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    Home > Biochemistry News > Biotechnology News > ​Is the double antibody necessarily better than the monoclonal antibody?

    ​Is the double antibody necessarily better than the monoclonal antibody?

    • Last Update: 2021-06-28
    • Source: Internet
    • Author: User
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    With the approval of the fourth dual-antibody drug in the world, the once "quiet" dual-antibody came to the eve of the outbreak, and the track was evaluated by industry experts as "it has begun to be crowded before it has officially entered the game
    .
    "

    So are double antibodies really better than monoclonal antibodies?

    So are double antibodies really better than monoclonal antibodies?

    The answer does not seem so sure
    .
    In theory, the effectiveness of facing two targets may be higher than that of a single target.
    However, due to the gaps in pharmacology and physiology research, whether the effect of 1+1>2 can be truly achieved still needs further verification

    .

    It is the common goal of doctors and pharmaceutical companies to have more drugs that can solve unmet clinical needs on the market
    .
    However, to match the target of the double antibody with the true curative effect, in addition to the technical level that needs to be further overcome, the clinical value and patient benefit need to be considered

    .
    Because, whether it is a double antibody or a combination therapy of PD-1 plus chemotherapy, there is only one approved standard, that is, it has a better effect than the existing standard treatment and has a better effect before it can be approved

    .

    Of course, if it is for a disease area where there is no treatment plan at present, a single-arm test can also be accepted by the drug regulatory department under normal circumstances
    .
    For example, on May 21, 2021, the FDA approved Johnson & Johnson's EGFR/cMet double antibody for patients with EGFF exon 20 insertion mutations that failed the platinum-containing regimen

    .
    It was
    approved based on a single-arm trial of 81 patients .

    01 Double anti-technology is ahead of science

    01 Double anti-technology is ahead of science

    In fact, in addition to double antibodies, both the third and fourth antibodies are in the research stage
    .

    The four antibodies most well-known in the industry are the two products of Baili Pharmaceutical, GNC-038 and GNC-039, both of which have entered the clinical stage
    .
    GNC-038 is the world's first four-antibody drug, targeting the four targets of CD19, CD3, PD-L1 and 4-1BB

    .

    Zejing, code-named ZGGS001, is a trispecific antibody molecule that mainly inhibits tumor immunity and multiple tumor angiogenesis pathways, and regulates the tumor microenvironment
    .
    It is currently in the pre-clinical development stage

    .

    There is a view that the current industry research on double antibodies and even polyclonal antibodies is that "technology is ahead of science
    .
    "

    Polyclonal combination has been able to achieve a technological breakthrough, but whether it will produce a 1+1>2 effect, whether it can be safe enough, and the toxicity is not increased, is still being explored
    .
    The question is nothing more than the following: How to choose the target? What is the order? What is the dose? How to control toxicity? Is there an advantage over existing treatments?

    Answering these questions requires a basic knowledge: how much do you know about the disease?

    Two separate and effective antibodies, combined together, some increase the efficacy, while others will bring side effects and increase toxicity.
    This requires good basic research to explain

    .
    Moreover, most of the double antibodies are deployed in the field of tumors.
    Of course, this also has commercial considerations, but why other disease fields are not so obvious? It also needs to be explained after in-depth basic research

    .

    02 Drug resistance and safety are the core

    02 Drug resistance and safety are the core

    In fact, regardless of double antibodies or polyclonal antibodies, the core goals are two, one is to overcome the resistance of the original drugs, and the other is to improve the efficacy and solve the unmet clinical needs
    .
    Of course, the biggest worry is also two: one is whether the combination is really effective and better than the effect alone; the second is how to balance the efficacy and the possible toxicity

    .

    Therefore, for the research and development of double-antibody drugs, it is necessary to return to the essence of science and the essence of drugs
    .
    Double antibodies and even polyclonal antibodies have many theoretical advantages, but whether these theoretical advantages can really be transformed into clinical advantages requires more scientific research to prove

    .

    The future is bright, and many pharmaceutical companies have already deployed in this field
    .
    But the road is long and difficult, because there are still many areas that need to be explored in basic research, clinical trial design, patient population screening, and key design of trial programs

    .

    However, one thing that needs to be clear is that after the industry has experienced the "backlash" of tinibs, PD-1/PD-L1, and the crowded ADC track, the development of double or multi-antibody drugs can be viewed more rationally: clinical Value is the core, it's not necessary to show off skills
    .

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