The world's first all human heavy chain antibody entering the clinical research stage: hbm4003, a platinum medicine, was successfully used in the first patient in Australia

November 6, 2019 / Biovalley BIOON / -- and platinum medicine announced that their new generation of all human anti-CTLA-4 antibody hbm4003 has launched the first global clinical trial for patients with advanced solid tumors, which is conducted in Australia, and the first patient has been successfully enrolled in the group Hbm4003 is the first all human heavy chain antibody to enter the clinical research stage in the world, which is produced from the HCAB all human antibody technology platform unique to platinum medicine Hbm4003 can eliminate regulatory T cells by enhancing antibody dependent cell-mediated cytotoxicity (ADCC) and shorten the half-life of antibody, which shows its great potential in anti-tumor and safety Compared with the first generation of anti-CTLA-4 antibody, hbm4003 showed stronger antitumor activity and lower systemic drug exposure in preclinical studies, indicating that it may have a significant improvement in clinical efficacy The results of the preclinical study of hbm4003 were presented in April 2019 at the annual meeting of the American Association for cancer research (AACR) This ongoing clinical trial aims to evaluate the safety, pharmacokinetics and preliminary antitumor activity of hbm4003 in patients with advanced solid tumors "Hbm4003 was produced on the HCAB platform unique to platinum medicine This innovative drug molecule entered clinical trials rapidly, further proving the great potential of heavy chain antibody as a new generation of tumor immunotherapy." "This clinical study conducted in Australia is the first step of hbm4003's global clinical development plan," said Dr Wang Jinsong, founder, chairman and chief executive officer of hepta pharmaceutical And Pt will launch a series of clinical trials of hbm4003 in the United States and China in the near future, and will launch a series of clinical trials of combined therapy based on hbm4003 " Dr Wang further pointed out that "HPP has always focused on the rapid development of innovative drug product pipeline, and in less than three years, it has promoted HBM4003, a completely independent innovative drug project, to the clinical research stage At the same time, HPM also has a number of mAb and MAb projects targeting different targets, which are in the stage of clinical development and preclinical development " CTLA-4 is one of the main negative regulators of T cell response CTLA-4 antibody is a kind of immunosuppressive checkpoint inhibitor which can enhance the killing ability of tumor by enhancing the activity of T cells The value of CTLA-4 antibody in cancer immunotherapy has been proved, but its safety has hindered its wide application in single therapy or combination therapy The results of preclinical studies on hbm4003 showed that the immune activation of hbm4003 was driven by two mechanisms: the immunosuppressive regulatory T cell elimination mediated by enhanced ADCC, and the inhibition of negative regulatory signal of CTLA-4 binding costimulatory molecule B7 Professor Paul de Souza, Dean of the Department of medicine, University of Wollongong, who is one of the main researchers in the Australian clinical trial of hbm4003, said, "although the industry has improved the standard treatment of advanced solid tumors, including melanoma, in recent years, the clinical treatment of advanced solid tumors is still a great challenge Hbm4003 has shown great potential in its preclinical research This clinical trial will be the first time for us to evaluate the effect of this innovative drug molecule on solid tumor treatment " As for the heavy chain antibody (HCAB), compared with the traditional antibody, the heavy chain antibody (HCAB) is composed of only two heavy chains, no light chains, its molecular weight is smaller than the traditional antibody, and has better tissue penetration potential At the same time, heavy chain antibody has the similar pharmacokinetic characteristics and immune activation (FC) function as IgG The heavy chain antibody can only bind to the antigen through the variable region of the heavy chain, and can still show the similar specificity with the conventional antibody The heavy chain antibody of HPM is produced on its unique all human transgenic mouse platform, which is suitable for the design of a variety of special structural antibodies in the later stage and produces a variety of mechanisms and uses HCAB antibody is a natural all human antibody produced for a specific target, so there is no need for subsequent humanization to reduce the immunogenicity of the antibody As a global biopharmaceutical company focusing on the field of immune diseases (including tumor immunity and autoimmune diseases), hepatin and platinum medicine have entered the clinical development stage The company uses two global patented all human antibody transgenic mouse platforms (harbour mice ®) to develop breakthrough and innovative therapies for tumor immune and autoimmune diseases And Pt pharmaceutical also rapidly expand its new drug R & D pipeline through diversified cooperation with business partners Original source: Platinum medicine