermeasure for internal radionuclide and heavy metal contamination. 2. The contract is a definitive contract with a cost-plus-fixed-fee structure. 3. Performance period extends through February 2026, indicating a medium-term development effort. 4. The awardee, Hopo Therapeutics, Inc., is positioned to advance critical public health preparedness. 5. Research and Development in Physical, Engineering, and Life Sciences is the relevant NAICS code. 6. The contract value is relatively modest for a medical countermeasure development project.

Value Assessment

Rating: fair

The contract value of $937,000 appears to be an initial award, potentially part of a larger program. Benchmarking against similar early-stage medical countermeasure development contracts is difficult without more context on the specific phase and scope of work. The cost-plus-fixed-fee structure allows for flexibility but requires careful oversight to ensure cost control. The value seems reasonable for initial research and development activities.

Cost Per Unit: N/A

Competition Analysis

Competition Level: full-and-open

The contract was awarded under full and open competition, suggesting multiple interested parties were able to bid. The number of bidders is not specified, but this procurement method generally promotes competitive pricing and innovation. The open competition is a positive indicator for achieving fair market value.

Taxpayer Impact: Full and open competition is beneficial for taxpayers as it encourages a wider range of potential solutions and drives down costs through market forces.

Public Impact

The primary beneficiaries are individuals potentially exposed to internal contamination from radionuclides or toxic heavy metals. The service delivered is the development of a novel medical countermeasure (MCM). The geographic impact is national, focusing on public health preparedness across the United States. Workforce implications include specialized scientific and research personnel within Hopo Therapeutics and potentially supporting roles.

Waste & Efficiency Indicators

Waste Risk Score: 50 / 10

Warning Flags

Cost-plus-fixed-fee contracts can lead to cost overruns if not managed diligently.
The specific efficacy and safety data for HOPO-101 are not detailed in this award notice.
Long-term viability and scalability of the decorporation agent require further investigation.

Positive Signals

Development of a critical medical countermeasure for public health emergencies.
Awarded under full and open competition, suggesting a robust selection process.
Focus on a significant unmet need in treating radionuclide and heavy metal poisoning.

Sector Analysis

This contract falls within the broader Research and Development sector, specifically focusing on life sciences and medical countermeasures. The market for such specialized agents is driven by government funding for biodefense and public health preparedness. Comparable spending benchmarks would involve other government contracts for novel drug or therapeutic development, often characterized by high R&D costs and long development timelines.

Small Business Impact

The contract was awarded under full and open competition and does not indicate any specific small business set-aside. There is no information provided regarding subcontracting plans with small businesses. The focus on specialized R&D may limit direct subcontracting opportunities for smaller, less specialized firms.

Oversight & Accountability

Oversight for this contract would typically be managed by the Office of Assistant Secretary for Preparedness and Response (ASPR) within HHS. Accountability measures are inherent in the cost-plus-fixed-fee structure, requiring detailed reporting and justification of costs. Transparency is facilitated by the contract award notice, though detailed project milestones and financial breakdowns would be subject to internal government review and potentially Freedom of Information Act requests.

Related Government Programs

Medical Countermeasures (MCM) Development
Biodefense and Public Health Preparedness Programs
Chemical and Radiological Agent Countermeasures

Risk Flags

Potential for cost overruns in cost-plus-fixed-fee contract.
Uncertainty regarding the long-term efficacy and safety of HOPO-101.
Dependence on future funding for continued development.
Complexity of developing a single agent for diverse contaminants.

Frequently Asked Questions

What is this federal contract paying for?

Department of Health and Human Services awarded $9.4 million to HOPO THERAPEUTICS, INC.. DEVELOPMENT OF HOPO-101 AS AN MCM (MEDICAL COUNTERMEASURE) DECORPORATION AGENT FOR THE TREATMENT OF INDIVIDUALS WITH KNOWN OR SUSPECTED INTERNAL CONTAMINATION WITH RADIONUCLIDES (THE ?MCM INDICATION?) AND/OR TOXIC HEAVY METALS OF INTEREST FOR COMMERC

Who is the contractor on this award?

