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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 (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.
Intensity Therapeutics, Inc. reported its first quarter 2024 financial results, highlighting the advancement of its lead drug candidate, INT230-6, into late-stage clinical programs for sarcoma and breast cancer. The company plans to initiate Phase 3 and Phase 2/3 studies for INT230-6 in mid-2024. Intensity Therapeutics also disclosed cash and investments of $10.5 million, expected to fund operations through the first quarter of 2025.
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