Spanish pharmaceutical company Zendal and IAVI are working together to bring the tuberculosis vaccine candidate MTBVAC into efficacy studies

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  • TB kills 1.4 million people annually, an infectious disease number only recently surpassed by COVID-19.

  • COVID-19 has undermined years of advances in TB control, cost additional lives and heightened the urgency of the global TB problem.

  • MTBVAC is a promising vaccine candidate that has the potential to be used as an alternative to BCG vaccination in infants and to prevent TB in adolescents and adults.

PORRIÑO, SPAIN & NEW YORK, July 14th 2021– (BUSINESS WIRE) – Spanish biopharmaceutical company Biofabri and IAVI, an international non-profit research organization focused on the development of vaccines and antibodies against infectious and neglected diseases, today announced their intention to collaborate on efficacy studies of tuberculosis vaccine candidate MTBVAC.

The Spanish researcher Dr. Carlos Martin of the University of Zaragoza designed in-licensed and is manufactured and developed by Biofabri, a subsidiary of the Zendal Group, in collaboration with the University of Zaragoza, IAVI and Europe. based tuberculosis vaccine initiative (TBVI).

MTBVAC will complete the Phase II evaluation this year and is one of the most promising new TB vaccines in the pipeline. The only available TB vaccine, Bacille Calmette-Guérin (BCG), does not prevent primary infection and has limited effectiveness in preventing pulmonary TB in adults, who, along with adolescents, are primarily responsible for the spread of TB. The first dose of the BCG vaccine was delivered 100 years ago on the day of July 18th.

This announcement comes amid the extraordinary pace of development of numerous vaccines to protect people from COVID-19 over the past year.

“The urgency of introducing COVID-19 vaccines worldwide is rightly given unprecedented attention. At the same time, this global focus on disease control is an opportunity to go the extra mile and try to eradicate the TB which, once COVID-19 recedes, will resume its position as the leading killer of infectious diseases worldwide, “said Dr. Mark Feinberg, President and CEO of IAVI.

“We saw with COVID-19 that adequate investment and public-private partnerships are essential for vaccine development to be successful and rapid. Likewise, concerted global efforts will be essential to develop an effective TB vaccine. We hope the support too.” win.” from public and private donors and healthcare partners to advance this promising vaccine candidate that has the potential to meet urgent unmet needs and be part of a solution to the TB epidemic. “

The European and Developing Countries Clinical Trials Partnership (EDCTP) is committed to supporting a Phase III study of MTBVAC in newborns that is scheduled to begin in several African countries in 2021. IAVI will support the development and further mobilization of resources for MTBVAC, also for a youth / adult exam. TBVI will also support the ongoing study preparations.

“Biofabri and the Zendal Group are excited to count on the support of two respected international organizations such as IAVI and TBVI to achieve our goal of making a TB vaccine available worldwide,” said Esteban Rodríguez, CEO of Biofabri.

“We are proud that the MTBVAC strain was developed here in Spain and I am cautiously optimistic that promising data from previous and ongoing studies with MTBVAC show that we are moving in the right direction. Phase II dose range studies in adults and neonates are ongoing and, encouragingly, no safety issues have been identified. We will select a final dose from these studies to continue in efficacy studies and if the results of these studies bear fruit we will be just as proud of them be to take over production. a life-saving vaccine on site. “

Should MTBVAC be found to be safe and effective, Biofabri will work with IAVI to ensure that MTBVAC is manufactured and supplied in sufficient quantities to newborns, infants, adolescents and adults and is available at affordable prices in low and middle income countries.

Tuberculosis and COVID-19

Tuberculosis is the world’s largest infectious disease killer, killing an estimated 1.4 million people each year, 10% of whom are children. These numbers have only been exceeded by COVID-19 in the past two years. In 2019 around 10 million people contracted tuberculosis, which is one of the 10 most common causes of death worldwide.

