NOTCH signalling is a developmental pathway known to play crucial roles in regulating cell fate, cell growth and maintenance. Aberrant activation of this pathway leads to aggressive forms of cancers, such as T-cell acute lymphoblastic leukaemia (T-ALL), and others. Currently, an estimated 250,000 people are afflicted by NOTCH-dependent cancers every year with no targeted effective targeted therapy. For these patients, current treatments are associated with poor survival rates, off-target toxicity, painful side effects and high costs of therapy. With no alternative therapies available, patients, especially those with Relapsed/Refractory (R/R) T-ALL have very low remission rates and a poor quality of life.
Cellestia Biotech AG (Cellestia) was founded in 2014 as a spin-off from Ecole Polytechnique Fédérale de Lausanne, Switzerland (EPFL). The company is actively engaged in clinical development of first-in-class targeted therapeutics with untapped mode of action, to address unmet medical need in patients with oncology and immunological disorders. Their mission is to develop the CB-103, a novel, first-in-class, oral pan-NOTCH inhibitor with a unique mode of action for treatment of NOTCH dependent leukaemia, lymphomas and solid tumours. The team is currently working towards establishing clinical safety and efficacy of the drug through phase Ib and phase IIa clinical trials. The key development and commercialisation objectives are to manufacture CB-103 for clinical trials, to successfully perform phase Ia and phase IIb clinical trials and then out-license further stages of pivotal trials and EMA/FDA approval to partner pharma companies. Cellestia undertook the feasibility study to determine whether the precision oncology solution and business model were scalable, cost-effective and profitable, and to identify any strengths and weaknesses moving forward.
