SARS-CoV-2 (COVID-19) Treatments and Vaccines Tracker Last update 07 November 2020 Fuente: https://Statnews.com
SARS-CoV-2 (COVID-19) Treatments Last update 07 November 2020
Gilead Sciences Phase 3 (authorized foremergency usein the U.S.)
Gilead’s drug, remdesivir, is an intravenous treatment meant to block viruses from replicating. Gilead developed it as an all-purpose antiviral, conducting preclinical tests in SARS, MERS, and other infectious diseases. In 2015, as Ebola spread through West Africa, Gilead’s treatment was part of a multi-drug clinical trial. In the final data, remdesivir was significantly less effective than the other tested medicines. In 2020, as the novel coronavirus spread across the world, Gilead began studying remdesivir again.
Feb. 6: Researchers begin two Phase 3 studies in China Feb. 26: Gilead launches to Phase 3 studies of its own, planning to enroll about 4,000 patients April 10: Gilead publishes data on 53 patients who received remdesivir under compassionate use April 15: Researchers suspend the two China studies over lack of eligible patients April 29: Remdesivir leads to a 31% improvement in recovery time compared to placebo in an 800-patient trial May 1: The FDA issues an emergency use authorization for remdesivir, allowing the drug to be used in limited cases May 7: Japan's health ministry approves remdesivir to treat Covid-19 May 22: The National Institutes of Health publishes full Phase 1 data in the New England Journal of Medicine Read More
Roivant Sciences Phase 3
Roivant is studying whether its investigational anti-inflammatory can treat acute respiratory distress syndrome, or ARDS, which is a severe and potentially fatal consequence of the novel coronavirus. The treatment, gimsilumab, is an intravenous antibody that targets GMCSF, a protein that drives inflammation. GM-CSF appears to be up-regulated in the blood of Covid-19 patients admitted to the ICU, and blocking it might be a way to improve outcomes in the most severe cases.
March 18: Roivant begins investigating gimsilumab as a treatment for Covid-19 April 15: Roivant doses first patient in a placebo-controled trial enrolling Covid-19 patients with acute lung injury or ARDS. The primary goal is improving mortality after 43 days. The trial will enroll up to 270 patients.
Regeneron Pharmaceuticals Phase 3
Regeneron has grown into a $50 billion business based on its ability to craft human antibodies out of genetically engineered mice. Now it’s tapping that technology in hopes of treating coronavirus. The company immunized its proprietary antibody-generating mice with a harmless analog of the novel coronavirus, generating potential treatments for the infection. The last time Regeneron embarked on this process, during the Ebola outbreak of 2015, it came up with an antibody cocktail that roughly doubled survival rates for treated patients.
March 17: Regeneron plans to select two of the most potent antibodies and enter clinical trials by early summer June 11: Regeneron begins Phase 1 studies of a two-antibody cocktail treatment, enrolling patients with and without Covid-19 to see whether its therapy can both treat and prevent the disease July 6: Regeneron begins a Phase 3 study to determine whether its cocktail can prevent coronavirus infection in healthy volunteers, and two mid-stage studies involving hospitalized and non-hospitalized Covid-19 patients Oct. 28: Regeneron's treatment led to a significant reduction in viral load and need for medical visits in a study involving more than 500 Covid-19 patients who aren't hospitalized. The company has filed for an FDA emergency use authorization
Read More
Eli Lilly Phase 3
Eli Lilly has partnered with a Canadian firm called AbCellera to develop antibody treatments for coronavirus infection. Using a blood sample from a coronavirus survivor, AbCellera identified more than 500 antibodies that might protect against the virus, and it’s working with Lilly to identify which are most potent.
March 12: Lilly says it will have an antibody ready for human trials within four months June 1: Lilly and AbCellera began a placebo-controlled Phase 1 study Sept. 16: Lilly announced interim data in which one of three antibody doses met the primary goal of speeding up viral clearance Oct. 7: Lilly releases data in which a combination of two antibodies reduced levels of the virus and prevented hospitalization. The company plans to request an FDA emergency use authorization next month
Read More
Vir Biotechnology Phase 3
Vir Biotechnology, a company focused on infectious disease, has isolated antibodies from people who survived SARS, a viral relative of the novel coronavirus. In addition, the company has aligned with Alnylam Pharmaceuticals to work on treatments that might halt viral replication by interfering with RNA signaling. Vir’s CEO, Biogen veteran George Scangos, is also coordinating the trade group BIO’s response to the coronavirus outbreak.
