CORRECTING and REPLACING Medicago and GSK Announce Start of Phase 2/3 Clinical Trials of Adjuvanted COVID-19 Vaccine Candidate - Business Wire | Canada News Media
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CORRECTING and REPLACING Medicago and GSK Announce Start of Phase 2/3 Clinical Trials of Adjuvanted COVID-19 Vaccine Candidate – Business Wire

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QUEBEC CITY, Quebec & LONDON–(BUSINESS WIRE)–Please replace the release with the following corrected version due to multiple revisions.

The updated release reads:

MEDICAGO AND GSK ANNOUNCE START OF PHASE 2/3 CLINICAL TRIALS OF ADJUVANTED COVID-19 VACCINE CANDIDATE

The COVID-19 vaccine candidate will contain GSK’s pandemic adjuvant

Phase 3 part of clinical trial to enroll over 30,000 volunteers worldwide

Medicago, a biopharmaceutical company headquartered in Quebec City, and GSK are pleased to announce the start of Phase 2/3 clinical trials of its plant-derived vaccine candidate for COVID-19 to evaluate its efficacy, safety, and immunogenicity. Based on the positive Phase 1 results and the approval of Canadian regulatory authorities, Medicago has decided to launch the Phase 2/3 clinical trial with GSK’s pandemic adjuvant.

“Our Phase 1 results of the adjuvanted vaccine candidate were very encouraging and fully support further clinical evaluation,” said Nathalie Landry, Executive Vice President, Scientific and Medical Affairs at Medicago.

Thomas Breuer, Chief Medical Officer GSK Vaccines said “This is the first of several GSK COVID-19 vaccine candidate collaborations to start Phase 2/3 clinical testing and an important step forward in our contribution to the global fight against the pandemic. We are delighted with the very promising Phase 1 results of Medicago’s COVID-19 vaccine candidate in combination with GSK’s pandemic adjuvant. Proven dose-sparing and a high immune response due to GSK’s adjuvant make us confident of delivering an efficacious vaccine with an acceptable safety profile in collaboration with Medicago.”

The Coronavirus-Like Particle COVID-19 vaccine candidate (CoVLP) is composed of recombinant spike (S) glycoprotein expressed as virus-like particles (VLPs).

The study is a multi-portion design to confirm that the chosen formulation and dosing regimen of CoVLP (two doses of 3.75 µg CoVLP combined with GSK’s pandemic adjuvant given 21 days apart) has an acceptable immunogenicity and safety profile in healthy adults 18-64 years of age and in elderly subjects aged 65 and over.

The Phase 2 trial part is a randomized, observer-blind, placebo-controlled study to evaluate the safety and immunogenicity of the adjuvanted recombinant COVID-19 plant-derived vaccine candidate in subjects aged 18 and above. It will be conducted in multiple sites in Canada and, upon FDA allowance, in the United States and on a population composed of healthy adults (18-64y) and elderly adults (over 65y). Each age group will have over 300 subjects randomized 5:1 to receive the adjuvanted CoVLP vaccine candidate: placebo and with 2:1 stratification in older adults (65-74 and ≥75). All subjects will be followed for a period of 12 months after the last vaccination for the assessment of safety and durability of the immune responses to the vaccine candidate.

The Phase 3 part of the study should start before the end of 2020 and is an event-driven, randomized, observer-blinded, placebo-controlled design that will evaluate the efficacy and safety of the CoVLP formulation, compared to placebo, in over 30,000 subjects in North America, Latin America and/or Europe and within the same population, or – alternatively – amongst a broader one pending approval by regulatory authorities.

About Medicago

Medicago is a biopharmaceutical company and pioneer in plant-derived therapeutics. Founded in 1999 with the belief that innovative approaches and rigorous research would bring new solutions in healthcare.

Our mission is to improve global health outcomes by leveraging innovative plant-based technologies for rapid responses to emerging global healthcare challenges. Medicago is committed to advancing therapeutics against life-threatening diseases worldwide. Our team includes over 450 scientific experts and employees in Canada and the United States and academic affiliations in Europe and South Africa.

Medicago has previously demonstrated its capability to be a first responder in a flu pandemic. In 2009, the company produced a research-grade vaccine candidate against H1N1 in just 19 days. In 2012, Medicago manufactured 10 million doses of a monovalent influenza vaccine candidate within one month for the Defense Advanced Research Projects Agency (DARPA), part of the U.S. Department of Defense. In 2015, Medicago also demonstrated in principle that it could rapidly produce an anti-Ebola monoclonal antibody cocktail for the Biomedical Advanced Research and Development Authority (BARDA), part of the U.S. Department of Health and Human Services.

For more information: www.medicago.com

To learn more about our plant-based technology: Video / Website

About GSK and its commitment to tackling COVID-19

GSK is a science-led global healthcare company with a special purpose: to help people do more, feel better, live longer. For further information please visit www.gsk.com/about-us.

