Synthon’s SYD985 outperforms Kadcyla in vitro and in vivo

Generics and biosimilars Initiative

Building trust in cost-effective treatments

Sign up
eng / esp

Synthon’s SYD985 outperforms Kadcyla in vitro and in vivo

Biosimilars/Research | Posted 23/05/2014 0 Post your comment

Synthon announced on 2 April 2014 that its antibody-drug conjugate SYD985 had outperformed Roche’s breast cancer blockbuster Kadcyla (trastuzumab emtansine) in a head-to-head comparison.

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).

Permission granted to reproduce for personal and non-commercial use only. All other reproduction, copy or reprinting of all or part of any ‘Content’ found on this website is strictly prohibited without the prior consent of the publisher. Contact the publisher to obtain permission before redistributing.

Source: EMA, Synthon