We just got the first data showing that antibody drugs could help keep COVID-19 patients out of the hospital. Here are the 9 top drugmakers racing to develop these promising coronavirus treatments.
- An antibody therapeutic could land in the sweet spot of the hunt for a coronavirus treatment.
- Several drug candidates have started human testing. Initial results released on September 16 showed the drugs could reduce the hospitalization rate for COVID-19 patients.
- There are at least nine major ongoing research efforts for an antibody treatment.
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In the sprint for an effective coronavirus treatment, several of the biggest drugmakers in the world have all landed on the same strategy.
Companies like Regeneron, Eli Lilly, and AstraZeneca are using the body's own disease-fighting proteins, called antibodies, as the source material to develop coronavirus drugs. Six leading efforts have already started clinical trials, led by Lilly, Regeneron, Vir Biotechnology, AstraZeneca, Celltrion, and SAB Biotherapeutics. Lilly and Regeneron are already in the final stage of clinical testing.
An antibody therapeutic could land in the sweet spot of the hunt for a coronavirus treatment. Researchers think they can effectively fight the virus in humans, and at least two pharma companies have said their antibody-based treatments could be ready by this fall.
On September 16, Lilly released early human data showing its antibody drug slashed the hospitalization rate. While 6% of COVID-19 patients with symptoms wound up in the hospital or emergency room when given a placebo, only 1.7% taking Lilly's drug went to the hospital or ER. That finding was based on 452 trial volunteers and larger ongoing trials will seek to confirm those results.
Antibody treatments could be ready more quickly than a vaccine, and they could be especially helpful if some vaccine efforts don't pan out or take longer than expected. Antibody drugs are being tested as both preventive treatments to stave off infection as well as in COVID-19 patients with moderate or severe illness.
"These are very promising across the many stages of the disease, particularly the earlier stages," said Dr. Janet Woodcock, a longtime US Food and Drug Administration director now leading the US government's coronavirus drug research strategy.
There are about 50 ongoing research programs to develop antibody drugs against COVID-19, Woodcock added on a July 13 call with reporters.
Billionaire Microsoft cofounder Bill Gates also highlighted antibody drugs in an interview with Insider. He said these therapies could "cut the death rate quite dramatically, which would be a very big deal."
While doctors have been testing a slew of existing drugs as potential treatments, early results have generally been disappointing. Two drugs have shown to help patients — Gilead Sciences' remdesivir and dexamethasone — but both had only modest effects and face limitations on their use. Vaccine programs are progressing rapidly, but will still require massive, large-scale trials to prove they work.
While an antibody-based treatment likely won't be a panacea, it could help society return to normal by the end of 2020, AllianceBernstein analyst Ronny Gal wrote in a recent research note. Gal estimates COVID-19 antibody drugs will be a $9 billion market in 2021.
How an antibody therapeutic works
To develop antibody therapies, scientists study the body's response to the novel coronavirus.
In response to detecting an invading threat, the human body's immune system produces virus-fighting antibodies. In this case, that invader is the novel coronavirus, which infects cells and hijacks them to produce more of the virus.
Our bodies pump out tons of customized antibodies to fight back and stop the virus. To make a therapeutic, scientists first collect a large pool of antibodies to sort through, hunting for the most potent at fighting the coronavirus. These often come from blood donations from recovered COVID-19 patients or by testing animals.
When scientists have found the best antibodies, biotechnology allows them to clone and produce them at massive scale.
It's a more modern version of using convalescent plasma, or the blood of sick patients, to treat COVID-19 patients. In that case donated plasma full of antibodies is injected into sick patients. The approach requires lots of recovered blood donors — making it difficult to scale — and has not yet been proven effective for this pandemic, despite securing an emergency approval from the FDA.
The technology to design and mass-produce antibody drugs has greatly improved over the past 30 years, allowing many companies to pursue this research.
Read more: The US is sprinting to develop a coronavirus vaccine or treatment. Here's how 19 top drugmakers are racing to tackle the pandemic.
Eli Lilly first to report clinical results, finding reduction in hospitalization rates
Eli Lilly may be best-known for selling insulin, but the $144 billion pharma giant has some powerful manufacturing capacity to pump out medicine. In responding to the coronavirus, it has two antibody candidates now in human testing.
Its most advanced program is called LY-CoV555, an antibody drug developed with a small Canadian biotech called AbCellera. On August 3, Lilly started a late-stage clinical trial that will test the drug in residents and staff members of nursing homes. The study will enroll up to 2,400 people, seeing if the experimental medicine can prevent infections and disease in places that have recently had confirmed coronavirus cases.
A smaller trial of LY-CoV555 found the drug slashed hospitalization rates for patients with mild or moderate COVID-19. In results announced on September 16, Lilly said that 6% of patients on placebo wound up in the hospital or emergency room when given a placebo compared to 1.7% taking Lilly's drug. That finding was based on 452 trial volunteers and larger ongoing trials will seek to confirm those results.
Lilly has also started human testing of a second antibody therapeutic. Called JS016, this antibody was developed with Junshi Biosciences, a Shanghai-based drugmaker.
The company hopes to have several hundred thousand doses of a treatment available by the end of 2020.
Read more: 'We've never moved at this speed before:' $120 billion pharma giant Eli Lilly just teamed up with a biotech startup to fight the coronavirus pandemic
Regeneron, a long-time industry leader in antibodies, launches trials for preventing and treating COVID-19
The biotech Regeneron is a leader in crafting antibody therapeutics. The company has engineered mice to mimic the human immune system in producing antibodies, a technology platform called VelocImmune.
That technology has produced several approved drugs, including the cholesterol-lowering Praluent and the arthritis therapeutic Kevzara. Regeneron also developed an antibody drug against the Ebola virus in 2016 using the system, which helped lower the risk of death from the virus.
Regeneron started clinical trials on June 11 for REGN-COV2, its two-antibody cocktail. These initial trials focus on patients already infected with the coronavirus — one for hospitalized patients and one for less severe, non-hospitalized cases. Early safety data on the first 30 patients supported moving these trials to assess the drug's effectiveness, the biotech said on July 6.
REGN-COV2 is also being studied as a preventive treatment, with Regeneron launching an efficacy trial in July. Researchers expect to enroll about 2,000 participants across 100 US trial sites. The study is designed to test people who have had close exposure to the virus, such as someone living with an infected person.
Results will depend on how quickly people enroll, but the company expects initial data from several hundred patients by the end of September. By then, Regeneron will have ramped up its manufacturing to to be able to produce "hundreds of thousands of prophylactic doses per month."
Korean biotech Celltrion also has started clinical trials
Celltrion, a South Korean biotech, launched human testing for its antibody drug on July 17. This first study will be small and focus on the drug's safety, enrolling 32 healthy volunteers at a hospital in Daejeon, South Korea.
But Celltrion also expects to launch studies in Europe for its drug, planning to have efficacy results in treating mild and moderate COVID-19 by the end of the year. Another trial to test Celltrion's drug as a preventive measure should have results by the first quarter of 2021, the company said.
The Korean biotech expects to know if its drug works as an effective treatment by the end of 2020, Ki-Sung Kwon, Celltrion's head of research and development, told Business Insider in an email.
"Celltrion should never be underestimated," AllianceBernstein's Gal wrote on July 9 to investors, adding the company has a "massive manufacturing footprint" and demonstrated ability to create antibody drugs.
GlaxoSmithKline bets $250 million on Vir Biotechnology, aiming for data before year's end
Vir Biotechnology was among the first biotechs to respond to the coronavirus outbreak, announcing its research on January 22. Company CEO George Scangos has been tapped to coordinate the biopharma industry's response as coronavirus czar of biotech's trade group.
