INNOVOTEX is catalyzing a fundamental shift in oncology drug development. Leveraging our proprietary platform and a differentiated therapeutic strategy, we are positioned to deliver safer, more effective cancer treatments with faster clinical validation.
Our lead candidate, NOVO-111, is advancing rapidly toward the clinic, supported by compelling new peer-reviewed data published in Molecular Pharmacology (Oct 2025). The data will be further discussed at upcoming conferences including an oral presentation at AACR 2026.
In colorectal cancer models, NOVO-111 achieved superior tumor growth inhibition compared to standard of care oxaliplatin while maintaining an improved safety profile. Pharmacokinetic and biodistribution studies confirmed selective and sustained tumor accumulation, with up to fivefold higher platinum retention in tumors. NOVO-111 demonstrated prolonged systemic exposure, mechanistic activation of the p53/p21 pathway, and no additional toxicity at efficacious doses.
Based on current data and regulatory precedent, NOVO-111 may qualify for the FDA 505(b)(2) accelerated development pathway, offering a potentially faster and more capital-efficient route to first-in-human studies and early proof-of-mechanism.
This newly published research and supporting data package further substantiates our approach and underscores INNOVOTEX’s potential to unlock meaningful breakthroughs for patients and investors alike.
Key Data Highlights from our newest peer reviewed publication:
NOVO-111 is a first-in-class macrocycle–platinum(IV) prodrug therapy — a “precision-engineered” platinum designed to selectively home to tumors and activate oxaliplatin within cancer cells. By harnessing redox-driven tumor targeting, NOVO-111 possesses unique rationally designed features that make it one of a kind. These include:
Feature
NOVO-111 Advantage
Tumor Uptake
5× higher vs. oxaliplatin
Half-Life
Enhanced exposure of free NOVO-111 at 11.4 hours
Efficacy
Superior tumor growth inhibition at equivalent tolerability
Safety
Improved systemic profile; preferential tumor delivery
Mechanism
Precision activation of the p53/p21 tumor-suppressor axis
Target Indication 80% of solid tumors that suffer from tumor antigen heterogeneity
Clinical relevance: sustained tumor exposure, improved safety window, and potential benefit in patients with limited options — including oxaliplatin-resistant disease.
“NOVO-111 represents the next phase in the evolution of platinum-based therapy. It was designed to deliver the potency of oxaliplatin while minimizing its systemic toxicity and it is meeting these expectations. INNOVOTEX’S macrocycle enables a level of tumor selectivity that should significantly broaden the therapeutic index for patients with advanced colorectal and other solid tumors.”
— Dr. Zahid H. Siddik, Co-Inventor of NOVO-111, Scientific Advisory Board Member at INNOVOTEX, Inc. and Professor of Medicine at MD Anderson Cancer Center
Near-Term Milestones
AACR 2026 – Oral Data Presentation
IND-enabling studies in progress
Phase I data within 9 months
About INNOVOTEX Therapeutics
INNOVOTEX is pioneering macrocyclic drug conjugates, a new class of precision based agents engineered for tumor selectivity, reduced toxicity, and the ability to overcome resistance. Our macrocycle platform represents a new frontier in targeted therapeutics.