# Low cost, Broad Spectrum Cancer Vaccine Targeting Human Papillomavirus

> **NIH NIH R41** · VAXSYNA, INC. · 2022 · $315,874

## Abstract

Project Summary. Human papillomavirus (HPV) is a major public health concern due to 1) its implication in
cancers of the anus, cervix, oropharynx, penis, vulva, and vagina; 2) global economic burden, and 3) vastly
disproportionate impact on low-to-middle-income countries (LMIC). HPV-related cancers are responsible for
4.5% of all new cancer cases worldwide, and 90% of HPV-related cervical cancer deaths occur in LMIC. The
global economic burden of HPV is especially serious in LMIC where cervical screening and vaccination is not
easily obtainable. Only 1% of LMIC have vaccination programs and current vaccines are limited in their breadth
of protection. The most broadly protective vaccine on the market, Merck’s Gardasil-9, only protects against nine
HPV strains and does not protect against strains that are prevalent in LMIC, such as HPV-35. Current vaccines
are also costly and challenging to distribute to LMIC due to their thermal stability and 3-dose regimen. The
limitations of current vaccines and burden of HPV on LMIC underscores the need for new cheaper HPV vaccines
that can be effectively deployed in LMIC. VaxSyna, Inc addresses this need with an HPV vaccine candidate that
is low-cost, broadly protective, and efficacious with a targeted two-dose schedule. Our vaccine candidate
displays the highly conserved HPV L2 antigen on our patented platform that uses virus like particles (VLP) and
recombinant immune complexes (RIC). The HPV L2 antigen has been shown to protect against up to 22 types
of HPV in mice and rabbits and has been evaluated in human phase I trials. Our vaccine is produced using an
optimized plant expression system that lowers the manufacturing cost (estimated at less than $0.5/dose vs.
$160/dose for Gardasil-9), thereby producing high levels of proteins in 4-5 days without human or animal
pathogen contamination. Preclinical, mouse vaccination studies with our candidate have confirmed its efficacy
in generating high antibody titers and viral neutralization in as little as two doses. Further tests of our vaccine
platform have shown that protective immunity is possible without the need of a chemical adjuvant. The goal of
this STTR phase I project is to conduct proof-of-concept studies to characterize the formulation of VaxSyna’s
HPV cancer vaccine as a broad-spectrum HPV vaccine that targets all clinically relevant HPVs. Temperature
stability is an important characteristic for vaccines that are targeted for LMIC. As such, our Aim 1 will assess the
thermal stability of both our VLP and RIC vaccine components. If one platform is more stable than the other, we
will adjust our vaccine formulation accordingly in Aim 2. Aim 2 will compare the antibody and neutralizing antibody
titers produced after mouse vaccination with varying ratios of VLP to RIC as compared to Gardasil-9. The
successful completion of this Phase I project is critical to initiate our proposed Phase II studies involving pre-IND
GMP manufacturing strategies and testing with...

## Key facts

- **NIH application ID:** 10477108
- **Project number:** 1R41CA271851-01
- **Recipient organization:** VAXSYNA, INC.
- **Principal Investigator:** Mary Pardhe
- **Activity code:** R41 (R01, R21, SBIR, etc.)
- **Funding institute:** NIH
- **Fiscal year:** 2022
- **Award amount:** $315,874
- **Award type:** 1
- **Project period:** 2022-04-01 → 2025-03-31

## Primary source

NIH RePORTER: https://reporter.nih.gov/project-details/10477108

## Citation

> US National Institutes of Health, RePORTER application 10477108, Low cost, Broad Spectrum Cancer Vaccine Targeting Human Papillomavirus (1R41CA271851-01). Retrieved via AI Analytics 2026-05-26 from https://api.ai-analytics.org/grant/nih/10477108. Licensed CC0.

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