March 25: Vir plans to get its antibodies into clinical trials within three to five months Sept. 1: Vir and its partner GSK begins Phase 1/2 trial of its Covid-19 antibody treatment Oct. 6: Companies say results of Phase 1/2 were positive but withhold results. Phase 3 of the trial, called COMET-ICE, is started.
Read More
Merck and Ridgeback Biotherapeutics Phase 2
Ridgeback Biotherapeutics, a privately held biotech company, has an exclusive license to develop an antiviral invented at Emory University. Called EIDD-2801, the drug is designed to interrupt the process by which viruses replicate. The mechanism is similar to that of Gilead Sciences’ intravenous remdesivir, but EIDD-2801 is an oral medicine. In animal studies, the drug has demonstrated promise against SARS and MERS, which are related to the novel coronavirus
March 19: Ridgeback licenses EIDD-2801 from Emory April 6: FDA permits Ridgeback to begin human trials in the U.S. April 10: Ridgeback begins Phase 1 study in the U.K. May 26: Merck licenses EIDD-2801 June 19: Ridgeback advances the drug, now called MK-4482, into two Phase 2 studies, enrolling Covid-19 patients in and out of the hospital
Athersys Phase 2
Athersys has a stem-cell therapy it believes could be helpful in treating acute respiratory distress syndrome, or ARDS, which is a severe and potentially fatal consequence of the novel coronavirus. The treatment, called MultiStem, is made from a type of stem cell harvested from adult bone marrow. MultiStem was demonstrated to be safe in an earlier ARDS study, but the efficacy results were inconclusive
April 13: Athersys plans to start a Phase 2/3 study in Covid-19 patients with ARDS by July
Read More
Ascletis Pharma Phase 1
Chinese drug maker Ascletis Pharma is testing a combination of antivirals, one approved for HIV and one approved for hepatitis C, that might treat coronavirus infection. Danoprevir, marketed in China as Ganovo, targets an enzyme hepatitis C uses to replicate. Ritonavir, sold as Norvir, acts on a different viral enzyme found in HIV.
Feb. 17: Doctors in China treat first patients with the combination March 25: Ascletis reports that 11 patients with moderate Covid-19 were discharged from the hospital after four to 12 days of treatment with the combination
Celularity Phase 1
Celularity is developing a treatment that would use immune cells to treat Covid-19. The company uses stem cells to generate so-called natural killer cells, which the innate immune system uses to fight foreign infections. The company’s investigational treatment, CYNK001, is also being developed as a cancer treatment.
April 2: Celularity got the FDA's permission to begin a Phase 1 trial
I– Mab Phase 1
I-Mab, headquartered in Shanghai, is developing a treatment for one of Covid-19’s dangerous side effects. Patients with severe infections sometimes develop cytokine release syndrome, in which the immune system overreacts by producing proteins that lead to inflammation. I-Mab’s therapy is an antibody against the protein GM-CSF, a key inflammatory cytokine.
April 3: The FDA signed off on I-Mab's plan for a placebo-controlled trial, which the company said it would begin "as soon as possible"
SAB Biotherapeutics and CSL Behring Preclinical
In addition to its work in plasma treatment alliance, CSL Behring is working with SAB Biotherapeutics on an antibody treatment. Monoclonal antibodies, as the name suggests, bind to a single point on the protein they target. But SAB’s potential treatment, SAB-185, is polyclonal, a difference the company believes will make it more potent
April 8: SAB and CSL say they plan to begin trials in the summer
Allo Vir Preclinical
AlloVir, working with the Baylor College of Medicine, is developing a cell therapy tuned to attack the novel coronavirus. The company’s technology involves taking T cells from healthy donors and then exposing them to a harmless fragment of the coronavirus, triggering an immune response. Once the T cells are activated, they’re cryopreserved and stored for transplant into a patient.
March 23: AlloVir and Baylor began work on T cell therapy for coronavirus but did not disclose a timeline to clinical study
Amgen Preclinical
Amgen has partnered with Adaptive Biotechnologies to develop antibody treatments for coronavirus infection. Adaptive will screen the blood of coronavirus survivors to isolate antibodies that might protect against the virus, and then Amgen will select, develop, and manufacture potential medicines.
April 2: The two companies announced their alliance and plans to begin clinical trials "as quickly as possible"
AstraZeneca and Vanderbilt University Medical Center Preclinical
Global drug maker AstraZeneca signed a deal with Vanderbilt University Medical Center to develop antibodies identified at the school’s lab. Vanderbilt has been screening the blood of Covid-19 survivors, isolating antibody-producing white blood cells, and using them to clone potential treatments. Under the agreement, Vanderbilt is providing those antibodies to AstraZeneca, which will choose the best candidates for clinical development. Vanderbilt’s work has been funded by the Department of Defense, the National Institutes of Health, and Dolly Parton.
March 23: Vanderbilt plans clinical trials by the summer April 8: AstraZeneca partners to develop Covid-19 antibodies
Celltrion Preclinical
South Korean drug maker Celltrion, which markets FDA-approved biosimilars, is developing antibody treatments for Covid-19. Working with the Korea Centers for Disease Control, the company has identified a library of protective antibodies from the blood of recovered patients, and it’s screening them to find the most effective. In addition, Celltrion is researching what it calls a super antibody, one that could protect against all viruses within the coronavirus family.
March 23: Celltrion begins its research program and plans to enter clinical trials in the third quarte
Grifols Preclinical
Spanish drug maker Grifols is working with the U.S. government to collect blood plasma from Covid-19 survivors and transform it into a treatment for the disease. The company aligned with the Biomedical Advanced Research Authority and the FDA to recruit recovered patients to one of its more than 250 plasma collection centers in the U.S. Grifols plans to process the resulting plasma at its facility in North Carolina.
March 25: Grifols enters agreement with federal authorities April 20: Grifols begins recruiting Covid-19 survivors
Neurimmune and Ethris Preclinical
Neurimmune, the Swiss drug maker that discovered Biogen’s Alzheimer’s disease treatment aducanumab, is working on an approach that would get anti-coronavirus antibodies directly into the lungs of infected patients. Working with Ethris, a German company focused on mRNA, Neurimmune is working to identify neutralizing antibodies from the blood of Covid-19 survivors. Once that’s done, Ethris will design mRNA that encodes for those antibodies and package it in an inhalant. If it all works out, the companies will craft a directacting drug that generates antibodies at the site of infection.
April 1: Neurimmune and Ethris begin development with plans to enter human trials in the fourth quarter
Pfizer Preclinical
Pfizer is developing an antiviral medicine that targets an enzyme viruses use to replicate. The drug came from a series of compounds Pfizer had previously developed against the virus that causes severe acute respiratory syndrome, or SARS, which is related to the new coronavirus.
April 9: Pfizer said its drug will be ready for human testing in August or September
Read More
Takeda, CSL Behring, Biotest, BPL, LFB, and Octapharma Preclinical
Six companies are collaborating to develop a Covid-19 treatment derived from the blood of people who have already been infected by the coronavirus. The approach involves drawing blood from coronavirus survivors, harvesting the plasma, and then isolating the protective antibodies that kept those patients alive. It’s not a new idea. Blood transfusions have been used to combat viral outbreaks since at least the Spanish Flu pandemic of 1918. The companies joined forces to make the development process more efficient.
April 6: The six companies announced their partnership but did not disclose a timeline for development May 13: Takeda said its plasma treatment, CoVIg-19, will begin human trials as early as July
Novartis and Molecular Partners Preclinical
Global pharmaceutical giant Novartis is working with Swiss biotech firm Molecular partners on a pair of antiviral therapies for Covid-19. The treatments, MP0420 and MP0423, are designed to bind to multiple sites on the surface of the novel coronavirus, blocking it from entering cells and replicating itself.
Oct. 28: Novartis agrees to co-develop Molecular Partners leading Covid-19 candidates, planning to begin a first human trial in November
SARS-CoV-2 (COVID-19) Vaccines Last update 07 November 2020
University of Oxford and AstraZeneca Phase 3
University of Oxford researchers have developed a potential vaccine that uses a harmless virus engineered to contain the genetic sequence that encodes for a protein on the surface of the novel coronavirus. The researchers, from the University’s Jenner Institute and Oxford Vaccine Group, are working at uncommon speed, starting a placebo-controlled clinical trial while finalizing the manufacturing of their potential vaccine. British drug maker AstraZeneca has partnered on the project.
March 27: Oxford begins recruiting patients for a placebo-controlled trial that will enroll up to 510 healthy volunteers. The vaccine will not be ready for "some weeks," according to the university. April 30: AstraZeneca announces it will partner with Oxford to develop the vaccine. July 20: Oxford publishes Phase 1/2 data demonstrating an immune response with mild to moderate side effects. Aug. 31: AstraZeneca begins enrollment in a U.S. Phase 3 trial that will involved 30,000 volunteers. Sept. 8: AstraZeneca says a hold has been put on the trial following a suspected adverse reaction in a participant. Sept. 12: AstraZeneca says trials in the U.K. have resumed.
Read More
Moderna Therapeutics Phase 3 Moderna’s vaccine, mRNA-1273, is a synthetic messenger RNA that encodes for a protein found on the surface of the novel coronavirus. By compelling cells to produce that protein, the vaccine would spur an immune response, causing the body to generate antibodies that would protect against infection. The company set a drug industry record with mRNA-1273, identifying a vaccine candidate just 42 days after the novel coronavirus was sequenced.
