"We are excited to welcome these new funding partners—from within Japan and across the globe—who have joined forces with the GHIT Fund because of their own unique commitments to global health, as well as their confidence that working together will transform R&D," GHIT Fund CEO Dr. BT Slingsby said. "The partnerships will not only broaden our scope, but also increase our ability to reach the world's most vulnerable people with lifesaving technology."
GHIT's announcement today also marks its third year investing in R&D for neglected diseases, having now allocated more than US$60 million into upwards of 60 collaborations for product development. Of these investments, 23 have resulted in partnerships to screen Japan's unique compound libraries, resulting in 18 potential drug candidates. GHIT grants in 2015 alone have also led to five projects advancing into its innovative hit-to-lead platform (HTLP), as well as four novel candidates entering clinical trials for the first time—two in Phase I (first-in-human) and two in Phase II (including one proof-of-concept).
New Partnerships, Both Local and Global
These new partnerships, along with GHIT's existing ones, will enable the organization to continue investing in new, innovative technology for neglected diseases, as well as promising candidates that have recently entered clinical trials, or will eventually enter late-stage trials.
The new partners, including those based in Japan, as well as across the globe, follow:
- FUJIFILM Corporation, a leading global healthcare company, headquartered in Japan, that was recently named a "Top 100 Global Innovator" by Thomson Reuters. Although known for their photography products, their R&D sector has led to major breakthroughs in cartilage regeneration and targeting refractory cancers. Along with the Foundation for Innovative New Diagnostics (FIND), they were recently awarded a GHIT grant for a new rapid diagnostic test that can identify active tuberculosis in HIV-positive patients.
- Otsuka Pharmaceutical, a "big venture" company based in Japan that focuses on new products for the treatment of challenging diseases and for the maintenance of everyday health worldwide. Otsuka is a leader in tuberculosis research, and discovered and developed delamanid, one of the only treatments for multidrug-resistant tuberculosis approved in the past half-century.
- GlaxoSmithKline (GSK), a science-led global healthcare company, headquartered in the UK, which is committed to widening access to its products and working to make its products available to as many people as possible, no matter where they live in the world or what they can afford to pay. GSK is a key developer of RTS,S, the world's most advanced malaria vaccine candidate.
- Johnson & Johnson, which has been committed to improving the health of individuals, families and communities around the world, including the most vulnerable populations for over 130 years. With the aspiration of making a lasting difference in human health, Johnson & Johnson's global public health strategy takes an end-to-end approach, leveraging the full breadth and scale of the company's capabilities and partnerships to deliver holistic, evidence-based and sustainable healthcare solutions to complex health challenges.
- Kyowa Hakko Kirin Co., Ltd., a leading biopharmaceutical company in Japan focusing on its core business areas of oncology, nephrology and immunology/allergy.
- Merck, a leading science and technology company in healthcare, life science and performance materials. Around 50,000 employees work to further develop technologies that improve and enhance life—from biopharmaceutical therapies to treat cancer or multiple sclerosis, cutting-edge systems for scientific research and production, to liquid crystals for smartphones and LCD televisions. Founded in 1668, Merck is the world's oldest pharmaceutical and chemical company. In 2015, Merck generated sales of €2.85 billion in 66 countries.
- Mitsubishi Tanabe Pharma Corporation, a research-driven pharmaceutical company whose head office is based in Osaka, the birthplace of Japan's pharmaceutical industry.
- Nipro Corporation, a Japanese medical devices and pharmaceutical company that develops, among other products, dialysis products, injection and infusion products, diabetic care products and generic medicines.
- Sumitomo Dainippon Pharma Co., Ltd., a pharmaceutical company based in Japan aiming to create innovative pharmaceutical products for designated therapeutic focus areas including psychiatry & neurology, oncology, and other areas with high unmet medical needs.
- Salesforce.com Co., Ltd., a customer success platform and world's #1 Customer Relationship Management (CRM) application, which empowers companies to connect with their customers in a whole new way.
