Oncology Programs
We have two oncology compounds, rhIGFBP-3 and INSM-18, in development. Both hold promise for the potential treatment for a variety of cancers. Preclinical models show that one or both treatments interact with the IGF-1 system to reduce tumor growth in models of breast, prostate, lung, colorectal and head and neck cancers.
rhIGFBP-3 is a protein that binds insulin-like growth factor (IGF) and has demonstrated preclinical efficacy in numerous cancer indications, including breast, prostate, liver, lung and colon. Additionally, several lines of recent evidence, from various cell systems, have suggested that rhIGFBP-3 may play a more active, IGF-1-independent role in growth regulation of cancer cells, binding specifically with high affinity to the surface of various cell types and directly inhibiting monolayer growth of these cells in an IGF-1-independent manner. Recent independent studies have demonstrated that when IGFBP-3 is used in combination with other cancer therapies it can accentuate and even synergize the efficacy of standard cancer therapies.
Our open-label, dose-escalation Phase I study designed to evaluate the safety, tolerability and pharmacokinetics of a single intravenous dose of rhIGFBP-3 is now complete and we are currently collecting and analyzing the data to determine the appropriate dose of rhIGFBP-3 for planned Phase II clinical trials.
INSM-18 is an orally available, small molecule, tyrosine kinase inhibitor. It has demonstrated dual inhibition of the IGF-1 and HER2 receptor - linked tyrosine kinase. Two single-dose Phase I clinical studies in healthy volunteers have been previously completed with this drug candidate. In both studies, the drug was safe and well-tolerated. Additionally, a dose-escalation Phase I-II clinical study designed to define the maximum tolerated dose of INSM-18 in patients with relapsed prostate cancer has been completed at the University of California, San Francisco. This study consisted of a 28-day treatment period at each dose level to investigate the effect of INSM-18 on levels of prostate specific antigen (PSA). An analysis of the data collected from the study is currently being conducted, and the results will be used to design further Phase II clinical studies.
