Protox strikes manufacturing deal with Dompe

Under the terms of the agreement, Dompe will manufacture PRX321 at its facility in Italy for the upcoming pre-pivotal clinical trial and has committed to supply commercial batches for a period of 5 years following product registration. Terms of the final agreement have not been released.

“After assessing a number of potential contract manufacturers, we are pleased to have secured a long-term strategic relationship with Dompé and look forward to working with them as we continue to advance PRX321 through the regulatory channels towards commercialization,” said Dr Fahar Merchant, President and CEO of Protox.

PRX321 is a novel targeted protein in which a cytokine, interleukin-4 (IL-4), is linked to a pseudomonas exotoxin, a potent substance that can destroy cancer cells. The IL-4 portion of the compound binds to IL-4 receptors found on the surface of various types of cancer cells. The drug subsequently enters the target cell where the toxin component causes cell death by inhibiting protein synthesis.

The drug PRX321 is in clinical development for the treatment of primary brain cancer, specifically malignant astrocytoma and glioblastoma multiforme (GBM). Results from a Phase IIa clinical trial completed in patients with recurrent and progressive GBM showed potent anti-tumor effects without drug-related systemic toxicity in the majority of patients.