Amendment 3 - HHS-NIH-NIAID-BAA2021-1.pdf

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NATIONAL INSTITUTE OF ALLERGY & INFECTIOUS DISEASES (NIAID)

2021 DMID Omnibus Broad Agency Announcement (BAA):

No. HHS-NIH-NIAID-BAA2021-1

Solicitation Amendment (Three)

Issuing Office: OFFICE OF ACQUISITIONS

National Institute of Allergy and Infectious Diseases (NIAID) 5601 Fishers Lane, Room 3D39, MSC 9821 Bethesda, MD 20892-9821

Solicitation Number: HHS-NIH-NIAID-BAA2021-1

Date of Solicitation Issuance: February 23, 2021

Date of Amendment Three Issuance: May 7, 2021

Number of Pages: Six pages

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

Research Area remains unchanged:

RESEARCH

AREA

NIAID

DIVISION

TITLE PROPOSALS DUE*

DMID

Advanced Development of Vaccine Candidates for Biodefense and Emerging Infectious Diseases

05/24/2021

Development of Therapeutic Products for Biodefense, Anti- Microbial Resistant (AMR) Infections and Emerging Infectious Diseases

Advanced Development of Sequencing- Based Diagnostics for Biothreats and Emerging Infectious Diseases

*Proposals must be received before 3:00 PM Eastern Time on May 24, 2021.

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Contracting Office Points of Contact:

Primary Contact:

Alexandra Buck, Contracting Officer Email: alexandra.buck@nih.gov Phone: 240-669-5174 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.

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

PURPOSE OF SOLICITATION AMENDMENT #3

The purpose of Amendment Three is to 1) provide a due date for the proposal intent response form (May 17, 2021) and 2) 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.

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

GOVERNMENT’S RESPONSES:

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

I. GENERAL QUESTIONS - APPLICABLE TO ALL RESEARCH AREAS:

QUESTION 1: Is there a due date to submit the Proposal Intent Response Form?

RESPONSE: If your organization intends to submit a proposal, please submit the Proposal Intent Response Form by 5:00 p.m. EDT on May 17, 2021.

QUESTION 2: Can the timeframe of options overlap?

RESPONSE: Yes.

QUESTION 3: Is there updated guidance/instructions in the budget worksheet on the Instructions tab? For the excel spreadsheet link on page 79 “4.3.3. – Business Proposal Instructions”, the instructions appear to be last updated on 10/9/2008. Is Stephen Shaffer still the appropriate contact for specific spreadsheet questions per the instructions?”

RESPONSE: Please refer to “Section 7 Attachment #9” on page 128 for the updated contact information via the link provided.

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II. SPECIFIC RESEARCH AREA QUESTIONS

1) RESEARCH AREA 001:

QUESTION 1: The BAA mention the budget covers "non-severable base work". We just wanted to confirm the costs can be used to cover preclinical and clinical trial activities?

RESPONSE: Yes. To clarify, the NIAID estimates a total FY 22 budget of up to $11 million for the non-severable base period across all contracts Research Area 001 and 002, depending on the number of technically meritorious proposals, importance to agency programs, and availability of funds. Pre-clinical and clinical trial activities are within scope thus their conduct and associated budgets can be proposed under this BAA. Please note, the base period is not limited to twelve months. 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. Clinical trial activities are encouraged to start as soon as possible and be completed within the 5-year period.

QUESTION 2: I have a question about foreign involvement. Specifically, could a trial be carried out in a foreign country by a subcontractor? Are there any budget limitations with respect to how much of the award could be subcontracted out to an organization, who I envision would manufacture the final drug product and carry out the clinical trial?

RESPONSE: The same full and open principal applies with regard to the clinical sites: the solicitation is considered full and open competition; thus non-US organizations may be included in a proposal as long as they are not a prohibited source identified in FAR 25.7. Please also refer to Sections 4 and 5 of the BAA regarding Human Subjects, Human Research and Clinical Trials.

Offerors should carefully review the content of the BAA to ensure compliance with all requirements of proposing subcontractors. The BAA does not specify budget limitation with respect to how much of award could be subcontracted, but offerors are encouraged to review FAR 52.215-23 Limitations on Pass-Through Charges.

QUESTION 3: It is mentioned that "SARS-CoV-2 vaccines based on solely using the spike protein as the antigen" are ineligible. Is a vaccine that is based on the RBD, which is a part of the Spike, within scope?

RESPONSE: No, please refer to Section 3.2.1.5 “Contracts awarded under this Research Area will not support”.

QUESTION 4: We are considering a pan-coronavirus vaccine – is this in scope with the BAA? Specifically it is mentioned: “Preference will be given to approaches that utilize novel immunogen design, as opposed to the development and ‘mixing’ of individual monovalent vaccines”. Our approach would involve multivalent immunogen display on nanoparticles using the CoPoP technology. However, the immunogens themselves would be monovalent. Is this within scope of the BAA?

RESPONSE: As stated in Section 3.2.1.2, the NIAID seeks to support the development of pan-coronavirus (pan-CoV) vaccine candidates that provide broad and durable protective immunity to multiple CoV strains. As stated, preference will be given to approaches that utilize novel immunogen design.

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QUESTION 5: It is mentioned that NIAID will exclude, specifically for this BAA, vaccine candidates that only protect against SARS-CoV-2 alone. In another project in the BAA (Research Area 002) it is mentioned a therapeutic could show activity against MERS, SARS-CoV-1, SARS- CoV-2. I was wondering for Research Area 001, whether vaccine coverage against MERS is within scope?

RESPONSE: Please refer to Section 3.2.1.2, “Specifically, NIAID seeks to support the development of pan-CoV) vaccine candidates that provide broad and durable protective immunity to multiple CoV strains.” So long as the vaccine will protect against other strains of coronaviruses including MERS, it is within scope.

