Intensity Therapeutics Inc（INTS）資訊與事件INTSIntensity Therapeutics Inc

Intensity Therapeutics Presents Preliminary Data from INVINCIBLE-4 Study at ESMO 2026

Intensity Therapeutics announced data for the first seven patients in Cohort A in the INVINCIBLE-4 Study will be presented in an ePoster by The Swiss Cancer Institute, the Company's collaborator in the INVINCIBLE-4 Study, at the ESMO 2026 Virtual Congress Platform beginning on Friday, 23 October. The Congress is being held at IFEMA Madrid, Spain. The presentation will be available to all registered delegates, both those attending in person and those attending online. INVINCIBLE-4 is a randomized, open-label multicenter phase 2 clinical study. There are two cohorts designed to determine the clinical activity, safety, and tolerability of INT230-6 in patients with early-stage, operable TNBC: INT230-6 in combination with standard-of-care neoadjuvant immuno-chemotherapy, or NAIC, and NAIC alone. Early activity signals of INT230-6 efficacy in Cohort A are encouraging, with pCR achieved in the breast and affected lymph nodes in 5 of 7 patients. No invasive breast cancer cells were detected in the axillary lymph nodes in 6 of the 7 INT230-6 patients in Cohort A after INT230-6 treatment, despite 5 being initially biopsy-proven node-positive. Results also show tumor necrosis after 1 or 2 injections in all 7 Cohort A patients. In the pre-surgery MRI at the completion of NAIC four patients had RECIST 1.1 radiological complete response and three patients partial response. All 7 patients in Cohort A met the criteria for breast-conserving surgery, but one proceeded with mastectomy owing to a high-risk germline mutation. The trial includes patients with newly diagnosed, previously untreated, locally advanced non-metastatic TNBC stage cT1c N1-3 M0 or cT2-4c N0-3 M0 per American Joint Committee on Cancer version 8, defining TNBC as 0% ER/PgR and HER2-negative. Multifocal and multicentric primary tumors are allowed. Patients must have measurable disease in the breast with at least one lesion with a diameter greater than or equal to1.5 cm that is evaluable per RECIST v1.1, visible in ultrasound and injectable. Women with aggressive forms of breast cancer, such as TNBC, are often counseled to undergo neoadjuvant systemic therapy to reduce the risk of the disease returning. Having a pathological complete response, meaning the absence of live cancer at the time of surgery, has been shown to result in a lower risk of disease recurrence from 50% to 16% at 5 years.

Company Cash and Cash Equivalents Reach $9.5M, CEO Reveals Research Progress

As of June 30, cash and cash equivalents totaled $9.5M. During Q2, the company raised $1.7M under the ATM, for net proceeds of $1.6M. "We are pleased that the capital raised in 2025 and to date in 2026 provides the resources to reinitiate the Phase 3 INVINCIBLE-3 Study. In addition, during the 2025 pause, we evaluated and modified the protocol based on feedback from key investigators and sarcoma thought leaders. The FDA-reviewed amended protocol will first be implemented in select U.S. sites," stated CEO Lewis Bender. "In the Phase 2 INVINCIBLE-4 Study, early data show potential for an improvement in the pCR rate with a reduction in the number of grade 3 adverse events including immune-related adverse events. These preliminary findings are encouraging, and we are excited that investigators have restarted treatment in patients in Switzerland. We look forward to enrolling new patients in this study in France now that sites are being activated. Lastly, we continue to pursue potential partnerships to advance our programs, and held meetings with potential strategic partners at the BIO International Conference in late June. While early, we are pleased with the interest expressed in our science and clinical trials, and we expect to continue discussions in the second half of 2026."

Intensity Therapeutics Initiates New Patient Enrollment in INVINCIBLE-4 Study in Switzerland

Intensity Therapeutics announces that new patients have been administered INT230-6 in the INVINCIBLE-4 Study in Switzerland. The trial analyzes INT230-6 given before administration of the standard-of-care neoadjuvant immuno-chemotherapy, or SOC, and the SOC alone by using a 2-cohort design. The study evaluates the pathological complete response, or pCR, rates of the two cohorts relative to a null hypothesis, which is a pCR rate of less than or equal to 0.6. The success of each cohort in rejecting the null hypotheses will be evaluated. The INVINCIBLE-4 Study is a randomized open-label, multicenter study to determine the clinical activity, safety, and tolerability of INT230-6 in patients with early-stage, operable triple-negative breast cancer who undergo SOC treatment and SOC alone. The primary endpoint is pCR in the primary tumor and affected lymph nodes. In the amended protocol, patients will be randomized to receive a regimen of one dose of INT230-6 followed by SOC, which consists of pembrolizumab, anthracyclines, carboplatin, cyclophosphamide, and paclitaxel, or to SOC alone. The INVINCIBLE-4 Study reopens following a pause in patient accrual to evaluate skin irritation issues seen in some patients. In March 2026, a protocol amendment was submitted to Swissmedic and the Swiss Ethics Committee to resume enrollment using a slightly lower drug-to-tumor volume ratio and a single injection of INT230-6. Prior to the pause, fourteen patients were treated, seven with the combination and received the SOC alone. Patients receiving INT230-6 prior to the SOC reported a favorable trend towards much fewer overall grade 3 or higher adverse events and immune-related adverse events compared to those patients receiving the SOC alone. The INVINCIBLE-4 Study is expected to enroll an additional 47 patients in Switzerland and France.