On June 15, 2017 Generon Corporation, a leading biotechnology company in China, reported the initiation of a clinical trial for A-337, a CD3-activating bi-specific antibody targeting EpCAM, in Australia (Press release, Generon (Shanghai), JUN 15, 2017, View Source [SID1234531381]). This is a "Phase I, Open-label, Dose-escalation Study to Evaluate the Safety and Pharmacokinetics of A-337 in patients with advanced solid tumors". EpCAM is up-regulated and over-expressed in most solid tumors.
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A-337 is the first immune oncology product generated by Generon’s immunotherapy antibody (ITabTM) platform to enter clinical development. ITabTM generates human CD3-activating bi-specific antibodies targeting tumor associated antigens (TAA), such as EpCAM. Bi-specific antibodies generated from this platform have demonstrated more than 1,000-fold potencies compared to conventional monoclonal antibodies. In preclinical studies, A-337 demonstrated potent anti-tumor activity and favorable pharmacokinetics, in addition to improved safety profiles compared to competitors’ products. Generon has developed a robust manufacturing process to produce ITabTM antibodies in mammalian cells.
Dr. David Lacey, the Chairman of Generon’s Scientific Advisory Board, stated, "A-337 represents a next-generation CD3-activating bi-specific antibody targeting EpCAM-expressing solid tumors. The multivalency of the EpCAM portion of the molecule may enable activity across a wide range of tumor EpCAM expressions, including tumors expressing lower levels. This potential advance presents an important option for patients who have failed previous lines of therapy".
The management executives of E-fan Pharmaceuticals congratulated Generon’s team for their passion, efficiency and outstanding achievement for the project. Dr. Xiao Qiang Yan, Chairman and CEO of Generon, commented, "A-337 is our first immunotherapeutic antibody entering clinical development. This is another important milestone in "innovating for life". A-337 has demonstrated compelling advantages in pre-clinical safety studies over other CD3-activating bi-specific antibodies targeting EpCAM. We are committed to bringing innovative immunotherapy antibodies to treat cancer patients, providing them with more effective treatment options".
About ITabTM
Generon’s ITabTM (immunotherapy antibody) platform generates bi-specific antibodies that bind to the CD3 molecule on human T cells, and simultaneously bind to specific tumor associated antigens (TAAs) in a mono-valent or bi-valent format. The formation of a synapse between the tumor cell and the T cell linked by the antibody leads to the activation of the T cell, and the release of mediators lysing the tumor cell. These bi-specific antibodies can drive the expansion of T cells, rendering T cells as serial killers of tumor cells. ITabTM antibodies are manufactured in CHO cells in serum-free conditions