Positive Phase 1/2 Clinical Data for Cancer Candidate Drug Sends Intensity Therapeutics (INTS.US) Soaring 395%

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Biopharmaceutical company Intensity Therapeutics (INTS.US), with a market capitalization of approximately $13 million, saw its stock surge nearly 395% at Thursday's close after announcing Phase 1/2 clinical trial results for its metastatic or refractory cancer candidate drug, INT230-6.

**Mechanism and Clinical Data Highlights** INT230-6 is administered via direct intratumoral injection, enabling the diffusion of cytotoxic agents cisplatin and vinblastine sulfate. The drug also incorporates a cell-penetrating enhancer molecule ("SHAO") that binds to these chemotherapy drugs. The company reported an increase in activated CD4+ and CD8+ T cells within the tumor microenvironment.

**Key Clinical Findings** The study involved 64 patients with over 20 different cancer types, all of whom had undergone extensive prior treatments (i.e., disease progression or intolerance after multiple lines of therapy). The disease control rate reached 75%. The median overall survival (mOS) was 11.9 months for the overall patient cohort, with a metastatic sarcoma subgroup achieving an mOS of 21.3 months.

**Safety Profile** No Grade 4 or 5 treatment-related adverse events (most severe) were reported, and only seven patients experienced Grade 3 adverse events. No dose-limiting toxicities were observed.

Lewis Bender, CEO and founder of Intensity Therapeutics, stated, "The market’s positive response to these data underscores the resonance of this research area—solid tumor therapy—and potentially our approach. These early results demonstrate the promise of a novel cancer treatment that could benefit more patients."

**Collaborative Developments** The company has partnered with Merck (MRK.US) and Bristol-Myers Squibb (BMY.US) to explore combination therapies involving INT230-6 with Keytruda (pembrolizumab) and Yervoy (ipilimumab), respectively.

A conference call to discuss the trial results is scheduled for October 31 at 9:00 AM ET. The findings have been published in the journal *eBioMedicine*.

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