Bluejay Therapeutics, a developer of therapeutics for functional cures of chronic hepatitis B virus (HBV) infection, and Lonza, a global CDMO, entered a manufacturing agreement for BJT-778, one of Bluejay’s lead candidates. This monoclonal antibody (mAb), targeting the HBV surface antigen (HBsAg), is currently under preclinical development for the restoration of patient’s adaptive immunity and functional cure for chronic HBV infection.

Under the terms of the agreement, Lonza has tailored its Ibex® Design offering to manufacture cGMP material for BJT-778 for preclinical and clinical testing. The agreement will cover the early stages from gene to IND and provide cell line development, process and analytical development, and drug product (DP) manufacturing at Lonza’s Visp, Basel and Stein (Switzerland) sites. The expression of BJT-778 will be performed using a cell line constructed with the GS Xceed® expression system and will utilize well-optimized process development and logistics workflows.

Development of BJT-778 requires a highly concentrated protein formulation to allow for optimal potency, epitope, dosing frequency and safety of the final product while ensuring low injection volume, according to Lonza.

“Chronic HBV infection (CHBV) is a significant global healthcare issue. More than 850,000 people die a year from CHBV related liver diseases. The current standard of care (SOC) has a low cure rate, and innovative therapeutics are much needed. We believe BJT-778 has significant potential to achieve a high rate of functional cures in CHBV patients in combination with SOC,” says Keting Chu, CEO, Bluejay Therapeutics. “We were impressed by the professionalism, deep knowledge and experience of the Lonza team, particularly the timeline to enable IND submission at the end of 2022. We look forward to working with the Lonza team to develop BJT-778.”

“This collaboration signifies our commitment and flexibility in accommodating the specific and unique needs of emerging biotechs taking their lead candidate to clinic,” adds Jeetendra Vaghjiani, executive director, clinical development & strategic Marketing, Lonza. “Our team has extensive expertise to set up a customized formulation platform, proactively anticipate risks and suggest mitigation measures that will help move Bluejay’s candidate from preclinical stages into the clinic.”