Intensity Therapeutics and SAKK Collaborate on Phase 2 Cancer Study in France

Collaboration in Cancer Research

Intensity Therapeutics, Inc. recently announced that they, in partnership with The Swiss Group for Clinical Cancer Research (SAKK), have secured the approval from the European Medicines Agency (EMA) to commence a significant Phase 2 clinical study, known as INVINCIBLE-4, in France. This trial will focus on their innovative investigational therapy INT230-6 for patients diagnosed with presurgical triple-negative breast cancer (TNBC).

What is the INVINCIBLE-4 Study?

The INVINCIBLE-4 Study is designed as a randomized, open-label, multicenter investigation which seeks to evaluate the clinical effectiveness, safety, and tolerability of INT230-6. Participants in this study will be composed of early-stage operable TNBC patients undergoing standard neoadjuvant immunochemotherapy treatment. Researchers will compare two groups: one receiving standard treatment combined with INT230-6, and the other receiving standard treatment alone.

The paramount objective of this trial is to achieve a pathological complete response (pCR), defined as the absence of viable cancer cells in tissue samples taken at the time of surgery, in both the primary breast tumor and affected lymph nodes. This is particularly critical for TNBC patients, as achieving pCR is associated with reduced chances of disease recurrence.

Background on INT230-6

INT230-6 is an investigational therapy developed using Intensity Therapeutics’ proprietary DfuseRx℠ technology, featuring a unique formulation of two potent chemotherapy agents—cisplatin and vinblastine sulfate—combined with an enhancer that facilitates superior drug penetration into tumors. This treatment aims to control tumor growth effectively while simultaneously stimulating an immune response against cancer cells.

Encouraging observational results have already been reported in the initial phases of the study, with MRI scans indicating significant tumor necrosis and inflammation following treatment with INT230-6. Dr. Ursina Zürrer, the Coordinating Investigator for the INVINCIBLE-4 study, stated that if the therapy proves effective, it could represent a major breakthrough in the preoperative management of breast cancer.

Study Impact and Future Considerations

With the EMA's endorsement, the Phase 2 study is now positioned to recruit participants from various sites in France and Switzerland, significantly increasing the pace of enrollment. This collaboration aims not only to enhance the patient screening process but also to provide more comprehensive data on the effectiveness of INT230-6 as a future standard of care for patients battling TNBC.

Across roughly 56,000 new cases of TNBC diagnosed annually in the US alone, this patient population primarily faces treatment challenges due to a lack of effective targeted therapies. By mitigating risks associated with conventional chemotherapy and showing potential for improved pCR rates, INT230-6 could change clinical practices in cancer treatment.

Conclusion

As the clinical landscape for TNBC evolves, the partnership between Intensity Therapeutics and SAKK symbolizes hope for many patients. This innovative approach not only seeks to enhance treatment outcomes but also aims to minimize the adverse effects often associated with cancer therapies. As investigators, including surgical oncologists and medical professionals, close in on new solutions, trials like INVINCIBLE-4 pave the way for future achievements in oncology.

For further details about this ongoing trial and Intensity's advancements in cancer therapeutics, visit Intensity Therapeutics' official website.