On December 12, 2024 Intensity Therapeutics, Inc. ("Intensity" or "the Company") (Nasdaq: INTS), a late-stage clinical biotechnology company focused on the discovery and development of proprietary, novel immune-based intratumorally injected cancer therapies intended to kill tumors directly and increase immune system recognition of cancers, and The Swiss Group for Clinical Cancer Research SAKK ("SAKK"), a decentralized academic research institute that has been conducting clinical trials of cancer treatments in all major Swiss hospitals since 1965, reported that Andreas Mueller, M.D., Past-President of the Project Group Breast Cancer of SAKK and Head of the Breast Center at Kantonsspital Winterthur, Switzerland and a supporting coordinating investigator for the study presented in an evening poster session on December 11 the final data from Intensity’s INVINCIBLE-2 Study (NCT04781725), and an overview / update of the INVINCIBLE-4 Study (NCT06358573) at the San Antonio Breast Cancer Symposium being held December 10-13, at the Henry B. Gonzalez Convention Center in San Antonio, Texas (Press release, Intensity Therapeutics, DEC 12, 2024, View Source [SID1234649087]).

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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 ("TNBC") who undergo standard of care neoadjuvant immunochemotherapy ("SOC") treatment and SOC alone. The primary endpoint is pathological complete response ("pCR") in the primary tumor and affected lymph nodes. Patients will be randomized one to one to receive a regimen of either two doses of INT230-6 followed by SOC, which consists of pembrolizumab, anthracyclines, carboplatin, cyclophosphamide, and paclitaxel (i.e. the Keynote-522 regimen), or the SOC alone. The study is recruiting and expected to enroll 54 patients.

"Women with aggressive forms of breast cancer, such as TNBC, are often counseled to undergo pre-surgical (neoadjuvant) systemic therapy in advance 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 recurrence. When the tumor diameters are bigger than two centimeters, recurrence is more likely, so that neoadjuvant treatment is warranted" said Dr. Mueller. "If the immunological cancer cell death caused by INT230-6 and the ignition of an anti-cancer immune response without increased toxicity shows a meaningful increase in pCR, it would be a major advance for the neoadjuvant treatment of breast cancer and potentially other cancers. Further, if the results of this study are highly favorable, perhaps the cardiotoxic anthracycline drugs could be reduced or eliminated in future studies."

The Company’s completed INVINCIBLE-2 Study, where INT230-6 was given alone in multiple tumor types including TNBC, showed several benefits:

Tumor-killing properties at levels greater than 95% in some patients on a single intratumoral dose with systemic immune activation.
Results in tumors larger than 2 cm showed significant necrosis in 74% of subjects at the time of surgery.
Gene expression analysis showed a significant difference between baseline biopsies and surgical specimens. Pathway analysis identified genes associated with TCR signaling, B-cell and T-cell activation, with increasing effects in post-treatment samples (SABCS 2023 #PS16-03).
The study demonstrated pathologic and immune priming effects of intratumoral cytotoxicity in traditional immune quiescent breast cancers, with a treatment that showed favorable safety and was well tolerated.
INT230-6 patients had significant differential gene expression present and identified genes were associated with T cell activation, lymphocyte activation and inflammatory response.
INT230-6 patients had increases in CD4 T cells and NK cells within the tumor, and associated changes in the diversity of T cell repertoire.
About INT230-6
INT230-6, Intensity’s lead proprietary investigational product candidate, is designed for direct intratumoral injection. INT230-6 was discovered using Intensity’s proprietary DfuseRx℠ technology platform. The drug is comprised of two proven, potent anti-cancer agents, cisplatin and vinblastine sulfate, and a penetration enhancer molecule (SHAO) that helps disperse potent cytotoxic drugs throughout tumors for diffusion into cancer cells. These agents remain in the tumor, resulting in a favorable safety profile. In addition to local disease control and direct tumor killing, INT230-6 causes a release of a bolus of neoantigens specific to the malignancy, leading to immune system engagement and systemic anti-tumor effects. Importantly, these effects are mediated without immunosuppression, which often occurs with systemic chemotherapy.