First Patient Dosed in Intensity Therapeutics' Global Phase 3 Study for Metastatic Soft Tissue Sarcoma

Intensity Therapeutics, Inc., a clinical-stage biotechnology firm, has commenced the dosing of its first U.S. patient in a Phase 3 clinical trial. This trial aims to assess the efficacy and safety of their leading product, INT230-6, as a monotherapy against standard systemic chemotherapy in treating metastatic sarcoma. The trial, registered under NCT06263231, targets patients with second or third-line metastatic, recurrent, or inoperable soft tissue sarcomas (STS).

The Phase 3 trial is a global study intended to include around 333 patients, with the primary goal being overall survival. The trial design assigns two out of every three participants to receive INT230-6, while the remaining one-third will be given standard chemotherapy. The STS subtypes included in the study are leiomyosarcoma, liposarcoma, and undifferentiated pleomorphic sarcoma. This trial builds on encouraging data from Intensity's earlier Phase 1/2 trials, where INT230-6 demonstrated significant tumor-killing and immune-activating properties, contributing to enhanced survival rates in metastatic conditions.

Lewis H. Bender, the Founder, Chairman, and CEO of Intensity Therapeutics, expressed optimism about this milestone, stating that the company has also filed regulatory documents to extend the trial to Canada and Europe. Over the upcoming months, they expect to initiate trial sites in eight countries. Bender emphasized the pressing need for better treatment options for sarcoma, a cancer with a median overall survival of only 10 to 15 months following second and third-line therapies. He highlighted that in Phase 1/2 studies, INT230-6 alone achieved a median overall survival of 21.3 months in a sarcoma population that had undergone a median of three prior therapy lines.

INT230-6 is Intensity's flagship investigational product, engineered for direct intratumoral injection. Discovered through the company's DfuseRx℠ technology platform, INT230-6 combines two potent anti-cancer drugs, cisplatin and vinblastine, with a unique penetration enhancer molecule known as SHAO. This formulation aids in the local dispersion of cytotoxic drugs throughout the tumor, allowing for effective diffusion into cancer cells. The drugs remain primarily within the tumor, ensuring a favorable safety profile. Notably, INT230-6 not only controls local disease and kills the tumor directly but also releases neoantigens that engage the immune system, triggering systemic anti-cancer effects without causing immunosuppression, a common issue with conventional chemotherapy.

Soft tissue sarcoma, a rare form of cancer originating in the body's soft tissues like muscles, fat, and blood vessels, predominantly affects the limbs and abdomen. There are approximately 197,000 sarcoma patients in the U.S., with over 50 different types of soft tissue sarcomas. Treatment usually begins with surgery, followed by radiation and chemotherapy. According to U.S. SEER database estimates, 14,337 patients have regional or metastatic leiomyosarcoma, liposarcoma, and undifferentiated pleomorphic sarcoma.

Intensity Therapeutics has proven the potential of INT230-6 through multiple clinical trials, including Phase 1/2 dose escalation and Phase 2 randomized control trials. The recently initiated Phase 3 trial in soft tissue sarcoma aims to establish INT230-6 as a viable monotherapy for second or third-line treatments, with overall survival as the primary endpoint. Additionally, the company plans to explore INT230-6 in a Phase 2/3 program for presurgical triple-negative breast cancer, in combination with the standard of care.