IT-01 Study manuscript of INT230-6 used alone in 64 refractory metastatic cancer patients published in the Lancet's journal eBioMedicine, including data for disease control rate, overall survival, immune activation, abscopal effects, tumor necrosis, dose ranging, and safety
Favorable efficacy and safety reported in a small sample of triple negative breast cancer ("TNBC") patients receiving INT230-6 prior to the standard of care ("SOC") compared to SOC alone in the INVINCIBLE-4 Study
SHELTON, Conn., March 27, 2026 /PRNewswire/ -- Intensity Therapeutics, Inc. ("Intensity" or "the Company") (NASDAQ:INTS), a late-stage clinical biotechnology company focused on the discovery and development of novel intratumoral cancer therapies that are designed to kill tumors and increase immune system recognition of cancers using its proprietary non-covalent conjugation technology, announces 2025 year-end financial results and highlights, and provides a corporate update.
Corporate Update
INVINCIBLE-4 Study: Phase 2 randomized open-label, multicenter study to analyze the clinical activity, safety, and tolerability of INT230-6 given before administration of the SOC treatment in patients with early-stage, operable triple negative breast cancer and SOC alone.
In March 2026, the Company reported the following:
Preliminary observations of the INVINCIBLE-4 Study showed that five (5) out of seven (7) patients (71.4%) who received INT230-6 prior to SOC ("Cohort A") achieved a pathological complete response ("pCR") whereas two (2) out of six (6) (33%) patients in the SOC arm alone ("Cohort B") achieved a pCR, with one patient still to be evaluated.
Forty-four percent (44%) fewer grade 3 or higher adverse events were observed in Cohort A compared to Cohort B.
A protocol amendment was submitted to Swissmedic, Switzerland's regulatory authority, and the Switzerland Ethics Committee to resume enrollment. Full approval to resume enrollment was granted on March 26, 2026.
The Company expects presentation of more detailed results for the seven (7) Cohort A patients at a future oncology conference.
INVINCIBLE-3 Study: Phase 3 open-label, randomized study testing INT230-6 as monotherapy compared to the SOC drugs in second- and third-line treatment for specific soft tissue sarcoma subtypes.
In March 2025, the Company paused new site activations and patient enrollments due to funding constraints. Before this pause, the trial had enrolled 21 patients. The Company continues to treat patients enrolled in this study, maintain the database, conduct pharmacovigilance, and conduct other study-related activities in cooperation with its third-party contract research organizations at significantly reduced ongoing costs during this pause. The Company has prioritized reinitiating patient enrollment and site activations during 2026 once sufficient funding is obtained.
IT-01 Study Manuscript Publication
In October 2025, the Company reported that eBioMedicine, a Lancet Discovery Science journal, published the Company's phase 1/2 IT-01 clinical study manuscript, "Safety and Efficacy of Intratumourally Administered INT230-6 in Adult Patients with Advanced Solid Tumours: Results from an Open-Label Phase 1/2 Dose Escalation Study," for the treatment of metastatic or refractory cancers. The manuscript included the following data results:
In heavily pretreated patients with advanced disease having over 20 different types of cancer who had progressed following multiple prior lines of therapy, intratumoral INT230-6 achieved:
A disease control rate of 75% (48/64 patients) and median overall survival ("mOS") of 11.9 months; these results compare favorably in phase 1/2 studies that historically reported an mOS of 4 to 7 months
In a metastatic sarcoma subset population receiving only INT230-6, the median overall survival was 21.3 months
In an exploratory analysis comparing patients receiving INT230-6 at a total dose (in mL) that treated greater than 40% of the patient's total tumor burden ("TTB") compared to those treated with less than 40% of their TTB, the:
Disease control rate was 83.3% (40/48) compared to 50% (8/16)
Median overall survival was 18.7 months (95% CI: 11.5–23.5) compared to 3.1 months (95% CI: 1.6–5.9) with a hazard ratio (HR) of 0.17 (95% CI: 0.081–0.342); P<0.0001
Improved survival was consistent across a range of low to high tumor burden and tumor sizes
Approximately 20% of patients in the >40% group had uninjected tumors shrink, abscopal effects
Fifteen of 64 patients survived for more than 21 months
INT230-6 induced a qualitative decrease in proliferating cancer cells in injected tumors and a qualitative increase in activated T-cells infiltrating the tumor microenvironment
No dose-limiting toxicities were reported among 64 monotherapy patients; seven patients had a grade 3 (10.9%) with no grade 4 or 5 treatment-related adverse events
Pharmacokinetic results showed that greater than 95% of the active cytotoxic agents remained in the injected tumors
Cash and Cash Runway
In 2025, the Company raised over $20 million in gross proceeds through two public offerings, one registered direct offering, and ATM issuances. These successful capital-raising efforts strengthened Intensity's balance sheet with cash and cash equivalents of $11.9 million as of December 31, 2025, and extended its current operating runway into the second quarter of 2027.
Lewis H. Bender, Founder, President, and CEO, stated, "Our data published in the Lancet's eBioMedicine journal for the treatment of metastatic disease, and the results reported on the safety and efficacy in the INVINCIBLE-4 study were promising and unique for a locally-delivered oncology drug. With the capital raised in 2025 and an unused $60 million ATM facility in place, we intend to resume patient enrollment in both studies as soon as possible. The American Cancer Society ("ACS") estimates that roughly 6,400 more deaths occurred in 2025 than in 2024, a trend that continues every year. Intensity remains committed to helping patients live longer, healthier lives with less toxicity. The ACS data supports the conclusion that today's cancer treatments have many limitations, and that the ...
