GUANGZHOU, China I June 2, 2024 I Bio-Thera Solutions Inc. (688177:SH), a commercial-stage biopharmaceutical company developing a pipeline of innovative therapies and biosimilars, will present a poster at the 2024 ASCO Annual Meeting entitled “Phase 1 study of BAT8006, a folate receptor α antibody drug conjugate with strong bystander effect, in subjects with advanced solid tumors,” that highlights clinical data for the potential best-in-class efficacy and safety of BAT8006 as a potential treatment for ovarian cancer patients and other patients with tumors that express Folate Receptor-alpha. The poster will be available on the company website after the presentation per ASCO rules

As of May 8, 2024, 156 subjects with advanced solid tumor were treated in phase 1 study. In 84 and 93mg/m2 dose optimal/expansion cohorts (including all advanced solid tumor subjects), 3.5% (2/57) and 3.9% (2/51) subjects experienced dose reduction, and 5.3% (3/57) and 13.7% (7/51) subjects experienced study drug interruption, respectively. No study treatment related death, and no ILD/pneumonitis and keratitis, uveitis, decreased vision was reported in this study. The major TRAEs were hematological toxicity. The dosages of 84 and 93 mg/m2 were selected in dose optimal study, the incidences of ≥ Grade 3 thrombocytopenia and neutropenia were 9% vs 28% and 19% vs 37%, respectively.

To the date of data cut-off, 54 subjects with platinum refractory or platinum-resistant epithelial ovarian, fallopian tube or primary peritoneal cancer were treated with BAT8006 doses of 1.8~2.4 mg/kg and 84/93mg/m2 and have received at least one tumor assessment. Among these patients, 38.9% (21/54) of them  had undergone>3 lines prior systemic treatment. Regardless of the FRα expression, the ORR including unconfirmed partial response (PR) is 37.0% (20/54). In subjects with FRα<50%, FRα ≥50% and FRα ≥75%, the ORR is 33.3% (7/21), 39.4% (13/33) and 46.7% (7/15), respectively. With a median follow up of 6.5 months (1.3, 18.0 months), the median duration of response (mDOR) was 6.3 months (1.8-16.5months). The median progression free survival (mPFS) was 7.47 months (4.27~NA). The overall survival (OS) rate in 6 months and 1 year were 83.0%, 83.0%.

The safety of BAT8006 is favorable with manageable toxicity. No ILD and notable ocular toxicity was reported. The preliminary efficacy of BAT8006 was superior even in all platinum-resistant ovarian cancer patients regardless of the FRα expression. BAT8006 may benefit broad patient population while providing a promising efficacy. Exploration study on endometrial carcinoma, breast cancer and NSCLC is ongoing, the efficacy was demonstrated in these tumor type as well.

BAT8006 is being developed for use as a single agent and in combination with other agents for the treatment of multiple cancers. BAT8006 is currently being evaluated in a Phase 2 clinical study for the treatment of ovarian and other Folate Receptor-alpha overexpressed cancers. Clinical study of BAT8006 in combination with BAT1308, a PD-1 mAb, was recently approved by the NMPA.

Presentation details are as follows:

Poster Session:Gynecologic Cancer
Session Date and Time:Monday, June 3rd, 9:00 am – 11:00 am
Location:Poster Area/Exhibition Hall
Abstract Number:5550
Poster Board Number:421

About Bio-Thera Solutions
Bio-Thera Solutions, Ltd., a leading innovative, global biopharmaceutical company in Guangzhou, China, is dedicated to researching and developing novel therapeutics for the treatment of cancer, autoimmune, cardiovascular, eye diseases, and other severe unmet medical needs, as well as biosimilars for existing, branded biologics to treat a range of cancer and autoimmune diseases. As a leader in next generation antibody discovery and engineering, the company has advanced multiple candidates into late-stage development, including three approved products: QLETLI® in China, and TOFIDENCE™/ BAT1806 and Avzivi® / Pobevcy® in the US and China. In addition, the company has more than 20 promising candidates in clinical trials, focusing on immuno-oncology in the post-PD-1 era and targeted therapies such as ADCs. For more information, please visit or follow us on Twitter (@bio_thera_sol) and WeChat (Bio-Thera).

SOURCE: Bio-Thera Solutions