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Researchers recently wrote that combining two monoclonal antibodies for treating chronic herpes simplex 2 (HSV-2) may provide a novel therapeutic option for this expanding disease.
The U.S. CDC says HSV constitutes a significant global health concern due to its wide range of clinical manifestations that can affect the skin and mucous membranes, the eyes, and the nervous system.
On May 28, 2024, the Journal of Biomedical Science published results from a study designed to develop a next-generation therapy by combining different antiviral monoclonal antibodies.
This research showed that the fully human antibody HDIT102 has the potential for further clinical development as a potent novel HSV therapeutic, particularly in combination with its clinical humanized ancestor antibody HDIT101.
HDIT101 is a humanized IgG that was previously investigated in phase 2 clinical trials.
Both antibodies induced the internalization of gB from the cell surface into acidic endosomes by binding distinct epitopes in domain I of gB and competing for binding.
CryoEM analyses revealed the ability to form heterogenic immune complexes consisting of two HDIT102 and one HDIT101 Fab bound to one gB trimeric molecule.
Both antibodies mediated antibody-dependent phagocytosis by antigen presenting cells which stimulated autologous T-cell activation.
In vivo, the combination of HDIT101 and HDIT102 demonstrated synergistic effects on survival and clinical outcome in immunocompetent BALB/cOlaHsd mice.
In conclusion, these researchers wrote, 'Antibody characteristics to inhibit cell-to-cell spread, to mediate uptake of cell-free viruses by phagocytic cells and concomitantly stimulate T-cell responses may promote cellular immunity and may have benefits in preventing recurrences.'
Antibody therapeutics are available to address a variety of diseases, and the U.S. Food and Drug Administration has approved more than 100 products.
Despite years of development, HSV vaccine candidates have yet to be approved. As of June 10, 2024, several herpes vaccines are conducting clinical research.
BioArctic AB's partner, Eisai, announced today that the U.S. Food and Drug Administration (FDA) has accepted Eisai's Supplemental Biologics License Application (sBLA) for less frequent monthly Leqembi™ intravenous (IV) maintenance dosing.
A Prescription Drug User Fee Act action date is January 25, 2025.
Leqembi (lecanemab-irmb) is a humanized immunoglobulin gamma 1 monoclonal antibody, not a preventive vaccine.
In the U.S., Leqembi is indicated for the treatment of Alzheimer's disease (AD) in patients with mild cognitive impairment or mild dementia stage of disease (collectively referred to as early AD).
As of June 10, 2024, Leqembi is approved in Japan, China, and South Korea, and applications have been submitted for review in several countries, including the European Union, Australia, Brazil, Canada, Hong Kong, Great Britain, India, Israel, Russia, Saudi Arabia, Taiwan, Singapore, and Switzerland.
As part of the monthly IV maintenance regimen, patients who have completed the biweekly IV initiation phase, the exact period under discussion with the FDA, would receive a less frequent monthly IV dose that maintains effective drug concentration to sustain the clearance of highly toxic amyloid beta (Aβ) protofibrils that can continue to cause neuronal injury.
The sBLA is based on the modeling of observed data from the Phase 2 study (Study 201) and its open-label extension (OLE), as well as the Clarity AD study (Study 301) and its OLE study.
Additionally, Eisai initiated the rolling submission of a BLA to the FDA for the Leqembi subcutaneous autoinjector for weekly maintenance dosing after the FDA granted it Fast Track designation in May 2024.
Alzheimer's disease is a progressive disease caused by toxic amyloid proteins. Once established, this pathophysiological process continues throughout the patient's life, so sustained treatment is necessary.
The company says treatment should be initiated early to maximize patient outcomes.
Data from Studies 201 and 301 and their OLEs show that continued therapy with LEQEMBI beyond the 18-month core phase prolongs the benefit as highly toxic protofibrils are continuously removed.
If approved, the clinical and biomarker benefits may be maintained through the once-monthly dosing regimen, which is less burdensome and makes it easier for patients and care partners to continue long-term.
BioArctic is a Swedish research-oriented biopharma company focused on neurodegenerative disorders. It has a broad and well-diversified project portfolio and the potential to improve patients' health.
Moderna, Inc. today announced that its Phase 3 clinical trial of mRNA-1083, an investigational combination vaccine against influenza and COVID-19, has met its primary endpoints, eliciting a higher immune response than the licensed comparator vaccines used in the trial.
mRNA-1083 met its primary endpoints, eliciting higher immune responses against influenza and SARS-CoV-2 viruses than licensed flu and COVID vaccines in adults 50 and older, including an enhanced influenza vaccine in adults 65 and older.
"Combination vaccines have the potential to reduce the burden of respiratory viruses on health systems and pharmacies, as well as offer people more convenient vaccination options that could improve compliance and provide stronger protection from seasonal illnesses," said Stéphane Bancel, Chief Executive Officer of Moderna, in a press release on June 10, 2024.
"Moderna is the only company with a positive Phase 3 flu and COVID combination vaccine."
