- An antibody therapeutic could land in the sweet spot of the hunt for a coronavirus treatment.
- Researchers think they could be relatively effective, and they could be available this fall, far sooner than a vaccine.
- They are likely to work much better against the virus than drugs being tested now in patients, since they are designed to fight the novel coronavirus.
- There are four major ongoing research efforts for an antibody treatment. Three are aiming to start human testing this summer, while the fourth program has not disclosed a timeline.
- Visit Business Insider’s homepage for more stories.
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, GlaxoSmithKline, and Amgen want to use the body’s own disease-fighting proteins, called antibodies, as the source material to develop coronavirus drugs.
Antibody-based drugs could land in the sweet spot of the hunt for a coronavirus treatment. Researchers think they could be relatively effective, and they could be available this fall, far sooner than a vaccine.
That sets them apart from the slew of existing drugs that doctors are testing in patients with COVID-19, the disease caused by the coronavirus. These repurposed treatments aren’t crafted to fight the virus and are widely expected to show modest, if any, benefits. Early results have been disappointing.
On the other extreme, more than 70 vaccine research efforts are underway. If successful, a vaccine could help decisively end the pandemic. Researchers are moving with historic speed, with more than a dozen vaccines expected to be in human trials by the end of 2020.
But it will take time to fully test a vaccine to see if it works and ramp up production to meet the world’s demand. Top US health officials have given a 12-to-18-month timeline, which others have called far too optimistic.
An antibody therapy could also be used not just in sick patients to help them recover, but also as a preventive treatment for people at high risk of becoming infected.
Scott Gottlieb, former commissioner of the US Food and Drug Administration, has called an effective therapeutic “our best near-term hope” of charting a path out of this crisis.
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.
Antibody therapeutics “will likely be effective and scalable enough to accelerate our return to normalcy in the post-peak period of the infection — offering decent treatment to affected patients, protection to health care workers and pre/post-exposure prophylaxis to populations at risk,” Gal wrote.
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.
In response, 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.
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, which requires lots of recovered blood donors, is difficult to scale. But some early data from China has shown its likely to be effective.
The technology to design and mass-produce antibody drugs has greatly improved over the past two decades.
Regeneron is a long-time industry leader in antibodies, eyeing human testing in June
Regeneron, a $60 billion New York-based biotech, 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 eye drug Eylea, the cholesterol-lowering Praluent, and the arthritis therapeutic Kevzara.
Regeneron also used this system to develop an antibody drug against the Ebola virus in 2016. That Ebola drug helped lower the risk of death from the virus.
The biotech is aiming to start testing a two-antibody cocktail against the novel coronavirus in people starting in June. Regeneron is ramping up manufacturing in the meantime, aiming to make “hundreds of thousands of prophylactic doses per month by the end of summer.”
Eli Lilly links up with a Canadian antibody specialist
Eli Lilly may be best-known for selling insulin, but the $150 billion pharma giant has some powerful manufacturing capacity to pump out medicine. Its working with a small Canadian company called AbCellera that specializes in discovering potent antibodies.
AbCellera uses microfluidic devices, which are machines about the size of a credit card. They can speed up the screening of cells by a magnitude of 100 times, AbCellera CEO Carl Hansen said, likening it to having a shrink gun.
On an April 23 earnings call, Lilly said it has already started manufacturing an antibody found by this process that showed it could neutralize a live sample of virus. The duo is hoping to file an application by the end of May, which should allow them to start clinical testing shortly thereafter.
“We’ve never moved at this speed before,” Dan Skovronsky, Eli Lilly’s chief scientific officer, told Business Insider.
GlaxoSmithKline bets $250 million on Vir Biotechnology
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 more than doubled 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.
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 could start human testing as early as July.
Amgen, Adaptive screening 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 Adapative Biotechnologies to develop an antibody therapeutic, announcing the collaboration on April 2.
Adaptive is leading the first part of the process of discovering potent antibodies. The biotech specializes in understanding the body’s immune system and how it responds to foreign threats like viruses.
Researcgers 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.
The West Coast duo have not given a timeline on when they expect to start human trials.