Intensity Therapeutics, Inc. (NASDAQ: INTS) is advancing a novel approach to cancer treatment through localized cancer reduction and systemic anti-cancer immune activation. Their lead product candidate, INT230-6, is currently undergoing human clinical trials for the treatment of refractory solid tumors.
Unique Approach to Cancer Treatment
Intensity Therapeutics' approach involves the direct injection of INT230-6 into tumors. This unique product, derived from their DfuseRxSM platform, is designed to remain within the tumor, effectively killing cancer cells while minimizing systemic side effects and activating the patient's immune system to fight the disease. According to Lewis Bender, Intensity’s founder and CEO, this method aims to "debulk large tumors and create a systemic, strong, adaptive immune response."
The DfuseRxSM platform addresses a key challenge in intratumoral treatment: the incompatibility of water-based drugs with the tumor's lipophilic, high-fat, dense, and pressurized microenvironment. The platform creates patented anti-cancer product candidates comprising active anti-cancer agents and amphiphilic molecules, ensuring the drug disperses throughout the tumor and diffuses into cancer cells, leading to cell death and tumor reduction. The dose of INT230-6 is determined by the tumor's diameter or volume.
Clinical Trial Progress
Intensity Therapeutics has completed two clinical studies involving over 200 patients using INT230-6. These include a Phase 1/2 dose escalation study in metastatic cancers, including sarcomas, and a Phase 2 randomized controlled clinical trial (INVINCIBLE-2) in locally advanced breast cancer. The company has initiated a Phase 3 trial (INVINCIBLE-3) in soft tissue sarcoma, comparing INT230-6 as a second or third-line monotherapy to the standard of care (SOC), with overall survival as the primary endpoint. Additionally, a Phase 2 study (INVINCIBLE-4) in collaboration with The Swiss Group for Clinical Cancer Research (SAKK) is evaluating INT230-6 followed by SOC immunochemotherapy versus SOC alone for patients with presurgical triple-negative breast cancer, using pathological complete response as the endpoint. Both Phase 3 and Phase 2 studies are actively recruiting patients.
Challenges and Milestones
A key challenge for Intensity Therapeutics is ensuring that investigators are well-trained in administering INT230-6. Unlike traditional chemotherapy, where dosing is based on a patient's height and weight, INT230-6 dosing is determined by tumor size. Precise placement of the dosing needle into the tumor, typically performed by interventional radiologists, is crucial. To address this, Intensity has developed extensive training software and videos.
Intensity Therapeutics has achieved significant milestones, including the completion of two large clinical studies. Results from these trials have been presented at major oncology conferences such as ASCO, SITC, CTOS, and SABCS. The company's Phase 3 sarcoma trial has received regulatory approval in Europe, North America, and Australia, with enrollment anticipated to be completed by the end of 2025 and data readouts expected in 2026. Enrollment in the breast cancer study is expected to be completed with data readout at the end of 2025.
Future of Intratumoral Immunotherapy
Intensity Therapeutics believes that the key to effective intratumoral delivery lies in overcoming the incompatibility between traditional drugs and the tumor microenvironment. The company's DfuseRxSM platform, with its amphiphilic molecules, addresses this challenge by creating water-based drug products that are miscible in dense, fatty tumors. The ongoing Phase 3 study, comparing a local therapy to systemic chemotherapy in metastatic disease, could mark a significant advancement in cancer research if INT230-6 demonstrates improved patient survival with a favorable safety profile.
