Justification_and_Approval_Redacted.pdf

Control No:_ Contractor: Sanaria, Inc.

JUSTIFICATION REVIEW DOCUMENT

FAR PART 6 JUSTIFICATION AND APPROVAL FOR OTHER THAN

FULL AND OPEN COMPETITION

Program/Equipment: Navy Advanced Medical Development/Improving Manufacturing Process for PfSPZ Malaria Vaccine.

Authority: 1 O U.S.C. 2304(c)(1) as implemented by FAR Part 6.302-1 -- Only One Responsible Source and No Other Supplies or Services Will Satisfy Agency Requirements.

Amount: $2,400,000.00

Prepared by:

Contracting Officer:

Technical:

Requirements:

Reviews: I have reviewed this justification and find it adequate to support other than full and open competition.

Program Mana Typed Name:

DSN:

Legal Counsel:

Typed Name:

DSN:

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Control No:

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FAR Part 6 Justification and Approval for Other than Full and Open Competition

1. Contracting Activity: U.S. Army Contracting Command, Aberdeen Proving Ground, Natick Contracting Division (ACC-APG-NCD)

2. Description of Action: Naval Medical Research Center - Navy Advanced Medical Development (NMRC-AMD) requests a cost plus fixed fee contract with Sanaria Inc.

located at 9800 Medical Center Drive, Rockville, MD, 20850. The Government projects award for June 2017 and fiscal year 2017, funds type Research, Development, Test and Evaluation (RDT&E) funds will be used.

The required acquisition plan in accordance with DFARS 207.103(d)(i)(A) is currently awaiting Branch Chief approval.

This action is a follow-on to contract W911QY-15-C-0076. W911QY-15-C-0076 was not competed under authority 10 U.S.C. 2304(c)(1) as implemented by FAR Part 6.302-1 -- Only One Responsible Source and No Other Supplies or Services Will Satisfy Agency Requirements. Paragraph, “Actions to Increase Competition” of the previous justification, stated: Current contract requirements support NMRC AMD's efforts to finalize establishment of capability requirement specifications by FY18-FY19. It is expected that a capability review will take place at the onset of FY19 in an effort to then generate a request for commercial procurement, via a Request for Proposals, to field procurement-ready technology satisfying the performance specification and capability gap by FY19. Those actions are still current and applicable.

3. Description of Supplies/Services:

Approval is requested to execute a cost plus fixed fee contract with Sanaria, Inc. to perform research and development, enhance and expand manufacturing, advance Quality Systems, upgrade Facilities, equipment, and utilities to Support Conducting of Successful Phase 3 Clinical Trials, Launch, and Implementation of Sanaria® PfSPZ Vaccine for the U.S. Military.

The proposed action involves an increase of the research and development work currently being performed under separate contracting effort that involves additional manufacturing and Quality compliant activities to produce PfSPZ Vaccine suitable for Phase 3 clinical trials. This includes manufacturing with upgraded regulatory compliance at capacity and scale, and required Quality activities on validation. Goals to be accomplished by Sanaria that will support the overall goal and objective of successfully submitting a Biological License Application (BLA) and launch include: Aseptic Mosquito Production for Phase 3 trials and launch; Gametocyte Production in bioreactors for Phase 3 and launch; Feeding; Semi-automated collection device for Harvest of PfSPZ;

Scaled up filters for Purification; Integrated system for scaled up Filling process and eventually automated Fill/Finish; Integration of the optimized and translated process steps methods into a finalized manufacturing flow in the upgraded CMF; Upgrade of Clinical Manufacturing Facility (CMF); pilot/engineering runs; process validation

Version – April 2016 FOR OFFICIAL USE ONLY activities; facility and utilities upgrade including qualification and validation of plant utilities; equipment validation activities; and Quality Control (QC) assay validation activities.

The development of Sanaria’s leading malaria vaccine product, Sanaria® PfSPZ Vaccine, is moving forward rapidly and Sanaria is on schedule for submission of a Biologics License Application (BLA) to the FDA for this product in late 2018/early 2019.

