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How Close Are Biotechs To Bringing A COVID-19 Treatment To Market?

The COVID-19 virus has sent the market and the global economy into a tailspin.

Benzinga · 03/10/2020 21:25

The COVID-19 virus has sent the market and the global economy into a tailspin. The Organisation for Economic Co-operation and Development slashed its global growth forecast for 2020 Monday by 0.5 points to 2.5% versus already-weak 2.9% growth in 2019.

Global banks have begun talking up the economy with the promise of stimulus injection.

As the world and China in particular battle the deadly pandemic, a small batch of biotechs and a handful of big pharma companies are racing against time to bring to the market potential treatment and/or vaccines to combat the virus.

Rocky R&D Pathway For Coronavirus Products 

Investors scurrying for cover amid the bloodbath in the stock market are investing in biotechs that are targeting the new coronavirus.

COVID-19 levered biotechs are offering investors an opportunity due to the kind of returns the stocks can generate in the eventuality that R&D efforts come to fruition.

Given that most of the investigational therapies are vaccines are only in the animal testing stage, is it too early to take a headlong plunge into these stocks?

"Given the community spread in the U.S., particularly in the states of Washington and California, we believe the current administration's support for rapid development of vaccines and therapies in the U.S. could pave the way for an accelerated regulatory pathway to be made available by government agencies for the rapid market entry of such products that show conclusive efficacy against COVID-19," H.C. Wainwright analyst Raghuram Selvaraju said in a note.

The analyst estimates it would take around 18-24 months to complete the clinical development of a COVID-19 vaccine.

Benzinga reviewed the COVID-19-related updates from biotechs to gain an understanding of how close each is in bringing a treatment or vaccine to market. 

See Also: Attention Biotech Investors: Mark Your Calendar For These March PDUFA Dates

Gilead: The Frontrunner?

Large-cap biopharma Gilead Sciences, Inc.'s (NASDAQ: GILD) investigational drug remdesivir has the World Health Organization's seal of approval.

"There is only one drug right now that we think may have real efficacy and that's remdesivir," WHO assistant director-general Bruce Aylward said at a late February press briefing in China.

Remdesivir is an investigational nucleotide analog with broad spectrum antiviral activity that has shown in vitro and in vivo activity in animal models against the viral pathogens MERS and SARS.

Gilead has initiated two Phase 3 studies in adults diagnosed with COVID-19 following the FDA's rapid review and acceptance of the IND filed by the company.

The company said it expects to enroll 1,000 patients at medical centers, mainly in Asia, beginning in March.

Chinese health authorities have initiated two trials with remdesivir in infected patients in the Hubei province, and those clinical trial results are anticipated in April.

The U.S. National Institute of Allergy and Infectious Diseases, or NIAID, has initiated a Phase 2 study to test remdesivir in hospitalized adult patients diagnosed with COVID-19.

Inovio Sets Timeline

Inovio Pharmaceuticals Inc (NASDAQ: INO) is working with Chinese contract development manufacturer Beijing Advaccine Biotechnology to develop INO-4800, a DNA vaccine for COVID-19, unveiled an accelerated development timeline.

The company expects to commence a Phase 1 trial in April and mass produce the vaccine by the end of 2020 to be used in case of emergency or for further trials.

One advantage of DNA vaccines is that they do not require refrigeration or cold chain logistics, according to H.C. Wainwright. 

Moderna's Vaccine Candidate To Enter Clinics

Moderna Inc (NASDAQ: MRNA) said in late February it has shipped MRNA-1273, its mRNA vaccine targeting COVID-19, to the NIAID to be used in a Phase 1 study.

H.C. Wainwright said Moderna could begin Phase 1 trials around the same time as Inovio.

Novavax In Animal Testing

Novavax, Inc. (NASDAQ: NVAX) said in late February that it is assessing multiple nanoparticle vaccine candidates in animal models to zero in on an optimal candidate for human testing.

The company said it expects clinical trials to begin by the end of spring 2020. 

Vir Biotech Identifies Antivirals

Vir Biotechnology Inc (NASDAQ: VIR) is working with WuXi Biologics on a COVID-19 treatment. The company said it has identified a number of monoclonal antibodies that bind to COVID-19 and is conducting research to determine if these can be effective as treatment and/or prophylaxis against the virus.

Cocrystal Pharma Licenses Treatment Candidates

Cocrystal Pharma Inc (NASDAQ: COCP) said Feb. 24 it has licensed from the Kansas State University Research Foundation antiviral compounds to treat norovirus and coronavirus infections. The company said it plans to pursue preclinical and clinical development of these compounds.

NanoViricides Screens Compounds

NanoViricides Inc (NYSE: NNVC) said in its fourth-quarter earnings release Feb. 24 it intends to perform initial testing of drug candidates for safety and effectiveness in cell culture studies in its own BSL-2 virology laboratory at its Shelton campus, using low-threat coronavirus strains.

Vaxart's Vaccine Program Kicks Off 

Vaxart Inc (NASDAQ: VXRT) said in late January it has begun work on a program to develop an oral COVID-19 vaccine.

The company said it plans to generate vaccine candidates based on the published genome of the coronavirus. 

Glaxo Lends Tech To Enhance Vaccine Efficiency

GlaxoSmithKline plc (NYSE: GSK), though not developing a vaccine, has forged two tie-ups to aid COVID-19 vaccine research.

The company announced a collaboration with the Coalition of Epidemic Preparedness Innovations, or CEPI, to provide its pandemic vaccine adjuvant vaccine technology to enhance the development of an effective vaccine against COVID-19.

An adjuvant is added to vaccines to enhance its immune response. CEPI will work with Glaxo and entities funded by it that want to test their vaccine platform with Glaxo's adjuvant technology.

Glaxo also announced Feb. 24 a research collaboration with Chinese biotech Clover for the latter's protein-based COVID-19 vaccine candidate S-Trimer, which is to be tested with the former's pandemic adjuvant system in preclinical studies.

J&J, Sanofi Work With BARDA

Johnson & Johnson (NYSE: JNJ) said in mid-February that its Janssen unit will work along with the Biomedical Advanced Research and Development Authority, or BARDA, on potential treatments for COVID-19.

Janssen will work with the Belgium-based Rega Institute for Medical Research for screening potential compounds.

The company said it is working with BARDA on a COVID-19 vaccine that will leverage its AdVac and PER.C6 technologies, which the company said will help rapidly upscale production of an optimal vaccine candidate.

Sanofi SA (NASDAQ: SNY) also has a working relationship with BARDA to develop a COVID-19 vaccine using its recombinant DNA platform that it said will help produce an exact genetic match to proteins or antigenfound on the surface of the virus.

This could be formulated to stimulate an immune response to protect against the virus, Sanofi said. 

Pfizer Joins The Race

Pfizer Inc. (NYSE: PFE) reportedly said Monday it has identified some antiviral compounds from its development pipeline that could potentially treat COVID-19 infection.

The pharma company said it plans to work with a third party to screen the compounds, with the results from the screening expected by the end of March. If they are found effective, Pfizer said it plans to begin clinical trials by the end of the year.

The Race For COVID-19 Drugs

Gilead as well as Moderna and Inovio could have an edge over the others, as Gilead's remdesivir is already in the clinics, while the latter two are set to start Phase 1 trials soon.

Most others are still screening compounds or pursuing animal testing.

The sell-side is guarded in its view regarding the value a potential therapy/vaccine could bring to its developer.

"Previous potential therapeutics for pandemics have failed to generate value in the medium-to-long term," Baird analyst Madhu Kumar said in a recent note.

Photo courtesy of the CDC.