China’s National Medical Products Administration has signed off on a clinical trial evaluating a COVID-19 vaccine made with proteins grown in insect cells, an approach that could speed up large-scale production.
The trial will be conducted by the West China Hospital of Sichuan University in Chengdu.
The vaccine prevented infection with no obvious side effects in a non-human primate study.
Chinese authorities also announced that they have been testing a potential coronavirus vaccine in a select group of workers, primarily border officials and health workers, since July, the first confirmation by any country of such activity outside of clinical trials.
Danaher Corp.’s Beckman Coulter division Monday said it would begin shipping its Access SARS-CoV-2 Immunoglobulin M antibody test to U.S. diagnostics labs.
The new test demonstrated 99.9% specificity against 1,400 negative samples and 98.3% sensitivity at 15 to 30 days after the onset of symptoms, Beckman Coulter said.
The company said its test targets antibodies that recognize the receptor binding domain of the spike protein that SARS-CoV-2 uses to bind to a human cell receptor. This is significant as antibodies that target the RBD have the potential to be neutralizing and thus prevent future infection by blocking the virus from entering the cell, the company said.
The test provides information about an individual’s immune status with a positive predictive value of 95.5% even when disease incidence in a population is as low as 3%, said Julie Sawyer Montgomery, the president of Beckman Coulter.
The Brea, Calif., company also said it is awaiting U.S. Food and Drug Administration emergency-use authorization for its interleukin-6 test, which could provide valuable information in clinical decision-making for Covid-19 patients.
The National Institutes of Health plans to independently explore whether a Gilead Sciences (GILD) compound, which some academics maintain is highly similar to remdesivir, but which the company has deemphasized in its efforts, may be useful in combating Covid-19.
The compound, called GS-441524, works in the same way as remdesivir to inhibit viruses, according to research that was conducted partly by the company. But the compound has not been tested in humans and, for the past few months, a pair of researchers at the University of Texas MD Anderson Cancer Center has argued publicly that Gilead ought to run tests.
Now, the NIH’s National Center for Advancing Translational Sciences is curious. Scientists at the institute have “reviewed the literature and agree that this compound merits further exploration,” according to an Aug. 20 letter sent to MD Anderson researchers and the advocacy group Public Citizen, which recently wrote to the NIH and the Food and Drug Administration in hopes of pressuring Gilead to conduct studies.
“We are planning to independently test the therapeutic hypothesis for GS-441524 in treating SARS-CoV-2, [which causes Covid-19], and have informed our colleagues at [the National Institute of Allergy and Infectious Diseases] about our plans for preclinical studies. We expect to conduct these studies quickly and make the results available to the research community for further consideration,” the agency said in the letter.
The compound actually made headlines for a different reason earlier this year. GS-441524 has been sold on black markets to repel feline infectious peritonitis, a disease in cats caused by a different coronavirus than the virus that causes Covid-19.
Lab tests have suggested GS-441524 is active against SARS-CoV-2, and it is apparently similar or superior to the effects of remdesivir at levels that do not cause much toxicity, according to the Anderson researchers, who want to run their own tests. They also maintain the compound is more easily synthesized than remdesivir, so it should be easier to create oral versions and make higher doses.
Earlier this month, the drug maker explained there were several reasons for pursuing remdesivir instead. These include evidence indicating remdesivir is more effective in test tubes and animal models than GS-441524 in blocking viral replication, and was also more active in lab tests against multiple coronaviruses, include SARS-CoV-2.
The company and the researchers sparred over such issues as toxicology findings in both remdesivir and GS-441524. So far, though, the drug maker has not offered to cooperate in their research. A Gilead spokesman recently noted that additional preclinical studies to further compare remdesivir and GS-441524 have begun. We asked for an update and will pass along any reply.
One of the Anderson researchers, Victoria Yan, a graduate research assistant specializing in phosphate chemistry, wrote us that she is “really excited” by the NCATS decision. But she added the researchers are still seeking permission from Gilead to use data on the compound that is on file with the FDA. She is hopeful any data generated by NCATS can support their own investigational drug application to the FDA.
Travel-related stocks have picked up steam during afternoon trading on hopes that therapeutic and vaccine developments will propel booking demand in the near future. In China, word is that people working in high-risk jobs have been given a vaccine from Sinopharm since July. That follows news of a therapeutic in the U.S. that reduces the fatality rate by 35%.
Carnival (CCL +10.3%), Travelzoo (TZOO +11.1%), MakeMyTrip (MMYT +7.3%), Norwegian Cruise Line Holdings (NCLH +8.1%), Expedia (EXPE +4.7%), Sabre (SABR +5.5%), TripAdvisor (TRIP +4.7%), Booking Holdings (BKNG +2.4%) and Royal Caribbean (RCL +4.7%) are all higher on the day.
The U.S. Global Jets ETF (NYSEARCA:JETS) is up a strong 4.46%, led by top gains for top holdings Southwest Airlines (LUV +5.4%), Delta Air Lines (DAL +8.3%) and United Airlines (UAL +9.1%). See JETS holdings.
BofA analyst Scott Puckhaber has initiated coverage on Retrophin (RTRX +3.9%) with a Buy rating and $30 (56% upside) price target.
Topline data from two Phase 3 clinical trials evaluating lead candidate sparsentan are expected in H2 2021 in two kidney indications, ahead of previous guidance of H1 2022 mentioned in its Q2 conference call.
He sees ~30% downside in the event if the trials are unsuccessful, but over 100% upside if both studies are winners.
Stryker (SYK -0.1%) has launched Surpass Evolve Flow Diverter, a 64-wire cobalt chromium flow diverter designed to re-direct blood flow and promote aneurysm healing.
Since its launch in Europe last year, Surpass Evolve has been approved in 45+ countries.
Mark Paul, president of Stryker’s Neurovascular division, added, “Surpass Evolve is our fourth PMA approval and second flow diverter approved by the FDA in the last two years.”
