Trump’s illness put a ‘middle antibody drug’ in the spotlight. On October 3rd Sean Conley, the White House doctor, released a list of drugs mr. Trump is treating, including regenerative cocktail therapy REGN-COV2, which includes vitamin D, famotin, melatonin, aspirin, redsiwe and regeneratives.
The first thing that sparked the public debate was, of course, the ‘drugs’ such as ‘sterilized water and hydroxychloroquine’ that Mr. Trump had touted before, and not on the list.
Then there are two drugs that really work: Redsyvir and REGN-COV2. What’s so amazing about the fact that these two drugs have been selected from a wide range of options by America’s top medical teams?
Redsiwe Chinese readers must already be familiar with it. Early in the outbreak, the drug, nicknamed ‘The Hope of the People’, caught fire. Wall Street has previously detailed whether Gilead is the company behind it, and interested readers can click to see it.
In contrast, regenerative cocktail therapy REGEN-COV2 is not well known to the public. This time, President Kawada entered the public eye for the first time.
Industry insiders know that regeneratives are one of the world’s most creative pharmaceutical companies and the forernest of the antibody cocktail therapy, which has previously had a successful precedent for Ebola antibodies. That’s why its cocktail therapy is so highly expected.
The so-called cocktail therapy refers to a combination of drugs. REGN-COV2 therapy consists of two combinations of monoantigens (REGN10933 and REGN10987). The researchers first screened more than 200 candidate antibodies from the blood of genetically modified mouse models and recovering patients with neocosmo pneumonia, and then further single-antigen composition ‘cocktail’ therapy.
Two antibodies are needed because in order to prevent virus mutations to make treatments greatly discounted, the two antibodies are targeted at different key locations of the virus, combined treatment, greatly improving the healing effect.
How effective is cocktail therapy?
Just days before Mr. Trump’s diagnosis, Regeneration has just released the latest stage effects of reGEN-COV2 therapy. The key points are as follows:
1,275 new crown patients were randomly divided into three groups, receiving high-dose antibodies (8 grams), low-dose antibodies (2.4 grams) or placebos.
2, reduce the viral load, shorten the new crown non-hospitalized patients symptoms of the length of time used to alleviate.
3. The medium time for symptom reduction in serum-negative patients receiving placebo was 13 days, 8 days for patients receiving high-dose therapy and 6 days for patients receiving low-dose therapy. Both doses of antibody cocktail therapy were well toned. (This time Trump is receiving 8 grams of high-dose therapy)
4, in the ‘no effective immune response before treatment’ in patients with a particularly significant effect.
5, the majority of the 275 subjects reported were younger than Mr. Trump and had less severe symptoms and did not include hospitalized patients.
6. This part of the trial is just one part of a huge ongoing project that also includes research into the efficacy of cocktail antibody therapy for hospitalized patients and the prevention of infections in people who have been exposed to new crowns, with no further results yet to be announced.
As Eric Topol, director of the Scripps Institute, said in an interview with the media, while the data is not yet enough for the FDA to issue emergency use authorizations, everything is moving in the right direction.
Antibody therapy: both can cure the disease, but also can prevent.
To understand antibody therapy, you first need to know what a medium antibody is.
When viruses, bacteria and other pathogenic microorganisms invade the body, it stimulates the body’s immune system and produces a variety of antibodies.
But only some antibodies can quickly identify pathogenic microorganisms, binding to their surface antigens, preventing the pathogenic microorganisms from binding to the subject cells on the surface of the target cell to invade the cells, thus protecting the body from infection. This process is called the meso-action, and the antibody that works is called the meso-antibody.
Similar to chemical acid-base melioth, the effect of the mesothetic action means that the virus comes, immune cells secrete the meso-protein into the blood, binding to the virus particles, preventing the virus from infecting the cells, destroying the virus particles, the virus ‘melising’ off.
The antibody therapy is a method of passive immunotherapy directly using the medium antibody, which is equivalent to artificially replenishing the ‘bullet’ to support the immune system.
Neutral antibody is a large molecule drug, compared with small molecule drugs (such as redsivir), has a good specificity, small side effects, in recent years, there has been a successful precedent for the development of neutral antibody drugs to deal with infectious diseases.