The company is a new player in the industry. It was founded in 2016 and went public in late 2019. While its stock has nearly tripled since the beginning of 2020, Vir is still a small biotech with no commercial drugs.
Instead, the San Francisco-based biotech has built credibility with a torrent of research partnerships, including with the US government and other drugmakers. These can provide Vir the muscle it would need to mass-produce a treatment, with the biotech estimating it will have 10 million to 15 million doses available in 2021.
Most notably, the British big pharma GlaxoSmithKline invested $250 million in an equity investment in Vir, as part of a broader research collaboration to advance an antibody drug, which is expected to start human testing in August.
Vir and GSK launched an efficacy-focused trial at the end of August, which could produce results before year's end. The study will enroll 1,300 COVID-19 patients with early symptomatic infections with the goal of keeping people out of the hospital.
Read more: GSK just bet $250 million on Vir as the pharma giant and the buzzy biotech team up to hunt for coronavirus treatments and vaccines
AstraZeneca jumps in the race in June and starts human studies in August
The British pharma giant AstraZeneca is working with Vanderbilt University researchers and the US government to advance an antibody therapeutic candidate that started human studies in August.
The drugmaker announced its plans on June 9, building on research done with Vanderbilt since April. The team has evaluated more than 1,500 antibodies, ultimately selecting six to move forward with. AstraZeneca brought two of those antibodies into the clinic as a cocktail treatment.
This initial trial will test the safety of the drug by giving it to 48 healthy people. If those findings are positive, AstraZeneca said it would advance into late-stage trials.
SAB Biotherapeutics starts human testing
SAB Biotherapeutics began human testing for its antibody drug candidate in mid-August. Eddie Sullivan, the CEO of the privately held biotech, said laboratory testing showed SAB's drug can fight mutated strains of the coronavirus and was stronger than convalescent plasma samples.
Since March, the drugmaker has received more than $70 million in grants to support its antibody drug research from the Defense Department and the US Biological Advanced Research and Development Authority.
Amgen, Adaptive are hunting for 'the Michael Jordan of antibodies'
Amgen, the world's largest biotechnology company, started later than most on its COVID-19 ambitions. But it is now working with Seattle-based Adaptive Biotechnologies to develop an antibody therapeutic, announcing the collaboration on April 2.
Researchers are now taking donated blood from recovered and infected COVID-19 patients to analyze and eventually test antibodies against the virus in test tubes. Adaptive's top scientist told Business Insider it is a hunt for "the Michael Jordan of antibodies," or the ones that can stop the virus essentially by themselves.
Amgen will take control from then on, tapping its vast experiences in maneuvering in the highly regulated space through lab testing, human trials, and eventually mass-producing a drug.
More than three months into the research, the West Coast duo has yet to provide a timeline on when they expect to start human trials.
Read more: A buzzy Seattle biotech is teaming up with Microsoft and Amgen to fight the coronavirus. Here's how Adaptive plans to find 'the Michael Jordan of antibodies.'
AbbVie supports an ongoing antibody research effort, eyeing the clinic
AbbVie, a $167 billion drugmaker, announced on June 5 it is working with a group of researchers that already identified a coronavirus-blocking antibody. Those scientists published their findings in May in Nature Communications.
The Illinois biopharma has the option to exclusively license the antibody later on for clinical development. AbbVie plans to start human trials as soon as possible, although executives have not specified a timeline.
IGM Biosciences is focused on a different type of antibody
The Mountain View, California-based biotech IGM Biosciences is preparing for the possibility that the world will need a second-generation of antibody drugs.
The company's leaders recently told Business Insider they are planning to start human testing in the first half of 2021 for its COVID-19 antibody drug. IGM is focused on a different type of the virus-fighting protein than all the first-wave efforts. The company is collaborating with the Chinese biopharma BeiGene and the San Francisco biotech Atreca on the research.
This article was updated on September 16 with multipe updates from drugmakers.
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