QUESTION 6: How do the “Additional Requirements” in 3.1.2.4 on page 8 relate to the requirements in the “Technical Proposal” listed in the previous section, 3.2.1.3? Are these desired features or actual requirements? Is there a TRL being sought, for example, if the candidate is entering GMP manufacturing, is a plan for upstream/downstream manufacturing sufficient, or is data showing actual development of those processes expected? Is potency assay development acceptable as part of the SOW in the event that a potency assay is not yet developed?

RESPONSE: As stated in 3.2.1.4 - Additional Requirements - ”Lead candidates shall have the following requirements provided in order of preference.” For the vaccine candidate there should be data that supports that the antigen(s) can be produced at a level that would allow for assessment in a phase 1 clinical trial with a downstream process that yields materials at a level of purity that would allow for testing in a clinical trial. Due to the competitive nature of the BAA, NIAID is unable to provide feedback or advice regarding an Offeror’s specific technical approach.

QUESTION 7: Section 3.2.1.2, penultimate paragraph, indicates that preference will be given to novel adjuvants that have not previously been used in clinical trials. Does this include combinations of two adjuvants wherein each has been used previously, but they have not yet been used together in a clinical setting?

RESPONSE: Novel combinations that have not been used previously are included.

QUESTION 8: Section 3.2.1.2 indicates preference will be given to single dose with adjuvant vs.

multi-dose administrations. Is a vaccine for which preclinical efficacy has only been tested using 4 doses (with success) eligible for consideration of funding if the clinical regimen is anticipated to be 1-2 doses and this is currently under test in the preclinical animal model?

RESPONSE: As stated in Section 3.2.1.2, “Additionally, where feasible, vaccines providing protection with a single dose with adjuvant are also preferred over multi-dose administrations”. As stated, a single dose is not a requirement for consideration. The BAA does not require that the studies be complete at the time of proposal submission.

QUESTION 9: Section 3.2.1.2 indicates an interest in novel delivery platforms that reduce logistical requirements, are scalable, etc. If the critical path for the vaccine candidate does not require such a platform (recombinant protein, for example), but is believed to be highly compatible with such a delivery platform (nucleic acid delivery, for example), is proposing both the critical path and a parallel path to investigate this alternative advised, and negotiable with

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NIAID if there is sufficient interest in the target, or is it advisable to include novel delivery platforms only when they are required for the critical path?

RESPONSE: Novel delivery systems should be used as appropriate for the proposed indication and population to be immunized.

QUESTION 10: There are two sections of the BAA where the detailed information for each of the tasks outlined in the SOW are requested. Can you please clarify what information is required in one section versus the other? How are these two sections different? What is required in section

3.3.2. part D vs Section 4?

o The description in the BAA indicates that the details of the approach to each task should be put in SECTION 3, Work plan (3.3.2) part d (page 18 of the BAA). “A detailed discussion of the proposed technical approach for each activity to be performed to achieve the key project objectives, with sufficient detail to fully explain and justify the scientific/technical rationale for the proposed approach and/or methodologies” o SECTION 4: TECHNICAL DISCUSSIONS (page 55 of the BAA) In addition to the guidance provided in the Technical Proposal Instructions of the BAA, this section of your technical proposal should include documentation to demonstrate how you will accomplish the work detailed in your proposed SOW.

RESPONSE: Section 4 – Instructions, Conditions and Notices to Offerors applies to proposals submitted to all of the Research Areas in the solicitation. Section 3.3 is specific to Research Areas 001 and 002 and supplements the information in Section 4.

2) RESEARCH AREA 002:

QUESTION 1: We work on multiple bacterial pathogens (Ftul, Burk, Ypest, Banthracis) as a goal for broad spectrum agents. Is development of a broad spectrum therapeutic of interest to should we focus on a single pathogen?

RESPONSE: Refer to 3.2.2.2. - Proposals are encouraged for the development of broad-spectrum therapeutics with extended therapeutic activity over more than one pathogen.

Therapeutic candidates with a limited spectrum that target high-priority pathogens for which no standard clinical treatment exists or for which drug resistance poses a significant public health concern are eligible. Refer to section 3.2.2.3 for pathogen priorities. Due to the competitive nature of the BAA, the NIAID is unable to offer advice or feedback regarding a specific technical approach.

QUESTION 2: We work on host-directed therapeutics as potentiating agents as well as small molecule antimicrobials. Is one area more preferable or would co-administration of both be preferable?

RESPONSE: Refer to Section 3.2.2.3. NIAID is unable to offer feedback regarding a specific technical approach.

QUESTION 3: We work with lead and clinical phase drugs as well as a focus on the host-pathogen interactions. Are molecules this advanced beyond the TRL for this BAA?

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RESPONSE: Research Area 002 will support lead optimization, pre-clinical (IND enabling) studies and clinical trials that include Phase 1 and Phase 2 studies or confirmatory trials no greater than 120 subjects. The scope of support differs depending on the stage of the project being proposed. Refer to section 3.2.2.2 – Technical Objectives for details describing the development phases in-scope of Research Area 002.

3) RESEARCH AREA 003:

QUESTION 1: 1) As per the most recent amendment, we already have a rapid, near-patient platform that will be commercially available in the near future, as it is currently under FDA 510(k) review for our initial assay panel. Could you please clarify the limitations of the scope ‘sequencing-based diagnostics’? We are confirming whether multiplexed RT-PCR testing is excluded from this scope.

RESPONSE: Please refer to page 13 of the solicitation: “the objective of Research Area 003 is to advance the research and development of nucleic acid and protein sequencing solutions on established commercial platforms…”