FDA Events for Intensity Therapeutics (INTS)
This section highlights FDA-related milestones and regulatory updates for drugs developed by Intensity Therapeutics (INTS).
Over the past two years, Intensity Therapeutics has reported clinical trial outcomes, regulatory submissions, approvals, and other FDA events for drugs and therapies such as
INT230-6. For definitions of regulatory abbreviations such as NDA, BLA, or PDUFA, see the event status legend.
INT230-6 - FDA Regulatory Timeline and Events
INT230-6 is a drug developed by Intensity Therapeutics for the following indication: treatment for certain soft tissue sarcoma subtypes.
This drug is under review by the U.S. Food and Drug Administration (FDA).
Below is a timeline of key regulatory milestones for this therapy.
- Drug:
- INT230-6
- Announced Date:
- June 30, 2025
- Indication:
- treatment for certain soft tissue sarcoma subtypes.
Announcement
Intensity Therapeutics, Inc. announces that INT230-6 achieved complete responses in a murine models of Malignant Peripheral Nerve Sheath Tumor ("MPNST").
AI Summary
Intensity Therapeutics, Inc. announced promising preclinical results for its investigational product INT230-6. In a study conducted at Johns Hopkins University’s Staedtke-Bai Laboratory, all five mice treated with INT230-6 in a malignant peripheral nerve sheath tumor (MPNST) model achieved complete responses by day 21. In contrast, all mice in the control group showed continued tumor growth. This outcome marks a significant milestone because no small molecule drug has previously produced such responses in this neurological cancer model.
Researchers are excited about the potential of INT230-6, especially given the difficulty in treating MPNST, a rare and aggressive sarcoma. The success in these preclinical studies could pave the way for further research into neurological cancers and other challenging tumor types, supporting the development of innovative cancer therapies that not only shrink tumors but also engage the immune system.
Read Announcement- Drug:
- INT230-6
- Announced Date:
- June 11, 2025
- Indication:
- treatment for certain soft tissue sarcoma subtypes.
Announcement
Intensity Therapeutics, Inc. announces first few patients receiving INT230-6 achieved high levels of necrosis after 8 days in the Phase 2, INVINCIBLE-4 study, before they initiated the standard-of-care regimen as shown in Figure 1.
AI Summary
Intensity Therapeutics, Inc. announced encouraging early results from the Phase 2 INVINCIBLE-4 study. In the trial, the first few patients treated with INT230-6 achieved high levels of tumor necrosis within 8 days before they began the standard-of-care immunochemotherapy regimen, as shown in Figure 1. This early effectiveness was observed through MRI scans reflecting substantial tumor damage and immune system activation. Dr. Ursina Zürrer, the study’s Coordinating Investigator, noted that this rapid response is promising in the fight against triple-negative breast cancer. Achieving a high level of necrosis before starting traditional treatments could play a key role in increasing the rates of pathological complete response, which is linked to lower cancer recurrence. These findings highlight INT230-6’s potential to improve treatment outcomes by directly killing tumor cells and triggering a supportive immune response early in the treatment process.
Read Announcement- Drug:
- INT230-6
- Announced Date:
- May 29, 2025
- Indication:
- treatment for certain soft tissue sarcoma subtypes.
Announcement
Intensity Therapeutics, Inc. announces that the Company will be presenting a Trials in Progress poster outlining its Phase 3 INVINCIBLE-3 clinical trial of INT230-6 for the treatment of metastatic soft tissue sarcomas.
AI Summary
Intensity Therapeutics, Inc. announced that it will present a Trials in Progress poster highlighting its Phase 3 INVINCIBLE-3 clinical trial at the ASCO 2025 Annual Meeting in Chicago. The poster, to be delivered by Dr. Sant P. Chawla during the “Sarcoma” session, focuses on the study of INT230-6 for treating metastatic soft tissue sarcomas. This Phase 3 trial investigates the use of INT230-6, a novel drug administered directly into tumors, which works by causing significant tumor necrosis and triggering an immune response. Unlike traditional chemotherapy, the trial’s design sets the dose based on tumor size and emphasizes improving overall survival compared to the standard systemic treatments. The study marks a promising approach in cancer therapy by aiming to enhance local tumor control and generate systemic anti-tumor effects, potentially leading to better treatment outcomes for patients with advanced soft tissue sarcomas.
Read Announcement- Drug:
- INT230-6
- Announced Date:
- May 6, 2025
- Indication:
- treatment for certain soft tissue sarcoma subtypes.
Announcement
Intensity Therapeutics, Inc announced that the European Medicines Agency ("EMA") has authorized the initiation of the INVINCIBLE-4 (SAKK 66/22) ("INVINCIBLE-4 Study") (NCT06358573) in France in collaboration with Unicancer.
