GenScript ProBio to manufacture clinical trial batches of Synimmune's lead antibody drug

The CDMO will manufacture drug substance and drug product for Phase II clinical trials in AML patients

The agreement covers the technology transfer and manufacturing of drug substance and drug product for clinical Phase II trials, said Dr Brian Min, CEO of GenScript ProBio.

Flysyn was recently evaluated in a Phase I/II study in Germany as a potential treatment for acute myeloid leukemia (AML) patients in complete remission.

GenScript ProBio claims its GMP manufacturing center is a true "zero-crossover, unidirectional flow" plant, which meets FDA, EMA and NMPA (The National Medical Products Administration) regulatory requirements. To ensure the manufacturing of multiple samples at the same time, strict physical isolation measures are adopted in the whole facility.

The CDMO now owns five independent large-scale cell culture GMP upstream production lines with a total culture volume of 2,600 L, and three independent downstream purification production lines. The company's annual production capacity can reach up to 104 batches per year.

Dr Martin Steiner, CEO of Synimmune said the company plans to test Flysyn in an international multicenter Phase II clinical study in AML patients to obtain additional indications for efficacy.