#United States #Intensity Therapeutics #Shelton #INT230-6 #INVINCIBLE-3

Continuation of the INVINCIBLE-3 Study Authorized by Data Monitoring Committee

Shelton, Connecticut — Intensity Therapeutics, Inc. (Nasdaq: INTS), a late-stage clinical biotechnology firm, has successfully obtained authorization from its Data Monitoring Committee (DMC) to continue its ongoing Phase 3 clinical trial, known as the INVINCIBLE-3 study. This approval follows careful scrutiny of six months' worth of patient data, specifically from July to December 2024. The DMC evaluated whether any safety issues arose and concluded that the trial's continuation is warranted.

“Receiving the DMC's authorization is encouraging,” stated Lewis H. Bender, the President and CEO of Intensity. “This study addresses significant medical needs in patients with sarcoma, and we are committed to advancing it further.”

Overview of the INVINCIBLE-3 Study

The INVINCIBLE-3 study is a global, open-label, randomized, controlled trial aimed at testing the safety and efficacy of INT230-6, a promising investigational drug administered intratumorally. This drug will be compared with standard systemic chemotherapy treatments. Approximately 333 participants with soft tissue sarcoma, who have seen disease progression after prior treatments, will take part in this research.

The primary assessment criteria for the trial include overall survival rates and safety, with quality of life being evaluated through the EORTC-30 survey. Participants will include those suffering from specific types of sarcomas, such as leiomyosarcoma and liposarcoma. The trial will administer the investigational drug directly into the tumor, using image-guided technology by trained physicians.

Highlights of the Trial's Design

Participants in this trial will not be allowed to cross over between treatment arms, emphasizing the study's integrity. Random assignment will be determined after screening and confirming eligibility while stratifying participants according to histological definitions of sarcoma.

Pazopanib, trabectedin, and eribulin mesylate are the three standard therapies against which INT230-6 will be evaluated, and all drugs utilized in this study have been approved in several regions, including the U.S. and Europe. Distributions are underway in eight countries, with ongoing recruitment in the U.S., Canada, and Europe.

About INT230-6

INT230-6, the lead product from Intensity, is developed using a proprietary platform that harnesses two established anti-cancer agents: cisplatin and vinblastine sulfate, alongside a penetration enhancer that allows for even distribution within tumor tissues. This method aims to improve local control of the disease while triggering an immune response without the side effects often associated with systemic chemotherapy.

INT230-6 not only eliminates tumor cells but also releases neoantigens which can stimulate the body’s immune response. This dual action positions INT230-6 as a potentially transformative therapy for patients who have limited responses to existing treatment modalities.

The Future of Intensity Therapeutics

Being a late-stage biotechnology firm, Intensity secured its position through innovative approaches to cancer therapies. Its trials have previously shown that INT230-6 can evoke a swift immune response within days of administration, presenting a revolutionary method in battling cancer.

Additionally, the company has undertaken several clinical trials for INT230-6, addressing a variety of malignancies and exploring its application in conjunction with existing immunotherapies. Intensity is dedicated to reshaping the treatment landscape for cancer, with a focus on pressing unmet medical needs.

Through ongoing collaborations and studies, the company aims to provide an extensive understanding and development of its novel treatments. For further details on their innovative approach and clinical findings, interested readers can visit their official website at www.intensitytherapeutics.com.