Guangzhou, China– June 2 , 2024 –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. Phase 1b/2a Study of BAT8006

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: