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On January 7, Insight database showed that CTLA-4 monoantibodies HBM4003 of Platinum Pharmaceuticals initiated a Phase I clinical trial for advanced solid tumors.
previously, on December 28, 2020, a clinical trial of HBM4003 in association with PD-1 monoantigen Ripley monoantigen for advanced/metastasis melanoma was just launched.
HBM4003 Project Details from insight database () HBM4003 is an all-human anti-CTLA-4 heavy chain antibody produced from the unique Harbour Mice® platform of platinum medicine, and platinum took 3 years to advance it from the drug candidate screening phase to the clinical phase.
compared with conventional antibodies, heavy-chain antibodies (HCAbs) consist of only two heavy chains, no light chains, and have a smaller molecular weight than conventional antibodies, so they have better tissue penetration potential.
same time, heavy-chain antibodies have pharmacodynamic properties and immunoactivation (Fc) functions similar to IgG.
-chain antibodies bind to antigens only through heavy-chain variable regions, they can still show specificity similar to conventional antibodies.
HBM4003 shows enhanced antibody-dependent cell-mediated cytotoxicity (ADCC), which is highly specific to highly expressed Treg cells in tumor tissue.
its powerful anti-tumor effects, differentiated pharmacodynamic characteristics and long-lasting llermic properties exhibit good product characteristics, and this novel and differentiated mechanism of action has the potential to improve therapeutic effectiveness and significantly reduce drug toxicity.
HBM4003's Mechanism of Role Photo Source: HBM4003 has been approved by the FDA in the U.S. in January 2020 and in September 2020 by china's State Drug Administration for a phase-one trial as a monotherapy for advanced solid tumors, according to the platinum pharmaceutical website and platinum pharmaceutical prospectus.
addition, the product was approved by the National Drug Administration in September 2020 for the development of HBM4003 as a combination therapy, used in combination with PD-1 monoantigen to treat advanced solid tumors (including melanoma, MSI-HCRC, and non-small cell lung cancer).
both clinical trials have recently been launched.
, phase I clinical initiation (CTR20210015) is an open-label, international multi-center study that explores the safety and toaling of HBM4003 monodratives in patients with advanced solid tumors, as well as the initial anti-tumor activity of HBM4003 single drugs in patients with metastatic or non-removable melanoma, hepatocellular carcinoma, and renal cell carcinoma.
, the market size of CTLA-4 antibodies has increased to $1.5 billion in 2019, with the world's listed CTLA-4 single-resistant BMS-only Ipimu monoantigen (Y-drug).
clinical outcomes and commercialization of CTLA-4/PD-1 combination therapies is one of the important reasons for their rapid growth.
, however, the current domestic competition for CTLA-4 targets is more intense, there are 7 single-resistance projects and 4 dual-resistance projects, in the domestic market to seize the first-in-the-nation advantage is essential for subsequent competition.
the fastest progress is the Y drug, which has been applied for market in China, followed by AstraZeneta's Qumeimu monoanti and Corning Jerry's PD-L1/CTLA-4 dual anti-KN046 have entered Phase III clinical.