London – September 29, 2016 – Cooley advised F-star on an agreement between Denali and 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 fees, development, regulatory and commercial milestones payments with a potential aggregate value of $1B and tiered royalties on product sales.
"We appreciate the contribution made by the team at Cooley to this exciting new collaboration and have been impressed by the breadth of experience they brought to the transaction,” said Jane Dancer, Chief Business Officer of F-star.
F-star, a clinical-stage biopharmaceutical company that is based in Cambridge (UK), is developing bispecific antibody immuno-oncology products selected for their potential to transform the treatment of cancer. Through the application of its highly efficient Modular Antibody Technology platform, F-star is the only biotechnology company able to create bispecific antibodies where the second binding site is in the constant Fc region of an antibody. The strength of the technology and programmes has been leveraged through partnerships with leading biopharmaceutical companies including AbbVie, Bristol-Myers Squibb, Merck Serono and Boehringer Ingelheim. F-star has currently one program in the clinic with a second immuno-oncology program heading toward IND.
The collaboration will leverage F-star’s Modular Antibody Technology and Denali’s expertise in the development of therapeutics for neurological diseases to generate Fcabs (constant Fc-domains with antigen-binding activity), which can bind to transporters in the blood brain barrier (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) which can both cross the BBB, as well as bind to specific targets within the CNS. This mechanism has the potential to treat neurological diseases by acting on specific targets in the brain.
“It was exciting to work with F-star on this innovative transaction structure that will allow F-star to maximize the potential of its Modular Antibody Technology,” said John Wilkinson, Partner in Cooley Life Sciences Transactions Group. “The key challenges were completing the transaction in a tight deadline whilst ensuring that the agreements reflected the needs of both parties in the collaboration.”
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"F-star Signs a Collaborative Agreement with Denali Therapeutics," Global Legal Chronicle