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Biopharma companies, academics, governments racing to develop medical countermeasures against novel coronavirus

The rapid sharing of the genetic sequence of the 2019 novel coronavirus (2019-nCoV), first identified in Wuhan, China, has sparked an extraordinary response from biopharma companies, academic researchers and governments.

At least seven initiatives to develop protective vaccines have been announced and at least three separate programs are under way to develop mAbs as potential therapeutics.

An international coalition is funding three 2019-nCoV vaccine development projects through Phase I, and several companies are using their own funds to start development.

No organization, however, has stepped forward to announce that it would fund Phase II trials or manufacturing. In previous outbreaks a number of companies that announced vaccine development plans never conducted clinical trials.

The Biomedical Advanced Research and Development Authority (BARDA), part of the U.S. HHS responsible for funding the development of medical countermeasures, does not have funding available for 2019-nCoV product development.

BARDA has “contracts in place that could be considered for use to initiate product development activities if funds become available,” an HHS spokesperson told BioCentury. “However, it is important to note that BARDA does not currently have adequate funding to initiate product development activities for this novel coronavirus or other emerging infection diseases. If funding becomes available, we would be positioned to be able to initiate activities quickly.”

Vaccines
The Coalition for Epidemic Preparedness Innovations (CEPI) -- a non-profit organization founded by the governments of Norway and India, the Bill & Melinda Gates Foundation, the Wellcome Trust, and the World Economic Forum -- is funding 2019-nCoV vaccine programs at Moderna Inc. (NASDAQ:MRNA), Inovio Pharmaceuticals Inc. (NASDAQ:INO) and The University of Queensland.

Moderna is developing an mRNA vaccine in partnership with the Vaccine Research Center (VRC) at NIH’s National Institute of Allergy and Infectious Diseases. NIAID has committed to conduct IND-enabling studies and a Phase I clinical study, the company said.

Inovio has received a grant of up to $9 million from CEPI for preclinical and Phase I testing of INO-4800, an investigational 2019-nCoV DNA vaccine.

CEPI is also funding an initiative at the University of Queensland to use its “molecular clamp” vaccine platform to develop a 2019-nCoV vaccine. The technology involves “synthesizing viral surface proteins, which attach to host cells during infection, and ‘clamping’ them into shape, making it easier for the immune system to recognize them as the correct antigen,” CEPI said.

Codagenix Inc. has started work on a 2019-nCoV vaccine using the company’s technology that uses a computer algorithm to create a live attenuated virus, J. Robert Coleman, the company’s co-founder and CEO, told BioCentury.

Novavax Inc. (NASDAQ:NVAX) has announced that it has started development of a 2019-nCoV vaccine using its nanoparticle technology.

The Texas Children's Hospital Center for Vaccine Development at Baylor College of Medicine is developing a virus-like particle 2019-nCoV vaccine. It is collaborating with the University of Texas Medical Branch, the New York Blood Center and the Virology Center at Fudan University in Shanghai, Peter Hotez, dean of the National School of Tropical Medicine at Baylor Medical School, told BioCentury.

The University of Saskatchewan's Vaccine and Infectious Disease Organization - International Vaccine Centre has also started developing an engineered protein-based vaccine.

Therapeutics
At least three groups have announced their intention to develop mAbs to treat 2019-nCoV.

Regeneron Pharmaceuticals Inc. (NASDAQ:REGN) is “starting work on a therapeutic antibody approach to the new coronavirus, though we are in very early stages,” the company told BioCentury Thursday.

Regeneron is conducting a Phase I trial of REGN3048-3051, a mAb to treat another coronavirus, Middle East respiratory syndrome (MERS). The company's mAb REGN-EB3 is being used to treat Ebola patients in the Democratic Republic of the Congo (see “Two Ebola Therapies Best ZMapp in Congo Trial”).

Vir Biotechnology Inc. (NASDAQ:VIR) announced on Wednesday that it is evaluating whether its previously identified anti-coronavirus mAbs bind and neutralize 2019-nCoV. It is also exploring the isolation of new mAbs specific for the virus.

In addition, Vir said it plans to use whole genome CRISPR-based screening to identify the host receptor that allows 2019-nCoV infection as a first step in identifying other therapeutic approaches.

NIH’s NIAID plans to develop a mAb therapeutic for the virus, NIAID Director Anthony Fauci told BioCentury.

Shares of Inovio were up $0.40 (12%) to $3.84 on Thursday for a 17% gain on the week. Novavax gained $0.57 to $7.66; its shares are up 33% on the week. Regeneron was off $2.54. Moderna slipped $0.50 to $21.47.

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