The Development of IgY(ΔFc) Antibody to Plasmodium falciparum as a Passive Antibody for Specific Treatment of Severe Malaria Infection, including MDR Malaria
WHO Urges Increased Implementation of Recommended Tools to Combat Malaria
In recent World Malaria Day, April 25 2023, the World Health Organization (WHO) is issuing a call for increased implementation of new and existing interventions to save lives from malaria. WHO is urging more effective implementation of available tools and strategies to prevent, diagnose and treat malaria, particularly among marginalized populations. According to the latest World malaria report, published in December 2022, in 2021, nearly half of the worlds population was at risk of malaria. There were an estimated 247 million new cases of malaria and the estimated number of malaria deaths stood at 619 000 and nearly 80% of malaria deaths in the African Region were among children under the age of five.
The Threat of Antimalarial Drug Resistance in Africa
The emergence of multidrug resistance is a public health concern that threatens the sustainability of global efforts to reduce the burden of malaria. WHO recently published, the strategy to respond to antimalarial drug resistance in Africa, aimed at minimizing the threat and impact of antimalarial drug resistance of Plasmodium falciparum parasites in Africa. The efficacy of conventional antimalarial drugs is perennially threatened by drug resistance; therefore, there is an ongoing need for novel drug discovery and development to overcome antimalarial drug resistance.
New-generation Antimalarial Drug: The Development of IgY(ΔFc) Antibody to Plasmodium falciparum as a Passive Antibody for Specific Treatment of Severe Malaria Infection, including MDR Malaria
Plasmodium falciparum malaria is a leading cause of morbidity and mortality in developing countries. The urgent problem of antimalarial drug resistance in Africa continues to be a public health challenge. Despite several approaches to prevent established infection, no single approach offers complete protection, so a multilayered approach is needed. A new source and innovation solutions are eagerly needed to solve this critical global health issue.
Good Biotech’s innovative duck IgY(ΔFc) antibody is a commercialized & validated technology with various applications. Duck IgY(ΔFc) antibody, a naturally existing analog to mammalian IgG (Fab’)2 antibodies, offers an alternative solution and is expected to be the promising candidate with the breakthrough technology as a new approach for the treatment of severe and multidrug resistance (MDR) Malaria.
Duck IgY(ΔFc) Polyclonal antibody therapy may be described as a multi-target approach, providing polyvalent interactions that permit the applications of therapeutic strategies against multiple epitopes and targets, especially for those emerging antibiotic-resistant microorganisms, such as multi-resistant Tuberculosis (TB) as well as Malaria parasites. The technology enables a quick-response production capability to characterize high titer & high efficacy polyclonal mixture specific targets with fast & mass production to respond to market demand.
In 2021, the World Health Organization endorsed a malaria vaccine for use in at-risk children. But the vaccine is only partially effective in preventing severe malaria. Researchers have been pursuing new approaches for the prevention and elimination of malaria. Unlike a vaccine, which requires time to induce protective immunity and depends on the hosts ability to mount an immune response, passive antibody can critically confer protection regardless of the immune status of the hosts. Antibody based therapies could, in therapy, be developed against any existing pathogen (Casadevall A, 2002). Monoclonal antibody to Toxoplasma gondii has reported to interfere with intracellular replication of the parasites (MineoJ.R. et al., 1994). Antibodies to Plasmodium falciparum schizont antigen-1 (PfSEA-1) block parasite egress from RBCs and protect against malaria infection has well discussed (Raj D.K. et al., 2014). Also, the surface antigens (VSA) expressed on the surface of Plasmodium falciparum infected RBC can be a candidate for active immunity (Marsh K. et al,. 1989, Dodoo D. et al,. 2001). In addition, in 1961, a research article claimed that passive transfer of IgG from African malaria immune donors to infected children resulted in a reduced parasitemia (Cohen et al,. 1961).
