Vivace Therapeutics, Inc., a small molecule discovery and development company developing first-in-class therapies targeting the Hippo pathway, announced today the completion of enrollment of the first cohort of patients being treated with VT3989 in its Phase 1 clinical study. The Company anticipates enrolling the next higher dose cohort in the second part of May.
The VT3989 Phase 1 study is now open at centers in both the US and Australia to evaluate the safety, tolerability, PK and biological activity of VT3989 in patients with refractory metastatic solid tumors, including refractory pleural malignant mesothelioma. The study is currently in dose escalation, to be followed by a dose expansion phase in which patients with NF2 mutant tumors will be enrolled after an optimal dose is determined. “To the best of our knowledge, we are the first company to test a small molecule in the clinic targeting this important pathway. Our preclinical work has shown that tumors with NF2 mutations are quite sensitive to VT3989, especially NF2-deficient mesothelioma,” said Leonard Post, Ph.D., Chief Scientific Officer of Vivace Therapeutics.
“The Phase 1 clinical study is designed to test the translatability of our preclinical observations in cancer patients as quickly as possible. We are enrolling patients with a variety of signaling abnormalities during dose escalation and will allow NF2-mutated patients to backfill any previously cleared dose cohorts. In addition, our study design allows for intra-patient dose escalation so that patients who are tolerating VT3989 at a given dose may increase to the highest well-tolerated dose,” said Andrew Dorr, M.D., Chief Medical Officer of Vivace Therapeutics.
The Company has filed patent applications across a diverse set of chemotypes, all of which inhibit palmitoylation of members of the transcriptional enhanced associate domain (TEAD) protein family. The latest publication from Vivace Therapeutics titled “Small Molecule Inhibitors of TEAD Auto-palmitoylation Selectively Inhibit Proliferation and Tumor Growth of NF2-deficient Mesothelioma” in Molecule Cancer Therapeutics presented some of the preclinical work done by the company.