2021 Biopharma Update on the Novel Coronavirus: February 2
News information is not all-inclusive and updates are published once a week on Tuesdays.
Testing Therapies, Antivirals and Vaccines
After months of touting its efficacy to the western world, the efficacy of Russia’s Sputnik V vaccine has been validated in a peer-reviewed study published in The Lancet.
China’s Clover Biopharmaceuticals is spurning GlaxoSmithKline’s adjuvant vaccine technology in favor of one created by California-based Dynavax Technologies. Clover announced it will initiate a Phase II/III study of its protein-based S-Trimer COVID-19 vaccine candidate adjuvanted with Dynavax's CpG 1018 plus alum in the first half of this year.
The results are in from Janssen (Johnson & Johnson's) global Phase III ENSEMBLE clinical trial, and its single-shot vaccine is 66% effective overall in preventing moderate-to-severe COVID-19, 28 days after vaccination. On the surface, these results do not appear to be overly impressive, dwarfed by Pfizer/BioNTech’s 90% and Moderna’s 94.5%. But this isn’t the whole story. Click here for more information.
Shares of Novavax soared more than 44% in premarket trading after the company announced a first Phase III analysis of its COVID-19 vaccine candidate which shows the medication demonstrated 89.3% efficacy in a large-scale study conducted in the United Kingdom that included the most common strain of the virus, as well as variants.
Following newly-released vaccine data from both Novavax and Johnson & Johnson, analytics company GlobalData said the vaccine developed by J&J may be better used to control the outbreak. J&J posted a 66% efficacy with its single-dose, while the Novavax vaccine demonstrated 89.3% efficacy in a U.K. study. GlobalData said twice as many people can become vaccinated with the J&J shot in the same time frame it will take to deliver the two-dose Novavax medication. More of the analysts’ thoughts can be found here.
Covaxx announced the Taiwan Ministry of Health and Welfare granted conditional approval to begin a Phase II trial of UB-612, its COVID-19 vaccine candidate. It is a multitope protein/peptide-based vaccine.
Abpro Corporation announced results from a Phase I trial of its ABP 300-, a human neutralizing antibody against COVID-19 derived from recovered patients. It was conducted in 42 healthy subjects. After it was finished in December 2020, several Phase II/III registrational studies were initiated recently.
CalciMedica presented new clinical data from its trial of Auxora in severe COVID-19 pneumonia. In the study, 17 patients with severe COVID-19 pneumonia were randomized to receive Auxora, a potent and selective small molecule CRAC channel inhibitor, plus standard of care, and nine patients received only standard of care. The data demonstrated that levels of D-dimer, a key marker of clotting and inflammation, decreased in patients receiving Auxora and SOC but increased in patients receiving SOC alone.
A DNA plasmid vaccine candidate developed by India’s Zydus Cadila is showing efficacy against COVID-19 in animal models. Following a dosing regimen, a strong immune response was noted in the animals injected with the vaccine. Details of the study were posted at bioRxiv.
The data is continuing to come in on the various COVID-19 variants, and so far the news is pretty good. Pfizer and BioNTech announced that their COVID-19 vaccine appears effective against an engineered virus developed with three key mutations found in the South African variant. This was conducted in a laboratory test by Pfizer and the University of Texas Medical Branch (UTMB).
Regeneron Pharmaceuticals announced positive initial data from its ongoing Phase III trial of its antibody cocktail, REGEN-COV, as a passive vaccine to prevent COVID-19 in people at high risk of infection from household exposure.
New research suggests an over-the-counter nasal spray is effective at significantly reducing and nearly eliminating SARS-CoV-2, the virus that causes COVID-19 after a single dose.
Organizational Actions/Announcements
The pharmaceutical industry continues to demonstrate its willingness to team up in the ongoing combat against the global COVID-19 pandemic. Last week, two pharma giants have agreed to leverage their manufacturing capabilities to produce the mRNA vaccine developed by Pfizer and BioNTech. Both Sanofi and Novartis entered into agreements to support the manufacturing and supply of the COVID-19 vaccine that has been authorized for use in the United States, the United Kingdom and elsewhere.
Vir Biotechnology, Eli Lilly and GlaxoSmithKline struck a three-way collaborative deal to evaluate Vir's investigational monoclonal antibody, VIR-7831, in combination with Lilly’s bamlanivimab in low-risk patients with mild to moderate COVID-19.
Other Industry News
There is some research going on to determine ways of increasing the availability of COVID-19 vaccines. One new study suggests that people who had previously had more severe symptoms of a COVID-19 infection may require only a single shot of the vaccines. This appears to be related to this patient group having the most severe reactions to the first shot of the Pfizer-BioNTech or Moderna mRNA vaccines.
A study in Scientific Reports of a subgroup of COVID-19 patients found an increased risk of bleeding. This is related to the well-known incidences of COVID-19 patients having a high risk of blood clots, which could result in strokes or heart attacks. In this subgroup, they appear to have an unbalanced ability to break down blood clots, which is good for removing the clots but then provides a greater risk of uncontrolled bleeding.
The need for sharing information across the medical research landscape was never starker than during the early days of the COVID-19 pandemic. A spirit of urgency and collaboration broke down traditional informational barriers as industry and academia organized like never before in modern history to develop a vaccine in just nine months. The life sciences ecosystem will need to capitalize on this momentum going forward to solve other diseases that will define the 21st century. Click here for more information.