Synthon reports promising initial results from Phase I trial with anti-HER2 ADC

October 1, 2015 11:50 AM

Synthon Biopharmaceuticals (‘Synthon’) reports positive  initial results from the dose-escalation part of its ongoing first-in-human trial with SYD985, an investigational HER2-targeting antibody-drug conjugate (ADC).

Partial responses were observed in breast cancer patients who are refractory to previous HER2-targeted treatments. The data were presented on 27 September 2015 during the European Cancer Congress in Vienna, Austria.

In the ongoing dose-escalation part of the trial, safety and efficacy of SYD985 have been evaluated in patients with locally advanced or metastatic solid tumors of any origin. The patients were enrolled in leading European oncology centers Radboud University Medical Center (Nijmegen, the Netherlands), the Jules Bordet Institute (Brussels, Belgium) and the Institute of Cancer Research at The Royal Marsden Hospital (London, United Kingdom). Partial responses are observed in breast cancer patients who are refractory to previous HER2-targeted treatments, including trastuzumab emtansine (T-DM1). In addition, efficacy was reported in a HER2 2+ / FISH-negative breast cancer patient.

Although the maximum tolerated dose has not yet been reached and the dose escalation part is ongoing, initial results, including safety, tolerability and pharmacokinetics, were reported on investigated dose cohorts up to 2.4 mg/kg.

Continuation of the dose-escalation part of the trial will further define the safety and efficacy profile of SYD985 before selection of the recommended Phase II dose and initiation of the expanded patient cohort part. These expanded cohorts will include breast cancer and gastric cancer patients with at least HER2 1+ expression. Apart from that, patients will be recruited in indications where presently no effective anti-HER2 therapy is available, including lung cancer, endometrial cancer and bladder cancer.

SYD985 is a HER2-targeting ADC based on trastuzumab and Synthon’s proprietary cleavable linker-duocarmycin (vc-seco-DUBA) payload.

Dr. Marco Timmers, chief scientific officer of Synthon, said: “These exciting initial results suggest that SYD985 may provide an additional treatment option for patients refractory to the established HER2-targeting drugs and may broaden the patient population eligible for HER2-targeted treatment.”

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