HHS-NIH-NIAID-BAA2024-1 - Amendment One.pdf

HHS-NIH-NIAID-BAA2024-1

Page 1 of 5 Amendment One (1)

NATIONAL INSTITUTE OF ALLERGY & INFECTIOUS DISEASES (NIAID)

2026 DMID Omnibus Broad Agency Announcement (BAA):

No. HHS-NIH-NIAID-BAA2025-1

Solicitation Amendment One (1)

Issuing Office: OFFICE OF ACQUISITIONS

National Institute of Allergy and Infectious Diseases (NIAID)

5601 Fishers Lane, Room 3D38, MSC 9821

Bethesda, MD 20892-9821

Solicitation Number: HHS-NIH-NIAID-BAA2025-1

Date of Solicitation Issuance: November 22, 2024

Date of Amendment One Issuance December 3, 2024

Number of Pages: Five (5) pages

Proposal Due Dates: The hour and date specified for receipt of offers for each

Research Area remains unchanged:

RESEARCH

AREA

TITLE PROPOSALS DUE*

Development of Candidate

Therapeutics, Vaccines, and In Vitro

Diagnostics for Antimicrobial-Resistant

(AMR) Bacterial or Fungal Pathogens

February 21, 2025

Development of Direct Acting

Antivirals (DAA) for Viral Families of

Pandemic Potential

January 21, 2025

* Proposals must be received before 3:00 PM Eastern Time on the date specified herein.

Contracting Office Points of Contact:

Primary Contact:

Swee L. Teo, Contracting Officer

Email: teosl@niaid.nih.gov

Phone: 240-669-5173

Offerors MUST acknowledge receipt of the amendment by Amendment number(s) and date of the amendment. Failure to receive your acknowledgment of this amendment may result in the rejection of your proposal.

mailto:teosl@niaid.nih.gov

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Except as provided herein, all terms and conditions of the solicitation remain unchanged and in full force and effect.

PURPOSE OF AMENDMENT ONE (1)

The purpose of Amendment One (1) is to:

I. Provide the NIAID’s response to questions received regarding the solicitation. The responses are offered for information only and do not modify or become part of this solicitation. Additional amendments may be provided as needed to address further questions and their related responses.

Due to the competitive nature of the BAA, NIAID cannot provide any technical direction or feedback regarding an offeror’s specific technical approach.

II. Provide a cut-off date for questions for each Research Area.

Please note, in the questions/responses below, specific organizational names have been removed or replaced where possible as well as other minor adjustments.

I. GOVERNMENT RESPONSES:

The Government’s responses to questions received regarding this solicitation are as follows:

A. GENERAL QUESTIONS APPLICABLE TO ALL RESEARCH AREAS:

Question 1: Can we use foreign CROs and what is the procedure to get permission to use a foreign CRO for some of the medicinal chemistry in an application to this BAA?

Response: Yes, an offeror may propose a foreign subcontractor, not otherwise prohibited by law, to perform some proposed activities. If successful, clearance by the State Department will be obtained prior to awarding a foreign contract, a foreign subcontract, or a domestic contract with a foreign component.

Question 2: Is this SBIR or STTR?

Response: This is not an SBIR or STTR solicitation. This BAA is being solicited under a full and open competition. All offerors, including small businesses, not otherwise prohibited by law are eligible to respond.

B. RESEARCH AREA SPECIFIC QUESTIONS:

1. RESEARCH AREA 002

Question 3: Are all host-targeted antivirals not allowed? Or just those modulating host response?

Response: Host-targeted antivirals are not allowed. Please refer to Page 13, under Section

3.3.2.1, the first bullet which states “Directly modify viral target function (not through the modulation of the host responses)”.

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Question 4a: Is there a limit to the budget? The proposed studies will focus on lead optimization and involve medicinal chemistry, PK/PD, structural biology, and animal model studies.

Response: The NIAID estimates a budget of up to $20 million for the award of 3-4 cost-reimbursement type contracts. The estimated FY26 funding is for the non-severable BASE requirement (direct and indirect costs combined). See page 5, Section 3.2. of the BAA and response to Question 7 below for additional information.

Question 4b: I am also considering submitting a proposal related to SARS-CoV-2 papain-like protease (PLpro) inhibitors. However, PLpro inhibitors do not have broad-spectrum antiviral activity, and our SARS-CoV-2 PLpro inhibitors do not inhibit MERS-CoV. Please let me know if the PLpro project fits into the scope of this grant.

Response: Please refer to Page 13, Section 3.3.2.1 of the BAA announcement under

“Important notice to Offerors”. It states - “Pan-coronavirus” activity requires demonstrated in vivo efficacy against clinical strains of SARS-CoV-2 variants and MERS-

CoV.

Question 5: Could you please clarify what is meant by “nanobody conjugate/fusion products” in this context? Could you provide more specifics?

