50% fewer grade 3 or higher Adverse Events were observed in the INT230-6 cohort compared to the Standard of Care ("SOC") neoadjuvant chemotherapy alone cohort.
A pathological complete response ("pCR") has been observed in the first patient evaluated in Cohort A, where each patient receives two doses of INT230-6 eight days apart, followed by the SOC.
In a study conducted in the Staedtke-Bai laboratory at Johns Hopkins University, at 21 days, animals tested with INT230-6 (n=5) all achieved a complete response, whereas all animals' tumors in the control group (N=5) continued to grow.
Intensity Therapeutics, Inc. (Nasdaq: INTS) ("Intensity" or the "Company"), a late-stage clinical biotechnology company focused on the discovery and development of proprietary, novel immune-based intratumoral cancer therapies designed to kill tumors and increase immune system recognition of cancers, 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.
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 .
Dr. Meyer shared the information during an oral podium presentation in a late-breaking session at the 2024 Connective Tissue Oncology Society ("CTOS") on November 16, 2024, at 9 AM PST.
INT230-6 demonstrated a systemic increase in the median diversity of T-cell repertoire in patients' blood compared to baseline that was also much larger than a control saline injection
The study, presented at the 2022 American Society of Clinical Oncology (ASCO) Annual Meeting being held in Chicago and virtually from June 3-7, 2022, reported data demonstrating efficacy and tolerability of INT230-6.
Intensity Therapeutics, Inc. ("Intensity"), a clinical-stage biotechnology company focused on the discovery and development of proprietary, novel immune-based intratumoral cancer therapies designed to kill tumors and increase immune system recognition of cancers, today reported safety, pharmacokinetic, biomarker and efficacy data using INT230-6, with and without pembrolizumab, in heavily pretreated refractory breast cancer patients as part of the Company's phase 1/2 study, IT-01.
Data from the Phase 2 IT-01 trial shows that Intensity’s lead asset, INT230-6 (PORT-1) is well tolerated with direct tumor-killing effects, both as a monotherapy and in combination with the approved checkpoint inhibitors pembrolizumab and ipilimumab.
Kaplan Meier estimates that approximately 60% of those of sarcoma subjects receiving INT230-6 monotherapy a dose volume greater than 40% of their total tumor burden will be alive at 1 year.