BAT1306 / Bio-Thera Solutions - LARVOL DELTA

PCOX: PD-1 Antibody Combined With COX Inhibitor in MSI-H/dMMR or High TMB Colorectal Cancer (clinicaltrials.gov) - P2 | N=29 | Recruiting | Sponsor: Sun Yat-sen University | Unknown status ➔ Recruiting | Trial completion date: Aug 2021 ➔ Aug 2025 | Trial primary completion date: Jul 2020 ➔ Aug 2022

Enrollment open • Trial completion date • Trial primary completion date • Tumor mutational burden • Colorectal Cancer • Gastrointestinal Cancer • Microsatellite Instability • Oncology • Solid Tumor • MSI • TMB

PD-1 blockade combined with COX inhibitor in patients with MSI-H/dMMR or high TMB, advanced or metastatic colorectal cancer (PCOX study). (ASCO-GI 2020) - P2; "Patients with MSI-H/dMMR or POLE mutation advanced or metastatic colorectal cancer received PD-1 blockade (pembrolizumab 200mg, q3w; or BAT 1306 100mg, q3w; or nivolumab 3mg per kilogram, q2w) plus COX inhibitor (celebrex 400mg or aspirin 200mg, p.o. qd). The combination of PD-1 blockade plus COX inhibitor was associated with higher response rates in advanced or metastatic colorectal cancer patients with MSI-H/dMMR or POLE mutation than anti-PD-1 alone as historical controls. Clinical trial information: NCT03638297. Research Funding: None"

Clinical • IO Biomarker • MSI-H • POLE

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

PD-1 Antibody Combined With COX Inhibitor in MSI-H/dMMR or High TMB Colorectal Cancer (clinicaltrials.gov) - P2; N=27; Recruiting; Sponsor: Sun Yat-sen University; N=54 ➔ 27; Trial completion date: Dec 2019 ➔ Aug 2021; Trial primary completion date: Dec 2019 ➔ Jul 2020

Enrollment change • Trial completion date • Trial primary completion date • Colorectal Cancer • Gastrointestinal Cancer • Oncology • Solid Tumor • MSI

Newly added product (clinicaltrials.gov) - P2, CRC, Oncology

Pipeline update