COVID-19 reversed previous advances in TB response by 10 years, resulting in a significant decline in TB case detection. The Stop TB partnership estimates an additional 1.4 million TB deaths from COVID-19 will occur over the next four years. A vaccine is more urgent than ever.

The drug-resistant / multi-resistant TB (DR / MDR-TB) is problematic with approx 465,000 cases in 2019. DR / MDR TB treatment is cumbersome, expensive, and not always successful. A vaccine that prevents TB disease would have a huge impact on the DR / MDR TB problem.

MTBVAC

MTBVAC is the only live damping Mycobacterium tuberculosis Vaccine in development. It is currently being developed for two purposes: as a more effective and potentially longer lasting vaccine than BCG for newborns, and for preventing tuberculosis in adults and adolescents for whom there is currently no effective vaccine.

Two phase II studies are currently ongoing, one supported by EDCTP and sponsored by Biofabri in infants in South Africa and one sponsored by IAVI and supported by the US National Institutes of Health and the US Department of Defense through its Congressional-led medical research program. Results are expected by the end of 2021.

A study published in early 2021 (White et al., NPJ Vaccines 2021) showed that a single dose of MTBVAC offers significantly better protection against aerosol exposure Mycobacterium tuberculosis in rhesus monkeys compared to BCG at the same dose. This confirms that the immunological responses induced in rhesus monkeys after vaccination with MTBVAC mirror those in phase I clinical trials with MTBVAC.

Biofabri sees IAVI as a key partner in the end-to-end development of this important vaccine candidate as the partners conduct efficacy studies for both the newborn / infant and adolescent / adult indications. IAVI will support Biofabri with access planning for the neonatal / infant indication and the development and implementation of the youth and adult studies. The partners are actively looking for donors to support clinical development for the adolescent / adult indication.

A global project

This agreement is another step in advancing the development of a promising TB vaccine candidate, especially for low- and middle-income countries, in a project in which the following allies play an essential role:

IAVI. IAVI is a not-for-profit scientific research organization headquartered in the United States and with locations in Europe, Africa, and India that develops vaccines and antibodies against HIV, tuberculosis, emerging infectious diseases (including COVID-19), and neglected diseases with a goal of global development access. It has contributed to efforts to evaluate most of the leading TB vaccine candidates currently in clinical development and has a very experienced TB vaccine clinical research team in South Africa.

Biofabri is a biopharmaceutical company founded in 2008 with the aim of researching, developing and manufacturing vaccines for humans. BIOFABRI is human health focused, has strong technical, research and manufacturing capabilities, and a strong track record in biotechnology. Biofabri is responsible for the manufacture and clinical development of MTBVAC.

Biofabri is part of the Zendal Group, a Spanish biopharmaceutical group of companies specializing in the development, manufacture and marketing of biotechnological and pharmaceutical products for human and animal health.

TBVI. The Tuberculosis Vaccine Initiative is a non-profit foundation that enables the discovery and development of new, safe, and effective tuberculosis vaccines that are accessible and affordable for everyone. As a Product Development Association (PDA), TBVI integrates, translates, and prioritizes research and development efforts to discover and develop new TB vaccines and biomarkers for global use. TBVI offers essential services that support the R&D efforts of its partners: 50 partners from universities, research institutes and the private sector in the field of TB vaccines.

UNIZAR. The University of Zaragoza in Spain is the main center for technological innovation in the Ebro Valley. It participates in various exchange programs and cooperates with universities and research centers in Europe, Latin America and the United States. Microbiologists from the university affiliated with CIBERES led the research and subsequent discovery of the experimental vaccine MTBVAC. Within the TBVI consortium, the MTBVAC discovery phase included rigorous clinical characterization by independent laboratories and research groups.

View source version on businesswire.com: https://www.businesswire.com/news/home/20210714005269/en/

contacts

IAVI media
Rose Catlos
+1 212 847 1049
[email protected]

Zendal media
Beatriz Díaz Lorenzo
+34 619 085 074
[email protected]



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