Inovio Pharmaceuticals Inc (INO)

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Definition of Research Vaccine Candidates

Research Vaccine Candidates means a vaccine, and any of its components, which is required in all cases to contain an antigen (or is otherwise co-administered with an antigen) except as provided in the last sentence of this definition, which is discovered, conceived, created or reduced to practice, or Researched, solely by or on behalf a Party or jointly by or on behalf the Parties prior to or in the course of conducting the activities under the Research Plan that incorporates or uses Selecta Licensed Technology and is intended to be used in, or can be used in the Field. A Research Vaccine Candidate for an Optional Indication of [***] that contains at least one adjuvant that enhances an antigen-specific manner an immune response to an exogenous allergen for prophylactic or therapeutic benefit need not contain an antigen, save that any such Research Vaccine Candidate and any related Development Candidate or Licensed Product, that in each case is without an antigen (collectively, “Antigen-Free Licensed Product”), is licensed hereunder, and may be used in, only the designated Optional Indication and shall not be eligible for any Extension Indications.

Making a Candidate Vaccine Virus (CVV)

https://www.cdc.gov/flu/avianflu/candidate-vaccine-virus.htm

SELECTING CANDIDATES FOR ACCELERATED DEVELOPMENT

The committee believed that its major contribution to establishing priorities would be the clear explication of a logical method for this task and that it probably could never satisfy all potential critics with its choice of candidates for assessment. As noted in Chapter 3, if a candidate is omitted from the full assessment, no conclusions should be made regarding its position in the priority rankings relative to the assessed contenders. When the prospects for vaccine control of disease were reasonable, however, the committee tried to include in the full analysis those candidates generally recognized in the developing world and the United States as major disease problems.

The process involved a number of iterations of selection, review, and revision. At an international workshop in Washington, D.C., on August 1–3, 1984, a draft list of infectious diseases prevalent in the developing world was reviewed and revised. This list was the starting point for candidate selection and is shown in Table A.1.
TABLE A.1. Important Diseases in Developing Countries.
TABLE A.1

Important Diseases in Developing Countries.

About 40 diseases were chosen from Table A.1 by the workshop participants as major health problems in the developing world. These diseases are listed in Table A.2. Some diseases were included in this list as models because vaccine prospects had been carefully reviewed in the committee's prior assessment.
TABLE A.2. Potential Candidate Diseases for New or Improved Vaccine Development.
TABLE A.2

Potential Candidate Diseases for New or Improved Vaccine Development.

A working group at the workshop then assessed the state of knowledge on these diseases in three areas: disease mechanisms, protective mechanisms, and protective antigens. A simple scoring system was used (+/++/+++), and on the basis of scores, pathogen/disease entities were assigned to one of three categories: good prospects for the technical feasibility of vaccine development, promising prospects, or insufficient knowledge to evaluate prospects. Based on these judgments, candidates were either included in the full assessment, excluded from it, or subjected to further review by a committee subgroup which consulted with experts on relevant vaccine development efforts.

Appendixes D-1 through D-19 describe the prospects for immunizing against the candidate pathogens, and the supplement to this volume describes prospects and knowledge gaps for a range of diseases prevalent in the developing world and for which accelerated development efforts are not feasible or appropriate at this time.

For a number of the pathogens considered in the supplement, vaccine development prospects are such that their exclusion from consideration was a difficult decision. Because of rapid technologic advances in the vaccine development field, the state of knowledge and vaccine development prospects for these potential candidates should be regularly reviewed.

Table A.3 lists the pathogens for which the vaccine development prospects were reviewed in the committee's first report. For various reasons, these pathogens were not included as primary contenders in the assessment of vaccine priorities for important diseases in the United States, although some are now included in this analysis.
TABLE A.3. Pathogens Not Included as Candidates but Discussed in the Committee's First Report (Appendix B).
TABLE A.3

Pathogens Not Included as Candidates but Discussed in the Committee's First Report (Appendix B).