NBE-002 / Sotio, Boehringer Ingelheim - LARVOL DELTA

The antibody-drug conjugate targeting ROR1, NBE-002, is active in high-grade serous ovarian cancer preclinical models. (PubMed, Ther Adv Med Oncol) - "This study explored the anti-cancer effects of NBE-002 alone and in combination with standard HGSOC therapies, carboplatin, paclitaxel and olaparib. The ROR1-targeting ADC, NBE-002, has therapeutic potential in HGSOC, with single agent activity observed both in vitro and in vivo. Broader clinical applications were evident when NBE-002 was combined with carboplatin or olaparib."

Journal • Preclinical • Hematological Disorders • Hematological Malignancies • High Grade Serous Ovarian Cancer • Oncology • Ovarian Cancer • Solid Tumor • BRCA2 • HRD • ROR1

NBE-002-01: NBE-002 in Patients With Advanced Solid Tumors (clinicaltrials.gov) - P1/2 | N=12 | Terminated | Sponsor: NBE-Therapeutics AG | N=100 ➔ 12 | Trial completion date: Dec 2025 ➔ Aug 2023 | Active, not recruiting ➔ Terminated | Trial primary completion date: Jun 2025 ➔ Aug 2023; End of Program

Enrollment change • Trial completion date • Trial primary completion date • Trial termination • Breast Cancer • Oncology • Solid Tumor • Triple Negative Breast Cancer

Preclinical assessment of GlycoConnect™ ADCs with potency-modulated derivatives of PNU-159,682 (AACR 2023) - "PNU-159,682 is an oxidized secondary metabolite of nemorubicin (MMDX), and substantially more potent (2100-6400-fold) than the commonly used chemotherapeutic anthracycline doxorubicin/adriamycin, but without the dose-limiting cardiotoxicity. Based on these beneficial features, PNU-159,682 is currently being clinically evaluated (phase 1) for solid tumor indications as a payload in various antibody-drug conjugates (NBE-002, SO-N102)...A Polar Sulfamide Spacer Significantly Enhances the Manufacturability, Stability, and Therapeutic Index of Antibody-Drug Conjugates. Antibodies 2018, 7, 12, doi:10.3390/antib7010012."

Preclinical • Oncology • Solid Tumor

NBE-002, An Anthracyclinebased Immune-Stimulatory ADC Targeting ROR1 (ADC-USA 2022) - "Presenting preclinical data on NBE-002, a novel ROR1-targeting ADC based on Sortase A-mediated, sitespecific conjugation of a derivative of the highly potent anthracycline PNU-159682 NBE-002 is a highly effective and promising targeted therapeutic for the treatment of ROR1-positive TNBC and other solid tumor indications and is currently in clinical development Understanding how, due to the pronounced immune-modulatory functions of the PNU payload, NBE-002 is particularly well suited for combination therapy with immune checkpoint inhibitors"

Immune Modulation • Inflammation • Oncology • Solid Tumor • Triple Negative Breast Cancer • ROR1

NBE-002-01: NBE-002 in Patients With Advanced Solid Tumors (clinicaltrials.gov) - P1/2; N=100; Recruiting; Sponsor: NBE-Therapeutics AG; Active, not recruiting ➔ Recruiting; Trial completion date: Jul 2023 ➔ Dec 2025; Trial primary completion date: Jul 2023 ➔ Jun 2025

Clinical • Enrollment open • Trial completion date • Trial primary completion date • Breast Cancer • Oncology • Solid Tumor • Triple Negative Breast Cancer

[VIRTUAL] NBE-002: A novel anthracycline-based antibody-drug conjugate (ADC) targeting ROR1 for the treatment of advanced solid tumors—A phase 1/2 clinical trial. (ASCO 2021) - P1/2 | "Ph 1 dose escalation was initiated on 17 JULY 2020 and is still recruiting in the US . Ph 2 is planned to be initiated in 2022."

Clinical • P1/2 data • Breast Cancer • Hematological Disorders • Oncology • Sarcoma • Solid Tumor • Triple Negative Breast Cancer • CD8 • ROR1

NBE-002 in Patients With Advanced Solid Tumors (clinicaltrials.gov) - P1/2; N=100; Active, not recruiting; Sponsor: NBE-Therapeutics AG; Recruiting ➔ Active, not recruiting

Enrollment closed • Breast Cancer • Oncology • Solid Tumor • Triple Negative Breast Cancer

[VIRTUAL] NBE-002, an Anthracycline-Based Immune-Stimulatory Antibody-Drug Conjugates (iADC) Targeting ROR1 for the Treatment of Solid Tumors (PEGS 2021) - "NBE-002 is a highly effective and promising targeted therapeutic for the treatment of ROR1-positive TNBC and other solid tumor indications and is currently in clinical development. Due to the pronounced immune-modulatory functions of the PNU payload, NBE-002 is particularly well suited for combination therapy with immune checkpoint inhibitors."

Immune Modulation • Inflammation • Oncology • Solid Tumor • Triple Negative Breast Cancer • ROR1

Boehringer Ingelheim to Acquire NBE-Therapeutics for EUR 1.18 Billion, Significantly Enhancing Its Cancer Pipeline Portfolio with Novel Antibody-Drug Conjugates (Businesswire) - "Boehringer Ingelheim...announced the signing of a binding agreement for acquiring all shares of NBE-Therapeutics, a private, clinical-stage Swiss biotechnology company focused on antibody-drug conjugates and advancing targeted cancer therapies derived from its immune stimulatory iADC™ platform. NBE-Therapeutics’ lead compound NBE-002 is currently in phase I clinical studies for triple negative breast cancer and other solid tumors....Boehringer Ingelheim gains access to an innovative and unique platform that it will use to build a leading ADC portfolio and develop potential combinations with other assets from its cancer immunology portfolio."

M&A • Oncology • Solid Tumor

NBE-Therapeutics Commences First Clinical Study of Anti-ROR1 Antibody-Drug Conjugate for Patients with Solid Tumors (PRNewswire) - "NBE-Therapeutics...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..."

P1/2 data • Trial status • Breast Cancer • Oncology • Solid Tumor • Triple Negative Breast Cancer

NBE-002 in Patients With Advanced Solid Tumors (clinicaltrials.gov) - P1/2; N=100; Recruiting; Sponsor: NBE-Therapeutics AG; Not yet recruiting ➔ Recruiting

Clinical • Enrollment open • Breast Cancer • Oncology • Sarcoma • Solid Tumor • Triple Negative Breast Cancer

NBE-002 in Patients With Advanced Solid Tumors (clinicaltrials.gov) - P1/2; N=100; Not yet recruiting; Sponsor: NBE-Therapeutics AG

Clinical • New P1/2 trial • Breast Cancer • Oncology • Solid Tumor • Triple Negative Breast Cancer