
Firefly glows for Day One
Day One Biopharmaceuticals’ stock received a much-needed boost today on data suggesting that tovorafenib might be a viable therapy for paediatric low-grade glioma. The company calls tovorafenib a type II pan-Raf inhibitor, and says most paediatric low-grade gliomas are driven by Braf alterations. The first 22 evaluable patients in the mid-stage Firefly-1 trial generated an overall response rate of 64%, comprising one unconfirmed and 13 confirmed partial responses. The trial has no control arm, but there are no approved therapies for this cancer type; Firefly-1 patients had a median of three prior lines of therapy. A larger dataset is due early in 2023, and the company hopes to file by mid-year, while a front-line pivotal study of tovorafenib, Firefly-2/Loggic, will soon get under way. Despite doubling in value today Day One is still worth 20% less than when it floated just over a year ago, though some have had skin in this game for considerably longer than IPO investors. The asset has an almost two-decade history, having been through the hands of Biogen and Takeda. Viracta, which sold off Sunesis's rights last year, might be kicking itself today.
Tovorafenib's convoluted history | |
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2004 | Sunesis and Biogen form small-molecule discovery deal, originating tovorafenib (then known as BIIB024) |
2011 | Biogen spins out two oncology assets, including the still preclincal tovorafenib, to Takeda; development continues in collaboration with Sunesis, which receives $4m up front and is eligible for $60m in milestones |
2012-2015 | Takeda moves the asset, coded MLN2480 or TAK580, into the clinic for melanoma |
2019 | Day One buys tovorafenib from Takeda and amends Sunesis deal; Sunesis recieves $2m up front and could get $54m in milestones and future royalties |
2021 | Sunesis collapses, and is reversed into by Viracta |
2021 | Viracta sells potential future milestones and royalties to tovorafenib to Xoma for $13.5m plus $20m pre-commercialisation milestone |
Jun 1, 2021 | Day One raises $184m in Nasdaq IPO; tovorafenib named DAY101 |
Jun 12, 2022 | Positive interim Firefly-1 data |
Source: company statements & Evaluate Pharma. |