The BLA will request licensure to prevent malaria-naïve adults from acquiring Plasmodium falciparum (Pf) infection and potentially all human malarias during travel or deployment to malaria-endemic areas, anticipating that the vaccine will provide at least 80% sterile protection against infection for at least 6 months. On April 26, 2016, the first injection of vaccine in the Warfighter 2 clinical trial was administered. This trial is the key Phase 2 clinical trial, and is intended to identify the PfSPZ Vaccine regimen to be taken forward into Phase 3 clinical trials. While this clinical program is exciting, the associated requirements for cGMP manufacturing, quality assurance, quality control, product release, regulatory submissions and clinical quality control, data management and analysis are placing enormous demands on Sanaria’s Clinical Manufacturing Facility (CMF) and Sanaria’s manufacturing, quality, regulatory, and clinical staff. Many of Sanaria’s clinical trials are funded by external sources, and in the majority of cases, Sanaria’s sponsorship of those trials, including provision of product and study oversight, are not funded, and have been sustained by NIH SBIR grants and modest sales of reagent products such as purified sporozoites, infected red blood cells, or infected mosquitoes.

The current $5.7M contract, W911QY-15-C-0076 has helped Sanaria to begin to fill this critical gap by funding gap analyses, additional research and development, facility modifications/upgrades, and changes in all teams so as to be able to transition to Phase 3 manufacturing, which will be initiated in the second quarter of 2017. Progress already funded and additional gap analyses, however, have identified many additional unfunded requirements, which will have to be funded during the next 1.5 years in order to achieve a successful BLA and product launch. The funds for this next stage will begin to fill these critically important gaps/unfunded requirements, and thereby significantly increase the chance of achieving a successful BLA, marketing authorization, and product launch. An amendment to the Investigational New Drug (IND) for PfSPZ Vaccine will be filed with the FDA in early 2017 outlining rationale and plans for Phase 3 clinical trials. A similar amendment will be filed regarding manufacturing shortly thereafter. The program outlined herein is intended to complete the readiness for Phase 3 manufacturing, quality control release of vaccine, and submission of BLA to the FDA that will be required. This funding support will be critical to maintaining the tight timelines to licensure, and commercial launch. An explanation of the specific funding requirements for Manufacturing, Quality Systems, Regulatory and Clinical follows below.

Manufacturing:

Sanaria’s manufacture of PfSPZ follows the life cycle of the parasite. Production of PfSPZ is in aseptic mosquitoes. The PfSPZ are harvested and purified before vialing and stabilization in liquid nitrogen vapor phase (LNVP). The PfSPZ manufacturing process is

Version – April 2016 FOR OFFICIAL USE ONLY robust, repeatable, and highly productive as evidenced by the successful supply of material in all Sanaria’s prior and current clinical trials.

To meet the demands of Phase 3 manufacture and launch, Sanaria’s manufacturing will need to initiate activities on process validation that ensures production of PfSPZ Vaccine with a high degree of assurance of meeting all the attributes PfSPZ Vaccine is intended to possess (21 CFR 211.100(a) and 211.110(a)).

Sanaria’s approach to malaria vaccine development is quality driven to provide a safe and efficacious product to military personnel, travellers, or residents of malaria endemic areas. The Sanaria quality program for Phase 3 and marketing will meet the regulatory requirements of 21 CFR Parts 210 & 211 cGMP for Manufacturing, Processing, Packing, or Holding Drugs and Finished Pharmaceuticals.

