INTENSITY THERAPEUTICS INC Stock Price, News & Analysis

Intensity Therapeutics (INTS) presented Phase 1/2 data for INT230-6 in sarcoma patients and provided an overview of its ongoing Phase 3 INVINCIBLE-3 Study. The Phase 1/2 trial showed a median overall survival of 21.3 months versus 6.7 months in the control group, with increased T-cell activation and favorable safety profile. The global Phase 3 study aims to enroll 333 patients with various sarcoma types across multiple countries. Key Phase 1/2 results included a 93.3% disease control rate at 2 months and 27% of patients showing shrinkage in uninjected tumors. The drug demonstrated good tolerability with only 20% of subjects experiencing Grade 3 adverse events.

Intensity Therapeutics (INTS) reports Q3 2024 financial results and provides updates on two clinical trials. The company's net loss increased to $3.5 million from $2.3 million year-over-year. R&D expenses rose to $2.2 million from $1.4 million, while G&A expenses increased to $1.4 million from $1.1 million. Cash position stands at $2.8 million, expected to fund operations into Q1 2025.

The company achieved regulatory authorizations in multiple countries for its Phase 3 INVINCIBLE-3 study in soft tissue sarcoma and Phase 2 INVINCIBLE-4 study in triple-negative breast cancer. The first patient was dosed in the INVINCIBLE-4 study in October 2024.

Intensity Therapeutics (Nasdaq: INTS) announced its selection for an oral podium presentation at the 2024 Connective Tissue Oncology Society (CTOS) meeting. Dr. Christian F. Meyer will present the completed Phase 2 results and the INVINCIBLE-3 Phase 3 randomized soft tissue sarcoma trial design on November 16, 2024, in San Diego. The presentation will focus on their intratumoral INT230-6 treatment compared to standard care therapy in metastatic soft tissue sarcomas. The study involves a combination of SHAO, vinblastine, and cisplatin as treatment components.

Intensity Therapeutics (INTS) and The Swiss Group for Clinical Cancer Research SAKK announce the first patient dosed in their Phase 2 INVINCIBLE-4 clinical trial. The study evaluates INT230-6 combined with standard-of-care (SOC) versus SOC alone in treating triple-negative breast cancer (TNBC). The randomized trial will enroll approximately 54 patients in Switzerland and France, focusing on pathological complete response rates. Patients will receive either two doses of INT230-6 followed by SOC (pembrolizumab, anthracyclines, carboplatin, cyclophosphamide, and paclitaxel) or SOC alone. The initiation follows promising data from INVINCIBLE-2, where INT230-6 showed >95% tumor-killing properties with a single dose.

Intensity Therapeutics (Nasdaq: INTS), a late-stage clinical biotechnology company, will present at the H.C. Wainwright 26th Annual Global Investment Conference on September 11, 2024. The event will be held at the Lotte New York Palace Hotel from September 9-11, 2024.

Lewis H. Bender, Founder, President and CEO, will deliver a corporate overview at 11:30 AM ET. The presentation will be available via live webcast and archived for approximately 90 days on the company's investor relations website. Joseph Talamo, CFO, will join Bender for one-on-one meetings throughout the conference.

Intensity Therapeutics focuses on developing novel immune-based intratumoral cancer therapies designed to kill tumors and enhance immune system recognition of cancers.

Intensity Therapeutics (INTS) reported Q2 2024 financial results and provided a corporate update. Key highlights include:

1. Initiated Phase 3 INVINCIBLE-3 Study for INT230-6 in soft tissue sarcoma, with first patient dosed.

2. Collaboration with SAKK for Phase 2 INVINCIBLE-4 Study in early-stage breast cancer.

3. Appointed Thomas Dubin to the board of directors.

4. Q2 2024 financials: R&D expenses $3.6M, G&A expenses $1.5M, net loss $5.0M.

5. Cash position of $6.3M, expected to fund operations into Q1 2025.

Intensity Therapeutics (Nasdaq: INTS) has announced the dosing of the first U.S. patient in its global Phase 3 study (INVINCIBLE-3) for metastatic soft tissue sarcoma using its lead product candidate, INT230-6, as a monotherapy. This trial will compare INT230-6 against standard-of-care chemotherapy in second and third-line treatments. The study will enroll approximately 333 patients across multiple countries. Phase 1/2 trials showed promising tumor-killing and immune-activating properties, with a median overall survival of 21.3 months. Regulatory filings for trial initiation have been submitted in Canada and Europe.

Intensity Therapeutics announced the appointment of Thomas Dubin to its Board of Directors, effective May 14, 2024. Dubin, who brings extensive experience in pharmaceutical business development, regulatory, and commercialization, will serve on the Audit Committee. This appointment expands the board from four to five directors, with four being independent. Dubin's background includes leadership roles at Alexion Pharmaceuticals, ChiRex, and various advisory positions. His expertise is expected to bolster Intensity Therapeutics as it advances into Phase 3 clinical trials for its cancer treatment, INT230-6.

Intensity Therapeutics, Inc. collaborates with SAKK to conduct a Phase 2 clinical trial in Europe for INT230-6 in early-stage breast cancer. The study aims to evaluate the effects of INT230-6 in combination with standard care in TNBC patients.