In 2021, it is expected that approximately 609,000 Americans will die of cancer. Cancer is the second most common cause of death in the U.S. after heart disease. Compared to the economic impact of premature death and disability of all causes of death, cancer has the greatest cost worldwide.

As a person’s cells accumulate mutations due to a combination of genetic, epigenetic and environmental factors, rapid cell growth can occur.  If the immune system is unable to recognize and kill those mutated cells, tumors can begin to form.  When those tumors reach a certain size, they can shed cells that spread throughout the body. Left undetected, those cells grow and soon the person has late-stage cancer consisting of large, well-defined tumors and small unseen groups of cells or micro-metastases. These metastases can exist either in the blood or body tissue.  As such, cancer is both a regional and systemic disease. To be effective against such a difficult disease, a treatment must destroy both the visible tumors as well as the unseen metastases.

A combination of local treatment (surgery, radiation, ablation) coupled with systemic chemo-targeted or immune regulating therapies given orally or intravenously (IV) are the most common methods to treat cancer today. Unfortunately, in later disease these therapies have only a small effect on outcomes for the majority of cancer patients (Morgan Clinical Oncology (R Coll Radiol) 2004 Dec;16(8):549-60). The lack of therapeutic efficacy for systemically administered drugs may be due in large part to the low levels of drug reaching the tumor sites.  In addition, once the drug arrives at the site of the tumor, it may not be able to reach all of the cancer cells. Systemic drug concentrations are generally insufficient for tumor destruction if a patient has several large, visible lesions. Immunotherapy has recently shown great promise in improving outcomes in certain cancers. These drugs stimulate or release restrictions on the body’s immune cells.  The problem with immunotherapy is recognition of the cancer by the immune cells and cloaking by the cancer.  As a result, immunotherapies have limitations. Immunotherapeutic agents only show benefit in a small subset of cancer patients and there are typically immune-related toxicities associated with treatment as the immune system often attacks healthy cells in addition to the cancer. Even with positive treatment outcomes, whether surgical, radiation, ablation, chemotherapy, immune-based or combinations of these techniques, the current local procedures remain highly invasive, and the systemic methods have severe side effects that damage the body and are demanding on the patient. If cancer is detected late, most treatments are highly toxic, and few provide patients with much hope of long-term survival.

INT230-6 is a multi-agent (more than one medication co-formulated together) product specifically designed to be directly injected into tumors. The first two compounds, cisplatin and vinblastine sulfate, are highly potent, FDA-approved agents that are normally dosed intravenously during chemotherapy and are used to treat several types of cancer. The third ingredient comprising INT230-6 is a unique tumor diffusing amphiphilic penetration enhancer molecule. This compound allows the first two ingredients to disperse throughout the tumor and move directly into the cancer cells.

INT230-6 is injected directly into the tumor(s).  Multiple tumors can be treated in one session.  Any type of tumor accessible by a needle could potentially be treated with INT230-6.  Participants in our Phase 1/2 clinical study are dosed every two weeks for a total of 5 treatments over approximately 2 months.   Retreatment is possible pending results of the first 5 doses.  Fourteen different cancer types have been treated to date, including adenoid cystic, adrenal cortical carcinoma, bile duct, breast cancer, colon cancer, chordoma, head and neck, liver metastases, lymphoma, melanoma, ovarian cancer, pancreatic cancer, squamous cell carcinoma, sarcoma, and thyroid cancer.

We are pioneering a new approach to treat solid tumor cancers. Our approach addresses both the regional and systemic aspects of cancer. The Company’s DfuseRxSM platform technology can rapidly identify a tissue dispersion and cell penetrating anti-cancer formulation for a given tumor type. Intensity’s technology approach creates a product with sufficient potency to destroy a patient’s primary tumors and train the immune system to hunt and kill metastases. Intensity’s products consist of proven, potent therapeutic agents formulated with specially matched, cell-penetration enhancing and tumor tissue dispersing molecules. The objective of this approach is to thoroughly transport the drug throughout the tumor and greatly increase intracellular concentrations of these potent drugs inside the cancer cells. The tumors die with the attenuated cancer cells, then act as sites that elicit a strong adaptive immune response specifically against the mutated cells.

In vivo  data generated to-date indicates that our therapeutic candidate, INT230-6, can effectively kill cancer cells, completely regress large tumors from baseline, greatly extend life and immunize the subjects against tumor recurrence. Our products achieve these efficacy benefits without the systemic toxicity associated with intravenous or oral drug administration. We developed the DfuseRxSM platform to identify effective formulations that consist of cell penetration enhancers matched with potent anti-cancer agents. Our technology can rapidly identify effective products to treat a given cancer type.