Cellestia enters clinical development for its lead compound

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14.08.2017
clinical trial

Cellestia announced today the full approval of clinical trial application for CB-103 Phase I-lla first-inhuman clinical trial in patients with advanced solid cancers and haematological malignancies. CB-103 is a new mode of action anticancer drug.

Dirk Weber, Chief Medical Officer of Cellestia stated: “Patients with advanced solid tumours and haematological malignancies which are functionally driven by activated NOTCH signalling generally have a poor survival prognosis. There are no approved NOTCH targeting agents on the market for this well-defined patient group. With CB-103, Cellestia is addressing a highly unmet medical need and we are delighted making a new therapeutic option available to patients.” Michael Bauer, Chief Executive Officer of Cellestia added: “Reaching clinical development stage is a major milestone for Cellestia. Integrating development of our new mode of action therapeutic with a dedicated biomarker program for patients’ selection represents the start of a new era in treatment of NOTCH positive cancers.”

CB-103 is a first-in-class oral pan-NOTCH inhibitor with a novel mode of action selectively blocking gene transcription related to NOTCH pathway activation. The trial has been approved by Competent Authority and Ethics Committee in Spain.

Cellestia Biotech AG is a privately owned pharmaceutical company with strategic focus on targeted small molecule anti-cancer drugs modulating the NOTCH pathway by a novel mode of action. Cellestia has developed a discovery platform for compounds targeting the NOTCH signalling pathway selectively at the level of the NOTCH transcription complex. The most advanced program, CB-103, is a novel, oral pan-NOTCH inhibitor with unique new mode of action, indicated for treatment of NOTCH dependent leukemias, lymphomas and solid tumors. CB-103 has achieved proof of concept in various xenograft and patient-derived tumor models of NOTCH driven human cancers.

This Phase I - IIa study of CB-103 is a first-in-human, open-label study investigating the safety, tolerability, pharmacokinetics, pharmacodynamics, biomarker profile and preliminary efficacy of the pan-NOTCH inhibitor CB-103 in adult patients with advanced or metastatic solid tumors and haematological malignancies. Primary objective of the Phase I part is to determine the maximum tolerated dose (MTD) or recommended Phase II dose (RP2D). Purpose of the Phase IIa Part is to confirm safety, and determine single agent preliminary efficacy in a range of different NOTCH-driven cancer indications.

Comprehensive biomarker profiles will be investigated throughout the study, in the Phase IIa part, only patients confirmed for NOTCH positive cancers will be enrolled.

(Press release)

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