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
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. 
Source: company presentation.

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