Bio-Thera Solutions announced the company has filed an Investigational New Drug Application (IND) with the China National Medical Products Administration (NMPA) for the company's anti-Trop2 Antibody-Drug Conjugate (ADC), BAT8003, as a therapeutic agent for the treatment of Trop2 positive cancers. Subject to NMPA acceptance, Bio-Thera Solutions plans to initiate the Phase I clinical trial early in 2019.

The planned Phase I trial will evaluate the safety, tolerability and pharmacokinetics of BAT8003 as a single agent in subjects with Trop2 positive cancers. The first cohort of patients in the planned clinical trial will be enrolled in a standard [3+3] dose escalation regimen to assess safety and pharmacokinetics and to determine maximum tolerated dose of BAT8003. Multiple dose expansion cohorts are planned with patients with Trop2 positive cancers, such as triple negative breast cancer and gastric cancer. The primary objective of the dose expansion cohort is to confirm the safety and clinical activity of BAT8003 in patients with Trop2 positive cancers.

"The filing of this IND for our novel Trop2-ADC is a significant achievement for Bio-Thera Solutions," said Dr. Shengfeng Li, CEO, Bio-Thera Solutions. "Pending NMPA acceptance of the IND, we will begin the dose escalation portion of this Phase I trial early in 2019 and anticipate reporting on the early safety assessment and determination of a maximum tolerated dose in mid-year 2019."

BAT8003 is an investigational Trop2-ADC being evaluated in multiple tumor types. BAT8003 utilizes Bio-Thera Solutions’ proprietary linker-payload combination, Batansine. The antibody component of the BAT8003 is engineered for site-specific conjugation to allow for better control of the ADC DAR providing a more homogenous product. The linker is non-cleavable ensuring superior delivery of the payload to the cancer cells and improving the safety profile of the ADC. BAT8003 is being developed for use as a single agent and in combination with other agents for the treatment of Trop2 positive cancers.

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