NIH [to 1 April 2017]
March 31, 2017
Phase 2 Zika vaccine trial begins in U.S., Central and South America
— Study will evaluate NIH’s experimental DNA vaccine.
Vaccinations have begun in a multi-site Phase 2/2b clinical trial testing an experimental DNA vaccine designed to protect against disease caused by Zika infection. The vaccine was developed by government scientists at the National Institute of Allergy and Infectious Diseases (NIAID), part of the National Institutes of Health (NIH). NIAID is leading the trial, which aims to enroll at least 2,490 healthy participants in areas of confirmed or potential active mosquito-transmitted Zika infection, including the continental United States and Puerto Rico, Brazil, Peru, Costa Rica, Panama and Mexico. The two-part trial, called VRC 705, further evaluates the vaccine’s safety and ability to stimulate an immune response in participants, and assesses the optimal dose for administration. It also will attempt to determine if the vaccine can effectively prevent disease caused by Zika infection…
“We are pleased to have advanced rapidly one of NIAID’s experimental Zika vaccines into this next stage of testing in volunteers. We expect this study will yield valuable insight into the vaccine’s safety and ability to prevent disease caused by Zika infection,” said NIAID Director Anthony S. Fauci, M.D. “A safe and effective Zika vaccine is urgently needed to prevent the often-devastating birth defects that can result from Zika virus infection during pregnancy. Evidence also is accumulating that Zika can cause a variety of health problems in adults as well. This trial marks a significant milestone in our efforts to develop countermeasures for a pandemic in progress.”…
Antimicrobial Resistance Diagnostic Challenge selects 10 semifinalists in first phase of competition
March 27, 2017 — Each will receive $50,000 to develop prototypes of diagnostics to improve detection of drug resistant bacteria.
GHIT Fund [to 1 April 2017]
GHIT was set up in 2012 with the aim of developing new tools to tackle infectious diseases that devastate the world’s poorest people. Other funders include six Japanese pharmaceutical companies, the Japanese Government and the Bill & Melinda Gates Foundation.
GHIT Fund Invests in Late-stage Trial for Child-friendly “Snail Fever” Medicines—One of the Most Debilitating and Widespread Parasitic Diseases in Africa
Completion of Phase 3 trial for treatment of “Snail Fever” (aka schistosomiasis) is final step before regulatory and WHO submission; GHIT also announces new investment in novel malaria vaccine and therapeutic for dengue, continued support for innovative tools to tackle malaria and neglected tropical diseases
TOKYO, JAPAN (March 30, 2017)—The Global Health Innovative Technology Fund (GHIT Fund), a unique Japanese public-private partnership formed to battle infectious diseases around the globe, today announced 11 new investments totaling US$23 million* that could help deliver a range of new innovative therapies for a host of debilitating conditions.
This latest round of targeted support includes funding for a Phase 3 clinical trial testing a pediatric formulation of a drug considered the gold standard for treating schistosomiasis, a water-borne parasitic disease linked to an assortment of acute and chronic health problems. Young children are most at risk, but the existing drug is so bitter and hard to swallow that kids often go untreated, leading to serious lifelong health and learning problems.
This clinical trial is one of the most advanced partnerships invested by the GHIT Fund, an organization that combines Japan’s historic leadership in global health and innovation with groundbreaking research from across the globe. The GHIT Fund also is making new investments in two malaria vaccine candidates, while accelerating work to find new drug treatments for malaria, dengue, Chagas disease, cryptosporidiosis and leishmaniasis.
“We’re reaching an exciting phase where GHIT’s approach to partnerships and drug and vaccine development is starting to produce tangible progress towards product deployment that could eventually lead to revolutionary breakthroughs,” said BT Slingsby, MD, PhD, MPH, who is CEO of the GHIT Fund. “We knew that combining Japan’s wealth of biomedical research talent and pharmaceutical capabilities with leading infectious disease experts near and far was likely to be a winning combination, and that’s been validated by the progress we are seeing across a rich diversity of projects.”…
Hilleman Laboratories [to 1 April 2017]
Hilleman Laboratories signs MoU with NICED, ICMR to develop Shigella Vaccine
March 29th, 2017, New Delhi: Hilleman Laboratories, a joint-venture partnership between MSD and Wellcome Trust, today, signed a Memorandum of Understanding (MoU) with National Institute of Cholera and Enteric Diseases (NICED), an ICMR organization for further development and commercialization of the Shigella vaccines and other enteric vaccines for diarrheal diseases. This agreement was signed as an effort of Hilleman’s mission to make affordable vaccines for the developing world population…
Addressing the press conference at the signing-in, Dr. Davinder Gill said, “Shigella is the second most fatal organism after Rotavirus that causes severe diarrhea in children with no approved vaccine available at this time. We are pleased at this opportunity to collaborate with NICED and jointly develop Shigella vaccine for a disease whose basic pathology is not yet properly understood. NICED comes with a variety of strengths in research and developing strategies for treatment, prevention and control of enteric infections. This will also be a strategic shift for Hilleman, since till now, our focus has been to optimise existing vaccines and address the gaps in low resource settings. We will now endeavour to develop an entirely new line of treatment and we look forward to jointly abating this fatal disease which threatens the Nation’s health”.
