Delving into the Latest Updates on Rabimabs with Synapse

Overview

Basic Info

Drug Type

Monoclonal antibody

Synonyms

Anti-rabies monoclonal antibody, Anti-rabies monoclonal antibody cocktail, Docaravimab/Miromavimab

+ [9]

Target

RABV-G

Mechanism

RABV-G inhibitors(RABV-G inhibitors)

Therapeutic Areas

Infectious DiseasesOther Diseases

Active Indication

Rabies

Inactive Indication-

Originator Organization

Zydus Cadila Healthcare Ltd.

Active Organization

World Health Organization (United States)

Zydus Lifesciences Ltd.

Inactive Organization-

Drug Highest PhaseApproved

First Approval Date

IN (03 Sep 2019),

Rabies

Regulation-

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Gene Sequence

Sequence Code 524290076L

Sequence Code 524290077H

Sequence Code 524290075H

Sequence Code 524290078L

AbstractCurrent postexposure prophylaxis of rabies includes vaccines, human rabies immunoglobulin (RIG), equine RIG, and recombinant monoclonal antibodies (mAb). In the manufacturing of rabies recombinant mAb, charge variants are the most common source of heterogeneity. Charge variants of rabies mAb were isolated by salt gradient cation exchange chromatography (CEX) to separate acidic and basic and main charge variants. Separated variants were further extensively characterized using orthogonal analytical techniques, which include secondary and tertiary structure determination by far and near ultraviolet circular dichroism spectroscopy. Charge and size heterogeneity were evaluated using CEX, isoelectric focusing (IEF), capillary‐IEF, size exclusion chromatography, sodium dodecyl sulfate polyacrylamide gel electrophoresis, and western blotting. Antigen binding affinity was assessed by enzyme linked immuno‐sorbent assay and rapid florescence foci inhibition test. Results from structural and physicochemical characterizations concluded that charge variants are formed due to posttranslational modification demonstrating that the charge heterogeneity, these charge variants did neither show any considerable physicochemical change nor affect its biological function. This study shows that charge variants are effective components of mAb and there is no need of deliberate removal, until biological functions of rabies mAb will get affected.

12 Jan 2024·Cureus

Real-World Safety of TwinRab, the World’s First Novel Cocktail of Rabies Monoclonal Antibodies, in a Clinical Setting

Article

Author: Manna, Asis ; Mahajan, Manish ; Sharma Sarkar, Biswanath ; Dutta, Trayambak ; Kundu, Asis Kumar ; Maji, Baisakhi

OBJECTIVESEvery year, 18,000-20,000 people die from rabies in India, with children younger than the age of 15 accounting for 30%-60% of all cases. Wound cleaning, vaccination, and rabies immunoglobulin (RIG) administration are all part of treatment. TwinRab^TM, a unique combination of two monoclonal antibodies (mAbs), docaravimab and miromavimab, effectively neutralizes rabies and rabies-like viruses. We conducted this study to evaluate the safety of the cocktail in patients infected with category-III animal bites according to WHO guidelines.METHODSThis open-label observational study was conducted in patients with WHO category-III animal bites by suspected rabid animals. All participants were screened, enrolled, and were administered the TwinRab^TM manufactured by Zydus Lifesciences Ltd. at the rate of 40 IU/kg by infiltration in and around the wound along with anti-rabies vaccine (ARVs). Participants were assessed at various intervals, and any adverse events (AEs) were documented and reported to the sponsor within 24 hours.RESULTThe study enrolled 401 participants, 55.61% (n = 223) male, whose median age was 34 years. Adults made up 69.83% (n = 280) of the participants. The most exposed sites were the lower parts of the body (60.6%, n = 243); 99.75% (n = 400) of the population showed normal cardiovascular, gastrointestinal, and central nervous systems. After seven days of the last postexposure prophylaxis (PEP) dose, 9.98% of the total study population experienced 80 mild local solicited AEs and were assessed and treated.CONCLUSIONThe study concluded that TwinRab^TM when given in a 40 IU/kg dose with Essen or the updated Thai Red Cross Vaccine regimen, provides safe and effective rabies prophylaxis in WHO category III patients exposed to suspected rabied animal bites.

17 Aug 2023·Vaccines

Efficiency Comparative Approach of Plant-Produced Monoclonal Antibodies against Rabies Virus Infection.

Article

Author: Mahong, Bancha ; Rattanapisit, Kaewta ; Hemachudha, Thiravat ; Lumlertdacha, Boonlert ; Phoolcharoen, Waranyoo ; Bulaon, Christine Joy I

Rabies encephalitis is a fatal zoonotic viral disease caused by the neurotropic rabies virus. It remains a major public health concern as it causes almost 100% fatality and has no effective medication after the onset of the disease. However, this illness is preventable with the timely administration of effective post-exposure prophylaxis (PEP) consisting of the rabies vaccine and passive immune globulins (HRIG and ERIG). Recently, conventional PEP has been shown to have many limitations, resulting in little support for these expensive and heterologous globulins. Monoclonal antibody (mAb) production via recombinant technology in animal and human cell cultures, as well as a plant-based platform, was introduced to overcome the costly and high-tech constraints of former preparations. We used transient expression technology to produce two mAbs against the rabies virus in Nicotiana benthamiana and compared their viral neutralizing activity in vitro and in vivo. The expression levels of selective mAbs E559 and 62-71-3 in plants were estimated to be 17.3 mg/kg and 28.6 mg/kg in fresh weight, respectively. The plant-produced mAbs effectively neutralized the challenge virus CVS-11 strain in a cell-based RFFIT. In addition, the combination of these two mAbs in a cocktail protected hamsters from rabies virus infection more effectively than standard HRIG and ERIG. This study suggests that the plant-produced rabies antibody cocktail has promising potential as an alternative biological to polyclonal RIG in rabies PEP.

100 Deals associated with Rabimabs

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