Denali, F-star in $1Bn CNS Collaboration
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F-star announces a collaborative agreement with Denali Therapeutics Inc. (Denali) to research and develop antibodies for t he delivery of medicines across the blood-brain barrier (BBB) into the central nervous system (CNS).
The collaboration will leverage F-star’s Modular Antibody Technology TM and Denali’s expertise in the development of therapeutics for neurological diseases to generate Fcabs TM (constant Fc-domains with antigen-binding activity) which can bind to transporters in the BBB. Using the “plug-and-play” properties of the platform, these Fcabs can be rapidly inserted into any existing antibody to generate a full size bispecific antibody (mAb² TM ) which can both cross the BBB, as well as bind to specific target s within the CNS. This mechanism has the potential to treat neurological diseases by acting on specific targets in the brain.
The agreement is with F-star Gamma Limited (F-star Gamma), a new Asset-Centric Vehicle in the F-star family. Under the agreement, Denali will make upfront payments to F-star totalling $6 million. Denali has the option to nominate a pre-specified number of Fcab targets. F-star Gamma will also receive research funding and is eligible for technical milestone payments. In addition, Denali also has the option to acquire F-star Gamma prior to the initiation of the first Phase 1 clinical trial in return for aggregate exercise and milestone payments to the F-star Gamma shareholders of up to $450M in total. If Denali does not exercise the option to acquire F-star Gamma, it has the right to license a pre-specified number of mAb² based on each Fcab generated by F-star Gamma, in return for license fee s, development, regulatory and commercial milestones payments with a potential aggregate value of $1B and tiered royalties on product sales.
John Haurum, CEO of F-star, commented: “Our Modular Antibody Technology is ideally suited to deliver biologic drugs into the Central Nervous System across the blood-brain barrier. Denali’s scientists are world leaders in understanding the complex mechanisms of the blood-brain barrier and we look forward to collaborating with the team to unlock the potential of our platform and develop more efficient treatments f or neurological disorders.”
Ryan Watts, CEO of Denali, said: “We are excited to partner with F-star to tackle one of the toughest problems in medicine, delivery of biologics across the blood-brain barrier. F-star’ s deep expertise and proven track record of engineering novel antibodies offer a promising approach for the treatment of neurological disease.”