The antibody has the dual effect of treatment and prevention. Antibody drugs are unique in comparison to vaccines or antiviral drugs because they both treat new coronavirus infections and prevent new coronavirus infections.
Antibodies are more stable in the blood, and injection-between antibodies can provide passive immunity to prevent new coronavirus infections. Prior to the advent of preventive vaccines, antibodies could be an effective way to provide immunity to specific high-risk groups, such as the elderly and frontline health workers.
However, the antibody also has a big drawback: the antibody can only guarantee short-term prevention, need every 1 month or every 2 months, to achieve universal immunization or wait until the vaccine is developed.
More to look forward to than vaccines.
At present, the market’s focus is mainly on the progress of vaccines. However, due to the long time of vaccine research and development, it will not be available in the short term. The antibody drug may be the most anticipated ‘god medicine’ in the short term.
Vaccine development is a long and expensive process with a high failure rate. The development of traditional vaccines generally follows linear steps and generally takes 5-10 years;
In the case of the Ebola vaccine, which erupted in West Africa in 2014, Russia’s GamEvac combined vaccine was first approved in two years through phase I/II clinical studies. Mercedon’s VSV-EBOV vaccine was approved by the European Union’s EMA and the U.S. FDA in November and December 2019, five years after the 2014 Ebola outbreak.
The CDC director of the cdc said the new vaccine will be available to medical workers and field responders at the end of this year or after it available in January, and is not expected to be available to the general public until spring and summer 2021.
In contrast, the development cycle of antibody drugs is much shorter. As with other drug development, clinical trials of monoclonal and antibodies of the new coronavirus are also phased in three phases. If all goes well, 8-12 months is expected to be a successful, and possibly even faster, development. Specifically:
Phase I clinical trials: preliminary clinical pharmacology and human safety evaluation trials, the number of cases in the group is generally 10-50 cases, the fastest not less than 20 days.
Phase II Clinical Trials: Preliminary Evaluation Phase of Therapeutic Effects. The aim is to initially evaluate the therapeutic effect and safety of the drug on target indication patients (possibly grouped according to their severity, age, race, etc.) and to provide a basis for the design of Phase III clinical trial studies and the determination of dosage options for administration. It takes a minimum of 1 month, and the number of cases in the group is generally 100-500.
Phase III Clinical Trials: The therapeutic effect of the confirmed stage. The layout of multiple adaptive disorders is mainly divided into therapeutic and preventive trials.
-Treatment trial: According to the patient’s condition is divided into mild treatment and severe treatment, the subjects in the clinical trial group of light treatment were light to moderate and non-hospitalized patients, and the subjects in the clinical trial group of severe treatment were patients hospitalized with severe illness. Blinding can be revealed at the end of a course of treatment (approximately 4 weeks).
-Prevention trials: The aim is to verify the effectiveness and safety of antibodies to prevent infection with neocyclone in high-risk infected populations, divided into pre-exposure prevention and post-exposure prevention. Pre-exposure prevention generally can obtain preliminary test results within 8 weeks, post-exposure prevention can obtain preliminary results within 1 month, the completion of the study requires follow-up 6-8 months.
04 and the race against time.
Currently, regenerative REN-COV2 is the fastest-growing antibody drug and has entered Phase III clinical trials, followed by Lilly’s LY-CO555.
The faster the research and development is successful, the wider the market for antibody drugs. The meso-antibody drug, which was available before the end of the outbreak, is the most valuable, so the development of the antibody is a race against time, not only to get ahead of the virus, but also in the limited but fierce competition for research and development.
According to Societe Generale, with the rapid advance of vaccine research and development, the time window for the use of antibodies for prevention is after the market to the end of 2020, and after the vaccine is on the market, with the gradual formation of group immunity, the outbreak or control, the expected time window for the use of antibodies for treatment is after the market to the end of 2021 (assuming the outbreak continues until the end of 2021 or longer).
Henyep Securities estimates that the commercial market space of the new crown will last until the end of 2020, and that the actual market space will depend mainly on the pricing of the new crown antibody and the speed of the release of the enterprises, assuming that the new crown outbreak continues until the end of 2021, the market space of the medium antibody will reach US$6.87-14.64 billion.
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