An Adjuvant Formulation Powerhouse

MARCH 2024

AAHI is pleased to announce its partnership with Croda, one of the largest and most respected contract development and manufacturing organizations specializing in adjuvant formulations, through which AAHI and Croda will collaborate to make AAHI adjuvant formulations globally accessible. The partnership marks a significant milestone in AAHI’s mission to make effective vaccines available to everyone, everywhere, and reflects both companies’ commitment to development of sustainably sourced novel adjuvant formulations and processes for manufacturing those formulations efficiently, at commercial scale.

Candice decaire

chief strategy officer & General counsel

AAHI

We are tremendously excited about this partnership, which brings together Croda's product development and manufacturing skills and AAHI's three decades of adjuvant formulations expertise, to ensure that cost-effective immune-stimulating adjuvant formulations of the highest quality are accessible to vaccine developers around the world.

A Global Impact  

The partners’ initial efforts will focus on AAHI’s novel formulations of adjuvants known as GLA and SLA. Croda will apply its substantial expertise to scale-up manufacturing processes for clinical-grade GLA and SLA adjuvants and formulations, to supply advanced clinical trials and commercial distribution of vaccines incorporating AAHI’s novel formulations. These efforts will provide a path to regulatory licensure for over 20 vaccine candidates using GLA or SLA formulations that have demonstrated safety and immune-stimulating effects in Phase 1 and/or Phase 2 clinical trials. These vaccine candidates promise to provide protection against complex and deadly infectious diseases such as:

  • TUBERCULOSIS - AAHI’s tuberculosis vaccine candidate, combining AAHI’s proprietary fusion protein antigen, ID93, and its GLA-SE adjuvant formulation, is being developed in liquid and dry powder versions, each of which has demonstrated good safety and immune response profiles in humans and may alleviate the tremendous disease burden in areas such as South-East Asia, Africa, and the Western Pacific. 
  • LEISHMANIASIS – AAHI’s cutaneous leishmaniasis and visceral leishmaniasis vaccine candidates combine AAHI’s recombinant protein antigen, LEISH-F2, with the GLA-SE adjuvant formulation to offer protection against infection and consequent disfigurement, injury, or death. Early phase clinical trials have demonstrated safety and efficacy, and the adjuvanted protein vaccine offers a manufacturing advantage over live-attenuated vaccine candidates, which can be difficult to manufacture in the quantities needed for public distribution.
  • SHINGLES - Curevo Vaccine's shingles vaccine candidate using AAHI's SLA-SE adjuvant formulation demonstrated in Phase 2 clinical trials that it worked just as well as the commercially available Shingrix vaccine, but with reduced adverse side-effects.
  • SCHISTOSOMIASIS - Each of the three different vaccine candidates against this devastating parasitic disease that are currently being tested in human clinical trials in the US, Burkina Faso, Senegal, and Madagascar use AAHI's GLA adjuvant formulations and has demonstrated potential to prevent infection. 
  • MALARIA – Several of AAHI’s GLA adjuvant formulations are being clinically evaluated in promising vaccine candidates targeting different stages of the malaria parasite life cycle, to provide effective protection against malaria.
  • HIV - Several of AAHI's GLA adjuvant formulations are being clinically evaluated in various HIV vaccine candidates for prevention and treatment of the virus.  

Enabling Vaccine Development 

Croda will also work with AAHI to make adjuvant formulations, access to which has been a long-standing challenge and barrier to optimal vaccine development, available to vaccine developers seeking to use adjuvant formulations to focus and improve immune response to their vaccine candidate, to be able to provide more robust protection, for a greater number of people, including vulnerable populations such as the elderly, the very young, and the immunocompromised.

Croda and AAHI celebrated the establishment of a new collaboration at AAHI's headquarters in Seattle, WA with some delicious cake!

ANNA marie beckmann, phd

executive vp,product development

AAHI

Together, AAHI and Croda can support innovation, research, product development, and commercial supply of immune-stimulating adjuvant formulations, to support global supply of more robust, durable, and sustainable vaccines.

Research-grade AAHI adjuvant formulations for preclinical studies and early product development will be available through Croda's adjuvant formulations catalogue. AAHI and Croda will collaborate to optimize those formulations, and specifically to ensure that they can be sustainably rouced, by using novel alternatives to scarce formulation components. Croda and AAHI will work to develop formulations that use sustainable alternatives to squalene, an adjuvant formulation component typically sourced from shark livers, and to identify responsible, sustainable ways to source another important adjuvant known as QS-21, derived from the bark of the rare Chilean soapbark tree. 

Christopher fox, phd

senior vp, formulations

AAHI

We are looking forward to the opportunities that this new collaboration provides to further innovate and optimize adjuvant formulations, including sustainable and scalable raw material sourcing. Our partnership with Croda will propel new developments in adjuvant formulation technology and help ensure greater accessibility for global health applications.

AAHI and Croda will be at the World Vaccine Congress in Washington D.C. next week and would be delighted to discuss the partnership and how you can gain access to AAHI adjuvant formulations.