This new work will support the overall goal of a successful BLA submission and launch and will facilitate the accomplishment (albeit some in-part) for Manufacturing, Quality Systems and Facilities and equipment and will address the following tasks: (1) Upgrade of Clinical Manufacturing Facility (CMF); (2) Increase Aseptic Mosquito Production for Phase 3 and launch; (3) Expand Gametocyte production in bioreactors for Phase 3 and launch; (4) Increase and Improve Feeding; (5) Develop Semi-automated collection device for Harvest of PfSPZ; (6) Scaled-up filters for Purification; (7) Integrated system for scaled up Filling process and automated Fill/Finis; (8) Integration of the optimized and translated process steps methods into a finalized manufacturing flow in the clinical manufacturing facility (CMF; (9) Process Validation; (10) Associated Facility Expansion and Utilities Upgrade; and (11) Validation of plant activities.

Each of the 11 tasks expand upon the DoD’s prior investments under contract W911QY- 15-C-0076 and are necessary to maintain the schedule to test and ultimately deliver a protective malaria vaccine to Service Members.

Estimated value for this contracting action is $2,400,000.00 for a twelve (12) month period of performance.

Period of Performance: June 2017 to June 2018 Total Value: $ 2,400,000.00

4. Authority Cited:

10 U.S.C. 2304(c)(1), as implemented by FAR 6.302-1, Only one responsible source and no other supplies or services will satisfy agency requirements.

5. Reason for Authority Cited:

As described at FAR 6.302-1(a)(2), when the supplies or services required by the agency are available only from one responsible source, or for DoD, NASA and the Coast Guard, from only one or a limited number of responsible sources, and no other types of supplies or services will satisfy agency requirements, full and open competition need not be provided for. Market research still determines that Sanaria Inc. of Rockville, MD is the only company that has produced the PfSPZ vaccine via irradiated sporozoites and there

Version – April 2016 FOR OFFICIAL USE ONLY are no other such companies that have shown any part of this capability. Other malaria vaccines are in development but none utilize irradiated PfSPZ sporozoites as required by the Government. There are quite a few candidate malaria vaccines that employ different approaches (e.g., protein [RTSS, full length CSP, SAPN-CSP]; gene [DNA/Ad (ChAd63) and DNA/Ad (GC36 vector); as well as the subject PfSPZ (i.e., the Plasmodium falciparum Sporozoite vaccine) – which is the only one has the ability to produce malaria sporoziotes for use in a vaccine. The requirement underlying the effort is for production capable of making sporozoites at a sufficient quality level (e.g., cGMP) compliant with U.S. Food and Drug Administration (FDA) regulations for Chemistry, Manufacturing and Controls (CMC).

Sanaria Inc.’s PfSPZ Vaccine has been shown to protect a significant percentage of recipients (in some instances up to 100%) in a clinical trial. The Sanaria malaria vaccine development for PfSPZ is currently in late phase 2 clinical trials designed to finalize an immunization regimen to be assessed in pivotal phase 3 clinical trials to support a BLA to the FDA. Because of this progress in clinical trials, Sanaria has recently received Fast Track status for its PfSPZ Vaccine from the FDA. The PfSPZ Vaccine is composed of aseptic, purified, cryopreserved Plasmodium falciparum (Pf) sporozoites (SPZ) and requires a highly specialized (and proprietary) production process. This new contract is intended to facilitate the finalization of the transition of manufacturing of an aseptic, purified, cryopreserved PfSPZ vaccine from late Phase 2 compliance to Phase 3 compliance. Sanaria, Inc. is the only organization in the world that can manufacture the aseptic, purified, cryopreserved PfSPZ required for a PfSPZ vaccine. Furthermore, it is the only organization in the world that has a manufacturing facility that is designed and suited for manufacturing the aseptic, purified, cryopreserved PfSPZ required for a PfSPZ Vaccine. Thus, Sanaria, Inc. is the only organization in the world capable of performing the manufacturing expansion of PfSPZ to phase 3 compliant manufacturing of a PfSPZ vaccine.

The potential benefits to the Government if this effort is successful are substantial.

