OUR FORMULATIONS PORTFOLIO

AAHI’s robust adjuvant formulation portfolio allows collaborators to select an adjuvant formulation that maximizes the impact of a specific vaccine candidate.
TLR Ligands + Alum
What is it?
The adsorption of TLR ligands to Alum, which shifts immune response to Th1 quality.
Where does it come from?
AAHI developed a formulation approach to adsorb lipid-based TLR ligands to Alum.
Unique to AAHI
AAHI’s formulations of both TLR 4 ligands and TLR 7/8 ligands adsorbed to Alum are tested in humans.
Resources
3M-052-Alum Adjuvant Portfolio
Vaccine Adjuvant Compendium, NIH
(Fox, 2016. J Control Release.)
NanoAlum
What is it?
NanoAlum consists of nanoparticle rods of aluminum oxyhydroxide
Where does it come from?
AAHI developed NanoAlum using a top-down manufacturing approach starting with commercial Alum (Alhydrogel®)
Unique to AAHI
NanoAlum enhances Th1-type adjuvant activity compared to Alum, can be sterile-filtered and is stable to freeze-thaw
Resources
Vaccine Adjuvant Compendium, NIH
(Orr, 2019. NPJ Vaccines)
Aqueous Nanosuspension
What is it?
Aqueous nanosuspensions of TLR ligands (e.g. GLA-AF) suitable for intradermal delivery.
Unique to AAHI
The manufacturing process of aqueous nanosuspensions is straightforward and the cost of goods is low.
Resources
Vaccine Adjuvant Compendium, NIH
Vaccine Adjuvant Compendium, NIH
Vaccine Adjuvant Compendium, NIH
Breadth of SARS-CoV-2 neutralization and protection induced by a nanoparticle vaccine
(Haynes, 2022. Nature Communications)
A Phase 1 trial of GLA-AF + VLP influenza antigen showed broadened responses to heterologous strains
(Carter, 2018. Science Advances)
TLR4 Ligands
What is it?
GLA and SLA are synthetic hexa-acylated monophosphoryl lipid A molecules with established safety and activity profile from Phase 1/2 clinical testing.
Where does it come from?
GLA and SLA were designed as synthetic analogues to the hexa-acylated component of the naturally derived MPL®
Unique to AAHI
GLA and SLA are highly pure defined compounds designed for optimal TLR4 receptor binding, enabling substantially lower clinical dose compared to MPL®. In a squalene emulsion, they can also be lyophilized for single vial thermostable presentation or can be spray dried for thermostable nasal dry powder delivery.
Resources
Vaccine Adjuvant Compendium, NIH
Vaccine Adjuvant Compendium, NIH
GLA-SE enhances malaria antigen-specific antibodies and circulating Tfh in humans
(Hill, 2019. J Exp Med.)
(Carter, 2016. Clin Transl Immunology)
TLR7/8 Ligands
What is it?
3M-052 (TLR7/8) is synthetic lipidated imidazoquinoline.
Where does it come from?
Developed by 3M and licensed to AAHI for specific indications.
Unique to AAHI
3M-052 formulations developed by AAHI elicit exceptional response durability with strong Th1 bias in NHPs.
Resources
Vaccine Adjuvant Compendium, NIH
3M-052-Alum Adjuvant Portfolio
Vaccine Adjuvant Compendium, NIH
Vaccine Adjuvant Compendium, NIH
3M-052-SE increases SARS-CoV-2 antibody magnitude and durability in infant non-human primates
(Permar, 2021. Sci Immunol.)
(Carter, Fox, 2017. Sci Rep.)
Saponin QS-21
What is it?
QS-21 is a saponin derived from Quillaja Saponaria associated with inflammasome activation.
Where does it come from?
cGMP QS-21 is obtained by AAHI from bark extract at high yield and high purity using a novel purification process.
Unique to AAHI
AAHI’s QS-21 has been formulated in liposomes with GLA and tested in Phase 1 clinical trials.
Resources
Vaccine Adjuvant Compendium, NIH
Vaccine Adjuvant Compendium, NIH
(Nielsen, 2019. Clin Infect Dis.)
(Qi, 2021. J Chromatogr A.)
Dual Agonist
What is it?
GLA-3M-052-LS is a dual TLR ligand liposome adjuvant.
Where does it come from?
GLA-3M-052-LS was developed by AAHI in collaboration with 3M and the University of Virginia using an amebiasis vaccine candidate as a proof-of-concept.
Unique to AAHI
This dual agonist develops a strong mucosal immune response as well as a Th1 type systemic response.
Resources
GLA-3M-052-LS Adjuvant Portfolio
Vaccine Adjuvant Compendium, NIH
(Petri, 2021. Nature)
(Fox, 2018. NPJ Vaccines)
FORMULATIONS PIPELINE
AAHI’S ADJUVANT TECHNOLOGY HAS BEEN CLINICALLY TESTED IN NEARLY 10,000 HUMAN VOLUNTEERS AND HAS AN OUTSTANDING SAFETY PROFILE.
ADJUVANT | Preclinical | GMP/Tox | Phase 1 | Phase 2 | Phase 3 |
---|---|---|---|---|---|
Squalene Emulsion | SE | ||||
TLR 4 Agonists | |||||
GLA-AF/Alum | |||||
SLA-SE | |||||
TLR/ 7/8 Agonists | |||||
3M-052-SE | |||||
TLR 4 Agonists + Saponin | GLA-LSQ | ||||
SLA-LSQ | |||||
Dual Agonist |
RNA DELIVERY VEHICLE | Preclinical | GMP/Tox | Phase 1 | Phase 2 | Phase 3 |
---|---|---|---|---|---|
Nanostructured Lipid Carrier | NLC |