Phase 3 Sarcoma Program Advances for Intensity Therapeutics

Intensity Therapeutics, a clinical-stage biotechnology firm, has received a green light from the FDA to proceed with a pivotal phase 3 trial of its lead drug candidate, INT230-6, for the treatment of soft tissue sarcoma. The company is set to initiate this open-label, randomized study in the first half of 2024, marking a significant step forward in its mission to develop innovative cancer therapies.

In late 2023, Intensity submitted an IND application to the FDA, outlining a phase 3 protocol designed to demonstrate the superiority of INT230-6 as a monotherapy in comparison to standard care drugs for specific subtypes of soft tissue sarcoma in the second and third lines of treatment. The FDA's prompt response, granting permission to proceed within 30 days of the IND submission, underscores the urgency and importance of this trial.

The phase 3 study is expected to involve 333 participants, with a 2:1 randomization ratio favoring INT230-6. This means that for every three patients enrolled, two will receive the investigational drug, and one will receive the standard of care treatment as determined by the research team.

Manufacturing advancements have also been made, with the development and validation of phase 3 quality analytical methods for INT230-6's key components. A clinical batch of the drug product meeting the required specifications has been successfully produced. Additionally, Intensity held a successful meeting with the FDA to discuss the chemical manufacturing and controls (CMC) for INT230-6, resulting in a collaborative plan for the necessary CMC activities to support the phase 3 study and a potential New Drug Application (NDA) in the future.

Lewis H. Bender, CEO of Intensity Therapeutics, emphasized the significance of the FDA's approval, stating that it brings the company closer to offering a safer and more effective treatment option for sarcoma patients. He highlighted the need for new treatment approaches, given the severe toxicities and limited survival benefits associated with current standard-of-care drugs after first-line therapies.

Preliminary data presented at a 2023 oncology meeting by Dr. Christian Frederick Meyer indicated that INT230-6 could significantly extend survival in refractory soft tissue sarcoma subjects. The median overall survival for INT230-6 monotherapy was reported to be 21.5 months, a substantial improvement over the synthetic control's median survival of 6.8 months.

Furthermore, INT230-6 has demonstrated a favorable safety profile in metastatic patients, with most treatment-emergent adverse events being mild to moderate in nature. The drug's design for direct intratumoral injection leverages Intensity's DfuseRx™ technology, which combines potent anti-cancer agents with a penetration enhancer to maximize tumor penetration and local disease control.

Soft tissue sarcoma, a diverse group of cancers affecting various soft tissues, remains a challenging diagnosis with poor prognoses when metastatic. The innovative approach of INT230-6, which also stimulates an immune response without immunosuppression, could potentially transform the treatment landscape for this patient population.

Intensity Therapeutics' commitment to developing INT230-6 as a novel cancer therapy is evident through its extensive clinical trial program and partnerships with major pharmaceutical companies to explore combination therapies. The company's focus on turning "cold" tumors "hot" represents a paradigm shift in cancer treatment, aiming to convert deadly cancers into more manageable chronic conditions.