Adaptin Bio (OTCQB: APTN) announced the opening of enrollment for a first-in-human, open-label, dose-escalation Phase 1 clinical trial of its BRiTE (Brain Bispecific T cell Engager) therapeutic APTN-101 in adults with WHO Grade IV malignant glioma (EGFRvIII+ glioblastoma) at Duke University.
The study plans to enroll up to 15 patients, with primary objectives to assess safety and determine the maximum tolerated dose based on dose-limiting toxicities. Secondary endpoints include pharmacokinetics and objective response rate, while exploratory endpoints cover cytokine changes, anti-BRiTE antibodies, overall survival and progression-free survival. According to Adaptin Bio, preclinical models showed over 7-fold higher brain distribution versus an EGFRvIII T-cell engager alone and complete eradication of EGFRvIII GBM tumors in 70–80% of mice, with a favorable safety profile.
Adaptin Bio (OTCQB: APTN) announced that its common stock has begun trading on the OTCQB Venture Market under ticker APTN. OTCQB trading is expected to increase U.S. investor access, improve liquidity, and enhance visibility.
The company’s lead candidate APTN-101 is expected to enter a Phase 1 clinical trial shortly, supporting its focus on precision cancer therapeutics targeting the brain and other hard-to-reach tissues.