VADP_BAA_Amendment1.pdf

Amendment #1 to BAA-NIAID-75N93022R00022

VACCINE ADJUVANT DISCOVERY PROGRAM

Amendment to Solicitation No.:

BAA-NIAID-75N93022R00022

Amendment No.: 1

Issue Date: February 01, 2023

Effective Date:

Proposal Due Date:

February 01, 2023

May 30, 2023 until 3:00 pm EST (CHANGED)

Issued By: Maribel Miranda Contracting Officer

NIH/NIAID

Office of Acquisitions 5601 Fishers Lane Room 3C20 MSC 9821 Rockville, MD 20852

Point of Contact: Maribel Miranda, Contracting Officer Maribel.Miranda@ nih.gov

Name and Address of Offeror: To All Potential Offerors

The above numbered solicitation is amended as set forth below. The hour and date specified for receipt of proposals has changed. Offerors must acknowledge receipt of this amendment. Failure to receive your acknowledgement of this amendment may result in the rejection of your offer.

NOTE: As part of this Amendment, we request that all questions pertaining to the BAA be submitted to the Government no later than April 19, 2023, 3:00pm EST.

The purpose of this amendment is to inform offerors of the new submission deadline and provide responses to questions which may be useful to all potential offerors.

SECTION 1- ADMINISTRATIVE

This section of the amendment notifies offerors the submission deadline has been extended until 3pm EST on May 30, 2023.

Please keep in mind the deadline to submit any questions to the Government pertaining to the BAA remains unchanged (No later than April 19, 2023, 3:00pm EST).

SECTION 2- QUESTIONS AND RESPONSES

This section of the amendment provides questions submitted by potential applicants/offerors and the responses provided by NIAID. The responses are offered for information only and do not modify or become part of this solicitation. This Amendment will be updated as needed to add further questions and their related responses. All potential offerors are advised to refer back to all previous amendments for additional questions and clarification.

Question 1: Would the further characterization and preclinical testing of novel, partially characterized derivatives of a well-known TLR agonist be eligible for funding under this solicitation?

Response to Question 1:

RFP BAA-NIAID-75N93022R00022 supports the discovery of novel immune stimulators that could subsequently be developed into vaccine adjuvants. While derivatives of any previously identified and characterized immune stimulator or established adjuvant would be considered new (potential) adjuvant, and while the program supports the optimization and formulation of novel adjuvant candidates, to be responsive to the solicitation, such novel compounds would have to be the result of a high-throughput screening campaign conducted under the mandatory “Activity 1” of the project. Work on previously generated adjuvant candidates is not permitted under this solicitation and is better suited for NIAID’s Adjuvant Development Program (https://www.niaid.nih.gov/research/adjuvant-development).

Also, while the solicitation does not define a specific threshold for the high-throughput screening requirement in Activity 1, the (de novo) generation and subsequent testing of only a few dozen compounds (in this case, derivatives of a known PAMP) would not qualify as “high-throughput screening”.

Additional details about the HTS requirement are described below under Response to Question 2.

Question 2: We are a foreign institution working on a lectin-based immunostimulator and have shown adjuvanticity in the context of an FMDV vaccine. Currently, we are working on derivatives of the lectin – would such a proposal be responsive?

Response to Question 2:

A. Proposals from foreign applicants are eligible under this solicitation, as well as proposals from domestic applicants with foreign components.

B. The inquiry cites a disease model that is mostly of interest from a veterinary perspective. However, the NIH’s mission is focused on diseases relevant to humans while issues related to animal health are managed by other US government agencies. As indicated in Attachment 4 of the solicitation, “For the in vivo testing, offerors are encouraged to consider any pathogen that causes disease in humans, any human-relevant allergen, or self-antigen associated with autoimmune disease.”

C. The investigators indicated that the core compound they are working with has well-documented adjuvant activity.

Please note that Attachment 5/Section II (Technical Objectives) clarifies that “Work on previously identified adjuvants…. will NOT be supported”. However, work on new derivatives of an immunostimulatory compound would be allowed. If such an approach is proposed, offerors should pay close attention to the description of Activity 1 (Adjuvant Candidate Screening) in Attachment 7/Section 4 (Technical Discussion): This activity shall “start with a high throughput screening (HTS) campaign of [compound] libraries….”. Such libraries may be obtained from third parties or created by the offeror and may be based on derivatives of previously identified immunostimulators. While, in the context of this solicitation, NIAID does not define HTS or set expectations regarding the number of compounds to be screened, a published definition of HTS is “HTS is an experimental process in which 10E3–10E6 small molecule compounds of known structure are screened in parallel” (Attene- Ramos et al., Encyclopedia of Toxicology (3rd Edition, 2014), p916). NIAID understands that the size of a targeted library can be significantly smaller than that of an unbiased library (such as commercial compound libraries) since the expected hit-rate is much higher in a targeted library.