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Intensity Therapeutics, Inc. (Nasdaq: INTS) is a Connecticut-based, clinical-stage biotechnology company pioneering new immune-based therapies to treat solid tumor cancers. Utilizing its proprietary DfuseRx℠ technology platform, Intensity Therapeutics develops unique drug formulations designed for direct intratumoral injection. These formulations disperse rapidly throughout a tumor, diffusing therapeutic agents into cancer cells to induce an adaptive systemic immune response. This innovative approach not only targets the injected tumors but also non-injected tumors, offering significant potential for cancer treatment.
The company's flagship candidate, INT230-6, is an investigational product composed of two potent anti-cancer agents, cisplatin and vinblastine, combined with a penetration enhancer molecule (SHAO). This combination allows the drug to saturate tumors, promoting local disease control and systemic anti-tumor effects without the immunosuppression often seen with systemic chemotherapy.
Intensity's product pipeline is robust, with a strong focus on the development and clinical testing of INT230-6. The company has completed enrollment for its Phase 1/2 clinical trial (IT-01), showcasing extended survival in refractory soft tissue sarcoma patients. The ongoing and planned trials include:
- Phase 3 study (INVINCIBLE-3) in soft tissue sarcoma, expected to start mid-2024, which will compare INT230-6 as a monotherapy against standard of care drugs.
- Phase 2/3 program (INVINCIBLE-4) in presurgical breast cancer, anticipated to initiate in mid-2024, evaluating INT230-6 combined with standard of care.
Additionally, INT230-6 is being explored in combination therapies through collaborations with major pharmaceutical companies, including Merck and Bristol-Myers Squibb, to evaluate its effectiveness with KEYTRUDA® (pembrolizumab) and ipilimumab, respectively.
Intensity Therapeutics has received multiple platform validations and support, demonstrated by its FDA orphan-drug designation for soft tissue sarcoma treatment and its successful upsized IPO in July 2023. The company continues to advance its mission, with a strong financial position and sufficient cash reserves expected to fund operations into 2025.
For more information about Intensity Therapeutics and its groundbreaking approach to cancer treatment, visit www.intensitytherapeutics.com and follow them on Twitter @IntensityInc.
Intensity Therapeutics presented promising results from the INVINCIBLE study at the San Antonio Breast Cancer Symposium. In this Phase 2 trial, the drug INT230-6 achieved up to 100% tumor necrosis in patients with early-stage breast cancer, demonstrating significant immune response activation. The study involved 91 participants and highlighted INT230-6's potential as a pre-surgical treatment with manageable adverse effects. The data is bound to impact future cancer therapy approaches and reinforces the company's pioneering position in immune-based cancer treatments.
Intensity Therapeutics announced data from its ongoing Phase 1/2 study of INT230-6 presented at the CTOS Annual Meeting. Preliminary findings indicate that administering INT230-6 either alone or in combination with ipilimumab improves median overall survival (mOS) in patients with refractory sarcomas. Patients receiving a cumulative dose equivalent to 40% or more of their tumor burden exhibited an mOS of 715 days, compared to historical controls at 205 days. The results suggest favorable safety, supporting the potential of INT230-6 in treating metastatic sarcomas.
Intensity Therapeutics announced promising results from its phase 1/2 trial involving the cancer treatment INT230-6. Patients receiving INT230-6 alone had a median overall survival (mOS) of 373 days, significantly longer compared to historical data. In combination with pembrolizumab, the mOS was 205 days in a heavily pretreated patient group. The treatment has shown good tolerability and efficacy, inducing both tumor cell death and immune activation. Results will be presented at the SITC Annual Meeting, indicating ongoing research towards potential commercialization.
Intensity Therapeutics announced positive data from the INVINCIBLE study, showcasing significant tumor necrosis in early-stage breast cancers resistant to chemotherapy. The trial utilized INT230-6, which demonstrated up to 100% necrosis from a single injection, alongside increased immune cell activity in the tumor microenvironment. No surgical procedures were canceled or delayed due to the treatment. Results will be presented at the 2022 SITC Annual Meeting, indicating INT230-6's potential to alter treatment paradigms for patients awaiting surgery.
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