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Polyionic Papillomavirus like Particles VLP for the Treatment of HPV oropharyngeal squamous cell carcinomas OPCs

Award Information
Agency: Department of Health and Human Services
Branch: National Institutes of Health
Contract: 1R41CA224469-01
Agency Tracking Number: R41CA224469
Amount: $300,000.00
Phase: Phase I
Program: STTR
Solicitation Topic Code: 102
Solicitation Number: PA16-303
Solicitation Year: 2016
Award Year: 2017
Award Start Date (Proposal Award Date): 2017-09-21
Award End Date (Contract End Date): 2018-08-31
Small Business Information
Baltimore, MD 21205-1508
United States
DUNS: 076398409
HUBZone Owned: No
Woman Owned: No
Socially and Economically Disadvantaged: No
Principal Investigator
 (443) 449-8836
Business Contact
Phone: (443) 449-8836
Research Institution
BALTIMORE, MD 21205-1832
United States

 Nonprofit College or University

The broader impact commercial potential of PathoVax s STTR phase I proposal is to improve outcomes of
cancer immuno therapy utilizing a vaccine formulation combining an immunogenic chimeric virus like particle
cVLP vaccine with FDA approved immune check point inhibitors PathoVax proposes to develop this
technology for treatment of human papillomavirus HPV associated cancers However cancer vaccines have
in general shown poor efficacy in clinical trials We contend that their failure reflects inherent deficiencies in
cancer vaccine technologies Plasmid DNA vaccines are weakly immunogenic in humans Live viral vectors
possess inherent concerns including cross reactive immunity and safety risks for immune compromised
individuals Peptides alone are poorly immunogenic and available adjuvants to enhance cellular immune
responses have limited efficacy To overcome the challenges faced by immunization and improve the
treatment efficacy of immunotherapy PathoVax has developed a novel technology for inducing T cell
responses PathoVax s patented VLP with checkpoint inhibitors formulation leverages the current paradigm
whereby cancer vaccines are likely to be most effective when combined with checkpoint inhibition There is
safety precedent for use of papillomavirus VLPs Gardasil and Cervarix Our VLP technology can prime the
intratumoral recruitment of immune cells to sensitize once non inflamed non permissive tumors to both
cytotoxic killing and checkpoint inhibitors In preliminary studies we have shown that our cVLPs displaying the
HPV E aa Kb restricted epitope induced robust CD T cell responses and demonstrated therapeutic
efficacy in the TC C BL mouse tumor model Translation into the clinic will require antigens spanning the
full length of HPV E and E proteins Technical objectives of this Phase I proposal are focused on
reformulating our vaccine to encompass these E E antigens and characterize our cVLP to ensure a product
with consistent features and biological activity upon translation into the clinic Aim We will then utilize this
final formulation to assess the efficacy of our characterized formulation in a clinically relevant mouse model of
HPV OPC aim Successful implementation of this proposal will be the foundation for additional
characterization and GLP efficacy studies in a Phase II STTR to create a robust pre clinical data package for
pre IND FDA discussions Positive results in the area of HPV OPSCC valued at US$ M globally will also
encourage extension of the technology as a platform to other cancers and infectious agents Importantly it
provides a pathway to attract institutional investors or pharmaceutical partners for support beyond the
STTR SBIR process This proposal aims to develop PathoVax s polyionic papillomavirus chimeric virus like particle
cVLP combined with immune checkpoint inhibitors for Human Papillomavirus HPV
associated oropharyngeal OPC cancers Our academic partner s proof of concept studies
have shown positive vaccine therapeutic effects against viral associated tumors and we have
received feedback from a potentially interested pharmaceutical collaborator on what further
studies we would need to perform to initiate potentially a collaboration beyond this STTR This
includes characterization studies of our cVLP vaccine utilizing multiple peptides and testing this
in combination with checkpoint inhibitors in a relevant clinical model emulating HPV OPCs

* Information listed above is at the time of submission. *

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