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Update: Biopharmas Developing Products for Wuhan Coronavirus Outbreak

publication date: Jan 29, 2020
 | 
author/source: Richard Daverman, PhD

The Wuhan coronavirus (2019-nCoV) continues to spread with 5970 documented cases in China and over 6,000 cases worldwide. That puts the current outbreak ahead of the 5,327 people infected during the 2002-2003 SARS crisis. So far, 132 people have died from the latest coronavirus, while the SARS epidemic caused 348 deaths. In general, the SARS coronavirus was slower to spread, but more virulent than 2019-nCoV. China is assembling a prefabricated hospital in Wuhan with 1,000 beds to treat people with the disease, a task that could be completed in just 10 days. Around, the world, biopharmas are gearing up to address the problem.

• WuXi Biologics (HK: 2269) put together a 100-person team to discover multiple neutralizing antibodies for the 2019-nCoV virus, which it hopes will be produced in two months and tested within four to five months, based on its experience with developing a treatment for Zika. At that point, the product would be at NDA stage. A single batch would treat 80,000 patients, WuXi said.

• Johnson & Johnson (NYSE: JNJ) announced it has already set up a "skunkworks” staffed with 15 people, to develop seven constructs for a vaccine, that could deliver a vaccine in as little as nine months to a year, using procedures it developed for its Ebola vaccine. J&J also donated supplies of its HIV drug Prezcobix to China in hopes it will prove to be an effective treatment.

• Shanghai ZJ Bio-Tech and Shanghai GeneoDx Biotech were both approved to produce 2019-nCoV nucleic acid detection kits by China's NMPA, after the deluge of patients caused a shortage of detection kits. ZJ Bio-tech already has kits for SARS and bird flu, while GeneoDx, a Sinopharm subsidiary, also focuses on molecular diagnostic products. The two companies are gearing up to manufacture the kits.

• A project to develop a mRNA 2019-nCoV vaccine was approved by Shanghai East Hospital of Tongji University and Stemirna Therapeutics, also of Shanghai. Hangwen Li, CEO of Stermirna Therapeutics, said the company would need no more than 40 days to manufacture the vaccine samples using its new generation of mRNA technology, which offers shorter timelines than traditional vaccines. After that, the vaccine would need to be tested.

• Sorrento Therapeutics (NSDQ: SRNE) of San Diego and China will collaborate with Celularity, a 25% owned subsidiary, to expand the therapeutic use of Celularity's CYNK-001, an allogeneic, off-the-shelf, placenta-derived Natural Killer (NK) cell therapy, to treat and prevent coronavirus infections. NK cells are the foundation of the innate immune response. Sorrento has contacted leading scientists and local Chinese experts to discuss the clinical validation of the therapy.

• Australian scientists at Melbourne's Peter Doherty Institute for Infection and Immunity have grown the 2019-nCoV coronavirus using a sample from Australia's first person to contract the disease. They will share the virus with the World Health Organization, which will distribute it to labs around the world with the prospect of developing a vaccine in two months.

• Yuen Kwok-Yung, a Hong Kong University professor, announced he has developed a vaccine for 2019-nCoV by modifying an influenza vaccine with a part of the surface antigen of the coronavirus, making the vaccine useful in preventing both influenza and coronavirus, though the vaccine has not been tested in either animals or humans.

As ChinaBio Today reported yesterday, other companies are also responding to the crisis in Wuhan:

• China officials recommended using an AbbVie fixed-dose HIV drug known as Kaletra (also Aluvia) as an unapproved treatment for 2019-nCoV. Kaletra has two components, lopinavir and ritonavir, both of which are protease inhibitors that are designed to block HIV viral replication. Although neither is approved to treat a coronavirus, the combination seemed to be effective in one very high-profile case. Guangfa Wang, the leader of Peking University First Hospital’s pulmonary and critical care medicine department, contracted the disease while serving as a member of a national expert team in Wuhan. He took Kaletra and was cured. AbbVie China agreed to donate $1.5 million of Kaletra to Wuhan to treat infected patients.

• Gilead Sciences is considering testing its Ebola drug, remdesivir, for 2019-nCoV. In a clinical trial during the Ebola epidemic, remdesivir was less effective than two other candidates for Ebola, but it was later shown to inhibit murine hepatitis virus and Middle East respiratory syndrome, both of them coronaviruses.

• BravoVax, a Wuhan vaccine developer, signed a letter of intent with Atlanta's GeoVax Labs (OTC: GOVXD) to jointly develop a 2019-nCoV vaccine. GeoVax will use its MVA-VLP vaccine platform to design and construct the candidate using genetic sequences from the coronavirus outbreak in Wuhan. BravoVax will provide testing and manufacturing support, and it will be responsible for interacting with China public health and regulatory authorities.

• The Coalition for Epidemic Preparedness Innovations, a public-private group that has raised hundreds of millions of dollars to fight infectious disease outbreaks, made two grants to companies to develop new vaccines for the Wuhan coronavirus.

• CEPI will support Moderna Therapeutics's work with the US-based NIH National Institute of Allergy and Infectious Diseases on the development of an mRNA vaccine. The researchers at the NIAID will conduct preclinical tests and a Phase 1 clinical trial.

• And Inovio will use its CEPI grant to cover development costs through Phase 1 of INO-4800. The vaccine is based on Inovio’s DNA medicine platform that enables rapid development of a vaccine against emerging threats.

In addition, Roche, AstraZeneca, Pfizer, Eli Lilly, Sanofi, Novo Nordisk, J&J, Allergan, GlaxoSmithKline, Boehringer Ingelheim, Bristol-Myers Squibb, Fresenius Kabi and Takeda have all announced plans to donate money or products in the million-yuan range each to support Wuhan's patients. Bayer said it would donate CNY 6.5 million worth of medicines to Wuhan and another CNY 4.5 million in cash to help purchase medical protection products for Wuhan.

Disclosure: none.


 

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