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Still little used, the antibodies Monoclonals, in addition to being together with the vaccine, are the most powerful weapon in circulation to stop Covid-19 once the virus is already in the body.
What are monoclonal antibodies?
Monoclonal antibodies (or MAbs, from Monoclonal Antibodies) are particular types of antibodies, therefore molecules, which have the function of recognizing invaders (particularly pathogens such as bacteria and viruses), to allow our body to neutralize them. Our immune system produces a multitude of different types, ready to identify the enemy that is invading our body with the massive production of the antibody in question: in this way (hopefully) the infection is defeated. There are billions of antibodies, but not all are equally effective against a potential invader. Also, it takes the body some time to produce them in sufficient quantities to eradicate an ongoing disease. Thus, artificially produced, they could more easily help the body to fight and overcome disease and this is what we are trying to do in the fight against Covid-19: once a particularly effective antibody has been identified, by producing en masse perfect copies, we would find ourselves. in your hands a drug very powerful with which to attack tumors, defective elements of our immune system (it occurs for example in the therapy of many autoimmune diseases) and, obviously, also in the case of the Sars-Cov-2 virus.
How do they work. “Monoclonal antibodies are drugs produced in the laboratory with special procedures, similar to the natural antibodies that we produce, specially designed to recognize and neutralize the coronavirus. In fact, they bind to the protein spike, considered as the key for the virus to enter cells, thus preventing the spread of the virus between cells and therefore its replication. In summary, we can define immunopharmaceuticals capable of effectively blocking viral infection ”, explained exclusively for ilgiornale.it Renato Bernardini, Professor of Pharmacology at the University of Catania and member of the Higher Health Council.
Antibody-vaccine difference. It is important to understand one thing, fundamental: monoclonals do not replace the vaccine, in any case they complement it. One does not exclude the other because they are totally two procedures and situations different. “The monoclonal antibody is a drug composed of a pre-manufactured antibody that is used to treat an ongoing disease (immunotherapy); the vaccine, on the other hand, is used for prophylaxis, that is, it prevents infection and the consequent disease (immunoprophylaxis) ”, Prof. explained to us, who added that, in the first case (monoclonal antibody) we speak of passive immunization because the patient is given an antibody from outside that neutralizes the virus and prevents its survival. In the case of the vaccine, however, we speak of active immunization for the prevention of coronavirus disease and the prevention of its spread. “It is not possible to compare the efficacy of drugs (monoclonal antibodies) used for the therapy of the current disease with that of prophylactic vaccines, whose efficacy is measured in terms of prevention of disease cases,” adds Bernardini.
The therapy that blocks Covid
Antibody therapy is ongoing development especially in the United States: the United States Food and Drug Administration (FDA) has already authorized its use for people with mild or moderate symptoms of Covid-19 who have not yet been hospitalized. Treatment should be administered as soon as possible to adults and pediatric patients over 12 years of age immediately after the positive test and within 10 days after the onset of symptoms. The results are increasingly encouraging and the cure appears to block Covid. “Yes, because monoclonal antibodies to block specifically the proteins that the coronavirus needs to infect cells. It is a real immunotherapy indicated for people who have already contracted the coronavirus infection “, Professor Bernardini tells us, underlining how it is” a therapy for patients in the home environment, but, for now, not indicated in the most serious forms in the hospital. “In short, block the virus before it’s too late, before it causes damage due to super-inflammation, also called a” cytokine storm. ” Evaluations are being carried out to understand whether monoclonal antibodies can be effective even in hospitalized patients in more advanced stages of the infection, but there is still no certainty of efficacy in this last condition, more research is needed ”, adds the pharmacologist.
More lights at the end of the tunnel
Next to vaccinations, which obviously remain the first weapon to stop the virus (because they intervene before the disease can break out), antibody treatment is a direction in which we are going with much more conviction (finally) than in the first months of the pandemic . Aifa (Italian Medicines Agency), through the voice of its general manager, Nicola Magrini, stated “maximum openness and maximum interest in monoclonal antibodiesThe drug is also under the scrutiny of the European authorities “who are evaluating its marketing authorization in the EU.” Some European countries have already planned their emergency use on the basis of an initial Ema effectiveness report, as well as data from the FDA, “says Professor Bernardini, who expects that in the spring of 2021” several products will be available. for the benefit of the infected Sars-cov 2 population, thus increasing the therapeutic potential against this disease ”.