March 16: First patient dosed in a Phase 1 trial April 16: Moderna plans to begin a Phase 2 study by July May 1: Moderna announces it will partner with Swiss firm Lonza on development May 7: FDA clears Moderna to start a 600-patient Phase 2 study, which will begin "shortly" May 18: Moderna discloses interim Phase 1 data, in which eight volunteers developed antibodies to the coronavirus May 29: Moderna doses the first volunteers in a Phase 2 study, planning to enroll about 600 people July 14: Moderna publishes Phase 1 data showing a consistent antibody response and mild to moderate side effects. July 27: Moderna begins enrollment in a 30,000-subject Phase 3 trial
Read More
BioNTech and Pfizer Phase 3
Germany’s BioNTech is working on a multitude of mRNA vaccines for the novel coronavirus, planning to develop them in parallel. Like its competitors, the company uses strands of mRNA to generate protective antibodies. Earlier this month, Shanghai’s Fosun Pharma signed a deal to market BioNTech’s vaccine in China if it’s eventually approved. Pfizer has agreed to co-develop the vaccine in the rest of the world.
April 9: BioNTech says it will begin its first human trials "as early as the end of April" April 29: BioNTech and Pfizer dose the first patients in a Phase 1 trial in Germany, planning to enroll about 200 patients May 5: BioNTech and Pfizer begin Phase 1 study in the U.S., recruiting up to 360 patients total May 12: BioNTech says it expects preliminary data in June or July July 1: In a Phase 1 trial, BioNTech's vaccine led to an increase coronavirus antibodies at three doses, according to a preprint paper July 27: Pfizer and BioNTech begin enrollment on a 30,000-volunteer study, expecting data as early as October Sept. 12: Pfizer and BioNTech announce a plan to expand enrollment to 44,000 participants Nov. 9: Pfizer and BioNTech's vaccine was found to be more than 90% effective in the first analysis of Phase 3 data, the companies said.
Read More
Novavax Phase 3
Novavax is at work on a coronavirus vaccine that begins in the ovaries of an insect. The company’s vaccine platform involves genetically engineering a harmless virus and exposing it to cells isolated from worms. Those cells then churn out the proteins needed to stimulate antibodies, and those proteins become vaccines. For Covid-19, Novavax has isolated the spike protein found on the surface of the novel coronavirus.
April 8: Novavax selects a vaccine candidate, planning to begin human trials in May with preliminary data in July May 26: Novavax begins Phase 1 trial, planning to enroll about 130 volunteers with data expected in July Aug. 4: Novavax presents detailed data from its Phase 1 trial, demonstrating an immune response with mostly mild side effects. Aug. 24: Company launches Phase 2 portion of Phase 1/2 Sept. 25: Novavax initiates Phase 3 trial in U.K., with plans to initiate Phase 3 in the U.S. late
Read More
Sinovac Phase 2
Sinovac, headquartered in Beijing, is developing a vaccine using an inactivated version of the novel coronavirus. The company used the same technology to craft approved vaccines for hepatitis A and B; swine flu; avian flu; and the virus that causes hand, foot, and mouth disease.
April 17: Sinovac begins a placebo-controlled Phase 1/2 trial, planning to enroll 144 healthy volunteers in China May 6: Sinovac publishes results from a preclinical study in which its vaccine successfully protected monkeys from contracting the novel coronavirus. The company plans to start a second, larger human trial by mid-May June 14: Sinovac released preliminary results from its Phase 2 trial, saying its vaccine induced neutralizing antibodies in “above 90%� of participants
Read More
CanSino Biologics Phase 2
CanSino Biologics, headquartered in Tianjin, is developing a coronavirus vaccine using the technology that led to a China-approved Ebola virus vaccine. CanSino’s approach involves taking a snippet of coronavirus’ genetic code and entwining it with a harmless virus, thereby exposing healthy volunteers to the novel infection and spurring the production of antibodies.
March 17: CanSino begins Phase 1 trial in China April 10: Based on preliminary data, CanSino says it will move into Phase 2 "soon" May 22: CanSino published data from a 108-subject trial, in which its vaccine generated a immune response in volunteers June 29: Chinese regulators provisionally approved CanSino's vaccine for military use July 20: CanSino publishes interim Phase 2 data showing a consistent antibody response but one that seemed to wane in older subjects
Read More
Inovio Pharmaceuticals Phase 1
Inovio has spent the last four decades working to turn DNA into medicine, and the company believes its technology could quickly generate a vaccine for the novel coronavirus. Inovio has come up with a DNA vaccine it believes can generate protective antibodies and keep patients from infection. The company has partnered with a Chinese manufacturer, Beijing Advaccine Biotechnology, to produce the vaccine.
