Cellestia’s clinical study has started

Cellestia Biotech AG is a clinical-stage biopharmaceutical company developing first-in-class Protein-Protein Interaction (PPI) inhibitors targeting oncogenic transcription factors. The company is developing an integrated diagnostic program for patient selection alongside the clinical development of CB-103.

This study is a combined Phase l - lla clinical trial of CB-103 to establish safety and efficacy in a range of cancer indications, treating patients with advanced or metastasized solid tumors, lymphomas and multiple myeloma. The dose-finding Phase l part of the study will be conducted in Europe and will assess safety, tolerability, pharmacokinetics, pharmacodynamics and will establish the recommended dose for further development. The dose-confirmation Phase lla with expansions in several cancer indications aims to confirm CB-103’s safety profile as well as assessing its clinical efficacy in a range of selected indications. It will be conducted across several EU countries and will also include clinical sites in the US following IND filing, which is anticipated in 2018.

“We are very pleased having reached this important milestone for Cellestia. The start of this trial at very experienced clinical sites in Spain, Switzerland and The Netherlands makes an innovative new anti-cancer drug available to patients, who at present have no access to targeted therapy for the treatment of tumors driven by genetic lesions of the NOTCH pathway,” commented Dr. Dirk Weber, Chief Medical Officer at Cellestia.

Michael Bauer, Chief Executive Officer at Cellestia, added: “Cellestia’s lead compound CB-103 is the first anti-cancer drug that can control NOTCH-driven cancers regardless of the molecular mechanism of NOTCH pathway activation, which is significant due to the wide range of genetic aberrations that can lead to such oncogenic activation. Controlling this selectively at the level of gene transcription is a major breakthrough in targeting this complex cause of cancer. Equally important is the biomarker diagnostic program, which is also well established and is already integrated in this Phase 1 trial.”

About CB-103
CB-103 is a new mode of action, highly potent small molecule protein-protein interaction inhibitor, which is selectively blocking gene transcription of oncogenic target genes triggered by NOTCH pathway activation. Blocking the NOTCH signalling pathway activation in its most downstream part at gene transcription level, by disrupting the NOTCH transcription complex, CB-103 effectively controls the disease as demonstrated in a range of in vitro and in vivo experiments. CB-103 is being developed for oral administration. The compound has excellent drug-like properties, is rapidly absorbed and well distributes into tissue. CB-103 has demonstrated excellent tolerability and efficacy in vitro, in vivo and ex-vivo in blood from leukemia patients, demonstrating clear disease control combined with excellent safety profile. Most importantly, CB-103 does not show the typical toxicities related with gamma secretase inhibitors or receptor/ligand targeting antibodies, due to the distinctly different new Mode of Action.

(Press release)