Amendment_3.pdf

BAA No.: NIAID-DAIT-NIHAI201700100 Page 1 of 2 Amendment #3

Amendment No. 3

Broad Agency Announcement (BAA) No.: NIAID-DAIT-NIHAI201700100 “Vaccine Adjuvant Discovery Program”

Amendment Number: Three (3)

Amendment Issue Date: May 15, 2018

Response Date: July 31, 2018 by 3:00 PM, EST

Issued By: George Ralis

Contracting Officer

OA/DEA/NIAID/NIH/DHHS

5601 Fishers Lane, Room 3C19, MSC 9821 Rockville, Maryland 20852

Point of Contact: PRIMARY ralisg@niaid.nih.gov George Ralis, Contracting Officer Phone: 240-669-5146

Please note that we do NOT intend to extend the due date for submission of proposals as a result of this amendment. The date specified for receipt of proposals is still July 31, 2018 by 3:00 PM, EST.

Offerors must acknowledge receipt of this amendment by identifying this amendment number and date of the amendment on each copy of the proposal submitted. Failure to receive your acknowledgement 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: This amendment is to provide responses to questions which may be useful to all potential offerors.

NOTE: As part of this Amendment, we request that all questions pertaining to the BAA be submitted to the Government no later than June 15, 2018, 3:00pm EST.

QUESTION/ISSUE 1:

As an alternative to conventional discovery of adjuvants using compound library screening in Study Area 1 of the BAA, we are proposing to explore the use of particles formulated with various molecules with known adjuvant effect, followed by the use of these formulations with polymers to form immunostimulatory complexes. Could such an approach be used in place of the compound library screen?

mailto:ralisg@niaid.nih.gov

BAA No.: NIAID-DAIT-NIHAI201700100 Page 2 of 2 Amendment #3

RESPONSE:

The solicitation requires the screening of compound libraries, but for the purpose of this solicitation, the NIAID does not restrict the term “compound” to specific types of molecules. As described in the solicitation, contractors from previous cycles of this program have identified immunostimulatory small molecules, lipids, nucleic acids and carbohydrates. Therefore, screening various nanoparticles or polymers for immunostimulatory activity is acceptable.

However, the proposed approach appears to involve a limited number of molecules and would thus not qualify as a “screen of compound libraries”. Awardees from previous iterations of the program have screened libraries containing between ~10,000 and 600,000 compounds.

Furthermore, as stated in Attachment 5, section (B) “Contracts awarded under this solicitation will NOT support” work on previously identified adjuvants, including compounds already discovered to possess adjuvant activity”.

While the proposed approach of creating nanoparticles containing various (known) immunostimulatory components and antigen is highly innovative and supported by the NIAID through other funding mechanisms, it does not fit within the scope of the Adjuvant Discovery BAA. You are strongly encouraged to look at the NIAID Adjuvant Discovery contract SBIR solicitation, which will be released later this year.

QUESTION/ISSUE 2:

We plan to screen the same compound library that we use in a previous adjuvant discovery contract. To remove cytotoxic, and inactive compounds, can we use the data from the previous HTS and analyze using different parameters or would that make our proposal unresponsive?

RESPONSE:

The solicitation does not permit the continuation of studies previously funded by NIAID through a prior Adjuvant Discovery Program. However, offerors may screen the same library, previously used for another NIAID adjuvant discovery project, if the new screening approach is clearly different. The offeror must describe how the compound library was/is being optimized, based on data obtained in their previous contract, in the Technical Approach section of their proposal. In addition, as described in the Research and Technical Objectives (Attachment 5), BAA NIHAI201700100 allows the use of in silico methods for initial screening of compound libraries (Study Area 1). Examples of in silico approaches may include re-analysis of existing high-throughput screening data, from compound libraries, to identify immune stimulatory molecules that work through different mechanisms than those previously supported by an NIAID Adjuvant Discovery contract.

END OF AMENDMENT NO. 3, NIAID-DAIT-NIHAI201700100