Specifically, the effort will result in enabling production of the PfSPZ vaccine that will prevent malaria infection of U.S. Service Members as well as civilians world-wide. This technology will enhance efficiency and synergy within the US Government's vision of assisting in the reduction of pandemic infectious disease and biological threats, global surveillance efforts and bio-defense. No other organization besides Sanaria Inc. has the extensive breadth and depth of technical expertise with the irradiated PfSPZ sporozoites required to perform the work.

6. Efforts to Obtain Competition:

Market research was conducted to identify sources of malaria vaccine developers. A number of malaria vaccines are under development, including those based on the Plasmodium falciparum reticulocyte-binding protein homologue 5 (PfRH5) antigen as well as recombinant vaccines consisting of the Plasmodium falciparum circumsporozoite protein from the pre-erythrocytic stage. However, market research could only identify one source utilizing irradiated PfSPZ sporozoites to meet the Government requirement, Sanaria, Inc. In accordance with FAR 5.201, a notice of intent to award this sole source

Version – April 2016 FOR OFFICIAL USE ONLY contract to Sanaria Inc. was issued on 13 March 2017 on FedBizOpps with a response date of 28 March 2017. No responses were received from other sources in reference to the synopsis posting.

7. Actions to Increase Competition:

Current contract requirements support NMRC AMD's efforts to finalize establishment of capability requirement specifications by FY18-FY19. It is expected that a capability review will take place at the onset of FY19 in an effort to then generate a request for commercial procurement, via a Request for Proposals, to field procurement-ready technology satisfying the performance specification and capability gap by FY19.

8. Market Research:

Market research was conducted by AMD has a requirement for the development of an enhanced manufacturing process for an irradiated sporozoites-based malaria vaccine to support large scale manufacturing for use in Phase 3 clinical trials that meets the following requirements:

- Ability to produce large scale automated manufacturing process that is in compliance with current Good Manufacturing Practices (cGMPs) that will produce large amounts of irradiated PfSPZ malaria vaccine to be utilized in future Phase 3 clinical trials.

- Must already have in place an established manufacturing process for PfSPZ vaccine, using irradiated sporozoites, under cGMPs that proved to be successful during Phase 1 and Phase 2 clinical trials.

- Must have the capability to develop a semi-automated process for the dissection and collection of infected mosquito salivary glands containing PfSPZ.

- PfSPZ vaccine must be able to be administered intravenously (IV).

- PfSPZ malaria vaccine must utilize irradiated aseptic, purified, cryopreserved, attenuated (non-replicating), metabolically active Plasmodium falciparum (Pf) sporozoites (SPZ) extracted from infected mosquitoes that are grown and incubated.

Based on updated market research conducted on 1 March 2017 via internet searches using keywords, PfSPZ vaccine, Sanaria, Inc. is the only vendor that comes up in the search results:

1. https://en.wikipedia.org/wiki/PfSPZ_vaccine

2. http://www.sanaria.com/

3. http://science.sciencemag.org/content/341/6152/1359

4. https://www.ncbi.nlm.nih.gov/pubmed/?term=26469720

5. http://www.makingmalariahistory.org/initial-trials-of-sanaria-vaccine-provide-complete-protection-against-malaria/

6. http://outbreaknewstoday.com/malaria-vaccine-pfspz-vaccine-offers-protection-in-us-adults-in-phase-i-trials-73339/

7. http://www.nature.com/nm/journal/v22/n6/full/nm.4110.html

8. http://www.pnas.org/content/early/2017/02/14/1615324114.abstract

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An updated SBA “Dynamic Small Business Search” was conducted on 1 March 2017 under NAICS code 325413, using the relevant key words “PfSPZ vaccine”, yielding no results. An updated SAM search was also conducted on 1 March 2017 using relevant key words “PfSPZ vaccine”, yielding no results. Results indicate that Sanaria, Inc. is the sole company that has the capability to produce the PfSPZ vaccine using irradiated Pf sporozoites. There is no such other company out there in the world that demonstrates this unique and innovative concept and capability to provide this particular research and development to the government. According to Sanaria’s SAM registration, it is a veteran-owned small business concern. The Sanaria PfSPZ malaria vaccine won the 2014 Vaccine Industry Excellence Award for “Best Prophylactic Vaccine”.

