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GMP production and GLP safety of bidirectionally targeted SARS-CoV-2 booster vaccine

Award Information
Agency: Department of Health and Human Services
Branch: National Institutes of Health
Contract: 1R44AI179586-01
Agency Tracking Number: R44AI179586
Amount: $1,000,000.00
Phase: Phase II
Program: SBIR
Solicitation Topic Code: NIAID
Solicitation Number: PA22-176
Timeline
Solicitation Year: 2022
Award Year: 2023
Award Start Date (Proposal Award Date): 2023-07-11
Award End Date (Contract End Date): 2025-06-30
Small Business Information
420 YALE AVE
Kensington, CA 94708-1109
United States
DUNS: 116968569
HUBZone Owned: No
Woman Owned: No
Socially and Economically Disadvantaged: No
Principal Investigator
 ELLEN SPARGER
 (530) 754-8461
 eesparger@ucdavis.edu
Business Contact
 COREY MILLER
Phone: (734) 646-6657
Email: corey@tendeltherapies.com
Research Institution
N/A
Abstract

Tendel’s CoTend-s3B SARS-CoV-2 booster vaccine targets T follicular helper (Tfh) cells to generate
extraordinarily broad and long-lived antibody responses, which are required for resilient vaccines that
maintain protection over long periods. The vaccine candidate incorporates the “s3” targeting moiety, which
induces a potent T follicular helper (Tfh) cell response. This novel, first-in-class adjuvant is fused to the receptor
binding domain (RBD) from the Omicron variant of SARS-CoV-2 (BA.4/BA.5). The combined molecule
simultaneously targets RBD-specific B cells and T cells, and especially local Tfh cells, thus accelerating and
expanding B-cell development. Preclinical non-human primate (NHP) studies have demonstrated extraordinarily
high neutralizing antibody titers that were stable for rt10 months when delivered via a low dose of adenovirus
type 35 (Ad35) delivery vector. In contrast, neutralizing antibody responses to control vaccine lacking the s3
moiety (i.e., CoTend-B containing immunogen alone), were diminished to below the level of protection within 6
months, similar to results seen in humans with FDA-approved mRNA vaccines.
In cooperation with academic partners Steve Deeks (UCSF) and Kara Chew (UCLA), Tendel completed
favorable pre-IND interactions for this s3-adjuvanted vaccine and designed a first-in-human trial. In this R44
application we propose several tasks that will provide the needed investigational products and toxicology data,
as well as additional supportive mechanistic data, to support comparative phase-1 testing of CoTend-B and
CoTend-s3B as booster vaccines beginning in early 2024. We will complete GMP-grade production of both
vaccines in amounts sufficient for both GLP safety studies and the planned phase-1 trial. We will test the
technical feasibility of adventitious-agent testing by next-generation sequencing (NGS). Finally, we will use the
vialed vaccine to complete GLP safety studies in macaques while simultaneously gathering high-dimensional
repertoire data to demonstrate superior B-cell recruitment by the s3 adjuvant platform.
The deliverables of this work are fully characterized, GMP-grade vaccine stocks (CoTend-B and CoTend-s3B)
and corresponding safety data that will permit a successful IND application and commencement of clinical trials.
Aim 1. Produce vialed CoTend-B and CoTend-s3B vaccine products according to GMP.
Aim 2. Complete release testing, including adventitious-agent testing by an NGS approach.
Aim 3. Perform GLP toxicology and immunogenicity testing of the vialed product.
The work proposed in this R44 application will enable necessary steps towards the first test in humans of a new
approach to promoting development of antigen-specific B cells. If successful, de-risking of the s3 platform will
provide a transformative new tool that can enable and drive human B-cell development along paths that are
infrequently reached by current vaccines.

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

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