APC, who specialises in the custom manufacturing of peptides, will produce Affymax's novel drug candidate, Hematide, for upcoming Phase II clinical trials in patients with anaemia from chronic kidney disease (CKD) and cancer.
Hematide is a next-generation erythropoiesis-stimulating agent (ESA), designed to stimulate the production of red blood cells.
APC has previously worked with Affymax to manufacture pre-clinical lots of Hematide and will now scale up production to meet clinical demand at its large-scale cGMP manufacturing facility near San Diego, California.
Since the agreement was made, Affymax has already initiated a new clinical trial of Hematide in patients with anaemia, CKD and pure red cell aplasia (PRCA), a rare autoimmune disorder.
Three other Phase II trials are already underway in haemodialysis patients with end-stage CKD in the US; in Europe in CKD patients who are not on dialysis; and in Europe in cancer patients on chemotherapy.
Affymax also recently announced a collaboration agreement with Takeda Pharmaceutical to develop and commercialise Hematide in Japan.
The deal, where Affymax is responsible for the manufacture and supply of drug substance to Takeda, will provide APC with further manufacturing opportunities.