Bio-Thera Solutions, a clinical-stage biopharmaceutical company developing a pipeline of innovative therapies and a pipeline of biosimilars, today 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 pharmcokinetics 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.

About BAT8003

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.

About the Trop2 Receptor

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.

About Antibody-Drug Conjugates

Antibody-drug Conjugates or ADCs are designed to harness the targeting ability of monoclonal antibodies (mAbs) to deliver cytotoxic agents selectively to tumor cells by linking the monoclonal antibody and cytotoxic agent through a chemical linker.  An ideal ADC consists of: 1) a highly selective mAb for a tumor-associated antigen that has little or no expression on normal cells, 2) a potent cytotoxic agent designed to induce target cell death after being internalized in the tumor cell and released and 3) a chemical linker that is stable in circulation but releases the cytotoxic agent in target cells.  By selectively delivering a cytotoxic agent directly inside a tumor cell, ADCs increase the safety and tolerability of the cytotoxic agent relative to giving the cytotoxic agent systemically to the patient.