Intensity Therapeutics (INTS) investor relations material

Study background and technology

• INT230-6 combines SHAO, cisplatin, and vinblastine for intratumoral delivery to enhance tumor penetration and immune activation.

• The formulation allows personalized dosing based on tumor burden, aiming to maximize local effect and minimize systemic toxicity.

• Preclinical studies showed both direct tumor killing and immune activation, with systemic anti-tumor effects observed.

Study design and patient population

• Phase 1/2 open-label, single-arm study (IT-01) evaluated INT230-6 in adults with advanced, refractory, or metastatic solid tumors across six clinical sites.

• Patients had over 20 different cancer types, most with multiple prior therapies, and tumors accessible for direct injection; sarcoma was the most common.

• Dose escalation involved increasing total injected volume, frequency, and number of tumors treated per session, with six monotherapy cohorts and maintenance dosing added.

• Dosing was adjusted to a 1:3 ratio every 14 days, with a maximum of 175 mL per session.

Safety and pharmacokinetics

• INT230-6 showed high tumor retention, with over 95% of active drugs remaining in the tumor and minimal systemic exposure.

• No dose-limiting toxicities or grade 4/5 adverse events were reported; 10.9% of patients experienced grade 3 adverse events, with most common side effects being injection site pain, fatigue, and mild nausea.

• The favorable safety profile is attributed to local retention of the drug via proprietary DfuseRxSM technology.

• Safety profile was favorable compared to systemic administration of cisplatin and vinblastine.