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Bilthoven Biologicals and Tonix Pharmaceuticals enter into strategic collaboration to advance development of viral vector based Mpox (formerly known as monkeypox) vaccine (TNX-801).
Bilthoven, August 22, 2024, Bilthoven Biologicals (“BBio”), part of the Cyrus Poonawalla Group, and Tonix Pharmaceuticals (“Tonix”) announced a collaboration to advance its Mpox vaccine candidate (“TNX-801”). Tonix is a fully-integrated biopharmaceutical company with marketed products and a pipeline of development candidates. BBio is a global vaccine company, producing prophylactic and paediatric vaccines as well as vaccines for therapeutic use. BBio is selected by EU for its Pandemic Preparedness program of ‘ever warm’ vaccine manufacturing companies.
Both companies are committed to advancing the development and commercialization of the Mpox vaccine candidate. TNX-801 is based on a viral vector technology, with the potential to be used as a viral vector platform, for which recombinant versions can be developed to protect against other infectious diseases.
TNX-801 (recombinant horsepox virus) is a live virus vaccine based on horsepox in pre-clinical development to prevent mpox and smallpox. Tonix reported positive preclinical efficacy data, demonstrating that TNX-801 vaccination protected non-human primates against lethal challenge with monkeypox.1 Tonix has received official written response from a Type B pre-Investigational New Drug Application (IND) meeting with the U.S. Food and Drug Administration (FDA) to develop TNX-801 as a potential vaccine to protect against mpox disease and smallpox.2 Tonix believes the FDA feedback provides a path to agreement on the design of a Phase 1 /2 study and the overall clinical development plan. More than 90,000 people contracted mpox globally. during the 2022-23 epidemic.3 The June 2023 cluster of mpox in Chicago revealed breakthrough cases of the disease in individuals who had been vaccinated with the currently authorized non-replicating vaccine, which is administered in two doses.4 In contrast, TNX-801 is delivered percutaneously with only one dose and therefore may achieve higher rates of community protection by eliminating drop-out between doses and limiting forward transmission. Moreover, relying on only one approved mpox vaccine at present is a risk for the global supply chain that has already led to insufficient availability of vaccines to meet global health needs, especially in Africa. TNX-801 has the potential to make a global impact on mpox and the risk of smallpox because of its durable T-cell immune response, the potential to manufacture at scale, and the use of a lower dose than non-replicating vaccines.
Seth Ledermann, CEO of Tonix: “We look forward to collaborating with BBio and to accelerating the development of our vaccine candidates to prevent Mpox, smallpox, other infectious diseases,” said Seth Lederman, M.D., Chief Executive Officer of Tonix. “TNX-801 is administered with a single dose, which we believe will improve acceptance and eliminate partial vaccination compared to the current two-dose regimens. We believe TNX-801 can be rapidly scaled up for manufacturing and can be distributed and stored without a costly and cumbersome ultra-cold supply chain.”
The global Mpox outbreak, which commenced in 2022, has affected over 90,000 persons in countries where Mpox had previously not been endemic, including Europe and the US. The spread of Clade IIb strain Mpox in 2022 underscores the pandemic potential of the disease. In several Central African countries, including the Democratic Republic of the Congo, Mpox is currently endemic, with the highly lethal Clade 1 strain which has a mortality rate of up to 10%.
“The recent Mpox outbreak, exemplifies precisely why we built the Pandemic Preparedness Facility at BBio”, states CEO of BBio, Jurgen Kwik. “The establishment of the ‘ever-warm’ facility for pandemic preparedness underscores the critical importance of readiness in the face of global health emergencies, such as Mpox. This collaboration encapsulates the essential role of the facility in bolstering pandemic preparedness and response capabilities”.
The worldwide availability of an affordable, safe, effective single dose Mpox vaccine is essential given the pandemic potential of the disease. Successful development of TNX-801 will establish the foundation for potentially expanding the viral vector platform, for which recombinant versions can be developed to protect against other infectious diseases and future outbreaks.
Jorrit van Hoorn, Director Corporate Development at Bilthoven Biologicals adds: “We look forward to this groundbreaking collaboration with Tonix and contributing to a solution for this global health emergency, leveraging the pandemic facilities at BBio in combination with the world leading vaccine expertise at our parent company Serum Institute of India”.
The full press release and further information about Tonix can be found at www.tonixpharma.com.
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1Noyce RS, et al. Viruses. 2023;15(2):356. DOI: https://doi.org/10.3390/v15020356
2TNX-801 PR pre-IND meeting 8/20/23: https://ir.tonixpharma.com/news-events/press-releases/detail/1417/tonix-pharmaceuticals-announces-results-of-pre-ind-meeting
3CDC. (2022-2023). Mpox Outbreak Global Map https://www.cdc.gov/poxvirus/mpox/response/2022/world-map.html
4 Faherty EA, et al. MMWR Morb Mortal Wkly Rep. 2023;72:696–698. DOI: http://dx.doi.org/10.15585/mmwr.mm7225a6.
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