New cure on the way
The latest news bodes well: British scientists are experimenting with a new a drug that could prevent people exposed to the coronavirus from developing the disease. This is an antibody therapy that would confer immediate immunity against Covid-19 and could be administered as an emergency treatment to hospitalized patients and in nursing homes to contain outbreaks. The drug was developed by University College London and AstraZeneca, the pharmaceutical company which, together with the University of Oxford at Irbm in Pomezia, also created a vaccine that the British Medicines and Healthcare Products Regulatory Agency should approve for use in the UK next week. The team hopes the study will show that the antibody cocktail protects against the virus for between 6 and 12 months. Participants in the trial will receive the drug in two doses, one after the other.
“It is one more tool in the arsenal of drugs defined as monoclonal antibodies”, says Bernardini – The English monoclonal antibody would have the ability to guarantee immunity immediate Sars-Cov-2 virus granted for a significant period of six to twelve months. This antibody could reverse the disease even in hospitalized patients. the final results of this immunotherapy should be announced around March-April 2021 “.
Here are the ready-to-use antibodies
Regeneron. Parallel to this novelty that is being tested, as mentioned at the beginning, antibody treatment has already begun in the United States: among all, Regeneron highlights, cocktail of antibodies (casirivimab and imdevimab) that was given to Donald Trump when he was infected with Covid (we talk about it here in our newspaper). It is a product to which the authorities gave an emergency green light on that occasion and it is the first drug designed for Covid to be included in the British trial called Recovery. Interim results showed that the drug has a viral load lowering effect, particularly marked in subjects with a high initial viral load and in seronegative patients. The FDA has received authorization for emergency use in patients with mild or moderate symptoms, 12 years of age and older and weighing more than 40 pounds. “at high risk of progressing to severe formsi “, as indicated in the Messenger Service.
Ely Lilly. Practically in tune with rival Regeneron, here’s another big name in the pharmaceutical industry: Eli Lilly, a global pharmaceutical company based in Indianapolis. This is the first treatment authorized for use by the general public. Also in this case, we have dealt with the subject in depth in our newspaper with an interview with Prof. Maria Rita Gismondo, Director of Clinical Microbiology, Virology and Diagnosis at the Sacco Hospital in Milan. “This is an antibody that has been isolated from patients who have contracted the infection, it has been protective and it was thought that it was appropriate to use it later, multiplying it. It is not built in the laboratory, it is multiplied in the laboratory. We are giving an absolutely natural therapy. that the laboratory only amplifies, ”Gismondo told us. The drug, known as LY-CoV555, has been shown to reduce the risk of hospitalization in patients with moderate symptoms by 72%.
The efficacy of this treatment has already led, in Italy, to the production of 2 million doses of bamlanivimab, Lilly’s monoclonal antibody used against Covid. Since the beginning of December, around 100,000 monthly doses have been produced at BSP Pharmaceuticals de Latina, which operates on behalf of Lilly, which are dedicated, at the moment, only to countries where the drug is already authorized. Italian production at full capacity in 2021 – reads a note – will be around 2 million bottles. In addition to the Italian site, 6 other factories are involved around the world. For our country to be given the go-ahead, AIFA is waiting for the green light, which takes time.
The “Italian” antibody
“The monoclonal antibody that we have selected as a result of laboratory research conducted in recent months by the MAD (Monoclonal Antibody Discovery) Lab, was produced by Menarini Biotech of Pomezia and now we are really one step away from starting the try clinics, scheduled for early January“To explain it to Ansa is Andrea Paolini, general manager of Fondazione Toscana Life Sciences, a center of scientific excellence.”Phase 1, which will verify the safety of the therapy – need – will be carried out in healthy people and will be carried out by the Spallanzani Institute in Rome and the Clinical Research Center in Verona“.
In short, 2021 brings many arrows to our bow: the road is still long, uphill and winding, but we can clearly see more lights at the end of the tunnel.