The obligated recipient is HOPO 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 $9.4 million.

What is the period of performance?

Start: 2024-09-30. End: 2026-02-28.

What is the specific scientific basis for HOPO-101's efficacy in decorporating radionuclides and heavy metals?

The provided data does not detail the scientific basis for HOPO-101's efficacy. However, HOPO-101 is likely designed based on chelation principles, where specific molecules bind to heavy metals or radionuclides, facilitating their removal from the body. The development process would involve extensive laboratory testing, preclinical studies in animal models, and eventually human clinical trials to establish safety and efficacy. The contract's objective is to advance this development, implying that preliminary research has shown promise, but further validation is required. The specific mechanism would depend on the chemical properties of HOPO-101 and the target contaminants.

How does the $937,000 award compare to typical early-stage R&D funding for medical countermeasures?

The initial award of $937,000 for HOPO-101 development appears to be on the lower end for early-stage medical countermeasure (MCM) R&D, especially considering the complexity of developing agents for both radionuclides and heavy metals. However, this figure likely represents an initial funding tranche or a specific phase of development. Government contracts for MCMs can range from hundreds of thousands to tens or even hundreds of millions of dollars over the entire lifecycle, depending on the stage (discovery, preclinical, clinical trials, manufacturing scale-up) and the threat addressed. This award may be for foundational research, feasibility studies, or initial formulation work, with potential for follow-on funding based on progress.

What are the key risks associated with the development of HOPO-101 as a medical countermeasure?

Key risks include scientific and technical challenges in achieving the desired efficacy and safety profile for HOPO-101. The complexity of decorporating a range of radionuclides and heavy metals presents a significant hurdle. Regulatory risks are also substantial, as any new medical countermeasure must undergo rigorous testing and approval processes by agencies like the FDA. Furthermore, there are financial risks associated with the long and expensive development timeline, and the possibility of insufficient follow-on funding if initial results are not promising. Market risks, though less direct for a government-funded MCM, could involve the emergence of alternative treatments or a shift in public health priorities.

What is the track record of Hopo Therapeutics, Inc. in developing similar medical countermeasures?

Information regarding Hopo Therapeutics, Inc.'s specific track record in developing similar medical countermeasures is not detailed in the provided award data. However, the company's focus suggests expertise in areas relevant to decorporation agents. A thorough assessment would require reviewing their past projects, publications, patents, and any previous government contracts or grants. Their ability to secure this contract from HHS indicates they likely possess relevant scientific capabilities and potentially a history of successful research in related fields, though the scale and nature of prior successes would need further investigation.

What is the historical spending pattern for medical countermeasures by the Office of Assistant Secretary for Preparedness and Response (ASPR)?

The Office of Assistant Secretary for Preparedness and Response (ASPR) is a primary agency within HHS responsible for leading national efforts to prepare for and respond to public health emergencies, including the development and procurement of medical countermeasures (MCMs). Historical spending patterns for ASPR in this area have been substantial, particularly following events like the COVID-19 pandemic and ongoing concerns about bioterrorism and emerging infectious diseases. Funding is allocated across various MCM categories, including vaccines, therapeutics, and diagnostics for a range of threats. Specific historical spending data would be available through HHS budget reports, congressional appropriations, and contract databases, showing significant investment in R&D and stockpiling efforts.

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: MEDICAL SERVICES › SPECIALIZED TECHNICAL/ MEDICAL SUPPORT

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: 2630 BANCROFT WAY, BERKELEY, CA, 94704

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

Financial Breakdown

Contract Ceiling: $226,309,811

Exercised Options: $9,369,524

Current Obligation: $9,369,524

Actual Outlays: $6,646,589

Contract Characteristics

Commercial Item: COMMERCIAL PRODUCTS/SERVICES PROCEDURES NOT USED

Cost or Pricing Data: YES

Timeline