Using Modern Imaging Technology

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With new, proprietary drug products

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To precisely treat late stage and metastatic cancer

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and to stimulate a natural, adaptive immune response.

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Intensity Therapeutics is creating a new, highly effective cancer treatment - in situ vaccination.

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Our Technology

 

About Cancer
In 2016, nearly 600,000 Americans died 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. These findings were recently published in a report from the American Cancer Society and the LIVESTRONG organization.  As healthcare costs in general continue to escalate, expenses due to cancer are a major contributing factor.  The most urgent need is the treatment of solid tumors that have progressed; ninety percent (90%) of cancer patient deaths are due to solid tumors.   

Treatment of Late Stage Cancer is often ineffective
Cancer originates from a person’s own cells and their immune system usually is not able to recognize the cancer.  As a result, tumors can begin to grow uncontrollably.  Late stage cancer consists of large well-defined tumors and small unseen groups of cells or micro-metastases that have been shed from the tumors.  These metastases can exist either in the blood or body tissue.  Cancer is thus both a regional and a systemic disease.  To be effective a treatment must destroy both the existing tumors as well as the unseen micrometastases.  However, tumors often thwart the immune system using a variety of processes.   The great challenge today is to find a treatment method that can effectively defeat both the large tumors as well as track down and kill the unseen micrometastases.

Most drug therapies are systemic given via oral or intravenous (IV) administration.  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 there is often poor mass transfer of the drug into the cancer cells. This results in drug concentrations that most often are insufficient for destruction of the large visible tumors.  

Even with good treatment outcomes, whether surgical, chemical, radiation or ablation methods, 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 Proprietary Approach - DfuseRxSM
Intensity Therapeutics, Inc. is pioneering a new approach to treat solid tumor cancer using its DfuseRxSM platform technology. Our Company’s treatment 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 drug agents formulated with a specially-matched, cell-penetration enhancing and tumor tissue dispersing molecule. The objective of the approach is to thoroughly transport the drug throughout the tumor and greatly increase intracellular concentrations of the 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 (mouse) data generated indicates that our patent pending products and methods (owned solely by Intensity Therapeutics) 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.

Our In Vivo Results – Lead Product INT230-6
Using mouse models of severe, late-stage pancreatic, breast and colon cancers, the Company demonstrated that the new formulations including INT230-6, our lead product, given intratumorally were highly effective with less observed toxicity than intravenous (IV) dosing of the same drugs.

INT230-6 completely regressed large tumors in animals treated.  For example, INT230-was able to clear completely Colon26 tumors greater than 300mm3   In one study using this tumor type INT230-6 increased median overall survival of animals from 16 days with no treatment to 77 days using one 5-day cycle at a dose that is scalable to humans.  Median survival using the product was also superior to the best drugs given systemically; 42 days vs. 77 days at comparable dose.  Our studies also showed that INT230-6 induces a strong adaptive immune response.  Ninety percent (90%) of the animals having the complete response were fully protected against developing the same cancer following either subcutaneous or intravenous re-inoculation of the same cancer - a response that lasted the entire life of the animal.  In addition, in mice INT230-6 also inhibited the growth of murine breast cancer and reduced the formation of breast cancer metastases.

 

Regulatory Efforts
In November 2016, the Company submitted an Investigator’s new drug application (IND) dossier to FDA for the Company’s lead drug product, INT230-6. The IND package included a clinical trial protocol (IT-01).. FDA provided Intensity Therapeutics with a Study May Proceed authorization letter in December 2016. The Company also filed a Clinical Trial Application (CTA) to Health Canada. Health Canada accepted the CTA and provided the company a No Objection Letter (NOL) to start clinical testing early in January 2017. Thus international study IT-01 is now recruiting patients in the US and Canada.


Intellectual Property
Our patent counsel conducted patentability research.  There were no issues identified to prevent a patent.  Our counsel also provided a freedom to operate opinion; the results of which were quite favorable. Accordingly, we filed provisional patent applications which were converted to PCT/non-PCT patent applications designating the U.S. and several foreign countries.  Our first patent related milestone occurred when the US patent and trademarks office issued the Company its first patent (number US 9,351,997) in May of 2016.  Additional US patents are still in prosecution.  While a few foreign countries have issued the Company a patent, we are awaiting action by several patent offices around the world.  The Company filed patent applications in all important markets and countries including BRIC.

 

Papers & Publications

 

Poster presented at NCI Cancer Conference

 

 

 

 

 

Contact Us


Intensity Therapeutics, Inc.
61 Wilton Road, 3rd Floor
Westport, CT 06880


Tel. (203) 221-7377
Fax (203) 664-1051


info@intensitytherapeutics.com

 

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Who we are


Intensity Therapeutics is a clinical development stage company.  We are seeking partnerships/investors interested in advancing the company’s anti-cancer platform technology and lead product INT230-6.

 

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