SANOFI Phase 2 Trial for RNA Covid Vaccine Generated Strong Levels of Antibodies

Sanofi and GSK announced positive results from a Phase 2 clinical trial of their joint Covid-19 vaccine, saying it generated strong levels of neutralizing antibodies in recipients across all ages studied. The partners said a large international Phase 3 trial will begin in coming weeks.

The duo, two of the world’s largest vaccine manufacturers, is far behind in the effort to produce a Covid vaccine and lock down markets for their product, having suffered a setback in an earlier Phase 1/2 trial last year. But with vaccine supplies expected to trail global need into the foreseeable future, the companies believe there is still a place for their vaccine.

Our Phase 2 data confirm the potential of this vaccine to play a role in addressing this ongoing global public health crisis, as we know multiple vaccines will be needed, especially as variants continue to emerge and the need for effective and, which can be stored at normal temperatures increases,” Thomas Triomphe, executive vice president and head of the vaccines division at Sanofi Pasteur, said in a statement.

The companies said they will begin producing the vaccineat risk” — meaning before they are certain it will work. While there is financial uncertainty in that approach, if the vaccine does prove to be efficacious, they will have product ready to distribute as soon as the vaccine is authorized for use. The companies are projecting a possible regulatory approval in the fourth quarter of 2021.

The companies released limited information about the results of the trial, saying they will publish the data shortly in a peer-reviewed journal. But they reported the vaccine induced strong rates of neutralizing antibodies, in line with what is seen in people who have recovered from Covid-19. The favorable response was seen across all adult age groups, though there were higher levels observed in people 18 to 59 years old. There were no safety or tolerability concerns arising from the trial.

High neutralizing antibody levels were generated after a single dose in participants with evidence of prior SARS-CoV-2 infection, which the companies said suggests the vaccine could be given as a booster used after an initial vaccination series.

We believe that this vaccine candidate can make a significant contribution to the ongoing fight against Covid-19 and will move to Phase 3 as soon as possible to meet our goal of making it available before the end of the year,” said Roger Connor, president of GSK Vaccines, said in a statement.

Source: https://www.statnews.com/

Two New Trials of Coronavirus Treatment

Drugs used for treating arthritis are being tested as treatments for COVID-19, the disease caused by a new coronavirus, as researchers rush to find ways of helping patients and slowing the number of infectionsSanofi and Regeneron Pharmaceuticals said on Monday they began a clinical trial of their rheumatoid arthritis drug Kevzara as a coronavirus treatment, while in Spain a separate trial is studying if a combination of two drugs can slow down the spread of coronavirus among people. Enrolments for the mid-to-late stage trial of Kevzara, an immune-system modifying drug known as a monoclonal antibody, will begin immediately and test up to 400 patients, Sanofi and Regeneron said in a joint statement. Regeneron in February announced a partnership with the U.S. Department of Health and Human Services to develop a treatment for the new coronavirus, called SARS-CoV2, and said it would focus on monoclonal antibodies.

The virus that emerged in central China in December has now infected more than 179,000 people worldwide, according to the Johns Hopkins University, which is tracking these figures. Doctors have seen that many of those who become critically ill from SARS-CoV2 are experiencing a so-called cytokine storm, which happens when the immune system overreacts and attacks the body’s organs. Some researchers think drugs that can suppress the immune system, including monoclonal antibodies, might be useful for limiting this autoimmune response.

Meanwhile, Barcelona-based researchers said on Monday they would administer a drug used to treat HIV – containing darunavir and cobicistat – to a coronavirusinfected person. The patient’s close contacts would be administered hydroxychloroquine, a drug for malaria and rheumatoid conditions because laboratory experiments suggest it prevents this strain of coronavirus from reproducing. “The goal of our study is to separate the transmission chains,” Oriol Mitja, researcher at Germans Trias i Pujol Research Institute, told a news briefing. Patients with coronavirus can infect between 5% and 15% of the people they come into contact with during the 14 days after starting to show symptoms, he said. The trial’s goal is to reduce that number below 14 days and also to reduce the percentage of contacts infected and researchers plan to analyze the results in 21 days. Around 200 patients with coronavirus and 3,000 of their close contacts will take part in the trial, which has private and public funding.

Source: https://www.reuters.com/