Intensity Therapeutics Announces First Patient Dosed in its Global Randomized, Phase 3 Study in Metastatic Soft Tissue Sarcoma

Intensity Therapeutics, Inc. recently announced the first US patient has been dosed in its Phase 3 study to treat metastatic sarcoma (NCT06263231). The trial is a superiority study testing INT230-6 as monotherapy compared to the investigator’s choice of three current standard-of-care systemic chemotherapy drugs in second or third-line metastatic, recurrent, or inoperable soft tissue sarcomas (STS).

The global Phase 3 study is expected to enroll approximately 333 patients. The primary endpoint is overall survival. For every three patients treated, two will receive INT230-6, and one will receive the standard of care. STS subtypes being enrolled are leiomyosarcoma, liposarcoma, and undifferentiated pleomorphic sarcoma.  The Phase 3 initiation follows reported data from the company’s Phase 1/2 trial, where INT230-6 showed tumor-killing and immune-activating properties with increased survival in metastatic disease.

“We have now dosed our first patient in the U.S. and have filed regulatory documents to initiate this trial in Canada and Europe.  Over the next several months, we anticipate initiating sites in eight countries.  Sarcoma is a deadly cancer with a median overall survival following second and third-line drug treatments of between 10 and 15 months,” said Intensity Therapeutics’ Founder, Chairman, and CEO, Lewis H. Bender. “During our Phase 1/2 metastatic dose escalation study, in a sarcoma population that had progressed following a median of 3 lines of therapy, we reported a median overall survival of 21.3 months with our drug alone. Patients, their caregivers, and physicians worldwide desperately need improved treatment options and we are excited to have finally begun testing our new approach in Phase 3. I want to take this opportunity to thank our dedicated team for getting us to this tremendous milestone.”

INT230-6, Intensity’s lead proprietary investigational product candidate, is designed for direct intratumoral injection. INT230-6 was discovered using Intensity’s proprietary DfuseRx technology platform. The drug comprises two proven, potent anti-cancer agents, cisplatin and vinblastine, and a penetration enhancer molecule (SHAO) that helps disperse potent cytotoxic drugs throughout tumors for diffusion into cancer cells. These agents remain in the tumor, resulting in a favorable safety profile. In addition to local disease control and direct killing of the tumor, INT230-6 releases a bolus of neoantigens specific to the malignancy, leading to immune system engagement and systemic anti-tumor effects. Importantly, these effects are mediated without immunosuppression, which often occurs with systemic chemotherapy.

Soft tissue sarcoma is a rare type of cancer that starts with the growth of cells in the body’s soft tissue, such as muscle, fat, blood vessels, nerves, tendons, and linings of the joints. The disease mostly occurs in the arms, legs and belly. There are 197,000 patients in the US living with sarcoma and more than 50 types of soft tissue sarcoma, the treatment of which first involves surgery. Other treatments might include radiation therapy and then chemotherapy. Using the US SEER database, the company estimated that 14,337 patients have regional or distal (metastatic) leiomyosarcoma, liposarcoma, and undifferentiated pleomorphic sarcoma.

Intensity Therapeutics is a late-stage clinical biotechnology company that applies novel engineered chemistry by enabling its aqueous cytotoxic-containing drug product, INT230-6, to mix and saturate the dense, high-fat pressurized environment of the tumor. As a result of the saturation, Intensity’s clinical trials have demonstrated the ability of INT230-6 to kill tumors and elicit an adaptive immune response within days of injection, representing a novel approach to cancer cell death that holds the potential to shift the treatment paradigm and turn many deadly cancers into chronic diseases even for cancers that do not respond to immunotherapy. INT230-6 has completed enrollment of over 200 patients in two studies; a Phase 1/2 dose escalation trial (NCT03058289), and a Phase 2 randomized control clinical trial in breast cancer (the INVINCIBLE 2 study) (NCT04781725).  The Company recently initiated a Phase 3 trial in soft tissue sarcoma (the INVINCIBLE 3 study) (NCT06263231), testing INT230-6 as second or third-line monotherapy compared to the standard of care with overall survival as an endpoint. The Company is also planning a Phase 2/3 program in presurgical triple-negative breast cancer testing INT230-6 in combination with standard of care compared to standard of care alone. Information on the Phase 2, (INVINCIBLE-4-SAKK study is listed under (NCT06358573). For more information, visit www.intensitytherapeutics.com.