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GlaxoSmithKline plc, Eli Lilly and Company, and Vir Biotechnology, Inc. announced topline data from the expanded Phase 2 BLAZE-4 trial studying low-risk adult patients with mild to moderate COVID-19.
Results showed that investigational bamlanivimab (LY-CoV555) 700 mg co-administered with VIR-7831 (also known as GSK4182136) 500 mg demonstrated a 70 percent (p<0.001) relative reduction in persistently high viral load (> 5.27; cycle threshold value < 27.5) at day 7 compared to placebo, meeting the primary endpoint.
Also, bamlanivimab administered with VIR-7831 demonstrated a statistically significant reduction compared to placebo in the key virologic secondary endpoints of mean change from baseline to days 3, 5, and 7 in SARS-CoV-2 viral load.
There were no events for the secondary endpoint of COVID-19 related hospitalization or death by day 29 in either study arm. One patient (in the treatment arm) visited the emergency room for COVID-19 related symptoms. No serious adverse events were seen with the coadministration of bamlanivimab and VIR-7831.
Bamlanivimab and VIR-7831 bind to different regions of the spike protein of SARS-CoV-2. Preclinical data suggest the administration of these two investigational antibodies together may protect against current variants of SARS-CoV-2 that are resistant to bamlanivimab.
Dr. Hal Barron, Chief Scientific Officer, and President R&D, GSK, commented in a related press release, “These early data from the BLAZE-4 trial, coupled with the results of the COMET-ICE trial demonstrating an 85% reduction in progression to hospitalization or death using VIR-7831, support our hypothesis that by targeting a highly conserved epitope, VIR-7831 may help deliver benefits to patients."
"We’re continuing to work with regulators to bring VIR-7831 as a monotherapy and potentially co-administered with other monoclonal antibodies to patients in need.”
VIR-7831 is an investigational compound not approved by the U.S. Food and Drug Administration (FDA) or any other regulatory authority. An Emergency Use Authorization application for VIR-7831 has been submitted to the FDA.
A new study published in the journal Nature on March 25, 2021, reveals promising results of phase 1 clinical trial testing of a novel brain cancer vaccine that's designed to assist a patient's immune system respond to certain brain tumors.
Diffuse gliomas are a type of brain cancer that is difficult to treat and can spread well across the brain, making it extremely difficult to eliminate through conventional surgery.
The published data suggest that the IDH1 peptide vaccine stimulated a critical immune response that slows tumor progression.
The NOA-16 study included 36 patients and met its primary endpoints by demonstrating the safety and immunogenicity of IDH1-vaccine in patients with newly diagnosed WHO grade 3 and 4 IDH1(R132H)+ astrocytomas without further positive prognostic factors.
Immunogenicity, irrespective of HLA type, and the high rate of PsPD warrant further clinical investigation of IDH1-vac. Patients who did not mount an IDH1-vac induced immune response showed reduced efficacy of the vaccine and disease progression within two years.
Targeting a shared clonal driver mutation in newly diagnosed patients overcomes these limitations6. It may provide a basis for future trials that target MHCII-restricted clonal shared and personalized neoepitopes in cancer immunotherapy.
Currently, a larger Phase 2 clinical trial is being planned, said these researchers.
The U.S. Food and Drug Administration (FDA) announced the approval of Abecma (idecabtagene vicleucel), a cell-based gene therapy to treat adult patients with multiple myeloma who have not responded to, or whose disease has returned after, at least four prior lines (different types) of therapy.
Abecma is the first cell-based gene therapy approved by the FDA for the treatment of multiple myeloma.
“The FDA remains committed to advancing novel treatment options for areas of unmet patient need,” commented Peter Marks, M.D., Ph.D., director of the FDA’s Center for Biologics Evaluation and Research, in a press statement issued on March 27, 2021.
“While there is no cure for multiple myeloma, the long-term outlook can vary based on the individual’s age and the stage of the condition at the time of diagnosis. Today’s approval provides a new treatment option for patients who have this uncommon type of cancer.”
Multiple myeloma is an uncommon type of blood cancer in which abnormal plasma cells build up in the bone marrow and form tumors in many bones of the body. This disease keeps the bone marrow from making enough healthy blood cells, resulting in low blood counts, says the FDA.
BioNTech SE announced on March 26, 2021, that the European Medicines Agency (EMA) approved the manufacturing of the Comirnaty COVID-19 vaccine drug product at the facility in Marburg, Germany.
The approvals make BioNTech’s Marburg manufacturing site one of the largest mRNA vaccine manufacturing sites in Europe as well as worldwide with an annual production capacity of up to one billion doses of our COVID-19 vaccine, once fully operational.
Furthermore, because of optimized operational efficiencies initiated in 2020, BioNTech has been able to increase the expected annual manufacturing capacity by 250 million doses.
'Together with our partner Pfizer, we are working continuously on multiple initiatives to respond to global demand,' stated the BioNTech press statement.
The Pfizer-BioNTech COVID-19 vaccine, which is known globally as Comirinaty, is based on BioNTech’s proprietary mRNA technology, was developed by both BioNTech and Pfizer. BioNTech is the Marketing Authorization Holder in the European Union, and the holder of emergency use authorizations or equivalent in the United States, United Kingdom, Canada, and other countries in advance of a planned application for full marketing authorizations in these countries.
Ebola virus outbreaks have primarily affected African countries, with occasional cases confirmed globally. In February 2021, the Republic of Guinea had its first Ebola outbreak in five years, which is of great concern given the countries of Liberia and Sierra Leone's porous borders, reported GAVI.org.
Furthermore, with international travelers returning from these African countries, the potential spreading of Ebola has become a heightened concern.
On March 26, 2021, Washington public health authorities announced monitoring (23) low-risk people who recently arrived from Guinea and the Democratic Republic of the Congo. These travelers are considered “people under control” for 21 days after arriving in the USA, per the US Centers for Disease Control and Prevention's recent Order.
And the state of Oregon confirmed they, too, are monitoring a small group of travelers.
To protect people from the deadly Ebola virus, there are two licensed vaccines.
The European Medicines Agency (EMA) and the US Food and Drug Administration licensed Merck's Ervebo vaccine during 2019. Ervebo has received regulatory approval from Burundi, Central African Republic, the Democratic Republic of the Congo, Ghana, Guinea, Rwanda, Uganda, and Zambia, and is recommended by the WHO's Strategic Advisory Group of Experts on Immunization.
On January 8, 2021, the CDC's Advisory Committee on Immunization Practices recommended pre-exposure prophylaxis vaccination with Ervebo for adults ≥ 18 years of age in the U.S. population at the highest risk for potential occupational exposure to Ebola virus species Zaire ebolavirus.
Previously, in May 2020, the EMA authorized a two-part Ebola vaccine produced by Janssen. The first is called Zabdeno (Ad26.ZEBOV), and the second Mvabea (MVA-BN-Filo). This combo vaccine works as a prophylactic and is not suitable for an outbreak response where immediate protection is necessary.
For more information about these vaccines, the CDC published 'Ebola Vaccine: Information for U.S. Healthcare Providers' on November 12, 2020.
Public health officials in Oregon announced they are monitoring four people who recently visited Guinea and the Democratic Republic of the Congo (DRC). These West African countries have been experiencing the 12th outbreak of Ebola virus disease.
Oregon Health Authority (OHA) and local public health departments have been in contact with these individuals, who are considered “persons under monitoring” since they arrived in the state earlier in March 2021.
This contact aims to determine their risk, if any, of being exposed to Ebola and ensure their safety and the safety of their families and the community. The OHA indicates there is a low risk for Ebola contamination to people in Oregon.
Beginning March 4th, the U.S. CDC has required all airlines to supply contact information for all U.S.-bound travelers who have visited Guinea or DRC in the last 21 days.
“We want to make sure these individuals have the support they need to monitor their health, stay in contact with public health officials and safely get help with medical services if it comes to that,” stated Richard Leman, M.D., Chief Medical Officer for Health Security, Preparedness and Response at the OHA Public Health Division, in a press statement.
As of March 26, 2021, both Guinea and the DRC have reported few Ebola cases over the past week. On March 12, 2021, the U.S. CDC re-issued a Warning - Level 3, Avoid Nonessential Travel, for Guinea and the DRC.
The U.S. FDA approved an EBOLA preventive vaccine named Ervebo in 2019. Merck's Ervebo is a recombinant, replication-competent Ebola vaccine, consisting of a VSV, genetically engineered to express a glycoprotein from the Zaire ebolavirus to provoke a neutralizing immune response to the Ebola virus.
On July 1, 2020, Janssen's Zabdeno and Mvabea Ebola vaccine therapy, a prime-boost vaccination approach for preventing infectious diseases, was granted authorization by the European Medicines Agency.
According to the latest data, Canada, Mexico, and the USA experienced unusually reduced influenza seasons this year. Globally, despite continued or even increased testing for influenza in some countries, influenza activity remained at lower levels than expected for this time of the year, stated the World Health Organization (WHO) on March 15, 2021.
In the USA, it has been the mildest flu season since 2005.
As of March 26, 2021, the US Centers for Disease Control and Prevention (CDC) reported during week #11, 0.9% of patient visits reported through ILINet were due to Influenza-like Illness. This percentage is below the national baseline of 2.6% for this time of year.
Furthermore, there has been one pediatric fatality related to influenza during the 2020-2021 flu season. This good news compares with last flu season when the CDC confirmed 198 pediatric fatalities.
In Canada, the government confirmed all indicators of influenza activity remain exceptionally low for this time of year, despite continued monitoring for influenza across Canada.
As of March 20, 2021, there has been no evidence of community circulation of influenza despite continued testing above seasonal levels. Influenza activity in Canada has remained below the threshold required to declare the start of the 2020-21 influenza season.
And in Mexico, during week #10 of 2021, no influenza detections were reported, reported the PAHO.
The CDC reminds everyone that 'an annual flu vaccine is the best way to protect against influenza and its potentially serious complications, such as pneumonia. '
