Cape Town-based biopharmaceutical company Biovac announced on Thursday that it has formed a local manufacturing partnership with US-based immunotherapy company ImmunityBio to manufacture that company’s second generation Covid-19 vaccine in South Africa.
Biovac is the result of a partnership formed with the South African government in 2003 to establish local vaccine manufacturing capability for the provision of vaccines.
It already produces numerous vaccines for the South African market as well as neighbouring countries, including for tuberculosis, measles, pneumonia, hepatitis B, diphtheria, tetanus, pertussis, poliomyelitis and haemophilus influenzae type B.
ImmunityBio was founded in 2014 to create innovative immunotherapies for use in oncology and the treatment of infectious diseases. It is a “leading late-clinical-stage immunotherapy company developing next-generation therapies that drive immunogenic mechanisms for defeating cancers and infectious diseases”.
“The company’s immunotherapy platform activates both the innate (natural killer cell and macrophage) and adaptive (T cell) immune systems to create long-term immunological memory.”
This partnership venture will work towards developing the capability for the full value-chain manufacturing of vaccines.
ImmunityBio’s second generation Covid-19 vaccine – hAd5 T-cell Sars-CoV-2, which is currently undergoing clinical trials in South Africa and the US – kills the infected cell, thus preventing virus replication.
It is anticipated that this vaccine will offer broader protection against multiple variants of Covid-19, such as the 501Y.V2 variant found in South Africa.
This vaccine differs from the first generation of Covid-19 vaccines which are antibody-based.
Biovac’s existing manufacturing capacity allows for the formulation and filling of inactivated and bacterial conjugate vaccines.
The collaboration with ImmunityBio will result in a technology transfer, which will build Biovac’s capability for active pharmaceutical ingredient (API) manufacturing.
The partnership, while initially targeted at manufacturing the hAd5 T-cell Sars-CoV-2 vaccine, will ensure a “sustainable and equitable approach to vaccine manufacturing and will form a solid foundation for an independent local response to future pandemics”.
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ImmunityBio’s collaboration with Biovac
Founder and executive chair of ImmunityBio, Dr Patrick Soon-Shiong, stated: “In addition to working with local researchers in the clinical development I am equally pleased to commence work with Biovac which is the only specialist vaccine company in South Africa and that has proven that vaccines can be produced in Africa at a high standard as demonstrated by their prior collaborations on paediatric vaccines with global multinational vaccine companies.
“This gives us the confidence that South African manufacturing capability is at an equally high standard to its global counterparts and has the potential to respond more fully to future pandemics. Biovac’s Private Public Partnership model also demonstrates that private sector can partner with government in the quest for a common health response.”
Phase I clinical trial of hAd5 T-cell vaccine in SA
University of Cape Town researchers commenced a Phase I clinical trial of ImmunityBio’s hAd5 T-cell Sars-CoV-2 vaccine after approval from the South Africa Health Products Regulatory Authority.
The trial is being conducted at the Wellcome Centre for Infectious Diseases Research in Africa’s clinical research site in Khayelitsha.
Soon-Shiong explained that: “T-cell-based vaccines kill the infected cell, preventing virus replication, and could provide long-term memory to recipients. Pursuing a vaccine that does not rely solely on targeting the S protein where the mutations are occurring is of critical importance as multiple variants of the Sars-CoV-2 virus have appeared globally, with concentrated outbreaks being detected in South Africa. In addition, we will be testing through clinical trials if our vaccine could be administered via the sublingual or oral routes.”
Building SA vaccine manufacturing capacity for future pandemics
Dr Morena Makhoana, CEO of Biovac, stated that: “Biovac has developed capability over many years of investment in formulation and filling of inactivated and bacterial conjugate vaccines adopting a reverse integration strategy. The ‘missing’ capability that Biovac and the country has is in the capability of active pharmaceutical ingredient/drug substance manufacturing of viral vaccines.
“This collaboration with ImmunityBio is a strategic step in our quest for fully fledged vaccine manufacturing capability in Africa. Biovac has also recently collaborated with Wits University’s AntiViral Gene Therapy Unity, where Biovac’s staff are being trained to handle viral vaccines.
“These collaborations are a significant stepping stone to addressing the gap in Africa of self-reliance and pandemic response capability.”