Flush with cash and bursting at the seams from rapid growth as it looks to break the long, ugly losing streak for Alzheimer’s R&D and other tough diseases, the executive crew at Denali $DNLI has struck an early deal to pick up their option on the antibody tech they’ve been using to smuggle drugs through the blood-brain barrier.
The South San Francisco-based biotech has completed a deal to buy F-Star Gamma, a group set up by F-Star’s Fc engineers developing Fcabs to target transporters in the BBB, a hurdle nature set up to protect the brain and a long-standing obstacle to drug developers. Denali is handing over $24 million to nail the option close to two years after they struck their pact. And there’s some added cash in that figure to expand their work to cover two new, undisclosed transporter targets.
As F-star CEO John Haurum explains via e-mail, the “technology introduces a ‘BBB transporter activity’ in the Fc domain of an antibody (also referred to as a Transport Vehicle or TV by Denali). This TV can be readily introduced into any monoclonal antibody or Fc fusion protein to facilitate the entry into the CNS and enable biologic drug exposure in the brain. This approach is compatible with delivery of both normal antibodies and bispecific antibodies, as well as delivery of therapeutic proteins in the form of Fc-fusion proteins.”
On top of the cash there’s another $447 million in milestones covering development work as well as commercial goals.
“Using this technology we’ve been able to increase the exposure of antibodies in the brain by more than 20-fold,” says COO Alex Schuth, offering a sustained pharmacological response in both mouse and monkey studies. And the new targets they’re working on now come as a result of the discovery efforts they have underway with some academic investigators.
By moving early, says CFO Steve Krognes, Denali is getting the F-Star deal at the low end of the price range.
Denali has a long way to go before it reaches anything like commercial planning. The next big development step comes with an IND for a Hunter syndrome therapy expected next year. In the meantime, Denali is moving into a bigger space near its South San Francisco base, to accommodate the 150 staffers now at the biotech. The new facility will be about half labs, half offices, says Krognes, and will be about triple the size of the space it has now.
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