Public Release: 

IDRI partners with Afrigen Biologics and Biovac to produce tuberculosis vaccine

Transferring technology to South Africa for on-site vaccine production

Infectious Disease Research Institute

In an effort to produce vaccines where they are needed most, IDRI (Infectious Disease Research Institute) is collaborating with the Cape Town, South Africa, based biotechnology startup company Afrigen Biologics, founded by the Industrial Development Corporation of South Africa and IDRI, and its production partner the Biovac Institute (Biovac), a vaccine manufacturer also located in Cape Town, to produce a vaccine for tuberculosis.

IDRI's TB vaccine, ID93 + GLA-SE, is composed of a recombinant fusion-protein antigen, ID93, plus IDRI's proprietary adjuvant, GLA-SE. In 2018, IDRI released results from a Phase 2a clinical trial in South Africa, which demonstrated that the vaccine was well tolerated, had an acceptable safety profile and induced a specific immune response, supporting further development and clinical testing. The vaccine candidate is now being developed, in conjunction with the Wellcome Trust, European Union and India's Department of Biotechnology for a therapeutic application.

This work is part of a worldwide effort to develop a new vaccine for the control of TB. There are 1.7 billion people across the globe who are already infected with TB; therefore, a vaccine that blocks progression from the precursor phase of TB (latent infection) to active disease, is critical. Each year, more than 10 million people develop TB disease and 1.7 million die from TB.

A vaccine produced on site in Africa has a number of potential advantages. Making a vaccine in sub-Saharan Africa can increase local trust in receiving the immunization, enhance preparedness for disease outbreaks, reduce the cost of production, and expedite local regulatory review. Afrigen Biologics is the first ever adjuvant formulation laboratory in Africa and has acquired the manufacturing and distribution rights for ID93 for Africa. Afrigen has partnered with Biovac, which formulates, fills, finishes and distributes vaccines already produced in bulk. Biovac was recently awarded a manufacturing license by a South African regulator, taking it one step closer to producing vaccines in Africa. IDRI has transferred technology for producing ID93 + GLA-SE to Afrigen and Biovac; the materials produced by the two South African companies showed good results.

"The transfer of technology into countries that have the highest burdens of infectious disease is an important part of IDRI's mission," said Steven Reed, PhD, IDRI President, CEO and Founder. "We believe that enabling countries to produce their own vaccines will not only improve health and ensure preparedness in case of a disease outbreak, but also build capacity for a growing biotech industry. We are pleased to partner with Afrigen and Biovac to produce vaccines on the African continent, and the successful replication of the ID93 antigen by Biovac and the formulation of GLA-SE by Afrigen is a great start. The specialized capacity that we are helping to build will be relevant to our current candidate as well as to all similar technologies developed in the future."

Prof Petro Terblanche, Managing Director of Afrigen Biologics, notes that the "vaccines and adjuvant formulations for Africa are developed and manufactured outside of Africa, except for the fill and finish production of a limited number of vaccines on behalf of multinational pharmaceutical companies. We have not fully capitalized on the opportunity to ensure local value add, even though 1 in 5 children in Africa does not receive basic life-saving vaccines. The partnership with IDRI, supported by our shareholders, the IDC and Avacare, enables us to build local capacity and capabilities in Afrigen and Biovac to meet current unmet needs in a sustainable manner. Aligned with the TB burden of disease challenge in South Africa, it is very appropriate for Afrigen and Biovac to focus on ID93 as a first collaborative production technology transfer."

In South Africa, 50-80% of adults are infected with Mycobacterium tuberculosis, the bacteria that causes TB, creating one of the highest burdens of TB in the world

"As a South African private public partnership, Biovac has been working diligently towards being a center of excellence in Africa for the development and manufacture of vaccines," said Morena Makhoana, MD, CEO of Biovac. "The partnership with IDRI and Afrigen for the transfer of the ID93 manufacturing technology has afforded us the opportunity to demonstrate capacity to absorb technology for the manufacture of potential TB vaccine in a productive partnership with local and international companies. This is the second recombinant protein technology project we've successfully transferred into Biovac. Given the high burden of TB in South Africa, Biovac is pleased to the partner of choice in Africa for the manufacture of a new generation TB vaccine as it enhances our position as a developer and manufacturer of vaccines relevant to Africa and the developing world."

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About IDRI: As a nonprofit global health organization, IDRI (Infectious Disease Research Institute) takes a comprehensive approach to combat infectious diseases, combining the high-quality science of a research organization with the product development capabilities of a biotech company to create new diagnostics, drugs and vaccines. Founded in 1993, IDRI has 125 employees headquartered in Seattle with nearly 100 partners/collaborators around the world. For more information, visit http://www.idri.org.

About Afrigen Biologics: AFRIGEN BIOLOGICS (Pty) Ltd is a South African based biotechnology company dedicated to the local development and production of adjuvants for human and animal vaccines, as well as biologics critical for Africa's healthcare challenges. Afrigen was founded by the Industrial Development Corporation (IDC) in South Africa and IDRI in 2014 with laboratories based in Cape Town. Afrigen has successfully in-licensed proprietary formulation technology from IDRI and completed a full technology and knowledge transfer program. Afrigen currently has built strategic partnerships with local and international partners to apply its adjuvant formulation capabilities in the development of novel vaccines. Afrigen and has a portfolio of veterinary and human health products in early development. Recently, Avacare Health, a pan-African health care company acquired a controlling stake in Afrigen(http://www.afrigen.co.za).

About Biovac: Biovac was established as a private-public partnership and is one of a handful of vaccine manufacturers in Africa. It is located in Cape Town, South Africa and its mission is to re-establish end-to-end vaccine development and manufacture in South Africa. It has established modern vaccine manufacturing infrastructure and is partnering with multinational vaccine companies for the transfer of technology thereby accelerating the building of the aforementioned capacities. In addition, Biovac has established expertise in conjugate vaccine development that it will exploit and build upon in the development of a novel conjugate vaccine against Group B Streptococcus disease. (http://www.biovac.co.za)

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