- The summer will be a critical time for the race to develop effective coronavirus treatments and vaccines.
- Business Insider identified the nine most important events expected to happen in July.
- Expect a flood of data this month from vaccine and drug programs wrapping up clinical trials. Other promising therapeutics and vaccines are aiming to start human testing.
- And the speediest vaccine programs, like Moderna’s, will soon start massive late-stage trials — the crucial test in seeing how well these experimental shots work in humans.
- Visit Business Insider’s homepage for more stories.
The dog days of summer are shaping into a critical stretch for developing COVID-19 drugs and vaccines.
There are hundreds of research efforts across the world hunting for a potential cure. Business Insider reviewed what’s underway and identified the nine most important events slated for July.
That includes potential vaccines from drugmakers like Johnson & Johnson starting human testing, while those that are farther along like Moderna’s experimental vaccine should be disclosing detailed results and even starting late-stage studies. Antibody drugs, which could be game-changing treatments for COVID-19, could be ready as soon as this fall.
We’re also likely to learn if some popular potential treatments like convalescent plasma and anti-inflammatory drugs like Kevzara and Actemra can help patients recover from COVID-19.
Here’s what to expect in July.
Options trading The first results from vaccines led by Pfizer and AstraZeneca could come out in July
Pfizer and AstraZeneca are both in charge of top vaccine programs that have yet to disclose any human results. The chief executives for both pharmas have said they are aiming to have their vaccine ready potentially by this fall.
Pfizer’s vaccine, which it developed with the German biotech BioNTech, released its first human data on July 1. That included 45 volunteers who received the two-shot regimen. The two companies are testing four variations of its vaccine, planning to select the most promising one for late-stage trials that could start as early as July, Pfizer said.
AstraZeneca partnered on a vaccine developed by the University of Oxford. A UK clinical trial has been enrolling patients for months now, but has yet to publicly release any human results.
Read more: Scientists are racing to create a coronavirus vaccine that can halt the pandemic in its tracks. Here are the top 3 candidates from Moderna, Pfizer, and AstraZeneca aiming to be ready this fall.
Options trading Moderna becomes the first to start late-stage vaccine trials
July will be a critical month for Moderna, as it expects to start a late-stage, 30,000-person trial to see how well its potential coronavirus vaccine works.
Once again, Moderna is primed to beat out the 100-plus other vaccine developers in reaching this starting its Phase 3 trial first. It’s possible one of the several China-based vaccine programs could beat Moderna, although it’s been hard to get a clear picture into how that vaccine’s being developed.
For months, the Cambridge, Massachusetts has been leading in the drug industry’s sprint toward a coronavirus vaccine.
It hasn’t been without controversy. The $25 billion biotech has yet to publish human data in a scientific journal, opening it to criticism of “publication by press release.” Stat News’ Damian Garde also reported that company executives have cashed out $89 million in stock and options this year, as Moderna’s stock more than tripled in the first half of 2020.
July could also feature the first taste of hard data for Moderna’s shot. The US National Institutes of Health is in charge of publishing the results from the initial safety study in a journal. The biotech has also been running a 600-person trial that likely will produce interim results in August or September, CEO Stephane Bancel said at a June 11 investor conference.
Options trading Gilead sells the first COVID-19 drug, building the market for others
While Moderna has led the vaccine race, the California biotech Gilead Sciences was the first company to have an effective coronavirus treatment. Its antiviral drug remdesivir has already been used to help tens of thousands of COVID-19 patients recover faster.
Gilead in June put a price tag on remdesivir, as the company plans to go from donating to selling the drug.
In July, Gilead is set to host its second quarter earnings call, during which company executives are expected to detail its sales strategy and revenue forecasts. Gilead’s market value has grown by about $12 billion since January 1, and Wall Street analysts will be eager to learn how much revenue and profit Gilead expects to rake in from remdesivir.
Gilead has yet to announce a date for the call, but it has consistently happened in the last week of July over the past few years.
Options trading Pharma giant J&J starts testing its vaccine in humans
Johnson & Johnson expects to enter the clinic with its coronavirus vaccine candidate in July. Last month, the world’s largest healthcare company accelerated its development timeline by a couple months.
If this first study is positive, it should allow J&J to launch a massive trial in September that would enroll between 30,000 and 100,000 volunteers to see how well the vaccine works at preventing the novel coronavirus, J&J Chief Scientific Officer Paul Stoffels told Business Insider.
July’s trial is set to recruit 1,045 healthy participants in the US and Belgium. The $365 billion drugmaker, which is one of the world’s biggest vaccine makers, has the resources, regulatory expertise, and scientific know-how to make a difference in a pandemic. J&J’s vaccine will instantly be a top program to watch.
Options trading A handful of smaller vaccine programs are also likely to start clinical trials
While next to vaccine giants like J&J, Sanofi, and GlaxoSmithKline, nearly any company can seem little. But many of these vaccine programs are led by companies or organizations facing an uphill battle in meeting the pandemic’s demands.
