#USA #Intensity Therapeutics #Shelton #INT230-6 #Triple-Negative Breast Cancer

Promising Results from INT230-6 in Triple-Negative Breast Cancer

Intensity Therapeutics, Inc., a late-stage clinical biotechnology company traded on Nasdaq under the symbol INTS, has unveiled groundbreaking findings from its randomized controlled Phase 2 INVINCIBLE-4 study. This trial investigates the efficacy of their investigational product INT230-6 in patients with early-stage, operable triple-negative breast cancer (TNBC) undergoing standard neoadjuvant immunotherapy.

Significant Findings on Tumor Necrosis

The study signals a notable breakthrough, as early patients treated with INT230-6 showed high levels of tumor necrosis just eight days post-administration. MRI scans reveal substantial tissue damage within the tumors, an encouraging sign before the initiation of the standard of care regimen.

Dr. Ursina Zürrer, Chief Physician at the Cantonal Hospital Winterthur in Switzerland and the coordinating investigator for the INVINCIBLE-4 study, expressed optimism about these early results. “Seeing these high levels of tumor necrosis, alongside indications of immune activation, is a promising development. We anticipate continued enrollment and are hopeful for more positive outcomes.”

The INVINCIBLE-4 study focuses on TNBC patients randomly assigned to receive either INT230-6 followed by the standard care regimen or the standard treatment alone. This regimen includes chemotherapy agents such as anthracyclines and the immunotherapy pembrolizumab. The core objective of the study is to assess the primary endpoint of pathological complete response (pCR), which signifies no detectable cancer in the primary tumor and lymph nodes.

The Mechanism of INT230-6

INT230-6 is an innovative therapy developed using Intensity’s proprietary DfuseRx technology, allowing direct intratumoral injections. The formulation combines two established anti-cancer agents—cisplatin and vinblastine sulfate—along with a penetration enhancer to maximize the cytotoxic effect on tumors. This method is designed to minimize side effects typically associated with systemic therapies, enabling targeted destruction of cancer cells.

In addition to direct tumor action, INT230-6 promotes the release of neoantigens that engage the immune system, potentially resulting in systemic anti-tumor effects without the suppression often seen in conventional chemotherapy.

Challenges in Treating Triple-Negative Breast Cancer

TNBC is a particularly aggressive subtype of breast cancer, accounting for approximately 11-17% of all breast cancer cases. Patients often face dire prognoses due to a lack of targeted treatment options. Consequently, intensive neoadjuvant therapies, including chemotherapy and immunotherapy, are frequently recommended to reduce recurrence risks and improve surgical outcomes.

Recent studies indicate that achieving a pathological complete response significantly increases event-free survival rates; however, about 40% of treated patients still experience insufficient responses, leaving room for improvement.

Future of INT230-6 and Clinical Trials

As the investigation continues, both Intensity Therapeutics and its collaborators at SAKK and Unicancer are eager to further understand INT230-6’s full potential in this challenging cancer type. With a total of 54 participants targeted in the INVINCIBLE-4 study, the findings could pave the way for more effective treatment paradigms for TNBC patients.

The initial outcomes are a beacon of hope, not just for effective cancer treatment but also for enhancing quality of life by reducing the adverse effects often associated with systemic therapies. Intensity Therapeutics continues to advance its research, striving to innovate and ultimately change the standard of care for patients battling aggressive forms of cancer.