Response: A nanobody-derived conjugate/fusion drug molecule contains a nanobody that is conjugated or fused with other nanobodies or other moieties (e.g., chemical, peptide, or protein) to achieve the desired antiviral spectrum and biological and/or pharmacological properties.

Question 6: We have developed a multivalent nanobody conjugate targeting SARS-like viruses and have demonstrated robust in vivo efficacy against SARS-CoV-2 variants. We seek clarification on the following questions regarding alignment with the solicitation requirements:

a) Our platform has shown in vivo efficacy against SARS-CoV-2 variants; however, MERS-CoV is not yet included for in vivo evaluation. Given this, would our demonstrated pan-sarbecovirus activity and adaptability to rapidly design candidates for MERS-CoV meet the "pan-coronavirus" activity requirement?

Response: Please refer to Page 13, Section 3.3.2.1 of the BAA announcement under

“Important notice to Offerors”. It states - “Pan-coronavirus” activity requires demonstrated in vivo efficacy against clinical strains of SARS-CoV-2 variants and

MERS-CoV.

b) The solicitation specifies that eligible therapeutic candidates include nanobody conjugates or fusion products but excludes proteins, monoclonal antibodies, and their conjugates. As our approach is based on multivalent nanobody assemblies, would this be classified as a nanobody conjugate/fusion product under the solicitation's definition?

Response: Please refer to 3.3.2.1 - Technical Objectives. A multivalent nanobody conjugate/fusion will be in scope.

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Question 7: We are interested in applying for this BAA (R002) and would appreciate some clarification on the budget amount.

If you look at Page 5 of the Detailed pdf, it says “For FY 26, NIAID estimates up to $20 million for the award of 3-4 cost reimbursement type base contracts in Research Area 002.”

And then the paragraph above that says “The total performance period comprising the combined Base Requirement, and any Options, if proposed by an Offeror, shall not exceed an estimated 5 years.” Assuming you give out 4 awards, so that is $5M per site. We are trying to clarify if that means for one applicant, it means $5 million total for up to 5 years

(~1M per year) or if it means $5M/year for up to 5 years (total $20M per site).

Response: The total estimated award amount of up to $20 million is for the non-severable

BASE requirement to be divided among all contract awards. NIAID estimates awarding 3-4 cost reimbursement type contracts; however, the number of awarded contracts will depend on the number of technically meritorious proposals, agency priorities, and availability of funds.

Offerors should propose a budget that is aligned with the Statement of Work proposed. The total cost for each award (Base and options) may vary depending upon the scope of the project and the technical objectives of the award. The Base will be fully funded at time of award, and each non-severable Option, if proposed, will be fully funded when it is exercised at the discretion of the Government. For example, if the Base performance period is two (2) years, the contract will be fully funded for two (2) years at time of award.

Base and options need not be proposed as consecutive one-year periods. Additionally, options are not required to follow sequentially from the Base or a previous option. Rather, each option should reflect a logically coherent set of tasks whose requirement is defined by certain prerequisites having been met during contract execution. It is possible for multiple options and/or the Base to be concurrent depending on the proposed design of the development program. It is permissible that a proposal includes only a Base period. The total duration of a proposed contract should be consistent with the nature and complexity of the offeror’s proposed research. The total performance period comprised of the Base and any options proposed by an Offeror should not exceed five (5) years.

In proposing the total cost and performance periods for the Base and each option, the

Offeror should use its professional judgement in estimating its best offer and make a reasonable estimate of the time in months that would be needed to complete the activities under the Base and each option.

“Non-severable” means work resulting in a final product or end-item and for which benefit is received only when the project is complete, such as process development activities resulting in a product development report or efficacy studies sufficient to submit for regulatory approval of a candidate to enter clinical trials.

Question 8a: With regards to the NIAID/DMID HHS-NIH-NIAID-BAA2025-1

Solicitation Research Area 002 requirements (see Section 3.3.2.4 parts f and g), is a small molecule combination therapy that includes at least one new chemical entity (NCE) (and meeting other requirements) appropriate for consideration?

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Response: Please see page 16, Section 3.3.2.4, parts f and g, the combination of new direct-acting antiviral (DAA) must be novel and developed under this contract.

Question 8b: We hope to confirm that up to 3-4 contracts will be awarded in Research

Area 002 with up to $20 million in total available for these contracts in FY26 for the non-severable Base Requirement. Can the Base Requirement be extended beyond FY26 (e.g. 2 yr Base Contract) with the anticipation of additional FY27 funding and is there any guidance available for Options funding limits as well as overall Base + Options?

Response: Please see Question 7 above for a response.

II. The cut-off date for questions for each Research Area is:

• Research Area 001 – February 10, 2025

• Research Area 002 – January 10, 2025

A final Amendment will be posted within a week after each cut-off date. Questions received thereafter may not be addressed.