identified Sanaria Inc. as the only company in the world that currently produces irradiated PfSPZ vaccines that is in compliance with cGMPs. He indicated that there are other companies out there working on developing malaria vaccines but none that uses irradiated PfSPZ sporozoites. He also noted that Sanaria, Inc. has previously collaborated with the Naval Medical Research Center (NMRC) and the Center for Disease Control (Malaria Epidemiology Branch) under Cooperative Research and Development Agreements.

Based on the above findings, it has been ascertained that of the products identified in the current market survey, only one (Sanaria, Inc.) meets all of the basic requirements. It has been ascertained then that there is a reasonable expectation of obtaining from Sanaria, Inc. the best scientific and technological source consistent with the demands of the proposed acquisition for the best mix of cost, performance, and schedule.

In accordance with Defense Federal Acquisition Regulation Supplement (DFARS) 205.205-71, DFARS 206.302-1(d), and DFARS Procedures, Guidance and Information (PGI) 206.302-1(d), a request for information was posted to Federal Business Opportunities) on 13 March 2017 for 15 days and the results were as follows: No responses were received from other sources in reference to the synopsis posting.

9. Interested Sources:

To date, no other sources have written to express interest in this acquisition.

10. Other Facts:

a. Procurement History:

(1) Contract numbers and dates of the last several contracts for these same/similar requirements.

a. Current contract is W911QY-15-C-0076

(2) Current Contract was awarded Sole Source to Sanaria, Inc.

(3) Authority previously cited if less than full and open competition was used.

Control No:_

1 O U.S.C. 2304(c)(1 ), as implemented by FAR 6.302-1 , Only one responsible source and no other supplies or services will satisfy agency requirements.

(4) If a justification was prepared to support the procurement made before this one, a summary of the contents of paragraph 7 of the justification for that procurement and an explanation of the results .

Para 7 from Original Justification-Upon conclusion of th is effort, should the Government determine that procurement of an irrad iated sporozoites-based malaria vaccine is necessary to support Phase 3 cl inical trials, a market survey will be conducted at that time to identify capable vendors that can supply such a vaccine meeting those specifications.

(5) If a justification was prepared to support the procurement made before th is one, briefly describe the circumstances justifying the procurement and whether there have been any significant changes.

Please see Sections 3 and 5 of th is Justification.

11. Technical Certification: I certify that the supporting data under my cognizance which are included in the justification are accurate and complete to the best of my knowledge and belief.

12. Requirements Certification: I certify that the supporting data under my cognizance which are included in the justification are accurate and complete to the best of my knowledge and belief.

13. Fair and Reasonable Cost Determination: I hereby determine that the anticipated cost or price to the Government for this contract action will be fair and reasonable.

This determination will be made using the following:

1 . Cost Analysis

2. Comparison to IGCE

As a part of th is basis, certified cost or pricing data will be required.

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14. Contracting Officer Certification: I certify that this justification is accurate and complete to the best of my knowledge and belief.

Typed Name: Date:

Title: Contracting Officer Signature:

Approval

Based on the foregoing justification, I hereby approve the subject procurement for Research and Development - Improving Manufacturing Process for PfSPZ Malaria Vaccine on an other than full and open competition basis pursuant to the authority of 10 U.S.C.2304(c)(1), as implemented by FAR 6.302-1, Only one responsible source and no other supplies or services will satisfy agency requirements, subject to availability of funds, and provided that the services or property herein described have otherwise been authorized for acquisition.

If the proposed contract action is not completed within 180 days from the below date or if there is a change to the substance of this J&A that does not meet the conditions of AFARS 5106.303-1-90, the Contracting Officer shall document these changes in a memorandum for file and obtain concurrence from the approval authority below.

Date:

Special Advocate for Competition Signature: