A Promising COVID-19 Antibody Treatment Enters Phase III Clinical Trials
August 5, 2020
While the global community eagerly awaits a COVID-19 vaccine, the science has progressed rapidly behind another form of preventative treatment: antibodies.
Because COVID-19 antibodies can be used to temporarily prevent infection, many in the scientific community believe that antibodies will provide a bridge until a safe and effective vaccine becomes widely available. In fact, Dr. Anthony Fauci recently stated that monoclonal antibodies are “almost a sure bet” to protect the body from the coronavirus.
There are over 620 clinical trials for COVID-19 vaccines and therapeutics–including antibody treatments–taking place across the United States.
Yet, for this investment in innovative treatments to continue, policymakers must support smart innovation policy and reject unnecessary regulations, including price controls. This will ensure that innovative companies can discover and deliver the treatments and vaccines which coronavirus patients desperately need.
One company leading the way in the race to deliver effective antibody treatments is Eli Lilly. The company started the first human trial of its potential antibody treatment in the beginning of June—and the clinical research has advanced rapidly in just two months. On Monday, Eli Lilly announced the company would begin a Phase 3 trial to test the antibody treatment in nursing homes.
Why nursing homes? The leading scientists and the innovative community recognize that we will only know if therapeutics are truly effective if they are tested in the communities most impacted by the disease. With a significant percentage of COVID-19-related deaths linked to nursing homes, there is an urgent need to test potential treatments in the most vulnerable populations among us.
If Eli Lilly’s antibody treatment proves successful, the drug could receive regulatory approval by the end of the year.
As Dr. Anthony Fauci said at a recent U.S. Chamber event, we must follow the science. The Chamber believes the science will soon lead us to effective therapeutics and vaccines which place us on the return to work and health once again.
Two Coronavirus Vaccines Enter Final Stages of Clinical Trials
July 28, 2020
As communities across the country consider whether to re-open schools and offices this fall, leaders are pinning their hopes to a COVID-19 vaccine that will soon be available.
The Chamber’s latest interactive map, released last Tuesday, breaks down where COVID-19 related clinical trials for vaccines and therapeutics are taking place in the United States. While there are currently 25 vaccines in the clinical stage of development, just yesterday, two entered the final stages of clinical trials.
On Monday, Moderna began a Phase 3, 30,000 person trial for its leading vaccine candidate, developed in partnership with the National Institute of Allergy and Infectious Diseases. A day ahead of the beginning of the trial, the U.S. government threw additional support behind Moderna’s vaccine, committing an additional $472 million to the Phase 3 trial.
Late Monday afternoon, Pfizer and BioNTech announced the start of a global Phase 2/3 30,000 person safety and efficacy clinical trial for their leading mRNA vaccine candidate. If the vaccine candidate proves effective, the companies plan to seek regulatory approval as early as October 2020, with a goal of providing up to 100 million doses globally by the end of the year.
The story of these three innovative companies sheds light on the risk required to invest in innovative life-saving treatments. While Moderna has been in the news for months and the company boasts a robust development pipeline, the vaccine candidate, if successful, would be company’s first FDA approved medicine.
What’s more: there has not yet been a successful mRNA vaccine developed to date. Should either the Moderna or Pfizer and BioNTech vaccine candidates be successful, it would be an unprecedented breakthrough not just for the companies but also for the global community who eagerly await an effective COVID-19 vaccine.
As these companies’ works at warp alongside the other innovative biopharmaceutical companies with vaccines in clinical development, the scientific community recognizes that an effective vaccine cannot come soon enough.
At a U.S. Chamber event last Tuesday, Dr. Michelle McMurry-Heath, the CEO the Biotechnology Innovation Organization, acknowledged that the scientific community has dedicated its full innovative capacity to identifying a COVID-19 vaccine. Dr. McMurry-Heath stated that we know it’s “not fast enough, but it’s faster than we would have ever dreamed possible.”
With our brightest scientific minds, the most innovative companies, and the nation’s leading universities on the task, the Chamber is confident that we will have an effective vaccine to help lead the global community out of this crisis soon.
COVID-19 Vaccine Innovators Making a House Call
July 15, 2020
Next Tuesday, July 21, the House Energy and Commerce Oversight and Investigations Subcommittee will hold a hearing with some of the innovative biopharmaceutical companies leading the coronavirus vaccine race. The companies will discuss their research and development efforts, as well as their ongoing preparations to manufacture and distribute resulting solutions.
Ahead of the hearing, let’s look at what we know about those efforts and preparations already.
Right now, there are two vaccine candidates in Phase 3 clinical trials – one is the result of a partnership between AstraZeneca and the University of Oxford. The University of Oxford recently embarked on a trial with 5,000 volunteers in Brazil – a coronavirus hotspot– to test efficacy of their vaccine candidate. Preliminary results are expected as soon as October.
Just yesterday, Moderna published data in the New England Journal of Medicine which showed that their vaccine produced an immune response in a Phase 1 study. The company will begin a Phase 3 trial testing the vaccine in 30,000 participants on July 27.
Other companies are tracking closely behind.
Merck plans to utilize its long-standing leadership in vaccine development to address COVID-19. CEO Ken Frazier recently noted that “In the last quarter century, there have only been seven, truly new vaccines introduced globally at the clinical practice… Merck has four.” The company soon hopes to add a fifth with a COVID-19 vaccine. Merck is currently investigating whether its previously approved Ebola and Measles vaccines can be re-engineered to combat COVID-19.
On Monday, Pfizer and its German partner BioNTech, received fast track designation from the FDA for two of its four vaccine candidates, which will help speed up regulatory approval should one of them prove to be effective during their Phase 1/2 clinical trial, happening now.
With the full innovative capacity of these companies dedicated to identifying an effective coronavirus vaccine, we remain hopeful that we will soon have an immunization to help place us on the return to a new normal in the wake of COVID-19.
Pfizer and BioNtech Partner Up to Develop COVID-19 Vaccine Candidate
July 9, 2020
Just last week two companies – Pfizer and its German partner, BioNTech –announced preliminary data as the companies race to develop a vaccine candidate to help prevent COVID-19.
While there are currently 19 vaccines in the clinical stages of evaluation by various companies, Pfizer and BioNTech have taken a unique approach to develop and test a potential COVID-19 vaccine.
Rather than test just one vaccine candidate, Pfizer’s Phase 1/2 clinical trial is designed to study the safety tolerability and immunogenicity of up to four mRNA vaccine candidates in order to identify which may be the most promising.
Last Thursday, the companies announced early positive results for one of those mRNA vaccine candidates, BNT162b1. The announcement stated, among other things, that the vaccine candidate was well-tolerated and generated a dose-dependent immune response.
Yet, this is just one of the many steps on the road to secure regulatory approval for a potential vaccine.
Pfizer and BioNTech are providing real-time data from its Phase 1/2 study with the goal of progressing into a global Phase 2b/3 study as early as this month.
Pfizer and BioNTech recognize that time is of the essence in the race to develop a vaccine in order to place our communities on the return to our new normal. Kathrin U. Jansen, Pfizer’s Senior Vice President and Head of Vaccine Research & Development noted “in the face of this global health crisis, we approach this goal with the utmost urgency.”
All colleagues in the biopharmaceutical industry – and in the business community as a whole – share that sense of urgency. We hope these colleagues are successful in their own respective efforts to deliver potential vaccines and therapeutics in the fight against COVID-19.
Another Promising Candidate in the Fight Against COVID-19
July 8, 2020
Our July 4th celebrations last weekend looked very different from years past, as America waits in anticipation to declare independence from the coronavirus.
While a number of vaccine candidates continue to make headlines as companies race to develop an effective immunization against COVID-19, scientists are making equally rapid progress on other therapies, including a cutting-edge antibody cocktail.
On Monday, the New York-based biotechnology company Regeneron announced the beginning of a Phase 3 trial to test whether the company’s double antibody cocktail can prevent and treat COVID-19 infection. The trial will take place in 100 locations with over 2,000 patients across the U.S.
Soon after the announcement of the Phase 3 trial, the U.S. government threw their weight – and funding – behind the innovative therapy. On Tuesday, Regeneron signed a $450 million contract with the U.S. government to manufacture and supply the double-antibody cocktail, should it receive regulatory approval.
Regeneron’s story provides a glimpse into the broader clinical trials process – and the public-private collaboration which supports it – occurring in communities large and small throughout the United States.
American biomedical innovation is one of this nation’s greatest strengths, and the numbers behind the search for coronavirus treatments and cures tells us this story. Right now, there are 513 clinical trials happening in hospitals and medical facilities in all 50 states.
Those trials are evaluating everything from new vaccines, to the use of existing innovative medicines, to the efficacy of different therapies.
The trials are sponsored by large pharmaceutical companies, small biotech operations, academic institutions, and hospitals, alike. With the most promising clinical efforts backed by the U.S. government as part of Operation Warp speed, it’s clear all everyone shares one common goal: ending the spread of COVID-19.
With the brightest scientific minds, the most innovative companies, and the backing of the U.S. government, we are hopeful that goal will soon be realized.
An Update on the Global Search for a Coronavirus Vaccine
July 1, 2020
As coronavirus cases increased in at least 35 U.S. states and the global number of cases surpassed 10 million, the question at the front of everyone’s minds is when will a vaccine be ready?
Scientists, industry, and the academic community are moving at unprecedented speed to identify a viable vaccine candidate, and progress is being made every day.
There are currently 17 vaccine candidates in the clinical stages of development, with another 132 under preclinical evaluation. So who leads the way?
The University of Oxford and AstraZeneca are currently conducting a Phase III trial to test the efficacy of their novel coronavirus candidate. As the number of cases in the UK decreased, the University of Oxford recently embarked on clinical trials in South Africa and Brazil to test the vaccine’s efficacy in countries where people have a higher risk of exposure to the coronavirus. They are also set to begin a large-scale Phase III trial in the U.S., following a $1.2 billion commitment by the U.S. government to invest in the vaccine as a part of Operation Warp Speed.
The innovative biotech company, Moderna, is close on the heels of the University of Oxford in the race to develop a vaccine. Moderna, which received widespread media coverage following the release of phase I data in May, will begin Phase III trials for its COVID-19 candidate in 30,000 participants in July. Just last week, Moderna announced a partnership with Catalent to prepare an initial 100 million doses of the vaccine, which could be distributed as early as October, should the vaccine receive FDA approval.
Governments, the biopharmaceutical industry, and the academic community recognize that a vaccine can’t come soon enough. The unparalleled level of public-private collaboration will help ensure that at least one – if not multiple – coronavirus vaccines should soon be available, which will place the global community on the path to a return to work, health, the new normal of life in a COVID-19 world.
Communities Across America are on the Frontlines to Identify Effective Treatments and Vaccines
June 25, 2020
When it comes to medicine, the most promising treatments may be those that already exist.
That’s why across the country, hospitals are conducting clinical trials with hundreds of existing therapeutics – therapeutics used to treat patients with other diseases – to measure their effectiveness in combating COVID-19.
For example Gilead’s promising anti-viral Remdesivir has made headlines for months, with data showing it helps shorten hospital recovery times. Now, Gilead is testing an easier-to-use inhaled version of the medicine.
Also in the pipeline to serve coronavirus patients: new drugs originally discovered to treat rheumatoid arthritis and a generic steroid that has been used for decades to treat patients suffering from everything from allergic reactions to spine and brain tumors.
These trials are happening everywhere – in 224 congressional districts and counting; in communities large and small; in hard-hit hot spots like New York City and in less affected regions like Dakota Dunes, SD.
In other words, the forefront of medical innovation might be right in your backyard. Soon, the U.S. Chamber will release a new, interactive map to show in real time where COVID-19 clinical trials are taking place throughout the United States.
We hope people will use the map to identify how they can support – and even participate in – important clinical trials. That support and participation could make all the difference in the fight against COVID-19.
Lilly Begins the World’s First Study of a Potential COVID-19 Antibody Treatment
June 16, 2020
Fully reopening the world economy is dependent on discovering safe and effective vaccines and treatments for coronavirus. As of today, there are over 320 vaccines and treatments in development to combat COVID-19.
While industry, academic institutions, and the government continue to collaborate at an unprecedented speed to develop a vaccine, scientists across the research community have also joined forces to develop another type of treatment to combat the virus: antibody therapies.
As one of the world’s leading biopharmaceutical companies, Eli Lilly and Company is dedicating its significant scientific prowess and medical expertise to attack COVID-19. On June 1, the company announced that it started the world’s first study in humans of a potential antibody treatment to fight COVID-19 infections.
Lilly believes the investigational medicine, LY-CoV555, holds promise because antibody therapies are designed specifically to attack the coronavirus. They may be particularly important for groups hardest hit by the disease, such as the elderly and those with compromised immune systems.
Lilly scientists developed the antibody in just three months after Lilly’s partner AbCellera and the Vaccine Research Center at the National Institute of Allergy and Infectious Diseases (NIAID) identified it from a blood sample taken from one of the first U.S. patients who recovered from COVID-19.
Should Phase 1 results show the antibody can be safely administered, Lilly expects to move into the next phase of testing, studying LY-CoV555 in non-hospitalized COVID-19 patients and in preventative settings with vulnerable patient populations. The company also has a second potential antibody therapy in development.
Following the announcement of the Phase 1 trial, Daniel Skovronsky, M.D., Ph.D., Lilly’s Chief Scientific Officer and president of Lilly Research Laboratories stated, “We are grateful to collaborate with colleagues at AbCellera, NIAID, and the many academic institutions who have helped us reach this milestone in humanity’s fight against COVID-19 — a disease first characterized only six months ago. We are privileged to help usher in this new era of drug development.”
Following the Science to a Vaccine
June 4, 2020
All signs point to the discovery of a coronavirus vaccine soon.
There are currently 10 vaccines in the clinical stage of development, with trials proceeding at warp speed. Last week, Moderna dosed the first patients in its Phase 2 study of its mRNA vaccine candidate. It’s just one of many positive developments.
Still, a broader, larger question looms: When will we be able to vaccinate the entire population against the coronavirus?
Scientists, physicians, and industry leaders agree that the world may need more than one coronavirus vaccine to meet global demand and adequately control the virus. Fortunately, plenty of companies have stepped up to the challenge.
Just last week, two of the world’s leading biopharmaceutical companies – Novartis and Merck – announced plans to begin trials to identify potential vaccine candidates.
In partnership with two Massachusetts hospitals and the University of Pennsylvania, Novartis will investigate whether a novel genetic vaccine will adequately immunize patients against the coronavirus. While safety and efficacy testing is still underway, Novartis subsidiary AveXis will begin manufacturing the vaccine, so it’s ready to distribute as soon as possible.
On the other hand, Merck will leverage its long-standing leadership in vaccine development to investigate whether two previously developed vaccines for measles and Ebola can be re-engineered to immunize against the coronavirus. Clinical trials for one of the vaccine candidates are set to begin as early as next month.
Recognizing the potential of both companies’ research, the White House has selected the Novartis and Merck vaccine candidates as two of the five leading immunizations currently under development.
Although the two companies are taking different paths to product, they each embody industry expertise: Any company developing a vaccine must first and foremost follow the science. We remain confident that soon, the science will lead us where we need to go.
Pfizer’s Unprecedented Approach to a Coronavirus Vaccine
May 26, 2020
As states across the U.S. slowly begin to reopen parts of their economies, a big question remains: When will a vaccine be available?
The scientific community recognizes that the unprecedented challenge of a global pandemic requires an equally unprecedented response in size, scale, and scope.
Take Pfizer, for example, one of the companies at the front of the race to create a vaccine. Today, Pfizer – in partnership with German biotech company BioNTech – has one of the 10 vaccines currently in the clinical stage of development.
What makes Pfizer’s approach unique is two-fold: First, Pfizer is one of only a handful of companies seeking to develop an mRNA vaccine candidate. Because an mRNA candidate is made from the genetic code of the virus itself, the vaccine can be produced and tested in a matter of months, rather than years. Second, Pfizer is simultaneously testing four mRNA vaccine candidates to determine which will be the most effective to immunize against COVID-19.
While the mRNA approach offers the advantage of speed, the biggest risk is that an mRNA vaccine has never been successful before. Yet the scientific team at Pfizer recognizes that the extraordinary challenge created by the global pandemic requires companies to think and act boldly.
Pfizer should know if the move will pay off by early July, with data available early this summer on which of the four mRNA candidates is the most promising.
Companies, communities, families, and individuals alike wait in anticipation to see if Pfizer’s investment in a previously unproven technology will help lead us out of the global pandemic.
The Sorrento Antibody Cocktail
May 19, 2020
Right now, there are 174 COVID-19 treatments and vaccines in the clinical stages of development, not to mention 81 additional therapies in the pre-clinical stage. The world is holding its breath for the data.
Already, early results are showing promise. And this week, a small San Diego biopharmaceutical company, Sorrento Therapeutics, released new laboratory evidence that could move the needle from promise to product.
Sorrento claims to have discovered a unique COVID-19 antibody – a blood protein the body makes in response to and in defense against a specific antigen – that can create “100% inhibition” of COVID-19. In other words, the unique antibody has so far been 100% effective in blocking COVID-19 from infecting healthy cells within just four days.
Sorrento, in partnership with Mount Sinai, is working to develop an antibody cocktail containing the unique antibody and other antibodies that they hope will prevent new COVID-19 infections. While the cocktail still needs to be tested in animal and human clinical trials, the initial laboratory performance has been positive.
According to Sorrento CEO Dr. Henry Ji, “Our […] antibody shows exceptional therapeutic potential and could potentially save lives.”
While the world awaits the discovery of a vaccine, the antibody cocktail could temporarily protect individuals from contracting COVID-19, which will be critical to getting America safely back to work. We hope to see that potential realized soon.
COVID-19 Vaccines in Development
May 13, 2020
Companies large and small, domestically and around the world, are devoting every resource to the discovery of a viable COVID-19 vaccine. According to the World Health Organization (WHO), there are 102 vaccine candidates in the pre-clinical stage of development; 8 vaccine candidates have reached the clinical stage of development, meaning human testing has already begun to assess safety and efficacy.
Last week, Moderna received approval from the U.S. Food and Drug Administration (FDA) to be become the second company to begin a Phase II COVID-19 vaccine trial. Just yesterday, Moderna received Fast Track designation from the FDA to help expedite the development and review of its potential vaccine.
The speed at which these innovators are working to develop and test vaccines is unprecedented. But perhaps even more unprecedented than this speed: the ongoing scale-ups of manufacturing in preparation to inoculate millions of people in need.
Pfizer and BioNTech began clinical trials in the U.S. last week for one of the leading COVID-19 vaccine candidates. Even before the vaccine completes clinical trials, Pfizer is bolstering their manufacturing capacity to deliver millions of vaccine doses by the end of 2020. In 2021, they will increase that capacity to deliver hundreds of millions of them. That kind of supply helps ensure broad access, bringing us one step closer to the herd immunity we need to control this virus for good.
It is worth noting: all of this investment in research and development is being made at risk. No one knows which vaccine candidates will be successful, and which ones will fail. That basic fact underscores the foundation of the life sciences community: A spirit of innovation coupled with a drive to serve patients and improve global health. It is clear that foundation is stronger than ever.
Putting Innovation to the Test for COVID-19
May 6, 2020
Moving forward, knowing who among us has previously contracted COVID-19 will help us understand the spread of the disease and the extent of societal prevalence.
Enter serological tests – or antibody tests – that can quickly identify who has been exposed to the virus but no longer carries an active infection.
The first COVID-19 antibody tests entered the U.S. in mid-March, but many of them lacked FDA review, and thus, did not meet FDA’s stringent standards for accuracy. Some were even maliciously intentioned.
FDA Deputy Commissioner Anand Shah and Director of the Center for Devices and Radiological Health Jeff Shuren warned of “unscrupulous actors marketing fraudulent test kits and using the pandemic as an opportunity to take advantage of Americans’ anxiety.”
So, this week, the FDA issued new guidance dictating stronger oversight of COVID-19 antibody tests. According to the guidance, manufacturers must submit an Emergency Use Authorization (EUA) request for their antibody tests, complete with data to prove the tests’ accuracy, within 10 days of entering the market.
To date, 12 antibody tests have an EUA, and 200 tests are undergoing review. One authorized test, delivered by Roche Holding, has 100% sensitivity in detecting the virus and 99.8% specificity, meaning only two in every 1,000 samples tested might produce a “false positive” result. In other words, it’s top of the line.
Thanks to productive collaboration between industry players like Roche and the government, we may soon have more data to help guide fact-based decision-making.
Enlisting Science to Help Solve COVID-19
April 29, 2020
Every year during the last week of April, the World Health Organization (WHO) celebrates World Immunization Week to promote all the ways vaccines are creating and perpetuating a healthier world. Never have vaccines been as top-of-mind as they are now in the midst of the COVID-19 crisis.
Public officials around the world are considering how best to re-open their businesses, schools, and ultimately, economies, in the coming weeks and months. One of the most critical factors in getting countries back up and running is the discovery of a vaccine to protect against COVID-19. It’s an unprecedented challenge that both the private and public sectors are meeting with equally unprecedented collaboration.
According to WHO, there are currently seven COVID-19 vaccines in the clinical stages of development. In the last week alone, the University of Oxford’s potential vaccine received widespread attention with the announcement that they could have doses available as early as September if the vaccine proves effective in clinical trials and receives emergency approval from regulators. Additionally, BioNTech and Pfizer announced a Phase I/II trial for their potential vaccine will begin in Germany.
Of the seven potential vaccines, two are the result of a partnership between a life sciences company and a public university or government. Additionally, there are 82 vaccines in the pre-clinical stage of development. Even in those instances, before human trials have begun, companies have announced partnerships with the public sector. For example, at Johnson & Johnson innovators are working with the U.S. government to produce more than one billion doses of an emerging vaccine.
These statistics inform an important conclusion: When we work together, we get more accomplished. Our collective work will help the world get back to work and more importantly, back to health for good.
Enlisting Science to Solve COVID-19
April 22, 2020
As governments take steps to re-open the economy, one sentiment prevails: Americans must get back to good health before we can get back to business as usual. That means we need reliable therapeutic treatments, diagnostic testing, and, eventually, an effective vaccine. The pharmaceutical industry is already delivering.
Right now, there are 173 vaccine and treatment candidates in the clinical stages of development for COVID-19, according to data released yesterday from BioCentury. With so many treatments under development, who is leading the way?
One of these leaders is Gilead. Early data from Gilead’s Phase 3 clinical trials for its investigational antiviral Remdesivir shows particular promise with coronavirus.
While Gilead first began to test Remdesivir in critically-ill patients in February 2020, the research that led to Remdesivir dates back to 2009. Remdesivir was used in clinical trials to combat Ebola from 2014-2016, and while Remdesivir ultimately proved less effective than other treatments, the story of Remdesivir sheds light on the drug development process more broadly. It often takes years of R&D, testing, and often times, failures, before a treatment reaches the market.
While Gilead awaits data from multiple ongoing studies exploring the safety and efficacy of Remdesivir, partial data last week from a University of Chicago Medicine study showed that nearly all enrolled patients were discharged from the hospital with no fever or respiratory symptoms in less than a week.
The early data has given scientists hope that Remdesivir could be one treatment which will help get patients back to health, and eventually, back to life.
It’s inspiring to see companies working around the clock to combat COVID-19. It’s even more inspiring to see their efforts pay off.