SYN004 is a recombinant chimeric monoclonal antibody (mAb) that binds specifically to the N-terminal portion of the human epidermal growth factor receptor (EGFR). SYN004 has the same pharmacological properties as cetuximab a leading oncology product for the treatment of colorectal and head and neck cancers. The glycan profile of SYN004 is appreciably less immunoreactive than that of cetuximab. Additionally, the sialic acid of the SYN004 is N-acetylneuraminic acid (NANA) instead of the N-glycolylneuraminic acid (NGNA) on cetuximab. As a consequence, SYN004 is proposed to be a safer product than cetuximab, while it has the same mechanism of action and similar efficacy to cetuximab. The phase I study of SYN004 has been completed in the US in patients with solid tumors in Oct 2018.
SYN008 is a biosimilar of Omalizumab (Xolair; a humanized anti-immunoglobulin E monoclonal antibody). It binds to the free IgE molecules in serum, thereby blocking the interaction between IgE and effector cells, which trigger the allergic response irrespective of allergen type. Stringent comparability studies between SYN008 and Omalizumab have been conducted and the investigational new drug (IND) application of SYN008 has been filed to the China Food and Drug Administration (CFDA) in Oct 2014. The phase I clinical trial has been completed in Australia in Sep 2016.
SYN023 is a mixture of two anti-rabies humanized monoclonal antibodies, CTB-011 and CTB-012, which bind to 2 different antigenic sites on the rabies glycoprotein. SYN023 is proposed for use in humans following exposure to the rabies virus. The proposed clinical indication is for post-exposure prophylaxis treatment of rabies in conjunction with rabies vaccine. The proposed mechanism of action is for the mAbs to bind to the rabies virus, which results in virus neutralization in a manner similar to an immune response producing neutralizing antibodies. SYN023 has been shown to neutralize greater than 15 contemporary wildlife isolates of rabies virus collected in China and 10 isolates collected in the North American. The preclinical studies of SYN023 have been completed. The Phase I study conducted in the US in healthy adult volunteers has been completed in Jun 2016. The phase Ib and II studies in the US in healthy adult volunteers have been completed in Jan 2018. Currently, the phase IIb study in the US and Philippines in patients with WHO Category III rabies exposures has been on-going, and will be completed the last patient last visit by Dec 2021.
SYN125 is a humanized IgG4 monoclonal antibody that binds to hPD-1 with high specificity and affinity. As an antagonist of PD-1, SYN125 effectively restores T cell anti-tumor responses by blocking the interaction between PD-1 and its ligands, PD-L1 and PD-L2. SYN125 is composed of complementarity-determining regions derived from mouse anti-human PD-1, and constant regions from human IgG4 isotype with a S228P mutation in the Fc region to prevent Fab-arm exchange. A number of nonclinical pharmacodynamic, pharmacokinetic, and toxicology studies have been completed. The phase I study in the US in patients with solid tumors (SYN125 single agent), and in patients with epithelial cancers with EGFR expressions (combination with fixed dose SYN004) has been conducting, and will be completed in 1Q 2022.