Intensity Therapeutics to Showcase Innovative Cancer Therapy at 2025 San Antonio Symposium

Introduction

Intensity Therapeutics, Inc., a pioneering firm in the biotechnology sector focused on developing advanced cancer therapies, is preparing to showcase its promising work at the upcoming 2025 San Antonio Breast Cancer Symposium. This year, they will unveil two significant posters that delve into their ongoing clinical trials aimed at combating Triple Negative Breast Cancer (TNBC), a notoriously aggressive form of the disease.

Posters Overview

The first poster, labeled PS5-08-16, presents early findings from the INVINCIBLE-4 study. This clinical trial investigates the efficacy and safety of INT230-6, an innovative cancer therapy designed for direct intratumoral injection. Preliminary results suggest that patients receiving INT230-6, paired with standard of care (SOC), experienced significantly fewer severe adverse effects compared to those treated solely with conventional neoadjuvant chemotherapy. Specifically, the INT230-6 cohort reported 50% fewer grade 3 or higher adverse events.

In contrast, the second poster, PS4-10-15, outlines a proposed Phase 3 clinical study design aiming to explore the therapeutic potential of INT230-6 alongside standard treatments without including anthracycline drugs like doxorubicin, known for their severe side effects.

The INVINCIBLE-4 Study

Launched in 2024, the INVINCIBLE-4 study has enrolled 14 patients, split evenly across two cohorts. One cohort received INT230-6 coupled with SOC, while the other received SOC alone. Insights from this study underscore a favorable safety profile for the INT230-6 treatment. Among the severe adverse events, a total of nine occurred in the INT230-6 plus SOC cohort, whereas those undergoing standard care experienced twenty such events, highlighting the comparative safety advantages of INT230-6.

Observations and Adjustments

A closer look at the patient data reveals an overarching trend toward enhanced safety, which results in a positive outlook for continued research. For instance, while some patients demonstrated skin irritation after treatment, others exhibited necrosis that necessitated revision of the treatment protocol, reducing the volume and frequency of injections in future participants.

Pathway to a Phase 3 Clinical Study

Given the promising early results, the researchers might pivot towards a Phase 3 clinical study leveraging INT230-6 in combination with SOC treatments, deliberately excluding toxic anthracyclines like doxorubicin. Discussions led by Lewis H. Bender, Intensity’s President and CEO, suggest a potential three-arm randomized trial design:
1. INT230-6 plus SOC,
2. SOC only, and
3. INT230-6 combined with SOC without anthracyclines.

This innovative approach could shift the treatment paradigm for patients suffering from this aggressive breast cancer form if the data supports continued efficacy and safety.

Christine Handy's Advocacy

Patient advocate and cancer survivor Christine Handy has also contributed valuable insights, emphasizing the need for safer alternatives to current treatments. Having experienced firsthand the cardiotoxicity linked to doxorubicin, she acknowledges the critical nature of innovations like INT230-6 that strive to enhance patient safety and treatment outcomes.

Conclusion

As preparations for the symposium progress, Intensity Therapeutics remains optimistic about what their findings might mean for the future of TNBC treatment. With a commitment to addressing the daunting challenges posed by this cancer subtype and improving patient safety through innovative therapies like INT230-6, the company is poised to make significant strides in the oncology landscape. The outcomes of both posters are anticipated to offer a beacon of hope for patients and healthcare professionals alike, reflecting a collective commitment to transforming cancer care.

For more information on Intensity Therapeutics and their ongoing efforts to revolutionize cancer treatment, please visit www.intensitytherapeutics.com.