SPECIAL NOTICE
A -- cNP8 Delivered Topically in a Tyrosine-Derived Fiber Mat to Reduce Burn Injury Progression, Speed Wound Closure, and Mitigate Scarring
- Notice Date
- 11/16/2021 8:42:07 AM
- Notice Type
- Special Notice
- NAICS
- 541715
— Research and Development in the Physical, Engineering, and Life Sciences (except Nanotechnology and Biotechnology)
- Contracting Office
- W4PZ USA MED RSCH ACQUIS ACT FORT DETRICK MD 21702-5014 USA
- ZIP Code
- 21702-5014
- Solicitation Number
- NOI-W81XWH-22-P-7499
- Response Due
- 12/2/2021 7:00:00 AM
- Archive Date
- 12/17/2021
- Point of Contact
- Matthew Teel
- E-Mail Address
-
matthew.d.teel.civ@mail.mil
(matthew.d.teel.civ@mail.mil)
- Description
- Notice of Intent (NOI) to Award Sole Source 1. Number: NOI-W81XWH-22-P-7499 2. Agency:� United States Army Medical Research and Development Command (USAMRDC) 3. Office: Congressionally Directed Medical Research Program (CDMRP) 4. Contracting Office: United States Army Medical Research Acquisition Activity (USAMRAA), Fort Detrick, Frederick, MD. 5. Contractor: NeoMatrix Therapeutics, Inc. (NMT) 6. North American Industry Classification System (NAICS) Code: The NAICS code for this action is 541715 (Research and Development in the Physical Engineering and Life Sciences, except Nanotechnology and Biotechnology) with a Size Standard of 1,000 employees. 7. Synopsis: The USAMRAA, on behalf of the USAMRDC�CDMRP Fiscal Year (FY) 2020 Joint Warfighter Medical Research Program (JWMRP) is issuing this Notice of Intent to Award Sole Source. This is not a request for proposals. This notice does not represent a commitment by the government to pay for costs incurred from the preparation and/or submission of data in response to this notice. 8.� Background: Congress appropriated $40M for this program in the �Consolidated Appropriations Act, 2020�, Public Law 116-93. Page 237 of Senate Report 116-103 states that the funds �shall be used to augment and accelerate high priority Department of Defense (DoD) and Service medical requirements and to continue both core and congressionally-directed prior year initiatives that are close to achieving their objectives and yielding a benefit to military medicine. These funds shall not be used for new projects or basic research, and they shall be awarded at the discretion of the Secretary of Defense following a review of medical research and development gaps, as well as unfinanced medical requirements of the Services.� For this reason, it was determined that the cited statutory authority permitting other than full and open competition is supported and required. This Bill essentially limits the competition to contractors that have existing research projects that have received funding from the Department of Defense (contracts or assistance agreements) and have a military relevance. The Bill also states that funds shall be awarded at the discretion of the Secretary of Defense following a review of medical research and development gaps. The strategy in executing the JWMRP was to find highly valued research efforts on research grants or contracts that could meet critical service requirements and that were not being continued through other appropriations.� The proposal was submitted by NMT in response to the funding opportunity number W81XWH-20-JWMRP (application due 24-Jun-2020) and was competitively reviewed by a scientific peer review panel, followed by a programmatic review panel. Funding recommendations were made at a second-tier, programmatic review meeting based on program goals and scientific merit. Notification was sent to the contractor on 21 October 2020 that the application was recommended for funding as an alternate due to lack of available FY20 funds in the JWMRP. Per the alternate funding notice issued by the USAMRAA authorized official, the application remained valid for funding up through 30 September 2021. The Joint Program Committee 6/Combat Casualty Care Research Program (JPC-6/CCCRP) elected to use available FY21 funds�to support this application. The notice was issued to NMT by the USAMRAA on 23 September 2021, prior to the 30 September 2021 deadline. 9.� Objective and Purpose: This notice is provided solely as information to the marketplace. This is a notice of the intent to award one (1) sole source contract to one (1) contractor that met the criteria of the FY2020 Joint Warfighter Medical Research Program (JWMRP) in accordance with FAR 6.302-1(a)(2), Only One Responsible Source and No Other Supplies or Services Will Satisfy Agency Requirements. Information regarding the intended sole source awards is listed below. 10.� Project Description: The objective of this work specifically addresses W81XWH-20-RFIJWMRP JPC6/Casualty Care Research Program�reduction of acute secondary organ damage (burn conversion). The original fibronectin (FN)-derived peptide P12 limits burn conversion and speeds burn wound closure after intravenous (IV) infusion; however, P12 was found to be sensitive to neutrophil elastase and thereby minimally active topically. Therefore, an elastase-resistant peptide cNP8 has been engineered that also speeds wound closure, and reduces scarring when given IV. It is posited that topical cNP8, given its homology and similar cationic isoelectric point to P12, can be delivered, like P12, from TyroMats in early debrided, deep-dermal burns AND it will speed wound closure and reduce scarring as effectively as IV cNP8 therapy for deep-dermal burns. If true, this stable, portable, user-friendly, topical cNP8 therapy will be ideal for localized, severe burns during prolonged field care (PFC). Specific aims include: a. Design, manufacture, and test TyroMat-based wound dressings that release cNP8 from eight hours (fast) to four days (slow), b. Determine whether topical cNP8, delivered from TyroMat (fast) and TyroMat (slow), reduces burn injury progression, speeds wound closure, and mitigates scarring in a porcine burn model, and c. Pre-Initial New Drug (IND) meeting for topical cNP8 in TyroMat (fast) and TyroMat (slow) to treat deep-dermal burns. 11.� Contact Information: Questions may be submitted to Mr. Matthew Teel at matthew.d.teel.civ@mail.mil no later than 10:00 AM Eastern on 02 December 2021.�
- Web Link
-
SAM.gov Permalink
(https://beta.sam.gov/opp/fd6ba6ec6d6342148c659f72c4de9323/view)
- Record
- SN06177772-F 20211118/211116230120 (samdaily.us)
- Source
-
SAM.gov Link to This Notice
(may not be valid after Archive Date)
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