New Treatment Concept

The Problem: 

In 2020, it is expected that over 610,000 Americans will die of cancer. Cancer is the second most common cause of death in the US 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 environmental and genetic 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.  Cancer is thus 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.

Today’s best treatment approaches are inadequate for later stage disease

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 at the tumor the drug may not be able to reach all the cancer cells in a tumor. Systemic drug concentrations most often are insufficient for tumor destruction if a patient has several large, visible lesions.

Immunotherapy has recently shown great promise to improve outcomes in certain cancers. These drugs stimulate or release restrictions on the body’s immune cells.  The problem with the approach is recognition of the cancer by the immune cells.  As a result, immunotherapies have limitations. These agents only show benefit in a small subset of cancer patients and there are toxicities as the immune often attacks healthy cells.

Even with good treatment outcomes, whether surgical, chemical, radiation, ablation methods, or immune-based these techniques remain invasive, have severe side effects that damage the body and are demanding on the patient. The reality today is that if cancer is detected late, most treatments are highly toxic and few provide patients with much hope of long term survival.

Our Solution

  • Using our novel technology, Intensity discovered a cytotoxic drug (INT230-6) that when injected directly into tumors disperses throughout the tumor, remains in the tumor and kills the tumor.
  • Cancer cells need to absorb nutrients at a high rate to grow and a cancer cell membrane is more fluid than those of normal tissue.  A cancer cell will absorb our amphiphilic formulation more readily than a healthy cell. We take advantage of the tumor’s need to feed to destroy it.
  • When injected tumors die, the cancer becomes recognizable to the immune system.  Essentially the soft manner by which the tumor dies convert a patient’s own tumor into a personalized vaccine with high quality antigen.
  • Once recognition is improved, there can be a whole-body attack against the cancer.
  • Our research, which was published in collaboration with the National Cancer Institute, has shown that the immune response is amplified significantly when Intensity’s drugs are dosed in combination with immunotherapies such as anti-PD-1 and anti-CTLA-4 antibodies.
  • The normal immunotherapy stimulation and attack on healthy cells may be reduced when dosed in combination with INT230-6 .
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