By Jaimy Lee
The list includes Gilead Sciences and Moderna, alongside smaller biotech companies
A mix of legacy drug makers and small startups have stepped forward with plans to develop vaccines or treatments that target the infection caused by the novel coronavirus.
COVID-19, which was first detected in December in Wuhan, China (), has since sickened nearly 4.6 million people worldwide and killed more than 300,000, ( ) ( ) as of mid-May.
The Food and Drug Administration has issued two emergency-use authorizations for COVID-19 treatments, including one for hydroxychloroquine sulfate and chloroquine phosphate (Gilead Sciences Inc.'s remdesivir ( ) on May 1. No drugs or vaccines have received FDA approval.) in March to treat COVID-19 patients and one for
Read more of MarketWatch's coverage of COVID-19 ().
In the U.S., many of the publicly traded companies that are initiating development have received funding from two organizations: the Biomedical Advanced Research and Development Authority, or BARDA, which is a division of the Department of Health and Human Services, and the National Institute of Allergy and Infectious Diseases, or NIAID, a division of the National Institutes of Health. Some companies have also received funding from Coalition for Epidemic Preparedness Innovations, or CEPI, a global organization based in Oslo that has provided millions of dollars in funding to vaccine makers. Other companies are funding trials by themselves or through life-sciences-company partnerships.
These are some of the companies developing treatments or vaccines in the U.S. for COVID-19, as of early May. (An earlier version of the article included several adjuvant platform technologies that are used to aid the development process and a privately held company, but they have since been removed to focus on public companies.)
Amgen and Adaptive Biotechnologies
Type: Antibody treatment
Background: The very early-stage collaboration between Amgen Inc. (AMGN) and Adaptive Biotechnologies Corp. (ADPT) seeks to discover antibodies that can be used to prevent or treat COVID-19. Financial terms of the exclusive collaboration will be completed "in the coming weeks," the companies said April 2 (). "There may well be more than one generation of antibody therapeutics entering the clinic," Amgen R&D EVP David Reese told investors on an earnings call.
Also in the works: Amgen will test Otezla as a COVID-19 therapy treating respiratory distress in late-stage patients, with the company saying April 30 that it plans to put the oral psoriasis drug into trials "in the coming weeks."
Year-to-date stock performance: Amgen's stock is down 1.9%; Adaptive's is up 10.3%.
Background: Altimmune Inc. (ALT) said March 30 it is partnering with University of Alabama at Birmingham to develop a single-dose, intranasal COVID-19 vaccine. They said they plan to put the vaccine candidate into Phase 1 trials in the third quarter. The preclinical company is also developing vaccines for anthrax and the flu.
Year-to-date stock performance: Shares of Altimmune have gone up 60.8%.
BioNTech and Pfizer
Type: mRNA vaccine
Stage: Phase 1/2
Name: BNT162 program
Background: Pfizer Inc. (PFE) announced ( ) March 17 it would help develop and distribute BioNTech SE's (BNTX) COVID-19 vaccine candidate, though the deal excludes China. The 360 patients in the U.S. trial ( ) had started to receive the first doses ( ) of the four vaccine candidates included in the study as of May 5. Dosing in 200 participants in the German trial began April 23. As part of the deal, Pfizer will pay $185 million upfront ( ), with additional possible future milestone payments of up to $563 million. Mikael Dolsten, Pfizer's chief scientific officer, said during an April 28 earnings call that the companies expect the first round of trial data in May or June, with the vaccine candidate moving into "expanded trials that could allow emergency use or accelerated approval coming in the fall, possibly October."
BioNTech is also testing the vaccine in collaboration with Shanghai Fosun Pharmaceutical Group Co. Ltd. in China.
Pfizer and BioNTech for several years have said they are working on mRNA-based influenza vaccines.
Year-to-date stock performances: Shares of BioNTech have soared 47.6%; Pfizer's stock is down 1.7%.
Stage: Phase 2 and Phase 2b/3 clinical trials
Background: CytoDyn Inc. (CYDY), a preclinical biotechnology company based in Vancouver, is testing () its experimental drug leronlimab in two types of COVID-19 patients. The investigational therapy hasn't been approved for any indications; for COVID-19, it is being proposed as a treatment for mild-to-moderate ( ) respiratory complications that occur in patients with the disease as well as severely and critically ill patients ( ).
The randomized, double-blind, placebo-controlled study will test the efficacy and safety of leronlimab in 75 patients. CytoDyn had been studying the experimental therapy as a treatment for people with HIV and a form of metastatic breast cancer.
Year-to-date stock performance: CytoDyn's stock has soared 213.0%.
Stage: Emergency use authorization
Background: Gilead Sciences Inc. (GILD) is a longtime drugmaker best known for developing the first major cure for hepatitis-C in Sovaldi, a therapy that changed the standard of care for that disease but also kicked off the national debate about drug pricing. The company has experience developing and marketing HIV drugs, including Truvada for pre-exposure prophylaxis (PrEP), its preventive HIV medicine.
It received an emergency-use authorization () from the Food and Drug Administration in the U.S. on May 1 based on preliminary results from two clinical trials: one conducted by the NIAID, and one by Gilead. In the NIAID trial, COVID-19 patients taking the drug had a median recovery time of 11 days, compared with 15 days for those patients taking placebo. NIAID director Dr. Anthony Fauci has said the drug is now considered the standard of care; however, other experts have had mixed responses to the data. Dr. Eric Topol, director of the Scripps Research Translational Institute, said he thinks the drug is effective based on the preliminary data that has been made public. "It's just not that potent," he said via email.
The drug was also used in two randomized, controlled clinical trials in China. Results from one trial, which was stopped early, found the drug didn't produce "statistically significant clinical benefits," according to findings published in The Lancet ().
Gilead in late March had to halt individual compassionate use requests () for remdesivir as outbreaks worsened in the U.S., having provided the investigational therapy to 1,000 patients. "The system cannot support and process the overwhelming number of applications we have seen with COVID-19," Gilead CEO Daniel O'Day said March 28.
The company told investors on May 1 it may spend up to $1 billion this year to develop and manufacture remdesivir, and it aims to have 500,000 treatment courses by October and 1 million by the end of 2020.
Gilead's notable clinical trials:
1. The National Institute of Allergy and Infectious Diseases trial has enrolled patients in a randomized, double-blind, placebo-controlled Phase 3 trial () evaluating 1,063 hospitalized patients with COVID-19 at 68 sites worldwide, including at three sites in Singapore and South Korea, according to the NIAID. However, the majority of the study locations are in the U.S. The study began Feb. 21 and is expected to conclude April 1, 2023. Preliminary results from this trial were used to inform the EUA.
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May 16, 2020 12:02 ET (16:02 GMT)
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