GSK is collaborating with companies and research groups across the world working on promising COVID-19 vaccine candidates through the use of our innovative vaccine adjuvant technology. The use of an adjuvant is of particular importance in a pandemic situation since it may reduce the amount of vaccine protein required per dose, allowing more vaccine doses to be produced and therefore contributing to protecting more people. GSK does not expect to profit from COVID-19 vaccines during the pandemic phase, and will invest any short-term profit in coronavirus related research and long-term pandemic preparedness, either through GSK internal investments or with external partners.

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Whooping cough is at a decade-high level in US

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MILWAUKEE (AP) — Whooping cough is at its highest level in a decade for this time of year, U.S. health officials reported Thursday.

There have been 18,506 cases of whooping cough reported so far, the Centers for Disease Control and Prevention said. That’s the most at this point in the year since 2014, when cases topped 21,800.

The increase is not unexpected — whooping cough peaks every three to five years, health experts said. And the numbers indicate a return to levels before the coronavirus pandemic, when whooping cough and other contagious illnesses plummeted.

Still, the tally has some state health officials concerned, including those in Wisconsin, where there have been about 1,000 cases so far this year, compared to a total of 51 last year.

Nationwide, CDC has reported that kindergarten vaccination rates dipped last year and vaccine exemptions are at an all-time high. Thursday, it released state figures, showing that about 86% of kindergartners in Wisconsin got the whooping cough vaccine, compared to more than 92% nationally.

Whooping cough, also called pertussis, usually starts out like a cold, with a runny nose and other common symptoms, before turning into a prolonged cough. It is treated with antibiotics. Whooping cough used to be very common until a vaccine was introduced in the 1950s, which is now part of routine childhood vaccinations. It is in a shot along with tetanus and diphtheria vaccines. The combo shot is recommended for adults every 10 years.

“They used to call it the 100-day cough because it literally lasts for 100 days,” said Joyce Knestrick, a family nurse practitioner in Wheeling, West Virginia.

Whooping cough is usually seen mostly in infants and young children, who can develop serious complications. That’s why the vaccine is recommended during pregnancy, to pass along protection to the newborn, and for those who spend a lot of time with infants.

But public health workers say outbreaks this year are hitting older kids and teens. In Pennsylvania, most outbreaks have been in middle school, high school and college settings, an official said. Nearly all the cases in Douglas County, Nebraska, are schoolkids and teens, said Justin Frederick, deputy director of the health department.

That includes his own teenage daughter.

“It’s a horrible disease. She still wakes up — after being treated with her antibiotics — in a panic because she’s coughing so much she can’t breathe,” he said.

It’s important to get tested and treated with antibiotics early, said Dr. Kris Bryant, who specializes in pediatric infectious diseases at Norton Children’s in Louisville, Kentucky. People exposed to the bacteria can also take antibiotics to stop the spread.

“Pertussis is worth preventing,” Bryant said. “The good news is that we have safe and effective vaccines.”

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AP data journalist Kasturi Pananjady contributed to this report.

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The Associated Press Health and Science Department receives support from the Robert Wood Johnson Foundation. The AP is solely responsible for all content.

The Canadian Press. All rights reserved.

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Scientists show how sperm and egg come together like a key in a lock

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How a sperm and egg fuse together has long been a mystery.

New research by scientists in Austria provides tantalizing clues, showing fertilization works like a lock and key across the animal kingdom, from fish to people.

“We discovered this mechanism that’s really fundamental across all vertebrates as far as we can tell,” said co-author Andrea Pauli at the Research Institute of Molecular Pathology in Vienna.

The team found that three proteins on the sperm join to form a sort of key that unlocks the egg, allowing the sperm to attach. Their findings, drawn from studies in zebrafish, mice, and human cells, show how this process has persisted over millions of years of evolution. Results were published Thursday in the journal Cell.

Scientists had previously known about two proteins, one on the surface of the sperm and another on the egg’s membrane. Working with international collaborators, Pauli’s lab used Google DeepMind’s artificial intelligence tool AlphaFold — whose developers were awarded a Nobel Prize earlier this month — to help them identify a new protein that allows the first molecular connection between sperm and egg. They also demonstrated how it functions in living things.

It wasn’t previously known how the proteins “worked together as a team in order to allow sperm and egg to recognize each other,” Pauli said.

Scientists still don’t know how the sperm actually gets inside the egg after it attaches and hope to delve into that next.

Eventually, Pauli said, such work could help other scientists understand infertility better or develop new birth control methods.

The work provides targets for the development of male contraceptives in particular, said David Greenstein, a genetics and cell biology expert at the University of Minnesota who was not involved in the study.

The latest study “also underscores the importance of this year’s Nobel Prize in chemistry,” he said in an email.

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The Associated Press Health and Science Department receives support from the Howard Hughes Medical Institute’s Science and Educational Media Group. The AP is solely responsible for all content.

The Canadian Press. All rights reserved.

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Turn Your Wife Into Your Personal Sex Kitten

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