Vaccine Trials Advance in Race for Virus Protection

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  • Moderna, AstraZeneca, and China’s CanSino are among the leading candidates.
  • China, Europe, and the U.S. report positive developments in trials of their shots.
  • Oxford and AstraZeneca Plc have also shown favorable immune responses in people and animals.
  • CanSino Biologics has received authorization for a limited deployment of its shot among the Chinese military.
  • Moderna Inc. vaccine candidate produced antibodies in all participants in a study.
  • More than 150 vaccines are under development and close to as many drugs being examined.

According to an article published in Bloomberg, Moderna, AstraZeneca, and China’s CanSino are among the leading candidates to produce a shot to fight the pandemic.

Acceleration to find a cure

The global push to develop coronavirus vaccines is accelerating, with companies in China, Europe, and the U.S. reporting positive developments in trials of their shots.

A Moderna Inc. vaccine candidate produced antibodies in all participants in a study, and early tests of experimental shots from Pfizer Inc. and BioNtech SE, as well as a partnership of Oxford and AstraZeneca Plc, have also shown favorable immune responses in people and animals. CanSino Biologics has received authorization for a limited deployment of its shot among the Chinese military. The U.S. government is working with a number of pharmaceutical companies under its “Operation Warp Speed” program, with the aim of securing shots by the end of the year.

Meanwhile, a low-cost, widely used anti-inflammatory drug has become the first treatment to show life-saving results against Covid-19. Dexamethasone reduced deaths among severely ill patients in a University of Oxford study, even as antimalarial medicines touted by President Donald Trump stumbled.

With more than 150 vaccines under development and close to as many drugs being examined, not every experimental program is included here. The tracker will add new ones as they start or advance in trials, gain significant backing or show promise. Almost all of these efforts are in the early stages, meaning that the gold standard of data―clinical trials with “blinded“ placebo and therapy groups―is still hard to come by. With loosened rules and a desire to get solutions to market quickly, it’s important to cast a skeptical eye on too-good-to-be-true data.

Legend

  • Preclinical: Test tube and animal experiments
  • Phase 1: Testing in small groups for safety
  • Phase 2: Larger tests for effectiveness
  • Phase 3: Large-scale efficacy and safety trials
  • Authorized: Results vetted by regulators in preparation for use; includes emergency use authorizations

Vaccines

Vaccines give broad parts of the population some level of immunity and are considered crucial to ending the pandemic. They also take longer to develop, in part because they must be proven to be extremely safe since they’re given to healthy people. While some researchers say a vaccine could be ready by the end of the year, others say it could take far longer.

  • COMPANY: Oxford University, AstraZeneca Plc
  • NAME: ChAdOx1 nCov-19
  • PROGRESS: Phase 3

The vaccine is made from a harmless virus that’s been altered to produce the surface spike protein from SARS-CoV-2.

With human trials underway, the U.S. government has pledged as much as $1.2 billion, and the company plans to produce as many as 30 million doses available in the U.K. by September. Other groups are moving to line up access elsewhere.

  • COMPANY: Moderna Inc.
  • NAME: mRNA-1273
  • RECENTLY UPDATED: Phase 2

Moderna’s mRNA-1273 uses messenger RNA to prompt the body to make a key protein from the virus, creating an immune response.

Moderna’s vaccine produced antibodies to the coronavirus in all patients tested in an initial safety trial. The company expects a phase 3 trial to begin July 27. 

  • COMPANY: CanSino Biologics Inc.
  • NAME: Ad5-nCoV
  • PROGRESS: Phase 2

CanSino’s vaccine was developed alongside China’s military and is genetically engineered with a replication-defective mutant virus. CanSino’s vaccine has received a special authorization to be used by China’s military after a study showed it generated an immune response. President Xi Jinping says the country will make any vaccine available as a global public good.

  • COMPANY: BioNTech SE, Pfizer Inc.
  • NAME: multiple candidates
  • PROGRESS: Phase 2

BioNTech’s BNT162 is another messenger RNA vaccine platform that the German company is developing with Pfizer. In China, BioNTech is co-developing vaccines with Shanghai Fosun Pharmaceutical Group.

One of the companies’ vaccines candidates has shown promising antibody responses. Further testing in up to 30,000 people may start as early as July.

