NANJING, China, Sept. 6, 2021 /PRNewswire/ — GenScript ProBio is delighted to announce the signing of a manufacturing service agreement for Synimmune’s innovative FLYSYN antibody project for clinical Phase II production.
FLYSYN is a fms-like tyrosine kinase 3 (FLT3) specific antibody for the treatment of acute myeloid leukemia (AML) patients in complete remission. FLYSYN was recently evaluated in a Phase I/II study in Germany. FLYSYN contains a genetic optimization of its Fc-part resulting in optimized binding to cells expressing the Fc receptor, particularly Natural Killer (NK) cells, and thus substantially improved antibody-dependent cell-mediated cytotoxicity (ADCC).
GenScript ProBio’s GMP manufacturing center follows the internationally leading design concept and is a true «zero-crossover, unidirectional flow» plant, which meets FDA, EMA and NMPA regulatory requirements. Strict physical isolation measures are adopted in the whole facility, which ensures the manufacturing of multiple samples at the same time.
«GenScript ProBio and SYNIMMUNE GmbH entered into collaboration on FLYSYN antibody project for technology transfer and manufacturing of drug substance and drug product for Clinical Phase II trials, it is our pleasure to support this innovative antibody project,» said Dr. Brian Min, CEO of GenScript ProBio, «GenScript ProBio’s GMP manufacturing center meets global regulatory requirements. ProBio’s technology transfer team has established a comprehensive and refined technology transfer process and has implemented comprehensive risk control in the technology transfer process, which ensures the smooth tech transfer. We look forward to the further progress of this innovative antibody project.»
«We are pleased to enter into a partnership with GenScript ProBio, a highly professional and competent CDMO. We are confident that GenScript ProBio will produce SYNIMMUNE’s lead antibody drug product FLYSYN to all global quality GMP standards within the agreed upon timeline. We are planning to test FLYSYN in an international, multicenter Phase II clinical study in AML patients to obtain additional indications for efficacy in this poorly treated patient population,» said Dr. Martin Steiner, CEO of SYNIMMUNE GmbH.
SYNIMMUNE GmbH is a biotechnology company dedicated to the development of innovative and effective mono- and bispecific anti-tumor antibodies for the treatment of patients suffering from life-threatening diseases, with a focus on orphan hematopoietic malignancies. SYNIMMUNE’s lead product candidate is the FLT3 specific antibody FLYSYN, which was recently tested in a first-in-human phase I/II clinical study in AML patients. SYNIMMUNE GmbH is a spin-off of the Department of Immunology of the University of Tuebingen, Germany.
More information: http://www.synimmune.de
About GenScript ProBio
GenScript ProBio is the biologics CDMO segment of GenScript, proactively providing end-to-end service from drug discovery to commercialization with proactive strategies, professional solutions and efficient processes in antibody drug and gene and cell therapy to accelerate drug development for customers.
GenScript ProBio’s innovative solutions for antibody drug development include antibody drug discovery, antibody engineering and antibody characterization. GenScript ProBio has successfully delivered multiple CMC and GMP manufacturing projects.
GenScript ProBio’s total gene and cell therapy solution covers CMC of plasmid and virus for IND filing as well as clinical manufacturing and commercial manufacturing. Our quality management systems ensure phase appropriate compliance, data integrity and traceability.
More information: https://www.genscriptprobio.com/