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Moderna, Novavax among biotechs working on novel virus -- but vaccine at least a year out

At least four groups have started to develop vaccines to protect against the 2019 Novel Coronavirus (2019-nCoV) that was first detected in Wuhan, China.

Among companies working on a vaccine, Moderna Inc. (NASDAQ:MRNA) has partnered with NIH, while Novavax Inc. (NASDAQ:NVAX) shares rose sharply Tuesday on its development plans.

It will, however, take at least a year and likely close to two years for a vaccine to be available on an emergency-use basis.

There are close to 300 confirmed cases of 2019-nCoV in China including at least four deaths, according to the U.S. Centers for Disease Control and Prevention (CDC). Cases have been reported in the U.S., Thailand, Japan and South Korea; all involve travelers from China.

While the earliest cases were linked to a seafood and animal market in Wuhan, “a growing number of patients reportedly have not had exposure to animal markets, suggesting limited person-to-person spread is occurring, though it’s unclear how easily or sustainably this virus is spreading between people,” CDC said.

Based on experience with two other coronaviruses, SARS and MERS, “it’s likely that some limited person-to-person spread will continue to occur,” CDC stated.

Public health measures including the development and deployment of diagnostics, possibly supplemented by therapeutics, will be keys to containing the outbreak, Luciana Borio, VP at IN-Q-Tel, a non-profit investment firm, told BioCentury. Borio is a former director for medical and biodefense preparedness at the White House National Security Council.

The response to the outbreak has been rapid compared to previous outbreaks of new pathogens, Borio said. “It is remarkable that China has been able to detect, diagnose, and share with the world the sequence of the virus.” Chinese authorities first reported the outbreak to the WHO on Dec. 31.

Borio predicted that the new virus will “spread around the globe pretty quickly. Within four to six weeks we could see cases all over the world.” It is too early to determine if it will burn itself out quickly or if it will become a serious public health threat, she said.

Public health measures, including the effectiveness of healthcare systems in detecting and isolating patients, will be key to containing it, Borio said.

Therapeutics before vaccines

It is likely to be possible to develop therapeutics to treat 2019-nCoV much more rapidly than vaccines, Anthony Fauci, director of NIH’s National Institute of Allergy and Infectious Diseases (NIAID), told BioCentury.

NIAID plans to investigate the efficacy of existing antivirals and mAbs, Fauci said.

The hunt will start with tests to determine if mAbs against the SARS virus are effective against 2019-nCoV.

NIAID will also try to develop mAbs based on the 2019-nCoV, starting with antibodies derived from blood drawn from a patient diagnosed in the state of Washington, and possibly with samples provided by Chinese authorities, Fauci said.

NIAID is partnering with Moderna on an mRNA vaccine against 2019-nCoV, Fauci said. “We are taking the gene for the spike protein S and inserting it into a mRNA platform to create a vaccine.”

“We likely will be able, unless there are unanticipated roadblocks, to start a Phase I trial in about three months,” Fauci told BioCentury. NIAID and its Vaccine Research Center (VRD) have sufficient funds to cover the cost of developing a candidate vaccine and conducting a Phase I trial, he said.

If a decision is made to proceed with a Phase II trial, additional funding will be required, Fauci said. The fastest an investigational vaccine could be ready for use on an emergency basis is one year and it could take up to two years, he reported.

“Moderna’s mRNA vaccine technology could serve as a rapid and flexible platform that may be useful in responding to newly emerging viral threats, such as the novel coronavirus,” the company said in a statement provided to BioCentury.

“While we have not previously tested this rapid response capability, Moderna confirms that we are working with NIH/NIAID/VRC on a potential vaccine response to the current public health emergency. Moderna is committed to addressing infectious diseases and improving global public health.”

Peter Hotez, dean of the National School of Tropical Medicine at Baylor Medical School, is working on another approach. His team at Baylor has received NIH funding since 2012 to collaborate with the New York Blood Center and The University of Texas Medical Branch at Galveston on a SARS vaccine. The vaccine is based on recombinant receptor-binding domain (RBD) of the SARS-CoV spike (S) protein.

“Because there are some similarities between the new virus and SARS, it is possible that our SARS vaccine will cross-protect against the new virus,” Hotez told BioCentury. “The sequence homology looks good so far.”

If the candidate SARS vaccine is cross-protective, Baylor and its partners could start Phase I trials quickly.

Novavax has also started development of a vaccine to protect against 2019-nCoV, Gregory Glenn, the company’s president of R&D, told BioCentury.

The vaccine candidate is based on Novavax’s recombinant nanoparticle vaccine technology and would incorporate the company’s Matrix-M adjuvant.

Novavax could have a candidate ready for Phase I trials in 90 days, Glenn said.

Novavax shares rose $4.08 (71%) to $9.82 on Tuesday. Moderna rose $0.32 to $20.94.

The University of Saskatchewan's Vaccine and Infectious Disease Organization - International Vaccine Centre has also started developing a vaccine, its director and CEO, Volker Gerdts, told BioCentury.

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