New-generation Anti-P. falciparum Antibody derived from Duck IgY(ΔFc) Antibody Immunoglobulins to Combat Malaria Infection
The advantages of antibody-based therapies include versatility, low toxicity, pathogen specificity, enhancement of immune function and favorable pharmacokinetics, etc. (Casadevall A, Emerg Infect Dis. 2, 200-8 1996). To date, there are numerous plasmodium parasite proteins as monoclonal antibody targets; however, until now there is no therapeutic antibody available for massive production (only in a small clinical trial). The development of monoclonal antibodies (mAbs) cocktail for effective malaria prevention is rather difficult due to the fact that monoclonal antibodies recognize only a single epitope which means that they have limited usefulness against pathogens that exhibit antigenic variation. Not to mention that the efficacy may not be as expected even for making monoclonal antibodies (Mabs) cocktail for malaria.
Besides, it is known that traditional mammalian IgG-based polyclonal antibodies are not possible to develop polyclonal IgG antibody-based malaria drugs mainly because of the production difficulties and safety issues, such as the side effects of life-threatening allergies.
Thanks to the unique characteristics of duck IgY(ΔFc) antibody, IgY(ΔFc) antibody-derived biotherapeutics, on the other hand, have achieved promising results. Good Biotech has dedicated our R&D projects to areas including antivenoms, antidotes, and neutralizing antibodies, and the targets are for medical emergencies treating new or reemerging pathogens and combating drug-resistant bacterial/ fungal infections of unmet medical needs. Polyclonal antibody preparations have the advantage of consisting of diverse immunoglobulins that target different antigens, the heterogeneity in isotype composition confers broader biological activity through the various constant regions. Polyclonal antibody preparations, in particular duck IgY (ΔFc) antibodies, are generally relatively easy to make, provided that therapeutic antibodies are available.
Duck IgY (ΔFc) polyclonal anti-Plasmodium falciparum antibody is expected to block, to interfere/inhibit Malaria parasite replication as well as has the capability of protection against severe malaria (including MDR malaria) infection.
The Advantages for the Use of Duck IgY(ΔFc) derived Therapeutic Antibodies
IgY(ΔFc) antibody-derived biotherapeutics enjoy the advantages including:
• For the Treatment of a Variety of Specific Illnesses, e.g., envenomation, intoxication, and infections caused by pathogens and/or antibiotics-resistant bacterial
• React with Multiple Epitopes on a Single Target
• Antibodies can be raised in a short time when a new infectious disease bursts out.
• Safety, Effective, Low Production Cost, Short Production Process and High Yields
• No bio-hazards Imposed.
It is expected that the development of Anti-P. falciparum Antibody derived from Duck IgY(ΔFc) Antibody Immunoglobulins has great potential to become the novel solution to prevent as well as for the treatment of malaria infection to meet the high unmet medical needs of malaria.
Benefits and Global Strategy Alignment of Using Antimalarial IgY(ΔFc) Ab for Prevention as well as for the Treatment of Severe Malaria & Multidrug Resistance Malaria Infection
The nature of monoclonal antibody which recognizes only a single epitope makes them have limited function in the face of pathogens thatexhibit antigenic variation. Duck polyclonal antibody enjoys the advantages, such as consisting of diverse immune-globulins that target different antigens; the heterogeneity in isotype composition confers broader biological activity which has the “multipotent” to target several species with constant regions. Hence, anti-malaria IgY(ΔFc) polyclonal antibody has the potential to become a new generation multi- targeted Malaria Therapeutics.
Duck antibody has no immunological cross-reactivity between avian and mammalian antibodies. They recognize more specific epitopes avoid non-specific binding and have high purity, free of egg white protein for eradicating side effects such as anaphylaxis.
Duck antibody recognizes more specific epitopes, so it can perform high antibody titer response as well as high Malaria antibody titer; therefore, Antimalarial IgY(ΔFc) Ab performs high malaria efficacy. Consequently, Antimalarial IgY(ΔFc) Ab enables patients to receive minimum heterogeneous protein, to minimize the risk of early adverse reactions and to prevent serum sickness from severe illness (reaction), thus render treatment safer and more effective.
Efficient commercial-scale production and cost-effective
Flexible for various administrations (oral administration, spray, injection, lyophilized powder form, and paste). High stability, easier for logistics management.