Intensity Therapeutics, Inc. (NASDAQ: INTS) is a clinical biotechnology company engaged in the discovery development, and commercialization of first-in-class cancer drugs that attenuate tumors with minimal side effects while training the patient’s immune system to fight the disease. The company’s lead product candidate, INT230-6, is currently in human clinical studies to treat refractory solid tumors.

In an interview with AlphaStreet, Intensity’s founder and chief executive officer, Lewis Bender, spoke about the company’s unique approach to cancer treatment and shed light on its drug development program.

How does Intensity Therapeutics’ approach to cancer treatment differ from others, and what benefits does it offer to patients?

Intensity Therapeutics is establishing a new field of localized cancer reduction leading to systemic anti-cancer immune activation. Our new approach involves the direct injection into tumors of a unique product (INT230-6) discovered from our DfuseRxSM platform. Our treatment is designed to remain inside a tumor without spreading to the rest of the body and functions to kill the injected tumor

The challenge with intratumoral treatment is that a tumor’s lipophilic, high-fat, dense, and pressurized microenvironment is incompatible with and does not absorb water-based products. Our platform creates patented anti-cancer product candidates comprising active anti-cancer agents and amphiphilic molecules, making active drug agents soluble in water and fat. Following intratumoral injection, our drug disperses throughout the tumor and diffuses into the cancer cells. The cancer cells die, and the tumor can be killed. The diameter or volume of the tumor sets the dose of our drug for a given tumor. It is unnecessary to inject all the tumors; indeed, tumors less than 1 cm in diameter need not be injected.

Metastatic cancer consists of tumors that are visible by scans and small clumps of cancer cells that are unseen and may even be undetectable. Local killing or surgery is insufficient to extend life in such patients. For cancer that has spread to other parts of the body, a local therapy will unlikely be effective unless the product can somehow attack the unseen metastases. Our product’s two cytotoxic drugs both have direct killing and immune-activating properties. These properties cause a type of cancer cell death, allowing for better recognition by immune cells that can attack the cancer throughout the body. This new drug has a favorable safety profile, and the potent immune response helps control uninjected tumors. No other therapy can debulk large tumors and create a systemic, strong, adaptive immune response. As a result, our drug has shown the ability to keep patients alive longer than expected with favorable safety.

Can you discuss the progress of clinical studies on INT230-6 and share your timeline for its commercial launch?

Intensity has completed two clinical studies that enrolled over 200 patients using INT230-6: a Phase 1/2 dose escalation study in metastatic cancers including sarcomas, and a Phase 2 randomized control clinical trial in locally advanced breast cancer (the INVINCIBLE-2 Study) in women without undergoing chemotherapy prior to their surgery. The company initiated a Phase 3 trial in soft tissue sarcoma (the INVINCIBLE-3 Study), testing INT230-6 as second or third-line monotherapy compared to the standard of care (SOC) with overall survival as an endpoint. Intensity also initiated a Phase 2 study in collaboration with The Swiss Group for Clinical Cancer Research, SAKK (the INVINCIBLE-4 Study) as part of a Phase 2/3 program evaluating INT230-6 followed by the SOC immunochemotherapy and the SOC alone for patients with presurgical triple-negative breast cancer. Pathological complete response is the endpoint. Both studies are recruiting patients. For more information about Intensity, including publications, papers, and posters about its novel approach to cancer therapeutics, visit www.intensitytherapeutics.com.

What are the major challenges you foresee for Intensity Therapeutics in the near term, and how do you plan to address them?

From a technical perspective, it is imperative that investigators in our clinical trials are well-trained to use this new technology. The size of the tumor sets dosing. For current chemotherapy treatments, a cancer patient’s IV or oral dose is set by their height and weight or is a fixed amount – one size fits all. There is no correlation between height/weight and outcome for patients. There is a correlation between outcome and the tumor sizes, number of tumors visible, and number of metastatic sites. With our drug the more tumors injected, the better the outcomes for the patient. So training is essential.

The dosing needle must also be precisely placed into the tumor. As a result, interventional radiologists conduct the treatment. Our treatment schedule is five doses every two weeks. Once set up, treatment with our new drug is regular and efficiently planned. Intensity has developed extensive training software and videos to help physicians get comfortable with the new dosing paradigm.

Can you shed light on the key milestones the company has achieved and how they are driving growth?

As noted above, the company has completed two large clinical studies. The first trial testing INT230-6 was in metastatic disease, and the second in pre-surgical breast cancer. Results have been exciting and presented in oral sessions by our key opinion leaders and medical experts at major oncology conferences such as ASCO, SITC, CTOS, and SABCS. Intensity is now approved for a sarcoma Phase 3 trial by the regulatory agencies in Europe, North American, and Australia. We anticipate completing enrollment by the end of 2025 with data readouts in 2026. Our breast cancer study is being conducted in Europe and is enrolling patients. We expect enrollment to be complete in the breast study with data readout at the end of 2025; however, enrollment in both studies is open-label, which can provide insight into how well our drug is performing compared to the standard of care controls. Both ongoing studies are randomized and controlled.

Please share your views on the future of intratumoral immunotherapy, and your strategy to stay ahead in that area.

Intratumoral delivery has not worked effectively due to the incompatibility of the drug and the tumor. We feel that this problem could only be solved by discovering these amphiphilic molecules that make the water-based drug products miscible in dense fatty tumors. Our phase three study is the first of its kind comparing a local therapy to the best systemic chemotherapy in metastatic disease. Should intratumoral INT230-6 keep patients alive longer with favorable safety, it will be an important milestone in cancer research. This new approach could open a new research window for many solid tumor types.

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