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COVID-19 update: Gilead ramping up remdesivir production; Codagenix partners with vaccine giant

Gilead is ramping up manufacturing of remdesivir, which is being tested as a potential treatment for COVID-19, the company told BioCentury Thursday. Gilead said it has not been in contact with BrightGene, a Chinese company that says it is manufacturing the investigational drug.

On Wednesday, BrightGene Bio-medical technology Co. Ltd. (Shanghai:688166) announced that it has synthesized the API and is mass producing remdesivir. BrightGene said it would seek authorization from Gilead Sciences Inc. (NASDAQ:GILD) to market the drug if remdesivir is approved in China.

“We are aware of BrightGene’s announcement,” Gilead spokesperson Sonia Choi told BioCentury. “There have been no discussions with BrightGene to date and we believe any discussion of licensing is premature.”

Gilead has “accelerated manufacturing timelines to increase our available supply as rapidly as possible,” Choi said. “We are doing this before knowing whether remdesivir will be determined to be safe and effective to treat patients with COVID-19.”

Gilead’s strategies for accelerating manufacturing and increasing supply include making two different formulations of remdesivir, expanding its network of manufacturing partners, and “casting a wide net to engage new partners in multiple geographies,” Choi said. In addition, the company has started “internal manufacturing of remdesivir to supplement the capacity of our external manufacturing network.”

Choi confirmed that enrollment has started in one placebo-controlled study of COVID-19 patients with severe disease. A second placebo-controlled study will begin in mid-February.

Researchers at NIH’s National Institute of Allergy and Infectious Diseases (NIAID) reported Thursday in PNAS results of an animal study of remdesivir to treat Middle East respiratory syndrome coronavirus. MERS-CoV is closely related to COVID-19.

Animals treated 24 hours before infection had “no signs of respiratory disease, significantly lower levels of virus replication in the lungs compared to control animals, and no lung damage,” NIH reported. Animals treated 12 hours “after infection fared significantly better than the control animals: disease was less severe than in control animals, their lungs had lower levels of virus than the control animals, and the damage to the lungs was less severe.”

‘Big decisions’ on vaccines must be made soon

Readouts from clinical trials of potential therapies for COVID-19 should be available in a matter of weeks, Michael Ryan, executive director of the WHO Health Emergencies Program, told reporters Thursday.

There is an urgent need to expand trials that have been started in China and to “use similar trial protocols in other countries like Japan and Singapore so that we can pool data around the drugs that are being tried and tested,” Ryan said. “Accelerating and expanding and standardizing those trials across a larger number of sites will give us a larger number of observations and a much stronger indication as to whether those drugs are working.”

Ryan said that while it will take much longer to develop vaccines, “we have to make big decisions now about the best candidate vaccines, and they are going to require huge investments.”

He noted that advancing a vaccine into Phase III trials “requires hundreds of millions of dollars to be invested and we may have to invest in multiple candidates without any certainty that one of them will work.”

Decisions about which vaccine candidates should be tested will “not be made just by the private sector,” Ryan said. “The state sector is going to have to get involved to stimulate [R&D] and take some of the risk with the private sector to advance those potential candidates.”

Codagenix partnering with India’s Serum Institute

Codagenix Inc. Thursday announced a collaboration with the Serum Institute of India Pvt. Ltd. to co-develop a live-attenuated vaccine against COVID-19.

The Serum Institute, one of the world’s largest manufacturers of vaccines, will provide milestone-based funding of preclinical and clinical development, Codagenix CEO J. Robert Coleman told BioCentury.

If Codagenix develops a successful vaccine, the Serum Institute has committed to manufacture it, Coleman said.

Codagenix is developing a COVID-19 vaccine using its computationally designed live attenuated virus technology. It has synthesized a full-length deoptimized genome and has multiple candidates that it plans to recover in tissue culture in a biosafety level 3 (BSL) facility, Coleman said. The company will contract with one or possibly two partners with access to BSL 3 facilities and expects to begin recovery of live-attenuated strains as early as the end of next week, he said.

After the strains have been isolated it will take about two weeks to complete animal testing, Coleman said. “We could be three to four weeks away from showing a vaccine strain that is both safe and immunogenic in both primates and small animals.”

Coleman said that if Codagenix is successful, it is has “one of the best shots at making a vaccine that’s scalable.” In contrast to technologies that require higher antigen doses, “we can theoretically make a thousand doses per milliliter.”

CSL’s adjuvant

CSL Ltd. (ASX:CSL) announced Thursday that is has partnered with the University of Queensland’s COVID-19 vaccine development program.

CSL subsidiary Seqirus will provide the MF59 adjuvant to the University of Queensland, which is developing a protein-based COVID-19 vaccine with funding from the Coalition for Epidemic Preparedness Innovations (CEPI). MF59 was developed by Novartis AG (NYSE:NVS; SIX:NOVN) AG. Seqirus acquired Novartis’ influenza vaccine business, including MF59, in 2015.

Separately, GlaxoSmithKline plc (LSE:GSK; NYSE:GSK) has agreed to provide its AS03 adjuvant technology to the University of Queensland and other CEPI-funded COVID-19 vaccine developers.

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