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CAMBRIDGE, Mass., May 28, 2024 /PRNewswire/ -- The Bill & Melinda Gates Medical Research Institute (Gates MRI) today announced the appointment of Patrice Matchaba, MD, as Chief Executive Officer (CEO), starting June 10, 2024. He succeeds the current CEO, Emilio Emini, PhD, who recently announced his retirement, effective on June 30, 2024. Dr. Matchaba began his career as a physician in South Africa before working for more than two decades in the pharmaceutical industry. In his time with Novartis Global Pharmaceuticals in the US and Switzerland, Dr. Matchaba gained expertise in drug development, global product registration, and market access. Prior to joining the institute, his most recent roles were President of Novartis' U.S. Foundation and Novartis Group Head of Global Health. Before joining Novartis, Dr. Matchaba was a Senior Research Scientist at the Cochrane Centre based at the South African Medical Research Centre in Cape Town, which he joined after practicing as an obstetrician and gynecologist in Durban. He also worked as a medical doctor in the mines of Botswana for three years, where he saw the ravages of tuberculosis (TB) firsthand. He was born in Zimbabwe and is a citizen of South Africa and the US. "After an extensive global search, we are delighted to announce that Dr. Matchaba will lead the Gates MRI," said Trevor Mundel, Board Chair of the Gates MRI and President, Global Health, of the Bill & Melinda Gates Foundation. "Dr. Matchaba has seen every aspect of global health drug development in his 23 years at Novartis, most notably in his work to build sustainable partnerships to treat sickle-cell disease in Africa and Chagas disease in South America. His extensive experience in global health will help the Gates MRI as it progresses candidate therapeutics, supplements, and vaccines through clinical development and ultimately, into manufacturing and distribution." "Dr. Matchaba's experience in harnessing the power of medical innovation—from research through to distribution and patient access—will serve us well," said Dr. Emini. "As we continue the clinical studies on potential interventions to fight the diseases that disproportionately impact low- and middle-income countries, we need continued leadership that can leverage the capabilities of current partners while building new collaboration models." "Tuberculosis, malaria, diarrheal diseases, and maternal and child health are public health challenges that impact communities in low- and middle-income countries," said Dr. Matchaba. "The Gates MRI was founded to help address these intractable concerns and to save lives. I look forward to joining with new colleagues and research partners in this critically important work." In March of this year, the Gates MRI launched a Phase 3 clinical trial to assess the efficacy of the M72/AS01E tuberculosis vaccine candidate. The institute is conducting a number of additional clinical trials, evaluating potential therapeutics, vaccine candidates, and a probiotic candidate to reduce the burden of illness in low- and middle-income countries globally. The Gates MRI is an affiliate of the Bill & Melinda Gates Foundation. About the Bill & Melinda Gates Medical Research Institute (Gates MRI) The Bill & Melinda Gates Medical Research Institute is a non-profit medical research organization dedicated to the development and effective use of novel biomedical interventions addressing substantial global health concerns, for which investment incentives are limited, including malaria, tuberculosis, enteric and diarrheal diseases, and diseases that impact maternal, newborn, and child health. For further information please visit . For more information, contact: [email protected] Logo -

A large Phase 3 trial will evaluate whether the M72/AS01E vaccine candidate can protect adolescents and adults from pulmonary tuberculosis Clinical trial site at University of the Witwatersrand, Johannesburg, South Africa, is first of up to 60 sites in seven countries The M72/AS01E vaccine candidate could be the first new TB vaccine in 100 years if proven effective CAMBRIDGE, Mass., March 19, 2024 /PRNewswire/ -- The Bill & Melinda Gates Medical Research Institute (Gates MRI) today announced that a Phase 3 clinical trial to assess the efficacy of the M72/AS01E tuberculosis (TB) vaccine candidate is now underway, with first doses given in South Africa, where TB takes a heavy toll. If shown to be well-tolerated and effective, M72/AS01E could potentially become the first vaccine to help prevent pulmonary TB in adolescents and adults, the most common form of the disease, and the first new TB vaccine in over a century. Globally, according to the World Health Organization, an estimated 10.6 million people fell ill with TB in 2022 and 1.3 million died — over 3,500 people per day. The disease primarily affects people in low- and middle-income countries, and those at highest risk are often living in poverty, with poor living and working conditions and undernutrition. In South Africa alone, around 280,000 people are diagnosed with TB each year. "The launch of this pivotal Phase 3 trial demonstrates our commitment to harnessing the power of medical innovation to fight diseases like TB that are particularly devastating for low- and middle-income countries," said Emilio A. Emini, Ph.D., CEO of the Gates MRI. "Clinical study of the vaccine will still require years, but our incredible partners in South Africa and elsewhere who have come together for the Phase 3 study share our hope in the vaccine's potential." The Gates MRI, a nonprofit organization and subsidiary of the Bill & Melinda Gates Foundation, is sponsoring the trial, which is supported by funding from the Gates Foundation and Wellcome. The M72/AS01E vaccine candidate has been in development since the early 2000s. It was originally designed and clinically evaluated by the biopharma company GSK up to the proof-of-concept phase (Phase 2b), in partnership with Aeras and the International AIDS Vaccine Initiative (IAVI) and was funded by GSK and in part by the Gates Foundation. In 2020, GSK announced a partnership with the Gates MRI for further development of M72/AS01E. GSK continues to provide technical assistance to the Gates MRI, supplies the adjuvant component of the vaccine for the Phase 3 trial and will provide the adjuvant post licensure should the trial be successful. An adjuvant is an ingredient used in some vaccines that can help create a stronger immune response. Making vaccines