Intensity Therapeutics (INTS) FDA Approvals

Intensity Therapeutics' Drug in the FDA Approval Process

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.

Provided Update - March 12,2026

• Drug: INT230-6
• Announced Date: March 12, 2026
• Indication: treatment for certain soft tissue sarcoma subtypes.

Intensity Therapeutics, Inc. provided an update on the INVINCIBLE-4 Study. In September 2025, enrollment was paused by the Company due to skin irritations observed in Cohort A. In early March 2026, a protocol amendment was submitted to Swissmedic and the Swiss Ethics Committee to resume enrollment using a lower drug volume per tumor volume ratio and a single injection of INT230-6.

Intensity Therapeutics reported an update on the INVINCIBLE-4 study. In September 2025 the company paused enrollment after skin irritations were seen in Cohort A. In early March 2026 Intensity submitted a protocol amendment to Swissmedic and the Swiss Ethics Committee to resume enrollment with a lower drug-volume-per-tumor-volume ratio and a single injection of INT230‑6.

To date 14 patients have been treated, seven in each cohort, with expected enrollment up to 61 patients. The pathologic complete response (pCR) analysis is ongoing and early. Through March 2, 2026, safety data for INT230‑6 plus standard of care remain favorable compared with standard care alone.

Results from the earlier INVINCIBLE‑2 presurgical study (58 women receiving one to three INT230‑6 injections) showed rare skin issues and uncomplicated surgeries. The company plans to present more detailed results for the seven Cohort A patients at a future oncology conference.

Publication - October 30,2025

Phase 1/2

• Drug: INT230-6
• Announced Date: October 30, 2025
• Indication: treatment for certain soft tissue sarcoma subtypes.

Intensity Therapeutics, Inc. announces that eBioMedicine, a Lancet Discovery Science journal, has published the Company's phase 1/2 IT-01 clinical study manuscript for the treatment of metastatic or refractory cancers.

Intensity Therapeutics, Inc. announced that eBioMedicine, a Lancet Discovery Science journal, has published its open-access phase 1/2 IT-01 study of INT230-6 for adults with metastatic or refractory solid tumors. The trial evaluated doses of intratumoral INT230-6, a combination of cisplatin, vinblastine sulfate, and a diffusion enhancer, in heavily pretreated patients across more than 20 cancer types.

Results showed a 75% disease control rate and a median overall survival of 11.9 months, outperforming historical benchmarks. In a subgroup receiving doses covering over 40% of tumor burden, disease control rose to 83.3% and median survival reached 18.7 months. About 20% of these patients experienced abscopal effects, and no dose-limiting toxicities were reported.

The company will host a webinar with lead authors from USC on Friday, October 31, 2025, at 9:00 AM ET to discuss these findings and future clinical plans.

Provided Update - June 30,2025

• Drug: INT230-6
• Announced Date: June 30, 2025
• Indication: treatment for certain soft tissue sarcoma subtypes.

Intensity Therapeutics, Inc. announces that INT230-6 achieved complete responses in a murine models of Malignant Peripheral Nerve Sheath Tumor ("MPNST").

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.

Provided Update - June 11,2025

Phase 2

• Drug: INT230-6
• Announced Date: June 11, 2025
• Indication: treatment for certain soft tissue sarcoma subtypes.

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.

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.

Presentation - May 29,2025

• Drug: INT230-6
• Announced Date: May 29, 2025
• Indication: treatment for certain soft tissue sarcoma subtypes.

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.

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.

Authorization - May 6,2025

EMA

• Drug: INT230-6
• Announced Date: May 6, 2025
• Indication: treatment for certain soft tissue sarcoma subtypes.

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.

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.

Regulatory Update - January 28,2025

IDMC Review

• Drug: INT230-6
• Announced Date: January 28, 2025
• Indication: treatment for certain soft tissue sarcoma subtypes.

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.

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.

Provided Update - January 10,2025

• Drug: INT230-6
• Announced Date: January 10, 2025
• Indication: treatment for certain soft tissue sarcoma subtypes.

Intensity Therapeutics, announces a business update highlighting key achievements with its lead drug candidate INT230-6.

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.

Intensity Therapeutics FDA Events - Frequently Asked Questions

Has Intensity Therapeutics received FDA approval?

As of now, Intensity Therapeutics (INTS) has not received any FDA approvals for its therapy in the last two years.

What drugs has Intensity Therapeutics submitted to the FDA?

In the past two years, Intensity Therapeutics (INTS) has reported FDA regulatory activity for INT230-6.

What is the most recent FDA event for Intensity Therapeutics?

The most recent FDA-related event for Intensity Therapeutics occurred on March 12, 2026, involving INT230-6. The update was categorized as "Provided Update," with the company reporting: "Intensity Therapeutics, Inc. provided an update on the INVINCIBLE-4 Study. In September 2025, enrollment was paused by the Company due to skin irritations observed in Cohort A. In early March 2026, a protocol amendment was submitted to Swissmedic and the Swiss Ethics Committee to resume enrollment using a lower drug volume per tumor volume ratio and a single injection of INT230-6."

What conditions do Intensity Therapeutics' current drugs treat?

Currently, Intensity Therapeutics has one therapy (INT230-6) targeting the following condition: treatment for certain soft tissue sarcoma subtypes..