  • COMPANY: Sinovac Biotech Ltd
  • NAME: No name yet
  • PROGRESS: Phase 3

The vaccine uses an inactivated virus, which can help the body develop antibodies to the pathogen without risking infection. Sinovac has begun human trials in China. The company says its vaccine candidate can neutralize different strains of the virus.

  • COMPANY: China National Biotec Group Co., Beijing Institute of Biological Products
  • NAME: No name yet
  • PROGRESS: Phase 3

The vaccine uses an inactivated virus, which can help the body develop antibodies to the pathogen without risking infection. With phase 2 trials complete, a vaccine could be available as soon as the end of this year, according to an official report in May.

  • COMPANY: Novavax Inc.
  • NAME: NVX-CoV2373
  • RECENTLY UPDATED: Phase 2

Novavax’s vaccine is meant to create antibodies that block a protein “spike” that the virus uses to infect its host. Novavax has received $1.6 billion from the U.S. government as it prepares for a final-stage study as early as this fall.

  • COMPANY: Johnson & Johnson
  • NAME: No name yet
  • PROGRESS: Preclinical

J&J is working on an unnamed adenovirus-based vaccine as well as two backups. J&J accelerated plans for human studies and aims to make up to 1 billion doses by the end of 2021. J&J has said its vaccine could be ready for emergency use by January, and it has received $456 million from the U.S.

  • COMPANY: Sanofi, GlaxoSmithKline Plc
  • NAME: No name yet
  • PROGRESS: Preclinical

Sanofi is working on a vaccine using technology already employed in one of its flu vaccines, which could speed development and production. France’s Sanofi has partnered with the U.K.’s Glaxo on a project backed by U.S. funding. The companies plan to start human trials in the second half of this year. Sanofi is also developing an mRNA vaccine with Translate Bio.

  • COMPANY: Inovio Pharmaceuticals Inc.
  • NAME: INO-4800
  • RECENTLY UPDATED: Phase 1

Inovio’s experimental vaccine uses DNA to activate a patient’s immune system. Inovio says an early trial showed positive immune responses but investors complained about a lack of detail.

  • COMPANY: Merck & Co.
  • NAME: No names yet
  • PROGRESS: Preclinical

Merck’s two vaccine candidates employ existing technology behind its Ebola virus shot and a measles virus vector platform discovered by the Pasteur Institute, respectively. Merck has partnered with AIDS researchers to develop a vaccine using technology already employed in its Ebola virus shot. The company has also agreed to buy biotech Themis, gaining a vaccine candidate that uses an existing measles virus vector platform.

  • COMPANY: Imperial College London
  • NAME: No name yet
  • PROGRESS: Phase 1

When injected, the RNA vaccine candidate delivers genetic instructions to muscle cells to make the “spike“ protein on the surface of the coronavirus. Researchers have received U.K. funding and have begun human trials.

Antivirals

Antiviral drugs work by stopping the virus from replicating or infecting cells. They can include everything from complex biotechnology therapies to older generics. Other examples of antivirals include many HIV drugs, treatments for hepatitis C, and the influenza treatment Tamiflu.
  • COMPANY: Gilead Sciences Inc.
  • DRUG: Remdesivir
  • PROGRESS: Authorized

Remdesivir targets genetic material called RNA and is meant to stop SARS-CoV-2 from replicating. Tried without success as an Ebola drug, it’s complex to manufacture and for now has to be given intravenously.

The FDA issued an emergency use authorization after early study results showed that remdesivir sped up patients’ recoveries. More recently, the company has said that remdesivir may have a mortality benefit. While other trials have shown mixed results, governments are stepping up efforts to secure the drug.

  • COMPANY: AstraZeneca Plc, Eli Lilly & Co., Regeneron Pharmaceuticals Inc., GlaxoSmithKline Plc, Vir Biotechnology Inc. and others
  • DRUG: Anti-COVID Antibodies
  • PROGRESS: Preclinical

Antibodies discovered by drugmakers can mimic an immune-system response to the virus, for example by blocking the so-called spike protein that the coronavirus uses to infect human cells. Several companies have begun human trials of antibody treatments, with others rushing to line up their own by the end of summer.

  • COMPANY: Merck & Co.
  • DRUG: EIDD-2801
  • PROGRESS: Preclinical

The antiviral drug discovered at Emory University inhibits the replication of multiple RNA viruses. Preclinical studies found the drug-induced mutations causing a range of coronaviruses to make catastrophic errors when they replicate. Merck CEO Kenneth Frazier told Bloomberg it has the potential to be easier to use than Gilead’s remdesivir.

