Amgen has licensed Ligand Pharmaceuticals’ Captisol® technology for use in the formulation of AMG 330, the biotech giant’s Phase I acute myeloid leukemia candidate, through an agreement whose value was not disclosed.
The companies have inked a commercial license and supply agreement that replaces an earlier research agreement that allowed Amgen to evaluate AMG 330 with Captisol in preclinical and early clinical studies. The new agreement gives Amgen exclusive worldwide rights to combine Captisol with AMG 330 in human drugs for a variety of therapeutic indications, Ligand said.
AMG 330 is an anti-CD33 x anti-CD3 Bispecific T cell Engager (BiTE®) antibody construct. Captisol is a patent-protected, chemically modified cyclodextrin whose structure is designed to optimize the solubility and stability of drugs.
“This agreement expands our license relationship with Amgen on AMG 330,” Ligand CEO John Higgins said in a statement issued yesterday. “Ligand’s portfolio of fully funded shots on goal continues to grow and contains a large number of Captisol-enabled drugs targeted to a number of serious diseases with unmet medical needs.”
Amgen has agreed to pay Ligand an up-front payment, as well as potential payments tied to achieving milestones, royalties, and revenue from future sales of AMG 330.
Captisol has also been incorporated into Amgen’s marketed drug Kyprolis® (carfilzomib), which Amgen acquired when it bought Onyx Therapeutics for $10.4 billion in 2013. Another Ligand technology, OmniAb®, has been incorporated into an Amgen preclinical compound whose indication is undisclosed, according to Ligand’s website.
Beyond Amgen, Captisol has been incorporated in the development of numerous marketed treatments, including Lundbeck’s antiepileptic drug Carnexiv™ (carbamazepine), Merck & Co.’s antifungal agent Noxafil®-IV (posaconazole), and Pfizer’s antifungal agent VFEND® (voriconazole).
Captisol has also been used in multiple investigational therapies, including Sanofi’s solid tumor candidate SAR125844, a c-Met kinase inhibitor; and BMS986231 (nitroxyl donor or CXL-1427), an acute decompensated heart failure candidate being developed by Bristol-Myers Squibb following its up-to-$2.075 billion acquisition of Cardioxyl Pharmaceuticals in 2015.
OmniAb is a patent-protected transgenic animal platform used in the discovery of fully human mono-and bispecific therapeutic antibodies.