The first-in-human study of NBE-Therapeutic’s lead program NBE-002 targeting ROR1, for triple-negative breast cancer and other solid tumours, has kicked off. Initial results from the study are expected in 2021.
NBE-Therapeutics is a Swiss-based company developing best-in-class cancer therapies based on its proprietary, highly differentiated Antibody-Drug Conjugate (ADC) platform. The iADC platform creates highly potent, safe and immune-stimulatory ADCs with a novel anthracycline payload, which have been shown to induce a long-lasting anti-tumour immunity in preclinical models of solid tumours. Lead candidate NBE-002 has shown a remarkable therapeutic index (a measure of extremely high safety and tolerability) during non-clinical development.
Through its newly launched phase 1/2 open-label clinical study, the company– together with a team of globally renowned investigators from the fields of oncology and antibody-drug conjugates – will evaluate the recommended dose for further clinical development. Additionally, the study will investigate the safety, tolerability, anti-tumour activity, immunogenicity, pharmacokinetics and pharmacodynamics of NBE-002, a novel anti-ROR1 antibody-drug conjugate, in patients with advanced solid tumours. Initial results from the study are expected in 2021.
Globally renowned investigators in the fields of oncology and antibody-drug conjugates are leading the clinical trials. The team includes Anthony W Tolcher, MD from NEXT Oncology, San Antonio, Texas; Funda Meric-Bernstam, MD from The University of Texas MD Anderson Cancer Center, Houston, Texas; and Meredith McKean, MD from Sarah Cannon Research Institute - TN Oncology, Nashville, Tennessee.
Bertrand Damour, CEO of NBE-Therapeutics, said: “The first patient was enrolled in July 2020 and we are already at the third dose level. I am very pleased that the trial is progressing so well. Our goal is to develop best-in-class oncology treatments to increase survival, with the potential to cure solid tumours and to improve quality of life for cancer patients worldwide. The start of this trial represents an important milestone for NBE-Therapeutics to clinically demonstrate that our ADC platform has a highly favourable safety profile alongside significant efficacy in multiple pipeline programs. We look forward to continued progress with our ADCs in advanced solid tumours.”
Positive preclinical results
Ulf Grawunder, Founder, COO & CDO of NBE-Therapeutics, said: “We consider NBE-002 the best-in-class ROR1 targeting ADC in development, and are excited it has entered the clinic. In preclinical, solid tumour studies NBE’s novel iADC platform has shown unparalleled safety and efficacy, together with induction of anti-tumour immune memory. This immune-oncology function also prevented tumour re-growth upon tumour re-challenge, after complete regression had been achieved in preclinical tumour models. If this dual function translates into clinical benefit, NBE’s iADC platform could transform cancer medicine.”
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