Pieris AG, the biopharmaceutical company developing Anticalins as a novel class of targeted human protein therapeutics, today reported continued progress in development of its lead therapeutic program for the clinic.
Under its manufacturing agreement with Wacker Biotech GmbH, a full-service contract manufacturer of biopharmaceuticals, Pieris has successfully completed the first cGMP run of its Anticalin candidate PRS-050, a potent VEGF antagonist with broad therapeutic applicability.
Having established production process parameters for PRS-050 earlier in 2009, Pieris has now met all regulatory CMC requirements to file an IND application by the end of January 2010. With toxicology studies running concurrently, PRS-050 is scheduled to commence first in man studies in the first half of 2010. Progress in the PRS-050 program demonstrates that Anticalin discovery programs can be successfully advanced from lead candidate to GMP production in around twelve months.
Commenting on these developments at Pieris, Claus Schalper, interim-CEO, said: "Sustained progress in development of PRS-050 underscores our commitment to advancing our lead Anticalin program into the clinic as quickly and efficiently as possible. This is in line with Pieris' strategy to bring Anticalins into the clinics while partnering selected project at an earlier development stage."
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