Baili Biopharmaceutical and AstraZeneca have signed a clinical trial partnership and supply agreement for SI-B001 plus Tagrisso (osimertinib) combination therapy to treat non-small cell lung cancer (NSCLC) patients.

An EGFR x HER3 bispecific antibody, SI-B001 is a cancer therapy of Baili.

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It can hinder the ligand elicited EGFR×EGFR homodimers, EGFR×HER3 heterodimer formation and initiation of its downstream signal pathway at the same time. 

Furthermore, the antibody can prompt EGFR and HER3 endocytosis and down-regulate EGFR and HER3 tumour cell levels. 

Tagrisso is an irreversible epidermal growth factor receptor (EGFR) TKI of AstraZeneca. 

Under the deal, the companies will assess SI-B001 and Tagrisso in a Phase IIa clinical trial enrolling subjects with NSCLC.

The trial will be sponsored and carried out by Baili.

SI-B001 was found to have tumour-killing activities in preclinical studies and demonstrated safety and initial efficacy in Phase I trials.

The companies have not divulged the financial details of the non-exclusive partnership.

Baili Biopharmaceutical founder, chairman and CEO Dr Yi ZHU said: “SI-B001 has demonstrated good tolerability and early sign of efficacy during Phase I trial in China. 

“We are excited about the collaboration with AstraZeneca to investigate the combination of SI-B001 and a leading third-generation EGFR TKI for patients with NSCLC. 

“By combining SI-B001 with Osimertinib, we believe it has the potential to provide more effective treatment options for patients with NSCLC.”

The biopharmaceutical company carries out the research and development (R&D), production and marketing of therapies to treat cancer and other ailments. 

With R&D teams in China and US, it has developed completely integrated platforms in bispecific, multi-specific antibodies and antibody-drug conjugates. 

Baili has a pipeline comprising six anti-cancer drug candidates that are currently being analysed in clinical trials.