Dr. Soumya Swaminathan added by saying, “This is a step in a new direction. India has immense potential in clinical research, drug and device manufacturing and we would like to see more of these types of partnerships to happen within the country to realize the ‘Make in India’ dream. We are keen that ICMR becomes more collaborative and partners with organizations in this direction and mutually expand capacities through cross-functional partnerships”…
Wellcome Trust [to 1 April 2017]
Published: 30 March 2017
We are pledging £125m to tackle drug-resistant infections
Wellcome is committing £125 million over five years to tackle drug-resistant infections through a transatlantic partnership, CARB-X
CARB-X, which stands for Combating Antibiotic Resistant Bacteria Biopharmaceutical Accelerator, has named its first projects to receive funding – three in the UK and eight in the US.
Drug-resistant infections kill 700,000 people a year globally. Within a generation, the death toll could be 10 million. The last new antibiotic class to be approved was discovered in 1984.
Tim Jinks, Wellcome’s Head of Drug Resistant Infections, said: “Antibiotic discovery is absolutely vital if we are to tackle drug-resistant infections, but it has been long neglected.
“New medicines and diagnosistic tools are needed so patients get better treatment. Through CARB-X, we’re filling the current void of support for early research.”
The CARB-X projects
UK biotech’s Oppilotech (opens in a new tab) and Redx (opens in a new tab) are among three projects working on potential new classes of antibiotics.
The funded projects also include four products offering new approaches to targeting and killing bacteria.
And University of Edinburgh is leading the Proteus (opens in a new tab) project to develop a new imaging tool that can rapidly diagnose bacterial lung infections and help prevent unnecessary use of antibiotics in intensive care units.
All 11 projects are targeting the most resistant and deadly Gram-negative bacteria.
Kevin Outterson, Executive Director of CARB-X, said: “The projects in the new CARB-X portfolio are in the early stages of research, and there is always a high risk of failure. But if successful, these projects hold exciting potential in the fight against the deadliest antibiotic-resistant bacteria.”
The aim is that over five years CARB-X funding will result in 20 new antibiotic products, and that at least two will progress to clinical trials for a medicine safe for human use.
Wellcome is calling on other governments and organisations to support CARB-X…
Global Fund [to 1 April 2017]
Global Fund Names Sylvie Billion Interim Chief Financial Officer
31 March 2017
The Global Fund to Fight Aids, Tuberculosis and Malaria today announced that Sylvie Billion, Deputy CFO and Treasurer, will become Interim Chief Financial Officer.
Japan Secures US$313 million Contribution to the Global Fund
27 March 2017
The Global Fund to Fight AIDS, Tuberculosis and Malaria welcomes the Japanese Diet’s passage of the fiscal 2016 supplementary budget and the fiscal 2017 budget, which includes Japan’s contribution of US$313 million to the Global Fund.
UNAIDS [to 1 April 2017]
UNAIDS welcomes David Beasley as new Executive Director of the World Food Programme
GENEVA, 31 March 2017—UNAIDS welcomes the appointment of David Beasley as the Executive Director of the World Food Programme (WFP).
“The appointment of David Beasley comes at a critical moment,” said UNAIDS Executive Director Michel Sidibé. “WFP’s work to achieve food security is at the heart of global efforts to break the cycle of hunger and poverty and essential to achieving the Sustainable Development Goals which include ending the AIDS epidemic.”…
PATH [to 1 April 2017]
Press release | March 28, 2017
Carla Sandine to oversee PATH’s cross-cutting communications efforts on global health innovation and impact
Seattle-born entrepreneur sells Phoenix marketing agency to lead communications for PATH
FDA [to 1 April 2017]
What’s New for Biologics
:: March 24, 2017 Approval Letter – Prevnar 13 (PDF – 32KB)
Industry Watch [to 1 April 2017]
:: Takeda’s Dengue Vaccine Candidate Elicited Broad Immune Responses in Children and Adolescents Living in Dengue-Endemic Areas; Interim Phase 2 Analysis Published in The Lancet Infectious Diseases
– Analysis showed two doses of the vaccine candidate induced antibody responses against all four types of dengue virus in a large population of participants ages two through 17
– No safety concerns were observed, further supporting the vaccine candidate’s safety profile
March 29, 2017