April 6: Inovio doses first patient in Phase 1 trial June 30: Inovio says its vaccine led to an immune response in 94% of patients but does not provide data
Read More
Sanofi and GlaxoSmithKline Phase 1
Sanofi is employing the same technology it employs for flu vaccines, which uses a genetically modified version of a virus to create proteins that train the immune system to react. The company is combining its approach with GlaxoSmithKline's proprietary adjuvant, an additive that makes vaccines more potent.
Feb. 18: Sanofi begins work on a coronavirus vaccine April 14: Sanofi partners with GlaxoSmithKline and plans to begin human trials in the second half of 2020 and generate pivotal data in 2021 Sept. 3. Sanofi and GlaxoSmithKline begin a 400-volunteer, Phase 1/2 trial, expect data in December
Read More
Johnson & Johnson Preclinical
Johnson & Johnson, which has in the past responded to outbreaks of the Ebola and Zika viruses, is using the same technology to develop a vaccine for the novel coronavirus. J&J’s vaccine is made by grafting the coronavirus genes that confer immunity onto a harmless virus, injecting it triggering an immune response without causing infection.
March 30: J&J expects to begin Phase 1 by September, with a vaccine available for emergency use as soon as early 2021. Sept. 23: J&J announces it is starting a Phase 3 trial that will recruit up to 60,000 participants
Arcturus Therapeutics Preclinical
Arcturus Therapeutics is pressing forward with a vaccine that relies on engineering RNA. The company plans to take an RNA virus that has been edited to encode for proteins that will protect against infection and load it into a liquid nanoparticle. The resulting vaccine, being developed in partnership with Duke University, promises a better immune response at a lower dose than competing mRNA approaches, according to the company.
April 9: Arcturus plans to begin a Phase 1 trial in Singapore over the summer
Clover Biopharmaceuticals and GlaxoSmithKline Preclinical
Clover Biopharmaceuticals, headquartered in Chengdu, is developing a vaccine that would inject patients with a protein found on the surface of the novel coronavirus. GlaxoSmithKline is providing its proprietary adjuvant, an additive that makes vaccines more potent.
Feb. 10: Clover identifies its vaccine candidate Feb. 24: GlaxoSmithKline provides its adjuvant
CureVac Preclinical
CureVac uses man-made mRNA to spur the production of proteins and protective antibodies. Like Moderna, the company got a grant from the nonprofit Coalition for Epidemic Preparedness Innovations to apply its technology to coronavirus.
March 17: CureVac said it expects to have a candidate ready for animal testing by April, aiming to start a clinical study in the summer
Imperial College London Preclinical
Led by the immunologist Robin Shattock, Imperial College London is developing an RNAbased vaccine for the novel coronavirus. The scientists have engineered a virus-derived RNA strand that will get into cells, spur the production of the coronavirus’s signature protein, and then replicate itself. In animal studies, the vaccine has resulted in the generation of protective antibodies.
April 17: With funding from the U.K. government, Imperial plans to complete preclinical work and begin human trials in June
University of Queensland and GlaxoSmithKline Preclinical
Australia’s University of Queensland, with funding from the Coalition for Epidemic Preparedness Innovations, has been developing a coronavirus vaccine since January. Queensland has a proprietary technology meant to make protein vaccines more effective at triggering an immune response. Called a molecular clamp, the university’s approach keeps the coronavirus’s key protein in its natural shape before grafting it onto the vaccine.
April 9: Queensland plans to begin human trials in the third quarter
Merck Preclinical
Merck purchased a Vienna-based company called Themis, which is developing an experimental Covid-19 vaccine based on a measles vaccine. It also partnering with the nonprofit IAVI on the development of a coronavirus vaccine related to the company's existing Ebola vaccine.
May 26: Merck says the Themis vaccine will enter human trials in a matter of weeks while the second candidate could reach the clinic by the end of the year
Read More
Sanofi and Translate Bio Preclinical
Sanofi partnered with Translate Bio to develop potential vaccines using synthetic messenger RNA, which would compel the body to produce antibodies against the novel coronavirus. The two companies have worked together in the past on vaccines for infectuous disease.
March 27: Sanofi and Translate Bio announce their collaboration but do not specify a development timeline
SARS-CoV-2 (COVID-19) Treatments and Vaccines Tracker Last update 11 November 2017 Fuente: https://Statnews.com