Rapid Progress on New Technologies for Neglected Diseases
GHIT's projects have progressed quickly in three years thanks to just such a scale-up in projects run by global collaborations. In fact, just in the last year, four progressed to clinical trials:
- A compound known as SJ733 went into Phase I clinical trials in April, 2016, to assess safety and pharmacokinetics. The compound, developed in collaboration between St. Jude Children's Research Hospital, Eisai Co., Ltd., and the Medicines for Malaria Venture (MMV), is fast-acting and could—as part of a combination medicine—provide a new treatment option for the disease and block transmission/prevent relapse with just one dose. Moreover, as SJ733 is a novel compound, it will not be affected by parasite resistance to existing malaria medicines.
- A promising malaria vaccine candidate called BK-SE36 has shown encouraging immunogenicity results in Japanese adults and Ugandan subjects aged 6-32 years. The vaccine candidate, developed by the Research Institute for Microbial Diseases at Osaka University, European Vaccine Initiative and the Centre National de Recherche et de Formation sur le Paludisme (Burkina Faso), entered a Phase I clinical trial in the summer of 2015 in Burkina Faso. The vaccine candidate will be tested in younger groups of children aged 1-5 years.
- A new pediatric formulation of Praziquantel for schistosomiasis entered the Phase II clinical development stage in November, 2015. The clinical trial has obtained regulatory clearance and the first subject will be dosed in June in the Ivory Coast, where researchers will evaluate the formulation in preschool-aged children, infants and toddlers in order to identify the optimal dosage. The new pediatric formulation is being developed by the Pediatric Praziquantel Consortium, a non-profit international public-private partnership between Lygature (The Netherlands), Merck (Germany), Astellas Pharma Inc. (Japan), Swiss Tropical and Public Health Institute, Simcyp Limited (UK) and Farmanguinhos (Brazil).
- An antimalarial drug known as DSM265 entered and completed a Phase IIa proof-of-concept study in 2015 in Peru, where it was studied in patients with uncomplicated P. falciparum or P. vivax malaria. The molecule being developed by Medicines for Malaria Venture (MMV), in collaboration with Takeda, could be used as part of a single-dose antimalarial cure when combined with other antimalarials currently in development. This drug combination therapy is aligned with the World Health Organization's recommendation that malaria be treated with a combination of effective antimalarials to reduce the development of drug resistance.
Since its founding three years ago, GHIT has built a robust portfolio of drugs, vaccines and diagnostics, which tap into Japan's cutting-edge science and technology platforms for global health. Today, several potentially game-changing candidates have entered clinical trials and others are moving steadily through the pipeline—many of which could someday save millions of lives.
"With these new partnerships, in addition to last month's pledge from the Government of Japan to contribute $130 million to GHIT's/UNDP's replenishment, recent progress has the potential to accelerate these tools even faster into the hands of the doctors, nurses and patients who need them most," said Dr. Kiyoshi Kurokawa, Chair of the Board at GHIT. "We'll be working with our partners from industry, the Gates Foundation and the Wellcome Trust to realize our full replenishment, and with that, our opportunities to change the face of R&D for global health are boundless."
The first of its kind in Japan, the GHIT Fund is a public-private partnership between the Japanese government, multiple pharmaceutical companies, the Bill & Melinda Gates Foundation, the Wellcome Trust, and UNDP. Launched in April 2013 with an initial commitment of more than US$100 million and now with capital of approximately US$140 million, the organization taps Japanese research and development (R&D) to fight neglected diseases. GHIT invests and manages a portfolio of development partnerships aimed at neglected diseases that afflict the world's poorest people. GHIT mobilizes Japanese pharmaceutical companies and academic and research organizations to engage in the effort to get new medicines, vaccines, and diagnostic tools to people who need them most, with Japan quickly becoming a game-changer in global health. For more information, please visit http://www.ghitfund.org.
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SOURCE Global Health Innovative Technology Fund (GHIT Fund)