NBE-Therapeutics Commences First Clinical Study of Anti-ROR1 Antibody-Drug Conjugate for Patients with Solid Tumors

BASEL, Switzerland I October 26, 2020 I NBE-Therapeutics, a Swiss-based company developing best-in-class cancer therapies based on its proprietary, highly differentiated Antibody-Drug Conjugate (ADC) platform, today 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 favorable 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 & CDOof 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 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."

To read more: Clinicaltrials.gov NCT number: NCT04441099

About ROR1

ROR1 is receptor tyrosine kinase-like orphan receptor 1. It is a cell-surface protein that is expressed during embryofetal development but disappears before birth and is usually not expressed on normal cells in children or adults. ROR1 can, however, reappear on malignant tissues and may be expressed across a broad variety of cancer types including solid tumors. By addressing ROR1 cancer-fighting therapeutics can be selectively targeted to tumor cells, while sparing normal cells.

About NBE-Therapeutics

NBE-Therapeutics is a privately-owned Swiss biotech company based in Basel and founded in 2012 with the vision of developing next-generation immune-stimulatory antibody-drug conjugate (iADC™) products. NBE advances its products to clinical proof of concept with the goal of improving treatment options for cancer patients.

The company leverages proprietary platforms covering all aspects of ADC development: its Transpo-mAb Display™ technology for antibody discovery, its SMAC-Technology™ for site-specific payload conjugation of toxins to antibodies and a novel highly effective and immune-stimulatory anthracycline-based toxin platform. The company is financially backed by the Boehringer Ingelheim Venture Fund (D), the PPF Group and Novo Holdings (DK) as institutional investors, and by additional Swiss, German and Dutch private investors. For more information about NBE visit the website www.nbe-therapeutics.com.

SOURCE: NBE-Therapeutics

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