Intensity Therapeutics, Inc., a clinical-stage biotechnology company developing proprietary technology and products to kill tumors and increase immune cell recognition of solid tumor cancers, today announced the receipt of patents protecting the Company’s technology and its lead product candidate, INT230-6, in China, Japan, Korea, Russia and Australia. All five countries have granted the Company a patent with multiple claims.
INT230-6, which was discovered using Intensity’s proprietary DfuseRxSM technology platform, is comprised of two proven, potent anti-cancer agents and a unique molecule that causes rapid drug dispersion throughout tumors and diffusion into cancer cells.
“We are pleased to expand our global IP portfolio with the issuance of five patents for INT230-6 in key Asian countries and Australia,” said Lewis H. Bender, Founder and CEO of Intensity Therapeutics. “Cancer is the leading cause of mortality in China with nearly 3 million deaths per year and a major public health problem, underscoring the potential impact of INT230-6 and the importance of protecting our novel technology in significant global markets. We continue to prosecute patent applications in the U.S. and countries around the world to further strengthen our IP position and secure our unique technology and treatment for solid tumor cancers.”
INT230-6 is currently being evaluated in a Phase 1/2 clinical study in patients with various types of advanced solid tumors at multiple centers in the U.S. Intensity plans to add more North American clinical sites, as well as international sites, to the study. The Company also plans to add combination arms in the study with an anti-PD-1 antibody.
As reported at the European Society for Medical Oncology (ESMO) 2018 Congress and the Society for Immunotherapy of Cancer’s (SITC’s) 33rd Annual Meeting, preliminary data from the Phase 1/2 study has demonstrated that INT230-6 is well tolerated with no drug-related serious adverse events or dose-limiting toxicity, indicating that INT230-6 can be safely injected, even into deep tumors. Preclinical research has highlighted the ability of INT230-6 to disperse and thoroughly saturate a tumor when administered at the proper dose-to-tumor volume ratio. In addition, preclinical data has shown INT230-6 induces a strong adaptive immune response to attack non-injected tumors and metastases.
INT230-6, Intensity’s lead product candidate designed for direct intratumoral injection, is comprised of two proven, potent anti-cancer agents and a penetration enhancer molecule that helps disperse the drugs throughout tumors and diffuse into cancer cells. INT230-6 is being evaluated in a Phase 1/2 clinical study (NCT03058289) in patients with various advanced solid tumors. In preclinical studies, INT230-6 eradicated tumors by a combination of direct tumor kill and recruitment of dendritic cells to the tumor micro-environment that induced anti-cancer T-cell activation. Treatment with INT230-6 in in vivo models of severe cancer resulted in substantial improvement in overall survival compared to standard therapies. Further, INT230-6 provided complete responder animals with long-term, durable protection from multiple re-inoculations of the initial cancer and resistance to other cancers. In mouse models, INT230-6 has shown strong synergy with checkpoint blockage, including anti-PD-1 and anti-CTLA4 antibodies. INT230-6 was discovered from Intensity’s DfuseRxSM platform.
About Intensity Therapeutics
Intensity Therapeutics, Inc. is a clinical-stage biotechnology company pioneering a new immune-based approach to treat solid tumor cancers. Intensity leverages its DfuseRxSM technology platform to create new drug formulations that, following direct injection, rapidly disperse throughout a tumor and diffuse therapeutic agents into cancer cells. Intensity’s product candidates have the potential to induce an adaptive immune response that not only attacks the injected tumor, but also non-injected tumors and unseen micro-metastases. INT230-6, Intensity’s lead product candidate, is being evaluated in a Phase 1/2 clinical study in patients with various advanced solid tumors. For more information, please visit www.intensitytherapeutics.com and follow us on Twitter @IntensityInc.
Forward Looking Statements
This press release contains forward-looking statements regarding Intensity Therapeutics’ plans, future operations and objectives. Such statements involve known and unknown risks, uncertainties and other factors that may cause actual performance or achievements to be materially different from those currently anticipated. These forward-looking statements include, among other things, statements about the initiation and timing of future clinical trials.