Intensity Therapeutics Secures New US Patent for Intratumoral Cancer Technology
Key Insights
Intensity Therapeutics received US Patent Number 12,496,345 for its intratumoral cancer treatment method, expanding its intellectual property portfolio to 19 issued patents across 41 countries.
The company's lead compound INT230-6 combines cisplatin and vinblastine sulfate with a proprietary diffusion enhancer to deliver cytotoxic agents directly into tumors while triggering immune responses.
Clinical trials have enrolled over 200 patients, with ongoing Phase 3 studies in soft tissue sarcoma and Phase 2 trials in triple-negative breast cancer showing the technology's potential to transform cancer treatment paradigms.
Intensity Therapeutics has strengthened its intellectual property position with the issuance of US Patent Number 12,496,345, entitled "A Method of Treating Cancer," which was granted in December 2025. The patent protects the company's novel intratumoral technology platform and its lead compound INT230-6, bringing the company's total patent portfolio to 19 issued patents with protection in 41 countries.
"The issuance of this new patent supports the novelty of our unique technology in the U.S. and around the world," said Lewis H. Bender, Founder, President & CEO of Intensity Therapeutics. "The Company now has four U.S. patents and one pending U.S. patent application. We have protection in 41 countries, including our European patent, which is validated in 27 countries."
Comprehensive Global Patent Protection
The company's intellectual property portfolio now includes four US patents, with the newest patent having a registration date of December 16, 2025, and an expiration date of September 15, 2033. The comprehensive patent protection extends across major pharmaceutical markets including Australia, Brazil, Canada, China, 27 European countries, India, Israel, Japan, Mexico, Russia, Singapore, South Africa, and South Korea.
In addition to patent protection, the company has received Orphan drug status for the three main components of INT230-6, which provides seven additional years of market exclusivity post-approval. The technology underlying the patents has been developed internally by Intensity and was not acquired through in-licensing from third parties.
Revolutionary Intratumoral Technology Platform
INT230-6, discovered using Intensity's proprietary DfuseRx™ technology platform, represents a novel approach to cancer treatment through direct intratumoral injection. The drug consists of two proven anti-cancer agents, cisplatin and vinblastine sulfate, combined with a diffusion and cell penetration enhancer molecule called "SHAO" that non-covalently conjugates to the payload drugs.
This innovative formulation enables the dispersion of potent cytotoxic drugs throughout tumors while allowing active agents to diffuse into cancer cells. The agents remain localized within the tumor, resulting in a favorable safety profile compared to systemic chemotherapy approaches.
Dual Mechanism of Action
Beyond direct tumor killing and local disease control, INT230-6 triggers the release of neoantigens specific to the malignancy, leading to immune system engagement and systemic anti-tumor effects. Importantly, these effects occur without the immunosuppression commonly associated with systemic chemotherapy.
The company's engineered chemistry enables aqueous cytotoxic-containing drug formulations to mix and saturate a tumor's dense, high-fat, pressurized environment following direct intratumoral injection. Clinical trials have demonstrated INT230-6's ability to kill tumors and elicit an adaptive immune response within days of injection.
Extensive Clinical Development Program
Intensity has completed two clinical studies enrolling over 200 patients using INT230-6. The first was a Phase 1/2 dose escalation study in metastatic cancers including sarcomas (NCT03058289), and the second was a Phase 2 randomized controlled clinical trial in locally advanced breast cancer called the "INVINCIBLE-2 Study" (NCT04781725) in women without prior chemotherapy before surgery.
The company has initiated a Phase 3 trial in soft tissue sarcoma, the "INVINCIBLE-3 Study" (NCT06263231), testing INT230-6 as second or third-line monotherapy compared to standard of care with overall survival as the primary endpoint. Additionally, Intensity launched a Phase 2 study in collaboration with The Swiss Group for Clinical Cancer Research, now the Swiss Cancer Institute, called the "INVINCIBLE-4 Study" (NCT06358573).
The INVINCIBLE-4 study is part of a Phase 2/3 program evaluating INT230-6 followed by standard of care immunochemotherapy compared to standard of care alone for patients with presurgical triple-negative breast cancer, with pathological complete response rate as the endpoint.
Paradigm-Shifting Potential
According to the company, this new approach to cancer cell death holds the potential to shift the treatment paradigm and turn many deadly cancers into chronic diseases, even for malignancies that do not respond to conventional immunotherapy. The technology represents a significant advancement in addressing cancers through localized delivery combined with systemic immune activation.