Kadcyla was approved by the European Medicines Agency in November 2013 for the treatment of human epidermal growth factor receptor 2-positive (HER2+) metastatic breast cancer in adults who had previously received trastuzumab and a taxane, separately or in combination.

Synthon’s SYD985 is a HER2-targeting antibody-drug conjugate based on trastuzumab and Synthon’s proprietary cleavable linker-duocarmycin (vc-seco-DUBA) payload. SYD985 and Kadcyla were compared both in vitro and in vivo. Patient-derived breast cancer xenograft models in mice – preclinical models known for their highly predictive value for clinical outcome – were used for the in vivo testing.

In vivo, SYD985 demonstrated unprecedented anti-tumour activity and clearly outperformed Kadcyla, particularly where there was a low expression of HER2. In low-expressing HER2 tumour models, SYD985 was able to induce complete tumour remission after a single dose of 3 mg/kg.

In vitro, in cell lines with high HER2 expression (characterized as HER2 3+), both SYD985 and Kadcyla showed similar potencies. However, in cell lines with low HER2 expression (characterized as HER2 1+ and HER2 2+), SYD985 was substantially more potent than Kadcyla.

Synthon believes the data supports the potential of SYD985 to address the high unmet medical need of patients with HER2 1+ and HER2 2+ breast cancer for whom there is currently no effective therapy available.

Synthon is preparing for a ‘first-in-human’ phase I study which the company plans to start in the second half of 2014.

Synthon also successfully completed a phase I clinical trial for its biosimilar trastuzumab candidate in March 2012, which showed bioequivalence of Synthon’s biosimilar to the reference product Herceptin (trastuzumab).

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