NBE-Therapeutics, a Swiss-based company developing best-in-class cancer therapies based on its proprietary, highly differentiated Antibody-Drug Conjugate (ADC) platform, announced that it has commenced first-in-human studies of its lead program NBE-002 targeting ROR1, for triple-negative breast cancer (TNBC) and other solid tumors.

This phase 1/2, open-label study will evaluate the recommended dose for further clinical development, safety, tolerability, anti-tumor activity, immunogenicity, pharmacokinetics and pharmacodynamics of NBE-002, a novel anti-ROR1 antibody-drug conjugate, in patients with advanced solid tumors. Initial results from the study are expected in 2021.

The clinical study (NCT04441099) is being led by globally renowned investigators in the fields of oncology and antibody-drug conjugates, including: 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.

NBE-Therapeutics' best-in-class 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-tumor immunity in pre-clinical models of solid tumors. Lead candidate NBE-002 has shown a remarkable therapeutic index (a measure of extremely high safety and tolerability) during non-clinical development.

Bertrand Damour, CEO of NBE-Therapeutics, said: "The first patient was enrolled in July 2020 and we are already at the third dose level. l 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 tumors 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 tumors."

Dr. 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 pre-clinical, solid tumor studies NBE's novel iADC platform has shown unparalleled safety and efficacy, together with the induction of anti-tumor immune memory. This immune-oncology function also prevented tumor re-growth upon tumor re-challenge, after complete regression had been achieved in preclinical tumor models. If this dual function translates into clinical benefit, NBE's iADC platform could transform cancer medicine."