Intensity Therapeutics, Inc. is a clinical-stage biotechnology company applying scientific leadership in the field of localized cancer reduction leading to anti-cancer immune activation. The company’s approach involves the direct injection into tumors of a unique product created from its DfuseRx℠ discovery platform.
Valuation/risk: According to Stifel, Phase 3 valuations are up 33% since the biotech index peaked in December 2021. All other phases have yet to recover peak valuations. Average EVs for Stage 3 was $1.03 billion in June 2023. As such, INTS’s EV of $65 million is likely to get re-rated much higher as it enters Phase 3 in the coming months, especially considering recent positive data published in early December. INTS is a speculative investment with a lot of promise.
The concept of intratumoral treatment (IT) has been an objective of clinicians since the first discovery of chemotherapeutic agents. This means keeping the drug in the tumor and sparing the body of toxicity. The challenge with IT treatment approaches is that a tumor’s lipophilic, high fat and pressurized microenvironment is incompatible with and does not absorb water-based products. The company believes that intratumoral drug delivery is a chemistry challenge and that prior or current IT treatments have formulated their product without consideration of the incompatibility of water and tumors. Another issue with IT or local delivery has been that metastatic cancer is a whole body disease.
Local treatments need a systemic component to be effective for a survival benefit. Accordingly, there remains a continued unmet need for the development of direct IT therapies for solid tumors that provide high local killing efficacy coupled with nontoxic systemic anti-cancer effects. The company believes it has created such a product candidate with the necessary chemistry to overcome this local delivery challenge and a mechanism of action that induces a systemic effect.
Clinical and nonclinical evidence shows that the drug candidate’s mechanism of tumor killing also leads to immune activation in certain cancers. The company’s platform creates patented anti-cancer product candidates comprising active anti-cancer agents and amphiphilic molecules. Amphiphilic molecules have two distinct components: one part is soluble in water and the other is soluble in fat or oils. When certain amphiphilic compounds are mixed with therapeutic agents, such as chemotherapies, the agents can also become soluble in both fat and water. Product candidates include novel formulations consisting of potent anti-cancer drugs mixed together with these amphiphilic agents.
INTS’s lead product candidate, INT230-6, consists of two proven anti-cancer cytotoxic agents, cisplatin and vinblastine sulfate, mixed with the amphiphilic molecule (SHAO)— all in one vial. The anti-cancer agents, cisplatin and vinblastine sulfate, used in its product candidate are both generic and are available to purchase in bulk supply commercially. In 2017, the company initiated a Phase 1/2 dose escalation study using INT230-6 in the United States under an investigational new drug application (“IND”) authorized by the FDA and in Canada following receipt of a no objection letter from Health Canada. The study, IT-01, explored the safety and efficacy of INT230-6 in patients with refractory or metastatic cancers. Complete enrollment of study IT-01 occurred in June 2022 and locked the IT-01 database in February 2023 and finalized the clinical study report in September 2023.
The IT-01 trial dosed 110 patients. This clinical trial used its lead product candidate INT230-6 alone; in combination with Merck’s Keytruda® (pembrolizumab) for patients with advanced solid malignancies including pancreatic, bile duct, squamous cell, and non-MSI high colon cancers; and in combination with Bristol Myers Squibb’sYervoy® (ipilimumab) for patients with breast cancer, liver cancer, and advanced sarcoma. In the third quarter of 2023 the completed the clinical study reports (CSR) for the IT-01 trial.
INTS’s second clinical trial (the INVINCIBLE Study or IT-02) tested INT230-6 in early stage breast cancer for patients not suitable for presurgical chemotherapy. The study enrolled 91 subjects and is now complete. This clinical trial was a Phase 2 randomized, window of opportunity for patients who were ineligible or chose not to have presurgical chemotherapy. The key endpoint was whether INT230-6 could reduce patient’s cancer by 50% to 100% defined as a major pathological response compared to no treatment (the current standard of care) or a saline injection and stimulate a systemic anti-cancer immune response prior to surgery. Substantial reduction of cancer presurgically in aggressive forms of cancer has been shown to correlate with delaying disease recurrence.
Other endpoints of the INVINCIBLE study were to understand the percentage of necrosis that can be achieved in tumors especially tumors larger than 2 cm in longest diameter and whether either a local or whole body anti-cancer immune response could be induced.
Results:
- INT230-6 demonstrated a systemic increase in the median diversity of T-cell repertoire in patients’ blood compared to baseline that was also much larger than a control saline injection;
- A single injection of INT230-6 can induce up to >95% necrosis of a tumor;
- INT230-6 demonstrated an increase in CD4 T-cells and NK cells within tumors;
- Gene expression profiling revealed treatment effect of up-regulation of immune pathways expressed by T-cell activation, lymphocyte activation and inflammatory responses;
- INT230-6 demonstrated a favorable safety profile and was well tolerated;
- Patient interest in the new treatment was high.
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