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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.

According to the weekly update of the Global Polio Eradication Initiative (GPEI), three countries confirmed additional polio cases.

As of June 5, 2024, Afghanistan and Pakistan each reported one wild poliovirus type (WPV1) case, the fourth WPV1 case for each country in 2024.

And Niger reported its second circulating vaccine-derived poliovirus type 2 (cVDPV2) case this year. 

Additionally, the GPEI posted the results of the Strategic Advisory Group of Experts on immunization meeting results from March 2024 at this link.

The U.S. CDC issued an updated Global Polio Alert on May 23, 2024, regarding polio outbreaks and poliovirus detections in 34 countries. 

The World Health Organization recently confirmed that the spread of the poliovirus remained a Public Health Emergency of International Concern and recommended its extension through July 2024. Various vaccines are available worldwide to prevent additional polio cases.

In the Northern Hemisphere, influenza activity was generally low at interepidemic levels in most countries, according to the World Health Organization (WHO) in Influenza Update N° 477.

As of the end of May 2024, the WHO says elevated flu activity continued to be reported in countries in Central America and the Caribbean.

In the United States, the Centers for Disease Control and Prevention (CDC) confirmed on June 7, 2024, that seasonal influenza activity remains low nationally and is forecasted to resume in Fall 2024.

As the Southern Hemisphere winter season accelerates, countries in South America continue to report elevated influenza activity. Influenza A(H1N1)pdm09 and A(H3N2) viruses have been detected. 

The WHO forecasts that influenza infections will increase in the coming months.

Both the WHO and CDC recommend international travelers speak with a healthcare provider about flu shot options before departing abroad.

The CDC recently reported that about 158 million flu vaccines were distributed in the U.S. during the 2023-2024 flu season.

Note: The CDC says most known influenza viruses are dissimilar to avian and pandemic influenza viruses; traditional flu shots are not expected to protect people against bird flu or cow flu.