BAT8003 / Bio-Thera Solutions - LARVOL DELTA

Clinical Trial of BAT8003 (for Injection) for Patients With Advanced Epithelial Cancer (clinicaltrials.gov) - P1 | N=5 | Terminated | Sponsor: Bio-Thera Solutions | N=50 ➔ 5 | Unknown status ➔ Terminated; Considering that the safety risk will affect the subsequent development, it is decided to terminate the test voluntarily

Enrollment change • Metastases • Trial termination • Oncology • Solid Tumor • TACSTD2

Bio-Thera nixes clinical development for anti-Trop2 ADC and PD-1 (GBI Health) - "Guangzhou-based biotech Bio-Thera Solutions (SHA.688177) announced the cancellation of clinical studies for two of its pipeline candidates, citing 'development risks' in the form of changing market dynamics. The decision was taken to chop development of anti-Trop2 antibody-drug conjugate (ADC) BAT8003 and programmed-death 1 (PD-1) monoclonal antibody (mAb) BAT1306...BAT8003 was under development to treat Trop2 positive triple negative breast cancer (TNBC)...BAT1306 was targeted towards treating Epstein-Barr virus-associated gastric carcinoma (EBVaGC) in combination with chemotherapy, and as a second-line treatment for HER2 positive advanced solid tumors..."

Discontinued • Breast Cancer • Gastric Cancer • Gastrointestinal Cancer • Oncology • Solid Tumor • Triple Negative Breast Cancer

Development of a potent Trop-2 antibody-drug conjugate, BAT8003, for the treatment of Trop-2 positive gastric tumors (AACR 2019) - "A multiple dose toxicity study in monkey reveals that the highest non-severely toxic dose (HNSTD) of BAT8003 is 20 mg/kg when dose once every 3 weeks. The preclinical profile of BAT8003 warrants further clinical development for the treatment of gastric cancer as well as other Trop-2 over-expressing cancers."

Bio-Thera solutions announces two poster presentations at the 2019 AACR Annual Meeting (Businesswire) - "The first poster...will highlight Phase I clinical data demonstrating the safety and efficacy of BAT8001 in HER2-positive cancer patients....The second poster...will present preclinical data that highlight advantages of BAT8003 as a potential treatment for gastric cancer patients. The IND for a Phase I clinical trial evaluating the safety and pharmacokinetics of BAT8003 was approved earlier this year by the China NMPA. Dosing of the first patient in this Phase I clinical trial is expected to occur during April 2019."

Enrollment status • Non-US regulatory • P1 data • Preclinical

Clinical Trial of BAT8003 (for Injection) for Patients With Advanced Epithelial Cancer (clinicaltrials.gov) - P1; N=50; Recruiting; Sponsor: Bio-Thera Solutions

Clinical • New P1 trial