Positive Data from Phase 2 Trial of INT230-6 in Early-Stage Breast Cancer Patients without Chemotherapy
A Phase 2 trial of INT230-6 in breast cancer patients without chemotherapy showed significant tumor necrosis and a promising safety profile.
Shares of Intensity Therapeutics soared by 100%, reaching $9.09, following the release of positive data from its Phase 2 trial of INT230-6 in patients with early-stage breast cancer who did not receive chemotherapy.
The stock closed Thursday's session with a 15% increase, marking a remarkable 93% surge over the past three months.
The biotechnology company conducted a randomized study focusing on women diagnosed with newly found, operable early-stage intermediate or high-grade T1-T2 invasive breast cancers, two to five weeks before scheduled surgery.
Determining the drug dose based on the tumor's diameter, participants were randomly assigned to receive one to three injections of INT230-6 or, as a comparison, no treatment or a saline sham injection. Various markers commonly associated with systemic treatment were evaluated.
Encouragingly, the trial of INT230-6 exhibited a significant level of necrosis in presurgical breast cancer tumors during the period between diagnosis and surgery. In fact, some patients in the Phase 2 study experienced greater than 95% tumor necrosis.
Furthermore, data demonstrated that INT230-6 displayed a promising safety profile and was well tolerated by patients. Over 95% of treatment-emergent adverse events reported were low grade 1 or 2, primarily indicating localized pain, fatigue, and nausea.