Takeda Pharmaceutical will partner with AstraZeneca to develop and commercialize a Parkinson’s disease (PD) candidate about to enter Phase I, through a collaboration that could generate up to $400 million-plus for AstraZeneca.
MEDI1341 is an antibody of alpha-synuclein (α-synuclein), an aggregation-prone protein shown to contribute to PD development. AstraZeneca and Takeda reason that MEDI1341 could prevent or delay the onset of PD, or at least slow down or stop its progression, by removing α-synuclein aggregates, preventing their formation, or stopping them from spreading.
The companies also said that MEDI1341 has high affinity, high selectivity, and less interaction with the immune system than other α-synuclein antibodies, thus showing the potential for better efficacy and a better safety profile.
MEDI1341 is due to enter Phase I clinical trials later this year, AstraZeneca said—as the company projected in its 2016 annual report for its Innovative Medicines & Early Development Biotech Unit: “We are making good progress with our antibody directed toward alpha-synuclein for PD.”
That progress, AstraZeneca said, resulted from a collaboration launched in 2014 by the company, its MedImmune biologics subsidiary, and the University of Cambridge, where the companies work with David Rubensztein, MBChB, Ph.D., and Maria Grazia Spillantini, Ph.D., looking at novel mechanisms related to its programs in neurodegeneration, “in particular Huntington’s disease and PD.”
“The collaboration has two key aims: to drive target selection and biomarker identification through the detailed study of key mediators in the autophagy pathway, focusing in on potential project starts, and to build a greater understanding of the pathological spread of α-synuclein, working with our candidate antibody,” according to AstraZeneca.
AstraZeneca has agreed to lead Phase I development, with Takeda overseeing future clinical development. Takeda and AstraZeneca have also agreed to share equally future development and commercialization costs for MEDI1341, as well as any future revenues.
While neuroscience is one of AstraZeneca’s areas of therapeutic focus, the company says its approach looks to “maximize revenue through externalization and on-market products, advance the novel product pipeline with partnerships where appropriate, and preserve a company stake in the most promising assets.”
The up to $400 million that Takeda has agreed to pay AstraZeneca includes initial revenue in 2017 and payments thereafter tied to achieving development and sales milestones.
“By combining our scientific expertise and sharing the risks and cost of development, we hope to accelerate the advancement of MEDI1341 as a promising new approach to support the treatment of people with PD around the world,” Mene Pangalos, Ph.D., evp, IMED Biotech Unit and Global Business Development at AstraZeneca, said in a statement.
Added Emiliangelo Ratti, Ph.D., head of Takeda’s Global CNS Therapeutic Area Unit: “Our collaboration with AstraZeneca is a sophisticated one that will enable us to efficiently advance a validated target in a new modality, with the aim of improving the lives of patients.”
Takeda and AstraZeneca aren’t the only companies looking to develop PD treatments based on α-synuclein. Last year, for example, AbbVie agreed to develop and commercialize α-synuclein antibodies of BioArctic, a Karolinska Development portfolio company, through a collaboration of undisclosed value.
And in April, Prothena announced positive results from a Phase Ib trial of PRX002/RG7935, being developed through a partnership with Roche—namely a mean reduction of free serum α-synuclein levels of up to 97% after a single dose.
The PD collaboration with AstraZeneca also reflects Takeda’s interest in the central nervous system (CNS) as one of its three key therapeutic areas as redefined by the company last year; the other two are oncology and gastroenterology.
The collaboration with Takeda is AstraZeneca’s second PD-related partnership announced this week.
On Monday, AstraZeneca agreed to team up with Boston-based biopharma BERG to identify and assess novel targets and therapeutics for PD and other neurological disorders, through a partnership whose value was not disclosed. AstraZeneca agreed to initially provide BERG with its curated library of CNS-optimized fragments, which BERG agreed in turn to use toward discovering drug candidates.