Partners | Cavion

Overview

Cavion is offering the opportunity to license the first small-molecule Cav3 blocker for the treatment of brain and solid tumors through its novel mechanism of action. Mibefradil is Phase 2 ready for a glioblastoma clinical trial. It has an open IND and drug supply is available. Mibefradil is orphan-designated in glioblastoma, ovary and pancreas cancers. Cavion discovered that the T-type calcium channel (Cav3) is essential for external calcium entry in cancer cells. Inhibition of Cav3 hampers a cancer cell’s ability to repair double-strand DNA breaks and causes cancer cell cycle arrest and apoptosis.

De-risked and safe: First marketed Cav3 blocker for the treatment of hypertension and chronic stable angina. Strong preclinical and clinical data package. Excellent oral bioavailability. Can safely be administered with temozolomide and radiation therapy (completed two Phase 1 glioma trials).
Early sign of clinical efficacy: Two Phase 1b GBM clinical trials completed and strong pre-clinical data in multiple solid tumor models, including breast, pancreas and ovarian cancers.
Phase 2 Ready: Successfully repositioned mibefradil by conducting three clinical trials in four years. IND-open and drug supply available.
Blood Brain Barrier Penetration: Reaches normal human brain and tumor tissues at desired levels to inhibit oncogenic signaling.
Exclusivity: Orphan designated in GBM, ovary and pancreas cancers.
Commercial Opportunity: Forecasted revenues >$1 billion. Short timeframe to registration.

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Resources

Published Papers and Presentations

Timed sequential therapy of the selective T-type calcium channel blocker mibefredil and temozolomide in patients with recurrent high-grade gliomas.
Holdhoff M, Schiff D. et al. Neuro - Oncology. 2017.
Targetable T-type calcium channels drive glioblastoma.
Zhang Y, Abounader R. et al. Cancer Res. 2017
T-type calcium channels blockers as new tools in cancer therapies.
Dziegielewska B, Gray LS, Dziegielewski J. Pflugers Arch. 2014.
A model for the regulation of T-type Ca2+ channels in proliferation: roles in stem cells and cancer.
Gray LS, Schiff D, Macdonald TL. Expert Rev. Anticancer Ther. 2013.

Clinical Trials

Phase 1 Trial in Recurrent GBM at Yale Cancer Center

TAU-2014-1: Mibefradil and Hypofractionated Re-Irradiation Therapy in Recurrent GBM

This Phase 1 trial was based at Yale University and run in partnership with Cavion. This was a dose-escalation study to assess the safety and determine the maximum tolerated dose (MTD) of mibefradil dihydrochloride, a partially selective T-type calcium channel blocker, combined with hypofractionated radiation therapy in subjects with recurrent glioblastoma multiforme (GBM). For more information, please visit the trial page at ClinicalTrials.gov.

Phase 1 Trial in Recurrent Glioma with National Cancer Institute

Mibefradil Dihydrochloride and Temozolomide in Treating Patients With Recurrent Glioma

This Phase 1 study at six Adult Brain Tumor Consortium sites completed enrollment in 2014. Preliminary results were presented at the Annual Society of Clinical Oncology Annual Meeting in Chicago in June 2015. Those results can be viewed here. More information on the trial can be viewed at the trial page at ClinicalTrials.gov.

Safety Study of Mibefradil in Normal Healthy Volunteers

Safety Study of Mibefradil When Given Four Times a Day in Healthy Volunteers

The objective of the study was to determine the safety and pharmacokinetics of a 7-day course of oral mibefradil given four times a day in healthy volunteers. This was a dose escalation study in which the total daily dose of mibefradil was increased with each cohort. More information can be found on the trial page at ClinicalTrials.gov.