  • COMPANY: Takeda Pharmaceutical Co.
  • DRUG: Convalescent plasma (TAK-888)
  • PROGRESS: Preclinical

Takeda is exploring whether blood plasma from recovered Covid-19 patients, which can contain infection-fighting antibodies, can be used against the illness. Similar treatments have shown promise in treating other serious infections. The Japanese drugmaker plans to start clinical trials in July and could file for approval of the treatment in some regions by the end of the year. U.S. studies will be done with the NIH.

  • COMPANY: Zhejiang Hisun Pharmaceutical Co.
  • DRUG: Favipiravir
  • PROGRESS: Authorized

Favipiravir is a flu medicine that is branded and sold as Avigan by FujiFilm Holdings Corp. in Japan. Favipiravir also targets viral RNA to stop the spread of the virus. An early study of favipiravir found potential benefits. Russia has shipped a version to hospitals across the country.

  • COMPANY: Generic drugs made by Teva Pharmaceutical Industries Ltd., Mylan NV, Sanofi, Novartis AG, Bayer AG, and others
  • DRUG: Hydroxychloroquine, chloroquine
  • PROGRESS: Phase 3

Hydroxychloroquine and chloroquine are anti-malarial drugs that have been tested in other viral outbreaks, generally without success. Years old, they’re available as lower-cost generics. Once touted by President Donald Trump, hydroxychloroquine has suffered a series of trial failures. The FDA has pulled its U.S. authorization for use against the virus.

Indirect therapies

These therapies don’t directly treat or prevent the virus, but can help patients who have fallen ill by mitigating the disease’s effects, such as difficulty breathing or severe inflammatory responses. Such treatments, including a promising generic steroid, could help some of the sickest hospitalized patients.
  • COMPANY: Generic drugs made by Mylan NV, Hikma Pharmaceuticals Plc and others
  • DRUG: Dexamethasone
  • RECENTLY UPDATED: Phase 3

The low-cost steroid is already widely used to treat a range of ailments including rheumatism, asthma, and allergies. It’s among a number of anti-inflammatories being studied to help patients cope with a powerful overreaction of the immune system, sometimes called a cytokine storm. The 60-year-old medicine reduced deaths among patients needing breathing assistance, according to the University of Oxford researchers.

  • COMPANY: Regeneron Pharmaceuticals Inc. and Sanofi; Roche Holding AG
  • DRUG: Kevzara; Actemra
  • PROGRESS: Phase 2

Rheumatoid arthritis drugs that target a pathway known as interleukin-6 or IL-6 can affect inflammation. These medicines could help very sick Covid-19 patients in respiratory distress. Regeneron and Sanofi stopped a study in patients who needed mechanical ventilation when it became clear Kevzara didn’t work any better than the placebo. Meanwhile, Roche’s Actemra has shown possible benefits in some patients.

  • COMPANY: Incyte Corp., Novartis AG; Eli Lilly & Co.
  • DRUG: Jakafi; Baricitinib
  • PROGRESS: Phase 3

Jakafi, or Jakavi as it’s called outside the U.S., belongs to a class of drugs known as JAK inhibitors that target inflammation and repress cellular proliferation. Baricitinib, marketed by the brand-name Olumiant, also belongs to the class of drugs.

In April, Incyte and Novartis started a trial of Jakafi to address a potentially deadly reaction to the disease, in which a patient’s immune system kicks into dangerous overdrive. Lilly and the NIH are studying baricitinib with remdesivir in hospitalized patients. A late-stage Lilly-sponsored study started enrolling patients in June to test barictinib on its own in such patients.

  • COMPANY: Kiniksa Pharmaceuticals, I-Mab, Humanigen, Roivant Sciences Inc., Sanofi
  • DRUG: Mavrilimumab, lenzilumab, others
  • RECENTLY UPDATED: Phase 2

To mitigate the complications of cytokine storm, companies are developing antibodies against human granulocyte-macrophage colony-stimulating factor or GM-CSF, a cytokine responsible for inflammation. Some of these medicines are also being developed for rheumatoid arthritis.

Various studies are underway after earlier results showed some patients treated with mavrilimumab had their fevers resolve and did not need mechanical ventilation.

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Source: BloombergNews