Drugmakers will have to simultaneously scale up manufacturing while testing their vaccines around the globe to meet the unprecedented levels of demand. The first step will be starting clinical trials, which more than a dozen candidates have already begun.
Vaccine candidates aiming to start studies in July include the small Maryland biotech Novavax and the University of Queensland. There’s also potential for several additional shots to enter the clinic. Medicago, Arcturus Therapeutics, NantKwest, VaxArt, and Reithera have also said they are targeting to start trials this summer.
Options trading We’ll find out more about how antibody drugs could help treat COVID-19
A slew of top drugmakers have been searching for potent antibodies, virus-fighting proteins that can neutralize the coronavirus. After finding one, two or three of particularly strong antibodies, they aim to clone them using biotechnology into a consistent drug product.
This month will likely see some of the first data from that program, as Lilly floated the possibility to have early safety data on its antibodies by the end of June. That didn’t happen, so the Indianapolis drugmaker is worth watching in early July for an update on its antibodies.
While Regeneron launched two studies for its two-antibody cocktail in June, it is poised to launch another two in July if early safety signals are OK. These additional trials will test its drug as a prophylactic treatment that could prevent infections, acting like a type of short-term vaccine.
Both companies are aiming to be ready this fall with an antibody therapeutic, in time for a second wave and likely before any vaccine candidate is ready for significant use. Several other drugmakers could join them in the clinic, with antibody drugs being developed by Vir Biotechnology, AbbVie, and AstraZeneca all aiming to start clinical testing sometime this summer.
Options trading We might find out if the blood of recovered COVID-19 helps treat patients
Convalescent plasma has been used for more than a century to treat infectious diseases, helping treat patients afflicted by the 1918 influenza pandemic.
The treatment is a transfusion of plasma, the nutrient- and antibody-rich portion of blood, from recovered COVID-19 patients into the ill. The theory is a blast of virus-fighting antibodies will help patients recover and fight off the virus.
While many physicians have expressed optimism about this treatment, it’s not clear how well it works in COVID-19 yet. A high-quality clinical trial expected to wrap up in July will help determine its value in fighting this pandemic.
The study aims to enroll more than 400 hospitalized patients and randomly assign them to receive standard care either with or without a convalescent plasma infusion.
Led by the Erasmus University Medical Center in the Netherlands, this Dutch study is one of the largest to analyze the plasma infusions in COVID-19. If the infusions work, it adds another treatment option that patients will benefit from.
Options trading A group of 10 drugmakers including Takeda start testing a plasma-based drug
Led by Takeda and CSL Behring, a group of 10 drugmakers is working together to advance a plasma-based treatment candidate.
They are aiming to start human testing in July, finish the study by the fall, and gain regulatory approval by year’s end.
The experimental treatment is called a hyperimmune globulin, a more standardized form of a convalescent plasma transfusion. The drug is made from the antibody-rich blood of coronavirus survivors. The companies hope this will help ill patients fight the virus and recover with a boosted immune response.
Options trading We might learn more about how the anti-inflammatory drugs Actemra and Kevzara work in treating critically ill COVID-19 patients
One of the first ideas to treat COVID-19 was using anti-inflammatory drugs like the IL-6 inhibitors Actemra and Kevzara. The definitive trials are due to produce results this month.
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Mark Eisner, Genentech’s global head of immunology, infectious disease, and ophthalmology clinical development, told Business Insider in April they expected to have data for its drug, Actemra, in early summer.
For the past few months, Genentech has aimed to enroll 330 patients with severe cases of COVID-19, randomly giving them either an IV infusion of Actemra or a matching placebo.
Regeneron has also been running a randomized trial with a placebo group for Kevzara, a drug that acts on the same genetic target as Actemra. In late-April, researchers narrowed that study to focus only on the sickest patients, as the drug wasn’t helping in less severe cases.
Options trading One of the unlikely leaders in the vaccine race faces its biggest test yet
For the small Pennsylvania biotech Inovio Pharmaceuticals, July will be a crucial month in its efforts to develop a coronavirus vaccine. The company has to handle several thorny situations simultaneously, or else its $5 billion valuation may be in jeopardy.
First, Inovio is mired in a legal fight with a contract manufacturer. Ramping up production now is a prerequisite for coronavirus vaccine developers, and it appears to be a concerning sign that Invoio recently sued its partner.
While Inovio provided a brief description of early results at the end of June, that only caused its stock to sell off by about 15%. The biotech said it plans to soon publish that data in a medical journal. If that happens in July, the details could reveal a lot about how well its vaccine candidate is working.
The small company will also need to solidify plans for late-stage testing it hopes to begin this summer, particularly as much larger pharmas are each planning to run their own 30,000-person trials.
In short, skepticism is building for Inovio. Since 1983, Inovio has been working on the unproven technology of DNA-based vaccines and has yet to have one approved. July will be a time of execution to show the company is serious in the coronavirus vaccine race. Watch for a resolution to the manufacturing lawsuit, more details on its vaccine results, and a finalized plan for efficacy trials to start this summer.
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