accessible and affordable for communities in areas of high disease burden in the long-term is a priority for all trial partners. The Gates MRI has worked with a wide range of stakeholders, including communities around clinical trial sites, to guide the TB candidate vaccine to Phase 3. To this end, the Gates MRI, GSK, Wellcome and the Gates Foundation are working together to understand the potential demand for the vaccine and build an end-to-end plan to ensure long-term sustainable access, should the trial be successful; from supporting research and building an evidence-base for the potential impact of the vaccine and community requirements for uptake, to collaborating with multilateral, regional and country partners required to introduce the vaccine. Additionally, the trial funders are planning to establish an international advisory group comprised of representatives from all these groups to provide input on the overall program. Developing and ensuring access to global health products is a complex task. As such, global collaboration and strong partnerships are a core component of planning for future access to the candidate vaccine. "Reaching Phase 3 with an urgently needed TB vaccine candidate is an important moment for South Africans because it demonstrates that there is a strong local and global commitment to fight a disease that remains distressingly common in our communities," said Dr. Lee Fairlie, Director of Maternal and Child Health at Wits RHI at University of the Witwatersrand, Johannesburg, South Africa, and national principal investigator for the trial in South Africa. "South Africa also has considerable experience with TB- and vaccine-related clinical trials and a strong track record for protecting patient safety and generating high quality data essential for regulatory approvals." At full capacity, the trial will include up to 20,000 participants, including people living with HIV, at up to 60 trial sites in seven countries — South Africa, Zambia, Malawi, Mozambique, Kenya, Indonesia and Vietnam. Participants will receive either the investigational M72/AS01E vaccine or a placebo in what is known as a double-blind trial, meaning neither the trial participant nor the clinical investigators will know who receives vaccine or placebo. This approach is considered the gold standard for evaluating the safety and efficacy of an investigational vaccine. "After dedicating over 20 years to developing this essential candidate vaccine, we at GSK are delighted that the Phase 3 trial is underway. Developing and ensuring access to global health products is complex but our collaboration with the Gates MRI, Wellcome and the Gates Foundation exemplifies the transformative power of leveraging diverse partners' expertise to change the trajectory of challenging diseases, like TB, which place a huge burden on communities around the world," said Deborah Waterhouse, CEO, ViiV Healthcare and President, Global Health, GSK. While TB is one of the world's deadliest infectious diseases — and the leading cause of death amongst people living with HIV — the only available TB vaccine, BCG, dates back to 1921. It protects babies and young children against severe forms of TB, but it offers inadequate protection for adolescents and adults against the pulmonary form of the disease, which is primarily responsible for transmission of the TB bacterium. "If effective, M72/AS01E could reinvigorate a global fight against TB that has been weakened by the COVID-19 pandemic," said Alemnew Dagnew, M.D., who leads development of M72/AS01E at the Gates MRI. "I am particularly excited to see this trial get underway because when I was working as a physician in Ethiopia, I saw first-hand what pulmonary TB does to communities — and a vaccine that could help prevent that from happening would be transformative." Dagnew noted that TB is both a health problem and a socioeconomic problem. He said the disease primarily affects people during their prime working years, leaving families without income and children without parents. Almost half of TB-affected households face costs higher than 20% of their household income. "We must continue to move with urgency to develop and equitably deliver innovative tools with the potential to transform the prevention, diagnosis, and treatment of TB. The start of the Gates MRI's M72 TB vaccine candidate Phase 3 clinical trial marks a pivotal moment in the fight to end TB, which devastatingly afflicts the world's most vulnerable communities. We think this trial marks the beginning of a series of opportunities that will usher in the most promising pipeline ever of new TB tools. The Gates Foundation remains committed to supporting local and global partners to accelerate the solutions needed to save lives and reduce suffering from this preventable disease," said Trevor Mundel, President, Global Health, Bill & Melinda Gates Foundation. Alex Pym, Director of Infectious Disease at Wellcome, said: "While it is a long journey to results, the start of this trial in South Africa brings us a critical step closer to having an effective vaccine to protect those most at risk of TB. Global collaboration with regulators, in-country decision makers and communities affected is crucial if those who need it most are to benefit from this vaccine, should the trial be successful." It is anticipated that it will take up to five years to complete the trial, followed by data analysis and then preparation for submission of data to regulatory authorities. In GSK's Phase 2b trial, M72/AS01E provided approximately 50% protection (13/1626 versus 26/1663) against progression to active pulmonary tuberculosis for three years in Mycobacterium tuberculosis-infected HIV-negative adults, which was unprecedented in decades of TB vaccine research. The World Health Organization estimates that over a 25-year time span, that level of protection could save 8.5 million lives, prevent 76 million new TB cases and save $41.5 billion for TB affected households. About the Bill & Melinda Gates Medical Research Institute (Gates MRI) The Bill & Melinda Gates Medical Research Institute is a non-profit medical research organization dedicated to the development and effective use of novel biomedical interventions addressing substantial global health concerns, for which investment incentives are limited, including malaria, tuberculosis, enteric and diarrheal diseases, and diseases that impact maternal, newborn, and child health. For further information please visit . For more information, contact: [email protected] Logo -