Office of Naval Research, 800 North Quincy St., Arlington, VA 22217-5660

A -- PROSTATE CANCER VACCINE INCORPORATING PROSTATE SPECIFIC MEMBRANE ANTIGEN DNA SOL 00-009 DUE 040400 POC Dr. J. Majde-Cottrell, (703) 696-4055, FAX (703) 696-1212; E-mail: majdej@onr.navy.mil Offeror will initiate a clinical trial of a vaccine for the treatment of prostate cancer which utilizes a plasmid, with or without a viral vector, designed to induce a cellular immune response against Prostate Specific Membrane Antigen. There should be no requirement to use autologous material from a patient. Offeror will provide evidence of safety and of the ability of the vaccine to stimulate a cellular immune response. The proposed effort should form the foundation for initiating a FDA-approved Phase I/II or, preferably, a Phase II study. Applicants must have the capability to analyze animal and patient cellular immune responses through assays of cytokines and lymphocyte responses and to conduct concurrent laboratory research in order to modify the vaccine design as indicated by the clinical data. It is not the intent of this solicitation to establish new facilities; investigators should be able to demonstrate the required research capability and the necessary facilities. Preproposals whose main objectives are to conduct analyses, literature reviews, or program evaluations are not encouraged. (1) Instructions for Preparation of Proposals: Offerors are invited to submit five (5) copies of a preproposal formatted as described on the Internet at http://www.onr.navy.mil/sci_tech/personnel/. The preproposal should not exceed three pages of text and should include an estimate of overall costs (including indirect) for a one year effort. A curriculum vitae of the principal investigator(s) should be appended together with any supporting information, such as reprints or preprints, that will assist in the evaluation of the preproposal. Offerors submitting the most promising preproposals will be invited to submit a full technical and cost proposal on all or part of their preproposal submission. However, any such invitation does not assure a subsequent award. Any offeror may submit a full proposal even if its preproposal was not identified as promising or if no preproposal is submitted; however any full proposal submission would be made without the benefit of feedback prior to full proposal submission. The deadline for preproposals will be 1600 EST, 01 March 2000. Formal proposals will be required by 1600 EST, 4 April 2000, with a completed DoD Animal Use Protocol if animals are employed. Proposals that involve the experimental use of human subjects must include a separate evaluation by the organization's committee for protection of human subjects, of proposed technical approaches and associated risks. This evaluation must conform with current Department of the Navy instructions relating to the use of human subjects and include submission of a letter from the institution's Assurance Issuing Authority specifying the HHS or DOD Assurance Number and any conditions or restrictions that apply, and a copy of the Institutional Review Board approval letter. Proposal format instructions are also provided at the above Web site. Offerors must state in their preproposals and full proposals that it is submitted in response to thisBAA. This BAA provides no funding for preproposals or subsequent proposal development purposes. All preproposals will be acknowledged. Preproposals will not be returned after evaluation. (2) Criteria for Selecting Proposals, their Relative Importance, and the Method of Evaluation Preproposal and full proposal submissions will be evaluated on the 1) overall basis of innovation and scientific merit; 2) programmatic relevance of the proposal; 3) the qualifications and experience of the proposed principal investigator and key personnel; 4) the offeror's capabilities, related experience, facilities, techniques or unique combinations of these that are integral factors for achieving the proposal objectives; 5) socio-economic merits of the proposal and 5) realism of the proposed cost and availability of funds. For awards made as contracts, the socio-economic merits of each proposal will be evaluated based on the extent of commitment in providing meaningful subcontracting opportunities for small business, HUB zonesmall business, small disadvantaged business, woman-owned small business concerns, and historically black colleges and universities and minority institutions (HBCU/MI). The standard industrial classification code is 8731 with the small business size standard of not to exceed 500. In addition, contract proposals that exceed $500,000 submitted by all but small businesses must be accompanied by a Small Business Subcontracting Plan in accordance with FAR 52.219-9. HBCU/MI's, as determined by the Secretary of Education to meet requirements of 34 CFR Section 608.2 and 10 U.S.C. Paragraph 2323(a)(1)(C), are particularly encouraged to participate, though no portion of this BAA has been set aside. This CBD notice itself constitutes the BAA as contemplated by FAR 6.102(d)(2). Unless otherwise stated herein, neither additional written information is available, nor will a formal RFP or other solicitation regarding this announcement be issued. Requests for the same will be disregarded. Preproposals and proposals shouldbe submitted by the due dates cited in the BAA to Dr. Jeannine Majde-Cottrell at the Office of Naval Research 341, Room 823, 800 N. Quincy St., Arlington, VA 22217-5660, phone (703) 696-4055; facimile (703) 696-1212; E-mail majdej@onr.navy.mil. The phone number of that point of contact should be used for express mail purposes. Questions regarding contractual matters relating to this BAA should be directed to: Office of Naval Research, Attention Brian Glance (Code 252), Room 720, 800 N. Quincy St., Arlington, VA 22217-5660, (703) 696-2596. Posted 02/01/00 (W-SN420658). (0032)

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