ITabMed announces the IND approval from NMPA for A-337, a CD3-activating bispecific antibody targeting EpCAM to treat solid tumors

On June 7, 2023 ITabMed Ltd., a clinical-stage biotech company in China, reported the IND approval from China National Medical Products Administration (NMPA) for A-337, a CD3-activating bi-specific antibody targeting EpCAM. 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" (Press release, ITabMed, JUN 7, 2023, View Source [SID1234632575]). EpCAM is one of the earliest identified tumor-associated antigens (TAA) and up-regulated and over-expressed in many solid tumors.

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A-337 is the second immune oncology product generated by the immunotherapy antibody (iTab) platform to enter clinical development in China. iTab is a T cell engager (TCE) platform for human CD3-activating bi- and tri-specific antibodies targeting tumor associated antigens (TAA). A-337 was designed with two EpCAM targeting fragments (EpCAM x EpCAM x CD3) with significantly enhanced biological properties and improved safety profile compared to the competitor’s products including EpCAM x CD3 TCE, EpCAM x CD3 bispecific antibodies. In preclinical studies, A-337 demonstrated potent anti-tumor activity, favorable pharmacokinetics, and a significantly improved safety window.

Dr. Xiao Qiang Yan, Chairman and CEO of ITabMed Ltd commented "A-337 is our second immunotherapeutic antibody entering clinical development in China. A-337 has the similar structural design as A-319 which is in phase I development to treat liquid tumors. Two phase I studies of A-319 are being conducted in patients with relapsed and refractory B cell acute lymphoblastic leukemia (r/r-B-ALL) and in patients with relapsed and refractory non-Hodgkin’s lymphoma (r/r-NHL). The preliminary results of the two phase I studies have demonstrated an excellent safety profile and promising anti-tumor responses of A-319 during dose-escalation. Likewise, we believe that A-337 has enormous potential to treat metastatic solid tumors due to its improved safety profile and its unique format design. The IND approval demonstrates our continued effort in "innovating for life" and to cure many cancer patients with our innovative medicines".

About iTab platform

ITabMed has been developing the iTAb (immunotherapy antibody) platform for more than a decade. iTAb generates bi- and tri-specific antibodies that bind to the CD3 molecule on human T cells, and simultaneously bind to TAAs or TSA on a tumor cell. The formation of a synapse between the tumor cell and the T cell linked by the antibody leads to the activation of the T cells, and the release of mediators lysing the tumor cells. These T cell engaging bi- and tri-specific antibodies can drive the expansion of T cells, rendering T cells as serial killers of tumor cells. The iTAb antibodies are very potent and are manufactured in CHO cells in serum-free conditions. The iTAb drug products are very stable in liquid formulation with extra-long stability profile.