18 September 2020 - - The first patient has been dosed with a combination of INT230-6, US-based clinical-stage biotechnology company Intensity Therapeutics, Inc's lead investigational product, and Yervoy (ipilimumab), Bristol Myers Squibb's (NYSE: BMY) Cytotoxic T Lymphocyte-Associated Antigen 4 (CTLA-4) immune checkpoint inhibitor therapy in Phase 2, Intensity said.

The combination is being studied in a series of phase 2 expansion cohorts within IT-01, Intensity's ongoing international clinical study (NCT03058289), which evaluates the safety and efficacy of the combination in patients with three different types of cancer (breast cancer, liver cancer, and sarcoma).

INT230-6, Intensity's lead proprietary product candidate, is designed for direct intratumoral injection. INT230-6 was discovered using Intensity's proprietary DfuseRxSM technology platform.

The drug is comprised of two proven, potent anti-cancer agents, cisplatin and vinblastine, and a penetration enhancer molecule that helps disperse the drugs throughout tumors for diffusion into cancer cells.

In preclinical studies, INT230-6 eradicated tumors by a combination of direct tumor killing, release of tumor antigens and recruitment of immune cells to the tumor.

Results generated by both the company and the National Cancer Institute showed 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 responses in animals with long-term protection from multiple re-challenges of the initial cancer and resistance to other cancers.

The company's research published in the International Journal of Molecular Sciences earlier this year and published jointly with the NCI as part of Intensity's collaborative research, published in July 2019 in the Journal OncoImmunology, also showed strong synergy when INT230-6 was combined with anti-PD-1 and anti-CTLA-4 antibodies.

INT230-6 is being evaluated in a Phase 1/2 clinical study (NCT03058289) in patients with various advanced solid tumors.

There have been no dose limiting adverse events observed in patients to date, even when dosing into deep tumors in the lung and liver.

Several patients demonstrated tumor shrinkage, symptomatic improvement, and evidence of cancer cell death and immune cell activation on tumor biopsy.

In the combination cohort with pembrolizumab the company reported the safety of the combination was comparable to INT230-6 monotherapy.

Intensity Therapeutics, Inc. is a privately held, clinical-stage biotechnology company pioneering a new immune-based approach to treat solid tumor cancers.

Intensity leverages its DfuseRx technology platform to create new, proprietary 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.

The company executed a Cooperative Research and Development Agreement (CRADA) with the National Cancer Institute's Vaccine Branch in 2014.

The company has a clinical collaboration with Merck Sharpe and Dohme (Merck) to evaluate the combination of INT230-6, Intensity's lead product candidate, and KEYTRUDA (pembrolizumab), Merck's anti-PD-1 (programmed death receptor-1) therapy, in patients with advanced solid malignancies.

The company also has a clinical collaboration with Bristol Myers Squibb to evaluate the combination of the company's lead product, INT230-6, with BMS's anti-CTLA-4 antibody, Yervoy (ipilimumab), in patients with advanced solid malignancies.