Bio-Thera Solutions Presents BAT8006 Data at 2024 ASCO Meeting

GUANGZHOU, China, June 2, 2024 – Bio-Thera Solutions Inc., a biopharmaceutical company focused on innovative therapies and biosimilars, will showcase a poster at the 2024 ASCO Annual Meeting. The poster, titled "Phase 1 study of BAT8006, a folate receptor α antibody drug conjugate with strong bystander effect, in subjects with advanced solid tumors," emphasizes the promising efficacy and safety profile of BAT8006 for ovarian cancer and other FRα-expressing tumors. This data will be accessible on the company’s website following the presentation.

Clinical Study Overview

As of May 8, 2024, the phase 1 study involved 156 patients with advanced solid tumors. In the 84 and 93 mg/m^2 dose cohorts, 3.5% and 3.9% of patients required a dose reduction, while 5.3% and 13.7% faced treatment interruptions, respectively. Importantly, no deaths or severe adverse effects such as ILD/pneumonitis or ocular issues were reported. Hematological toxicity emerged as the primary treatment-related adverse event (TRAE). The optimal dosages of 84 and 93 mg/m^2 were chosen based on their safety profiles, with Grade 3 or higher thrombocytopenia and neutropenia incidences of 9% versus 28% and 19% versus 37%, respectively.

Efficacy in Ovarian Cancer

The trial included 54 patients with platinum-resistant or refractory epithelial ovarian, fallopian tube, or primary peritoneal cancer, who received BAT8006 doses ranging from 1.8 to 2.4 mg/kg or 84/93 mg/m^2, and had at least one tumor assessment. Notably, 38.9% of these patients had undergone more than three lines of prior systemic treatment. Regardless of FRα expression levels, the overall response rate (ORR)—including unconfirmed partial responses—was 37.0%. Specifically, ORRs were 33.3% for patients with FRα <50%, 39.4% for those with FRα ≥50%, and 46.7% for those with FRα ≥75%. After a median follow-up of 6.5 months, the median duration of response (mDOR) was 6.3 months, and the median progression-free survival (mPFS) was 7.47 months. The six-month and one-year overall survival (OS) rates were both 83.0%.

Safety Profile

BAT8006 demonstrated a favorable safety profile with manageable toxicity levels. There were no reported cases of ILD or significant ocular toxicity. The preliminary efficacy appeared superior in patients with platinum-resistant ovarian cancer, irrespective of FRα expression. The data suggest that BAT8006 may benefit a broad patient population, and ongoing studies are exploring its potential in other cancers such as endometrial carcinoma, breast cancer, and non-small cell lung cancer (NSCLC).

Future Directions

BAT8006 is under development both as a monotherapy and in combination with other agents for multiple cancers. It is currently being evaluated in a Phase 2 clinical study for ovarian and other FRα-overexpressing cancers. Notably, a clinical study investigating BAT8006 in combination with BAT1308, a PD-1 monoclonal antibody, was recently approved by the NMPA.

Bio-Thera Solutions remains committed to advancing its pipeline of therapeutics to address severe unmet medical needs. The company continues to leverage its expertise in antibody discovery and engineering to develop novel treatments for cancer, autoimmune disorders, and other serious conditions. With several candidates in late-stage development and multiple products already approved, Bio-Thera Solutions is poised to make significant contributions to the field of biopharmaceuticals.

How to obtain the latest research advancements in the field of biopharmaceuticals?

In the Synapse database, you can keep abreast of the latest research and development advances in drugs, targets, indications, organizations, etc., anywhere and anytime, on a daily or weekly basis. Click on the image below to embark on a brand new journey of drug discovery!