Program overview
Novel Antimicrotubule Agent
Similar mechanism of action to taxanes, but effective in taxane-resistant cancers
Celgene's Abraxane (nab-paclitaxel)
Currently used in 50% of pancreatic cancer patients
Expected to generate $2.2B annually in sales by 2020
Taxol (paclitaxel)
Taxotere (docetaxel)
Jevtana (cabazitaxel)
Despite impressive efficacy relative to taxanes, the epothilone class drugs have stalled clinically due to toxicity
IT-147 significantly reduces the toxicity of epothilone D
Epothilone D (KOS-862), originally developed by Kosan and Roche, previously completed Phase 2 trials in colorectal, metastatic breast, and non-small cell lung cancers, but development was halted
IT-147 uses Intezyne's nanoparticle platform (IVECT) to administer up to 4x more epothilone D safely, resulting in significantly better anti-tumor efficacy in established preclinical models
IT-147 Preclinical Data
About Breast Cancer
Most prevalent cancer in the U.S., representing 15% of new cancer cases
First-line therapy is typically taxanes
225,000 patients diagnosed annually; 40,000 deaths annually
10-20% of patients are triple negative breast cancer patients
Triple negative breast cancer is generally more aggressive
34% recurrence rate within 3 years
Potentially eligible for both Breakthrough Therapy and Orphan Drug Designations (triple negative breast cancer)
IT-147 Development Rationale
The epothilone class has demonstrated efficacy in treating taxane-resistant cancers
Both epothilone B and epothilone D were halted in clinical development due to safety challenges, specifically neuropathy, despite showing promising efficacy
In preclinical models, IT-147 delivered more (10x) epothilone D safely, significantly widening the therapeutic window
IT-147 could provide a compelling therapeutic alternative to patients with taxane-resistant cancers, with downstream potential as front-line therapy, driven in part by the increasing prevalence of taxane resistance