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Intensity Therapeutics, Inc. (Nasdaq: INTS) is a late-stage clinical biotechnology company focused on proprietary, immune-based intratumoral cancer therapies. News about Intensity centers on the clinical development of its lead investigational product candidate, INT230-6, corporate milestones, capital raises, and interactions with regulators and the Nasdaq Capital Market.
Company press releases frequently highlight progress in key clinical programs. These include the Phase 3 INVINCIBLE-3 study in specific soft tissue sarcoma subtypes, where INT230-6 is tested as second- or third-line monotherapy against standard-of-care drugs, and the Phase 2 INVINCIBLE-4 study in presurgical triple-negative breast cancer, which evaluates INT230-6 followed by standard-of-care immunochemotherapy versus standard of care alone with pathological complete response as the primary endpoint. Updates have covered enrollment status, dosing regimen adjustments, early safety observations, and notable findings such as a pathological complete response in the first evaluated patient in the INT230-6 cohort of INVINCIBLE-4.
News flow also includes scientific and medical communications, such as publication of the IT-01 Phase 1/2 study results in eBioMedicine, a Lancet Discovery Science journal, and presentations or posters at major oncology meetings like the San Antonio Breast Cancer Symposium. These items describe disease control rates, overall survival data, abscopal effects, immune activation, and pharmacokinetic findings for INT230-6 in advanced solid tumors.
Investors following INTS can also expect announcements on financial results, registered direct offerings, at-the-market equity sales, and updates on cash runway. Additional disclosures cover Nasdaq listing matters, including extensions to regain compliance with minimum bid price rules and stockholder votes on potential reverse stock splits. For those tracking Intensity Therapeutics, this news page provides a centralized view of clinical, scientific, financial, and regulatory developments related to the company and its intratumoral oncology pipeline.
Intensity Therapeutics (NASDAQ: INTS) and The Swiss Group for Clinical Cancer Research (SAKK) have received EMA authorization to expand their INVINCIBLE-4 Phase 2 study for INT230-6 into France. The study evaluates INT230-6 in early-stage, operable triple-negative breast cancer (TNBC) patients.
The trial, currently active in Switzerland, will randomize 54 patients to receive either two doses of INT230-6 followed by standard of care (SOC) immunochemotherapy, or SOC alone. The primary endpoint is pathological complete response in the tumor and affected lymph nodes. Initial results show promising tumor necrosis and inflammation after INT230-6 treatment. The expansion into France through Unicancer is expected to accelerate enrollment starting Q2 2025.
Intensity Therapeutics (NASDAQ: INTS) has announced a public offering priced at $0.75 per share, aiming to raise $2.35 million in gross proceeds. The offering includes 3,133,333 shares of common stock with accompanying Series B-1 and B-2 warrants.
The Series B-1 warrants have a 5-year term while Series B-2 warrants expire in 18 months, both with an exercise price of $0.85 per share. The offering, expected to close around April 28, 2025, is led by A.G.P./Alliance Global Partners with Brookline Capital Markets as co-placement agent.
The company plans to use the proceeds for patient enrollment in the INVINCIBLE-4 Study, treatment of existing patients in the INVINCIBLE-3 Study, and working capital purposes.
Intensity Therapeutics (NASDAQ: INTS) has reported its 2024 year-end financial results and provided updates on two key clinical trials. The company's INVINCIBLE-3 Phase 3 study has contracted 32 sites and screened 25 patients, testing INT230-6 as monotherapy for soft tissue sarcoma subtypes. The study aims to enroll 333 patients across eight countries.
The INVINCIBLE-4 Phase 2 study for triple-negative breast cancer has activated eight Swiss sites and treated several patients, with plans to expand to France. The company expects to complete enrollment for INVINCIBLE-3 in H1 2026 and INVINCIBLE-4 by Q1 2026.
Financial results show R&D expenses increased to $10.5M from $4.8M in 2023, while G&A expenses rose to $6.1M from $3.5M. The company reported a net loss of $16.3M for 2024, compared to $10.5M in 2023. Cash and cash equivalents stood at $2.6M as of December 31, 2024.
Intensity Therapeutics (INTS) announces that the Data Monitoring Committee (DMC) has authorized the continuation of its Phase 3 INVINCIBLE-3 sarcoma trial for INT230-6 without modifications following a periodic review of data from July to December 2024.
The INVINCIBLE-3 Study is a global open-label, randomized, controlled study comparing intratumoral INT230-6 administration to standard chemotherapy in approximately 333 adult patients with soft tissue sarcoma (STS). The trial focuses on patients with leiomyosarcoma, liposarcoma, and undifferentiated pleomorphic sarcoma who experienced disease progression after standard therapies.
The study's primary endpoints are overall survival and safety, with an exploratory quality of life assessment. The trial has received authorizations in the U.S., Canada, Europe, and Australia, and is currently recruiting participants across these regions.
Intensity Therapeutics (NASDAQ: INTS) provided updates on its lead drug candidate INT230-6's clinical development. The company's global Phase 3 study (INVINCIBLE-3) for Metastatic Soft Tissue Sarcoma has been authorized by major regulatory agencies, with 23 sites contracted and actively treating patients. Additionally, seven Swiss sites are participating in the Phase 2 (INVINCIBLE-4) study for early-stage Triple Negative Breast Cancer (TNBC).
The INVINCIBLE-3 study, initiated in July 2024, compares INT230-6 monotherapy to standard of care in second and third-line sarcoma treatment, targeting 333 patients across eight countries. Phase 1/2 data showed promising results with median overall survival of 21.3 months versus 6.7 months in the control group.
The INVINCIBLE-4 study, launched in October 2024, focuses on early-stage TNBC patients, with previous Phase 2 data showing over 95% tumor-killing properties in some patients and significant necrosis in 74% of subjects with tumors larger than 2cm.
Intensity Therapeutics (INTS) and SAKK presented Phase 2 data from the INVINCIBLE-2 study and provided updates on the ongoing INVINCIBLE-4 trial at the 2024 San Antonio Breast Cancer Symposium. The INVINCIBLE-4 study is a randomized trial evaluating INT230-6 in early-stage Triple Negative Breast Cancer (TNBC) patients, comparing standard of care (SOC) plus INT230-6 versus SOC alone. The trial aims to enroll 54 patients across seven Swiss sites.
The completed INVINCIBLE-2 study demonstrated that INT230-6 achieved >95% tumor killing in some patients with a single dose, with 74% of subjects showing significant necrosis in tumors larger than 2cm. The treatment showed favorable safety profiles and increased immune system activation, including enhanced T-cell and NK cell presence within tumors.
Intensity Therapeutics (INTS) has announced a $3 million registered direct offering and concurrent private placement. The company will issue 1,237,113 shares of common stock at $2.425 per share in a registered direct offering, along with warrants to purchase an equal number of shares at $2.95 per share in a private placement. The warrants will be exercisable after six months and expire in 5.5 years. The proceeds will be used for general working capital. A.G.P./Alliance Global Partners is leading the placement, with Brookline Capital Markets as co-placement agent. The offerings are expected to close around November 22, 2024.
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.
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