Mercadon stopped developing coVID-19 vaccine candidates

January 25, Mercadon announced that it would stop developing COVID-19 candidate vaccines V590 and V591, and plans to focus its COVID-19 research strategy and production capacity on advancing MK-4482 and MK-7110 therapeutic candidates.The decision came after Mercedon reviewed the results of its Vaccine Phase 1 clinical study. In the study, both V590 and V591 showed good tolerance, but their immune responses were lower than those of other SARS-CoV-2/COVID-19 vaccines after natural infection. Mercator and its partners plan to submit the results of the V590 and V591 Clinical Studies 1 to peer-reviewed journals for publication."The results of the first phase of the trial were disappointing and a bit of a surprise," said Nick Kartsonis, senior vice president of clinical research for infectious diseases and vaccines at Mercedon Research Laboratory. Both vaccines produce fewer meso-antibodies than the other COVID-19 vaccines. "We don't have what we need to move forward," Kartsonis told Bloomberg on Sunday.We don't yet know how bad the two vaccines are until the first study is published, but the U.S. Food and Drug Administration (FDA) has long said it is willing to approve any vaccine that protects more than 50 percent from the virus. At the same time, Mercadon decided to continue the SARS-CoV-2/COVID-19 study and expand the research and production scale of the two experimental drugs MK-7110 and MK-4482 (molnupvirvir).In May 2020, Mercadon teamed up with Ridgeback Therapeutics, Florida, to develop an oral antiviral candidate drug, MK-4882. Then, in November 2020, Mercado acquired OncoImmune, a Maryland-based company, for $425 million in cash advances and acquired its COVID-19 candidate drug CD24Fc (MK-7110).MK-7110 (formerly known as CD24Fc) is a potentially first-class research recombination protein that regulates the inflammatory response to SARS-CoV-2 by targeting a new immunologic pathway checkpoint, Mercadon said. The interim results of a Phase 3 clinical study showed that the drug reduced the risk of death or respiratory failure by more than 50 percent in patients with moderate to severe COVID-19. The full results of this study are expected to be published in the first quarter of 2021. In December 2020, Mercadon announced a supply agreement with the U.S. government to advance the manufacturing and initial distribution of the MK-7110 (link).Molnupiravir (MK-4482) is a new oral antiviral drug that is being developed in collaboration with Ridgeback Bio. Molnupiravir is currently conducting Phase 2/3 clinical trials in hospitals and outpatient clinics. The main completion date for the Phase 2/3 study is May 2021. Mercer expects preliminary efficacy data to be available in the first quarter of 2021, and Merck plans to make them public if clinically significant.In addition, Mercadon will continue to assess the potential of measles virus vectors and blistered oral disease vector platforms and seek a broader COVID-19 pandemic response capacity. The COVID-19 pandemic shows that companies and the pharmaceutical industry as a whole need to continue to invest in research to address health and safety threats, Mercedon said.Mercedon announced its acquisition of Austrian-based Themis in May 2020, acting belatedly in the COVID-19 vaccine race. Because Mercadon has a history of successful vaccine development, it was somewhat surprising when they entered the field of COVID-19 vaccine research and development so late. They chose a traditional vaccine development method that uses weak viruses. V590 uses the company's Ebola vaccine technology, V591 technology is based on the measles vaccine used in Europe. The company is not completing volunteer recruitment for Phase 1 clinical studies until the end of 2020, when Pfizer/BioNTech and Moderna are already reporting data from Phase 3 studies and submitting applications for Emergency Use Authorization (EUA) to the FDA. Currently, these two COVID-19 vaccines are being used throughout the United States and Europe, but there is already a serious shortage of products. With U.S. health officials struggling to address the slower-than-expected pace of vaccine launches, and with many developed countries facing an uncertain future, the need for more vaccines is becoming increasingly important."There is reason to believe that multiple vaccines are needed to address this unusual global epidemic, especially when we consider the heterogeneity of the people we want to vaccinate," Roger Perlmutter, the former chief executive of Mercer East's research and development division, said on the company's Q2 earnings conference call in 2020. But just after Sanofi and GlaxoSmithKline were forced to restart their search for an effective SARS-CoV-2 vaccine, Mercadon, one of the world's largest vaccine makers, is starting to pull out. In the near term, both setbacks will make it more difficult to produce enough vaccines.In December 2020, Sanofi and GlaxoSmithKline delayed the start of their Phase III trial because of a lack of immune response in older patients in their clinical trials. So if possible, they will delay it until the end of 2021. In addition, vaccines from Johnson and Johnson, AstraZeneta/Oxford University and Novavax, which have been approved in the UK, have shown hope, but they are not universal.Data are likely to be released this week or next in the third phase of the Johnson and Johnson vaccine trials. On January 14, 2021, the company released interim Phase I/II data for the vaccine, which produced an immune response that lasted at least 71 days and was between the ages of 18 and 55. The data showed that the vaccine induced an immune response and was generally well-to-do. More than 90 percent of the volunteers observed a meso-antibody against the SARS-CoV-2 virus on the 29th day and 100 percent of the 18-55 year olds were vaccinated once on the 57th day.Vaccines developed by AstraZeneta and Oxford University have been licensed in the UK and are awaiting approval in the US. Like the Pfizer/BioNTech and Modelna vaccines, it requires two doses, three to four weeks apart. Another vaccine under development comes from Novavax. The Australian Therapeutic Goods Authority (TGA) this week approved an interim decision on the company's vaccine, meaning it can apply for provisional registration, a step before clinical data is submitted for provisional approval. Novavax is also conducting another trial in the UK, registering more than 15,000 volunteers. Data are expected to be released this quarter. In the United States, Novavax's clinical trials began on December 28, 2020. (Sina Pharmaceutical News
): 1.Merck Shutters COVID-19 Vaccine Programs, Shifts Focus to Therapeutics 2.Merck Discontinues Development of SARS-CoV-2/COVID-19 Vaccine Candidates; Continues Development of Two Investigational Therapeutic Candidates