Cancer cells need to absorb nutrients at a high rate to grow, and a cancer cell membrane is more fluid than the cell membrane of normal tissue.
INT230-6 is a formulation consisting of our proprietary amphiphilic cell penetration enhancer molecule, 8-((2-hydroxybenzoyl)amino)octanoate, also referred to as SHAO, combined with cisplatin and vinblastine. The penetration enhancer facilitates dispersion of the two drugs throughout injected tumors and enables increased diffusion into cancer cells. Nonclinical safety studies showed no evidence of drug penetrating healthy tissue.
INT230-6 is currently being studied in multiple phase 2 clinical cohorts to treat several types of metastatic cancers in the U.S. and Canada. Our drug is also being studied in presurgical breast cancer patients in Canada in the INVINCIBLE phase 2 randomized controlled trial.
Due to the use of a novel cell penetration enhancing agent, INT230-6 treatment has demonstrated promising efficacy in animals having large tumors, as well as clinical benefit in humans. Our in vivo data show that INT230-6 thoroughly saturates and kills injected tumors. In addition, the drug induces an adaptive (T cell mediated) immune response that attacks not only the injected tumor, but non-injected tumors and unseen micro-metastases. Cured animals become permanently immunized against the type of cancer that INT230-6 eliminated. INT230-6 has shown long-term stability when stored properly. The drug is currently being studied in a Phase 1/2 clinical trial being conducted in the U.S. and Canada.
Traditionally, physicians administer the two active drugs comprising INT230-6 by intravenous (IV) infusion to achieve a systemic blood level at the limit of tolerability. Unfortunately, dosing drugs intravenously delivers only a small amount, with a low concentration at the tumor site. This approach, especially for late-stage cancers, is largely ineffective and often extremely toxic to the patient. Past attempts at direct intratumoral injection with chemotherapeutic agents have not demonstrated the ability to treat the injected tumor, non-injected tumors or micro-metastases. This lack of efficacy for local administration may be due to poor drug dispersion and a lack of cell uptake of the anti-cancer agents. Intensity has solved the problem of dispersion and absorption by adding a novel, tissue dispersing and cell penetrating molecule to its proprietary formulation.