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Towards a New Generation of Glycoengineered Pneumococcal Bioconjugate Vaccines

Award Information
Agency: Department of Health and Human Services
Branch: National Institutes of Health
Contract: 2R44AI131742-02
Agency Tracking Number: R44AI131742
Amount: $2,908,953.00
Phase: Phase II
Program: SBIR
Solicitation Topic Code: NIAID
Solicitation Number: PA18-574
Solicitation Year: 2018
Award Year: 2020
Award Start Date (Proposal Award Date): 2020-02-04
Award End Date (Contract End Date): 2023-01-31
Small Business Information
Saint Louis, MO 63108-2505
United States
DUNS: 080343938
HUBZone Owned: No
Woman Owned: No
Socially and Economically Disadvantaged: No
Principal Investigator
 (843) 331-2505
Business Contact
Phone: (843) 331-9533
Research Institution

Pneumococcal conjugate vaccines (PCVs), composed of a pneumococcal polysaccharide covalently linked to a
carrier protein, are life-saving prophylactics used to prevent pneumococcal disease. Importantly, PCVs provide
immunity for all age groups, including, infants and children under the age of two, which is not the case for purely
polysaccharide vaccines. Like all conjugate vaccines, PCVs are manufactured using chemical conjugation,
which is notoriously complex, labor intensive, and ultimately hinders the development of better versions that
provide immunity to more disease-causing serotypes. As an example, the PCV, Prevnar 13, was licensed in
2010 and only protects against 13 pneumococcal serotypes; whereas, the purely polysaccharide vaccine,
Pneumovax 23, was licensed in 1983 and protects against 23 serotypes. Pneumovax 23 is approved for use in
the elderly; however, it does not provide protection to infants and children. Thus, for more than three decades,
infants and children have not had a vaccine option that protects against 20+ disease causing pneumococcal
serotypes. In order to provide a 20+ valent PCV for use in all age groups, VaxNewMo has been developing a
method for manufacturing pneumococcal and other conjugate vaccines that bypasses the dependency of
chemical conjugation and instead exploits prokaryotic glycosylation systems in process termed bioconjugation.
VaxNewMo’s proprietary bioconjugation platform relies on a conjugating enzyme to transfer a bacterial
polysaccharide, like a pneumococcal capsular polysaccharide, to a carrier protein all within the lab safe
bacterium E. coli. Since bioconjugation is an enzyme driven technology, the conjugates produced are
homogenous and readily purified. Importantly, bioconjugation can be used to rapidly produce a plethora of
conjugates against many serotypes simply by introducing the genetic information encoding for a different
pneumococcal serotype into a bioconjugation competent strain of E. coli. Thus, bioconjugation can be used for
the streamlined development of a PCV covering more than 20 serotypes. In Phase I of this project, we
successfully established proof of principle that VaxNewMo’s bioconjugation platform could generate PCVs
containing conventional vaccine carriers. Moreover, VaxNewMo’s PCVs were both immunogenic and protective
against pneumococcal disease. The proposed research in this Phase II SBIR application will focus on (Aim 1)
establishing bioprocessing capabilities for large volumetric production of VNM8, a serotype 8 pneumococcal
bioconjugate. Establishing bioprocessing procedures for a single serotype bioconjugate is an important first step
towards commercial scale production and will help streamline future upstream processing for other
pneumococcal bioconjugates. Subsequently, (Aim 2) we will confirm that VNM8 produced in a large volumetric
bioprocess is protective using in vitro and in vivo models. In addition, (Aim 3) we will generate a library of E. coli
strains capable of producing a 24 valent PCV. For Phase IIB, will seek to formulate a 24 valent PCV (24vPneumo)
for pharmacokinetic and toxicity studies and prepare for pre-IND meetings with the FDA.

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

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