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$18.7 million new gift from Gates’ to improve access to medicines and an additional $10 million for novel T cell vaccine development program
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$18.7 million new gift from Gates’ to improve access to medicines and an additional $10 million for novel T cell vaccine development program

The Medicines for All Institute at Virginia Commonwealth University will work on 14 new global health projects and expand its capabilities to improve access to medicines around the world thanks to an $18.7 million grant from the Bill & Melinda Gates Foundation. The grant will support projects to reduce the costs of medicines for tuberculosis, malaria, HIV and neglected tropical diseases.

Medicines for All dramatically improves global access to these medicines by developing significantly more cost-effective methods to produce these materials. Working with the Foundation, Medicines for All then provides direct access to these new technologies through market engagement with pharmaceutical manufacturers worldwide.

With this grant, Medicines for All has received more than $60 million from the foundation over the past decade -; including $25 million in 2017 to establish the institute that allows VCU to work on multiple projects. The institute will use this latest grant to strengthen its partnerships with a global network of researchers, manufacturers and distribution partners who work together to maximize the impact of novel development processes for lifesaving medicines.

Over the past three years, TB has been the second-leading cause of death among infectious diseases, behind COVID. More than 10 million people contract TB each year, almost 5% of which have resistance to standard first-line TB treatment. Unfortunately, costs for second-line TB treatment remain high and only about one in three people with drug resistant TB are able to access treatment. M4ALL has been and will continue working on making these critical treatments more affordable for people living with TB around the world.

Additionally, growing resistance to current malaria treatments is putting proven protocols at risk. The pipeline for new treatments is small, with potential candidates remaining too expensive -; issues that Medicines for All is actively trying to solve.

“VCU Medicines for All is a transformative step in meeting the nation’s needs to make lifesaving medications more available and accessible,” said Michael Rao, Ph.D., president of VCU and VCU Health. “The renewal of this Bill & Melinda Gates Foundation grant demonstrates the foundation’s continued confidence in VCU’s work across disciplines to leverage expertise, creativity and innovation in pursuit of better health for all human beings. Support like this enhance our work to put the needs of our patients and our communities first. This also helps VCU continue to serve as a national model for research that matters to the public and strengthens student learning.”

Under the leadership of Gupton, an internationally recognized scholar and industry expert, the Medicines for All Institute has:

Successfully pivoted resources on short-notice to COVID-19 treatments at the height of the pandemic, delivering cost-saving processes for antiviral medicines including molnupiravir and nirmatrelvir (Paxlovid).

Demonstrated the impact of working on in-development drugs, such as those for TB, ensuring that new targets can launch at accessible prices.

Delivered significant cost reductions for malaria treatments and HIV antiretrovirals, including those that have long been available as generics such as tenofovir, a medication used for HIV prevention and treatment.

Built strong partnerships with researchers, global health partners and manufacturers whose collaboration helps to enable the continued impact of M4ALL’s work.

“Watching Medicines for All grow into an organization with such a significant impact is something we’re really proud of,” said Gary Tepper, Ph.D., interim dean of the College of Engineering at VCU. “From its early moments as part of the College of Engineering, Medicines for All has become a model for how to connect research with manufacturing, using partnerships between the public and private sectors to deliver affordable, quality medication.”

Medicines for All’s methodology for developing cost-effective processes relies on its unique utilization of chemistry. Working closely with the VCU College of Engineering -; of which Gupton is the Floyd D. Gottwald, Jr. Chair in Pharmaceutical Engineering and chair and professor in the Department of Chemical and Life Science Engineering -; Medicines for All has reimagined every step of the pharmaceutical manufacturing process from simplifying raw materials to optimizing development processes.

For instance, Medicines for All improved the manufacturing process for bedaquiline -; a crucial medicine in the global fight against TB -; resulting in yields twice as high as current methods and, therefore, more economical.

As the cornerstone of the regional Alliance for Building Better Medicine, Medicines for All is helping to bring essential medicine production back to the United States. Last year, the U.S. Department of Commerce’s Economic Development Administration awarded the public-private coalition $53 million through the Build Back Better Regional Challenge. The alliance will use a portion of the funding to build a first-of-its-kind scale-up facility that bridges research and manufacturing to accelerate commercialization of lab discoveries. The facility will make Central Virginia a hub for advanced pharmaceuticals.

The success of Medicines for All demonstrates a novel set of tools and approaches that can help ensure access to medicines for people around the world. Growing drug shortages and continued affordability challenges to essential medicines provide a reminder that the work of Medicines for All is just getting started. The next five years will see the institute look to expand its capacity and capabilities, impact access to a wider variety of critical medicines, help build capacity around the world for advanced manufacturing, all while demonstrating that this work can be done with a smaller impact on the environment. The new grant will also include a co-funding mechanism, which will leverage matching support from the Gates Foundation to lower the cost of projects for sponsors interested in working with Medicines for All on new high priority global health drug targets.

“Medicines for All has been fortunate to realize a number of successes over the first eight years of our work supported by the Gates Foundation,” Gupton said. “However, the problems we hope to solve are immense, and we are just getting started on this journey. We are looking forward to continuing this work with our existing partners and working with new partners to help fulfill our mission of improving access to medicines around the world.”

Vir Biotechnology, Inc. also announced that it received a new $10 million grant from the Bill & Melinda Gates Foundation to support Vir’s novel T cell vaccine development program. The new grant will support the Phase 1 clinical development of VIR-1388, an investigational novel T cell vaccine for the prevention of human immunodeficiency virus (HIV). VIR-1388 is based on the human cytomegalovirus (HCMV) vector platform. Using applied learnings from VIR-1111, Vir’s initial investigational proof-of-concept HIV T cell vaccine, VIR-1388 is designed to elicit T cells that recognize different HIV epitopes with the goal of creating a safe and effective HIV vaccine. Through close scientific partnership with the National Institute of Allergy and Infectious Diseases (NIAID) and the HIV Vaccine Trials Network (HVTN), the Phase 1 trial of VIR-1388 (HVTN 142) is expected to begin in the second half of 2023. The trial will also be funded in part by NIAID, part of the National Institutes of Health, through grant funding to HVTN. NIAID has provided funding throughout the product development lifecycle of VIR-1388.

“Vir’s long-standing support from the Bill & Melinda Gates Foundation has been a formative part of our company history in global health,” said Rajesh Gupta, M.D., M.S., M.P.H., Vice President, Global Health Portfolio and Public-Private Partnerships at Vir Biotechnology. “This new grant underscores the importance of our goal of developing innovative solutions for the prevention and treatment of global infectious diseases, including HIV. We look forward to advancing VIR-1388 into the clinic later this year.”

Vir’s support from the Bill & Melinda Gates Foundation includes existing equity investments and grants for the development of therapies for the prevention and treatment of HIV, the prevention of tuberculosis and the prevention of malaria. Collectively, these programs aim to address infectious diseases that significantly impact people in low- and middle-income countries. Currently, VIR-1111 is the most advanced program in this collaboration. The Company expects safety and immunology data from the highest dose cohort 3 in the proof-of-concept Phase 1 trial of VIR-1111 in the first half of 2023.

HIV continues to be a major global public health challenge with no cure for the approximately 38 million people living with HIV infection.

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