China-based Bio-Thera Solutions, a clinical-stage biopharmaceutical company developing a pipeline of innovative therapies and a pipeline of biosimilars, 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, BAT8003, as a therapeutic agent for the treatment of Trop2 positive cancers.

BAT8003 is an investigational Trop2-ADC being evaluated in multiple tumor types. the novel agent uses 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 drug to antibody ratio (DAR) providing a more homogenous product.

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The linker is non-cleavable ensuring superior delivery of the payload to the cancer cells and improving the safety profile of the ADC.

The investigational agent is designed for the treatment of Trop2 positive cancers
Trop2, also known as tumor-associated calcium signal transducer 2 and trophoblast cell surface antigen 2, is a transmembrane glycoprotein that functions as an intracellular calcium signal transducer. It signals cells for self-renewal, proliferation and invasion. While Trop2 is expressed in some normal tissues at low levels, Trop2 is overexpressed in many types of cancers and the overexpression of Trop2 is of prognostic significance.

Phase I trial
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.

The primary objective of the dose expansion cohort is to confirm the safety and clinical activity of BAT8003 in patients with Trop2 positive cancers, which include triple negative breast cancer (TNBC) and gastric cancer.

“The filing of this IND for our novel Trop2-ADC is a significant achievement for Bio-Thera Solutions,” said Shengfeng Li, Ph.D, the Chief Executive Officer of 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,” Li concluded.