![]() ![]() The biggest stakeholder is Canaan Partners at 21.9%, followed up by the Atlas Venture Fund at 16.9%.ĭay One also noted that Derek DiRocco, the RA Capital partner who joined the board with February’s raise, will be leaving the company after a very short stint once the biotech begins trading publicly.īiotech IPOs continue to boom as 2021 marches forward, with more than 50 companies having either filed or priced their IPOs so far this year. The subsidiary, Millennium Pharmaceuticals, will continue to own that stake when Day One goes public.īender for his part, owns a 3% stake, while CMO and founder Sam Blackman has a 4.6% stake. Day One only paid $1 million for the DAY101 candidate and at the time of the agreement, December 2019, offered a Takeda subsidiary about a 12% stake in the company. The S-1 also provided some details regarding that deal with Takeda and the company’s equity. Its goals also include a Phase II trial for RAF-altered solid tumors in patients older than 12, as well as a Phase Ib/II study combining DAY101 with Merck KgGA’s MEK inhibitor pimasertib to treat adult MAPK-altered solid tumors. Within its S-1, Day One plans to funnel its cash not only toward this Phase II trial, but also launch a new Phase III study for the frontline treatment of pediatric low grade gliomas next year. Day One plans to ultimately enroll 60 patients in the single-arm, open-label study and hopes it can form the basis of an approval package. The biotech recently launched a Phase II study for the experimental drug, with the goal of reading out top-line results in the first half of 2022. ![]() The current standard of care is platinum-based chemo, with no clear favorite beyond that, Bender told Endpoints News in February. As such, Day One is aiming for an indication to treat pediatric low-grade gliomas, the most common form of brain tumors in children. Their lead program is a former Takeda program called DAY101, an oral pan-RAF inhibitor that can cross the blood-brain barrier and block mutations in gliomas. Their proposed treatments are entirely new efforts rather than reformulating adult treatments that come with heavy side effects, like radiation therapy and chemo. Adult patients make up a significantly bigger portion of the market, the company said, and there have been lags in understanding pediatric biology properly.ĭay One’s mission, then, is to try to fill that gap by developing targeted therapies aimed specifically at children. Nearly 60% (n=46) of patients had already received at least one prior MAPK inhibitor prior to study participationīased on the data from the FIREFLY-1 trial, the Company plans an NDA submission in 1H2023.As the pharma industry continues developing and pushing forward cancer treatments, Day One execs argue that the mainstream players left pediatric cancer behind. The median duration of tovorafenib treatment was 8.4 months, with 77% (n=59) of patients on treatment at the time of the data cutoff Participants were heavily pretreated, with a median of three prior lines of systemic therapy (range: 1-9) The most common side effects reported related to tovorafenib were change in hair color (75%), increased creatine phosphokinase (64%), anemia (46%), fatigue (42%) and maculopapular rash (42%). Safety data, based on 77 treated patients, indicated monotherapy tovorafenib to be generally well-tolerated. 64% ORR and 91% clinical benefit rate (complete response + partial response/unconfirmed partial response + stable disease)ĥ9% (n=41) partial responses (31 confirmed and 10 unconfirmed)Ĩ6% (n=59) of patients had a BRAF fusion alteration, for which there are no approved systemic therapies, while the remaining 14% (n=10) had a BRAF mutation ![]()
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