Bio-Thera Solutions Announces Positive Phase 1 Clinical Data for BAT8006 (Folate… – Press Release

GUANGZHOU, China, Aug. 12, 2023 /PRNewswire/ — Bio-Thera Solutions, Ltd (688177:SH), a commercial-stage biopharmaceutical company developing a pipeline of innovative assets and biosimilars, today announced positive Phase 1 clinical data for BAT8006 (Folate-Receptor-α-ADC) as part of a presentation of the clinical results of a Phase 1 dose escalation study evaluating the safety and efficacy of BAT8006 at the Bethune Obstetrics and Gynecology Forum in China. BAT8006 is an antibody-drug conjugate (ADC) that is composed of an anti-FRα antibody and an ADC linker-payload combination that is composed of a proprietary cleavable linker that is highly systemically stable and a small molecule topoisomerase I inhibitor.

As a co-principal investigator of the BAT8006 Phase 1 study that was performed at First Bethune Hospital of Jilin University, Professor Songling Zhang presented dose-escalation results from the study at the Bethune Obstetrics and Gynecology Forum. July 6, 2023 served as the cut-off date for the data presented at the conference. At that time twenty-nine (29) subjects with advanced solid tumors were recruited into four (4) dose cohorts (1.2 mg/kg, 1.8 mg/kg, 2.1 mg/kg and 2.4 mg/kg) in the dose-escalation study. FRα expression was not an eligibility criterion in the study and patients with multiple tumor types, such as ovarian cancer, breast cancer, non-small cell lung cancer (NSCLC) and cervical cancer, were include in the study. Ovarian cancer patients accounted for approximately 60% of the subjects in the study.

All twenty-nine (29) subjects enrolled in the study (regardless of tumor type) had at least one tumor assessment with an Overall Objective Response Rate (ORR) of 31.0% and a Disease Control Rate (DCR) of 86.2%. For the ovarian cancer subgroup fifteen (15) subjects were recruited in the 2.1 mg/kg and 2.4 mg/kg cohorts. Among the twelve (12) ovarian cancer subjects with TPS >25%, the ORR was 58.3% and the DCR was 91.7%. Based on FRα expression…