Astellas is blasting off into the new year with new licensing deals, including a bolt-on preclinical attachment to its Pompe disease treatment.
The Japanese pharma has long used business development to reach clinical and commercial galaxies, and that’s carrying onto 2023 just as the J.P. Morgan Healthcare Conference gets underway. The more notable of the two deals announced Monday is a bolt-on pact with Selecta Biosciences for the latter’s preclinical immunoglobulin protease, Xork. Astellas is paying up to $10 million upfront to pair the med with its existing gene therapy, AT845, for adults with Pompe disease, with the majority of the deal residing in a $340 million pile of biobucks.
Astellas is also signing onto another antibody research collaboration with Twist Bioscience, its second in eight months. Twist will work on antibody research work for “multiple targets” pinpointed by Astellas in exchange for an undisclosed upfront fee and research costs in addition to $11 million in milestone payments per target. This tacks onto the companies' first collaboration in May 2022, although no specific financial figures were released with that deal.
The deals underscore two of Astellas top modality priorities, namely the deal with Selecta which is a plug-and-play pipeline add that bolsters Astellas' gene therapy ambitions. Of particular interest to Astellas is the ability of Selecta's protease to not draw attention from the body’s naturally occurring antibodies, which has inhibited some patients from receiving AAV capsid gene therapies.
“Most other IgG proteases in development are derived from common human pathogens, and as a result there is a high prevalence of pre-existing antibodies against these proteases that can restrict their use,” said Selecta CEO Carsten Brunn, Ph.D. in a release. “Xork is differentiated by its low cross-reactivity to pre-existing antibodies in human serum.”
Selecta will be responsible for development costs associated with Xork but will have the rights to any additional indications beyond Pompe disease. Astellas with have the exclusive commercialization right for Pompe disease and can pair Xork with any other gene therapy product.
But before the combination of Xork with AT845 can prove fruitful, Astellas will have to relinquish the latter from an FDA clinical hold placed in July 2022. The FDA slapped the cuffs on the phase 1/2 trial after a grade 1 case of peripheral sensory neuropathy in one of the trial participants.