Covid-19 roundup: SAB's antibody treatments move to PhIII; After long journey, Novavax submits vaccine to WHO for review
A day after the company lands another $60.5 million to help advance an antibody Covid-19 treatment, SAB Biotherapeutics has announced a positive review from the Data Monitoring Safety Board, and will move into Phase III trials.
Both of the doses tested in a Phase II trial met the pre-trial efficacy goals, the company says, though trial results have not yet been posted to the clinicaltrials.gov website.
SAB-185 specifically targets polyclonal antibodies without the need for human donors. While monoclonal antibodies use identical immune cells that are clones of a specific parent cell, polyclonal antibodies are made through several different immune cells. SAB-185 used genetically engineered cattle to make antibodies.
The DSMB recommended the move to Phase III for the treatment of non-hospitalized patients with mild to moderate Covid-19. Phase III will compare the treatment to active monoclonal antibody treatment in about 600 participants. SAB is looking to bring the third FDA authorized antibody treatment to the US, after Regeneron, Eli Lilly and GSK/Vir Biotechnology.
“Advancement of SAB-185 to Phase 3 is a major milestone for our DiversitAb™ immunotherapy platform, which uniquely produces fully-human targeted polyclonal antibodies that have broad applicability to treating other infectious diseases and medical conditions,” SAB CEO Eddie Sullivan said in a press release. “The recent publication of nonclinical data demonstrating SAB-185’s potent neutralization of multiple emerging SARS-CoV-2 variants provided additional evidence that SAB-185 has the potential to become a valuable therapy for mild to moderate COVID-19. We now look forward to the completion of the Phase 3 trial and if successful, the opportunity to make SAB-185 widely available to the many COVID-19 patients battling this persistent and evolving disease.”
The polyclonal antibody was developed with the US government using the DiversitAb Rapid Response Antibody Program, as part of Operation Warp Speed. SAB says that in nonclinical studies, the treatment has shown neutralization of the Delta and Lambda strains.
SAB is set to merge with Big Cypress Acquisition Corp. later this year.
After long journey, Novavax submits vaccine to WHO for review
Another Covid-19 vaccine has been submitted to the World Health Organization to be reviewed for emergency use listing.
Novavax’s recombinant nanoparticle protein-based candidate, made in collaboration with The Serum Institute of India, is headed to the regulators. The submission is based on the previous submission to Indian regulators. An OK from the WHO is a requirement to export doses to the COVAX vaccine sharing program.
“Today’s submission of our protein-based COVID-19 vaccine to WHO for emergency use listing is a significant step on the path to accelerating access and more equitable distribution to countries in great need around the world,” CEO Stanley Erck said in a press release.
The announcement comes after the timeline for an FDA emergency use approval has already been pushed back several times, most recently with the biotech announcing in its Q2 review that it would be in Q4. A New York Times report raised concerns surrounding a note from the FDA stating that the company’s manufacturing future and the funding that it was receiving from the US government was dependent on getting its production process to FDA standards.
The company’s gone through some ups and downs during the pandemic, including landing $2 billion in funding, and manufacturing struggles that led to other companies beating them to the finish line in the hunt for a vaccine.
NVX-CoV2373 is currently in two Phase III trials, one of which demonstrated 89% efficacy against the virus and another that suggested 90% efficacy.
India to ship Sputnik Light doses elsewhere
Sputnik Light has yet to be approved in India, and the country will likely export its batches of the vaccine produced in-country later this month, Reuters reports.
Indian drugmaker Hetero has already manufactured 2 million doses of the single-shot vaccine, according to Reuters. Sputnik Light is the first of the two-shot Sputnik V vaccine that has been authorized in India, and while Light has been approved elsewhere, Indian regulators are holding out for another clinical trial.
So far, India has administered 907,766 Sputnik V vaccines out of the 839 million it’s given out so far, Reuters said.
Cadila lands a manufacturing partner
Shilpa Medicare Limited will produce Cadila’s three-dose Covid-19 vaccine in India, the company said Friday.
India gave Cadila’s jab emergency approval in August for adults and children above the age of 12. The company looks to make between 100 million and 120 million doses a year.
The jab, dubbed ZyCoV-D, is the world’s first Covid-19 DNA shot. Shilpa will make the drug substance, and the vaccine is set to be in supply in October.
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