Moderna plans to present the Phase 3 clinical data for mRNA-1083 at an upcoming medical conference, submit them for publication, and engage regulators on the next steps.
mRNA-1083 comprises components of mRNA-1010, Moderna's vaccine candidate for seasonal influenza, and mRNA-1283, Moderna's next-generation COVID-19 vaccine candidate. Moderna says each investigational vaccine has independently demonstrated positive Phase 3 clinical trial results.
A Short Communication published by the journal Influenza and Other Respiratory Diseases added to the research-based and real-world evidence the respiratory syncytial virus (RSV) can be prevented in most infants receiving a new monoclonal antibody (mAb).
RSV is the #1 cause of hospitalization of infants in most countries. In France, hospitalizations with RSV represent 28% of all-cause hospitalizations in children under the age of one during the RSV season.
This new study found a single dose of the extended half-life Beyfortus™ (nirsevimab) was found to be 75.9% effective against RSV-related hospitalization in France.
This long-duration mAb was also 80.6% (61.6–90.3) and 80.4% (61.7–89.9) effective in two sensitivity analyses.
These real-world estimates confirmed the efficacy observed in RSV clinical studies, wrote these researchers on June 5, 2024.
Sanofi and AstraZeneca recently announced they are producing Beyfortus before the 2024-2025 RSV season in the U.S.
On November 16, 2023, the CDC announced the release of the U.S. FDA-approved Beyfortus to physicians and hospitals through the Federal VFC Program and commercial channels.
The New Jersey Department of Health (NJDOH) today announced a Somerset County resident developed measles following international travel.
As of June 5, 2024, no additional cases have been identified. Secondary cases would be expected to occur no later than June 26, 2024.
This is the second confirmed case of measles reported in NJ in 2024, the first of which was identified in Camden County in January.
In 2019, New Jersey reported a significant travel-related measles outbreak.
The NJDOH urges all residents planning to travel, regardless of destination, to ensure they are current on all routine and travel vaccinations, especially MMR vaccinations.
MMR vaccination services are generally available at travel vaccine clinics and pharmacies in the U.S.
As of June 2024, 52 countries are currently experiencing measles outbreaks, according to the U.S. CDC.
Liberia is one African nation leading a crucial fight against polio. Unfortunately, Liberia recently reported a resurgence of variant polio type 2 in wastewater.
Liberia reported two variant polio type 2 detections from environmental sampling in 2023 and six so far in 2024.
Although historic polio vaccine coverage rates have shown promising progress, the battle against polio requires unwavering commitment and action, wrote the Global Polio Eradication Initiative on June 4, 2024.
Despite the challenges, the number of variant poliovirus cases in Liberia has significantly declined, with no children paralyzed by polio since 2021.
To stop the spread of the virus quickly, Liberia has launched nationwide immunization campaigns using the novel oral polio vaccine (nOPV2).
The second round of nOPV2 vaccinations is set to begin on June 7, 2024.
Primarily deployed in Africa during the last two years, the nOPV2 vaccine has been offered over 1 billion times.
Mr. Adolphus Clark, Expanded Programme on Immunization Manager in Liberia, expressed his optimism in a media release about the pending vaccination campaign, stating, “Our collective efforts have brought us closer than ever to a polio-free Liberia.... we are renewing our commitment to ensure that every child is protected from this preventable disease.”
Liberia has also introduced seven vaccines into its routine immunization schedule: Pneumococcal Conjugate Vaccine, Rotavirus, Inactive Polio Virus, Haemophilus influenzae Tue B, Typhoid, and measles-containing vaccine.
To alert international visitors, the U.S. CDC has included Liberia in its recent polio and measles Travel Health Advisories. The CDC suggests travelers speak with a travel vaccine expert about immunization options one month before visiting Liberia.
Auro Vaccines LLC's Nipah Virus vaccine candidate HeV attachment G glycoprotein (HeV-sG-V) was recently found to induce antibodies within one month of vaccination, and the persistence afforded by two dosages suggests the vaccine candidate has the potential for reactive Nipal outbreak control and preventative use.
On May 30, 2024, results from a Phase 1 study funded by the Coalition for Epidemic Preparedness Innovations and published by The Lancet preprint evaluated a recombinant subunit vaccine consisting of a soluble version of HeV-sG-V for safety, tolerability, and immunogenicity. The highest response rates were among vaccinees receiving two administrations of the 100 mcg vaccine candidate 28 days apart.
As of June 6, 2024, several Nipah Virus vaccine candidates were conducting clinical research, but no approved Nipah vaccines were available.
The World Health Organization says that Nipah was first discovered in Malaysia in the 1990s. This virus causes yearly outbreaks throughout South and Southeast Asia, with associated mortality rates of 40 to 75 %. Nipah infection is a zoonotic illness transmitted to people from animals such as bats.
The virus can also be transmitted through contaminated food or from person to person.
The WHO published a Technical Brief in early 2024 as an interim document to guide countries in planning for a Nipah virus event.
No cases of Nipah have been diagnosed in the U.S.