AI Summary
Intensity Therapeutics, Inc. announced that the European Medicines Agency (EMA) has authorized the initiation of the INVINCIBLE-4 (SAKK 66/22) Study (NCT06358573) in France. This study is conducted in collaboration with Unicancer, a French cooperative group known for its academic excellence in clinical cancer research. The study is a randomized, open-label, multicenter trial evaluating the safety, tolerability, and clinical activity of INT230-6 in patients with early-stage, operable triple-negative breast cancer. Patients will be randomized to receive two doses of INT230-6 followed by standard-of-care neoadjuvant immunochemotherapy, or the standard therapy alone. With the EMA approval backing its expansion into France, the enrollment rate is expected to increase significantly from the second quarter of 2025, nearly doubling the number of sites actively screening patients. This advancement marks a significant step in potentially improving treatment outcomes for aggressive breast cancers.
Read Announcement- Drug:
- INT230-6
- Announced Date:
- January 28, 2025
- Indication:
- treatment for certain soft tissue sarcoma subtypes.
Announcement
Intensity Therapeutics, Inc. announces that following its most recent periodic review meeting, the Data Monitoring Committee (DMC) overseeing the Company's ongoing Phase 3 sarcoma study of INT230-6 (INVINCIBLE-3) (NCT06263231) has agreed that the study should continue without modification.
AI Summary
Intensity Therapeutics, Inc. announced that the Data Monitoring Committee (DMC) for its ongoing Phase 3 sarcoma study of INT230-6 (INVINCIBLE-3) has approved the trial to continue without any modifications. The DMC conducted its review over the past six months, from July to December 2024, and found no safety concerns that would require changes to the study design. This Phase 3 trial focuses on treating patients with leiomyosarcoma, liposarcoma, and undifferentiated pleomorphic sarcoma by comparing intratumoral injections of INT230-6 to standard chemotherapy options. The study, which is authorized for use in the U.S., Canada, Europe, and Australia, continues to recruit eligible patients. By deciding to move forward as planned, the committee’s decision reinforces confidence in the safety profile and potential effectiveness of INT230-6 in addressing a significant unmet need in soft tissue sarcoma treatment.
Read Announcement- Drug:
- INT230-6
- Announced Date:
- January 10, 2025
- Indication:
- treatment for certain soft tissue sarcoma subtypes.
Announcement
Intensity Therapeutics, announces a business update highlighting key achievements with its lead drug candidate INT230-6.
AI Summary
Intensity Therapeutics announced a business update focusing on its lead drug candidate, INT230-6. The company is advancing INT230-6 through two major clinical trials. The global Phase 3 study, INVINCIBLE-3, is evaluating INT230-6 as a monotherapy for metastatic soft tissue sarcoma. Nearly two dozen top sarcoma-focused hospitals across several countries are now actively recruiting patients.
The Phase 2 INVINCIBLE-4 trial for early-stage, operable triple-negative breast cancer is also underway, with multiple Swiss sites now dosing patients. Early data have shown promising results, including increased overall survival and significant immune activation. These achievements underscore INT230-6's potential to become a new treatment option for various cancers, while the company continues to pursue strategic partnerships to further advance and secure market access for this novel therapy.
Read Announcement
Intensity Therapeutics FDA Events - Frequently Asked Questions
As of now, Intensity Therapeutics (INTS) has not received any FDA approvals for its therapy in the last two years.
In the past two years, Intensity Therapeutics (INTS) has reported FDA regulatory activity for INT230-6.
The most recent FDA-related event for Intensity Therapeutics occurred on June 30, 2025, involving INT230-6. The update was categorized as "Provided Update," with the company reporting: "Intensity Therapeutics, Inc. announces that INT230-6 achieved complete responses in a murine models of Malignant Peripheral Nerve Sheath Tumor ("MPNST")."
Currently, Intensity Therapeutics has one therapy (INT230-6) targeting the following condition: treatment for certain soft tissue sarcoma subtypes..
More FDA Event Resources from MarketBeat
FDA Event Stage Terminology & Abbreviation Guide
- NDA: New Drug Application
- ANDA: Abbreviated New Drug Application
- sNDA: Supplemental New Drug Application
- BLA: Biologics License Application
- sBLA: Supplemental Biologics License Application
- FDA Approved: Approved by the FDA
- EMA: European Medicines Agency
- CE Mark: European Union Certification
- NMPA: China National Medical Products Administration
- MHLW: Japanese Ministry of Health
- FDA Meeting: Consultation with FDA
- Pre-IND: Pre-Investigational New Drug Meeting
- Breakthrough Therapy: Special FDA designation for promising therapies
- Fast Track: Accelerated FDA approval pathway
- Orphan Drug: Designation for rare disease treatments
- RPD: Rare Pediatric Disease Designation
- RMAT: Regenerative Medicine Advanced Therapy
- DSMB Review: Data Safety Monitoring Board Review
- IDMC Review: Independent Data Monitoring Committee
- MAA: MHRA Marketing Authorization Application
- RTF: Refusal to File (Rejected Application)
- 510(k): FDA Clearance for Medical Devices
- Rolling Submission: Staggered regulatory review process
This page (NASDAQ:INTS) was last updated on 7/10/2025 by MarketBeat.com Staff
