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21-Jan-2019

BerGenBio announces start of phase I trial evaluating ADCT-601, a novel anti-AXL ADC, in patients with advanced solid tumours

  • ADCT-601 uses a proprietary AXL antibody developed by BerGenBio and licensed to ADC Therapeutics for antibody drug conjugate (ADC) development
  • Phase I dose escalation and expansion trial will evaluate ADCT-601 in 75 cancer patients
  • ADCT-601 is BerGenBio’s third clinical candidate targeting AXL

Bergen, Norway, January 21 2019 - BerGenBio ASA (OSE:BGBIO), announces that the first patient has been dosed in a phase I clinical trial evaluating the safety, tolerability, pharmacokinetics and anti-tumour efficacy of ADCT-601, an AXL-targeting antibody drug conjugate (ADC), in patients with advanced solid tumours. 

ADCT-601 is composed of a humanised monoclonal antibody against human AXL (BGB601) discovered by BerGenBio, conjugated to a pyrrolobenzodiazepine (PBD) dimer toxin. BGB601 was out-licensed for ADC development to ADC Therapeutics SA (ADCT). In preclinical studies, ADCT-601 has demonstrated potent and specific anti-tumour activity in multiple in vivo models and was stable and well tolerated, as reported by ADCT at the American Association of Cancer Research (AACR) annual congress in 2018. 

The open-label, multi-centre, single arm phase I trial will enrol approximately 75 patients with selected tumour types and will be managed and sponsored by license partner ADC Therapeutics. For more information see https://clinicaltrials.gov (accessing trial identifier NCT03700294). 

Richard Godfrey, Chief Executive Officer of BerGenBio, commented: “We congratulate ADC Therapeutics on reaching this important milestone. We are pleased to now see three of our AXL-targeting modalities in clinical development with the potential to address large patient populations. Our focus remains on completing our ongoing oncology phase II programme with bemcentinib, a first-in-class highly selective oral AXL inhibitor, and start randomised, potentially pivotal trials later this year. In the meantime, we look forward to providing updates on the development of BGB149, a therapeutic AXL antibody, and ADCT-601, an anti-AXL ADC, as they progress through phase I testing.”

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Last Updated: 21-Jan-2019