With 'rapid' progress of pediatric brain cancer treatment, Day One sees broad excitement in new crossover round
Roughly nine months after emerging from stealth, Day One Biopharmaceuticals returned to the venture capital well and came away with a nine-figure prize. And with the hefty crossover round, it raises the big question of whether they’re prepping an S-1 to enter a hot biotech IPO market.
Day One raised $130 million in a Series B, the biotech announced Wednesday, with the funding led by RA Capital. The funds will help support a variety of pipeline projects, including the development of their lead compound DAY101 in preparation for a potential commercial launch in 2023.
The rapid progress of that program ultimately led to the excitement for the round, CEO Jeremy Bender told Endpoints News, and Day One has now raised a total of $190 million since late 2019.
“As a result of both some publication of data that underpinned the development plan, as well as building out the full team including myself, we started having discussions with investors in Q4,” Bender said. “Those accelerated over time.”
Day One’s mission is centered around improving the landscape for pediatric cancers, an area that the company says pharma has left behind over the last several years. Children represent a much smaller patient pool than adults, giving the industry less market incentive, and for years experts have said the biology has not been properly understood.
With additional concerns over safety, many pediatric treatments end up being reformulations of adult therapies like radiation and chemo. But that can come with heavy long-term side effects. Day One aims to fill that gap, bringing effective and safe treatment specifically with children in mind, Bender said.
They got started with an old Takeda program in DAY101, formerly named TAK-580. The compound itself is a pan-RAF inhibitor that can cross the blood-brain barrier, blocking mutations that drive cancer in both childhood and adult gliomas.
Day One has made significant progress with this program since it came out of stealth mode last May, Bender said, recently launching a pivotal Phase II study in the most common brain tumor in children — pediatric low-grade glioma. Currently, pediatric patients with pLGG don’t have much in the way of effective treatment, utilizing typical platinum-based chemotherapy in the frontline setting with no clear favorite beyond that.
About a third of patients see their tumors effectively cured through biopsies and surgical removal, Bender said, but the “vast majority” of the rest go on to receive these systemic chemo treatments. “It’s hard on patients and parents, but the only clear standard of care,” he said.
The company is looking to enroll 60 patients in a single-arm, open-label trial, which would form the basis for an approval package once the data read out topline results in the second half of 2022. The experimental drug also received breakthrough therapy designation from the FDA in the fall, and it was around that time when Series B interest from VCs started ramping up.
With Wednesday’s funding, Day One has enough runway to get through the end of 2022 and through the Phase II readout “at minimum,” Bender said. Should everything go well with the study, a commercial launch of DAY101 could be in the cards as early as 2023.
Day One is also looking at testing this program in adult solid tumors with RAF-altered mutations, and expects to launch a Phase II study with the funding. The candidate had previously been tested in melanoma, but not yet in the adult brain cancer setting.
But the main mission remains focused on children, and there is clear enthusiasm surrounding DAY101 as evidenced by Wednesday’s raise, Bender said.
In addition to RA Capital, other new investors included Boxer Capital, BVF Partners, Franklin Templeton, Janus Henderson Investors, Perceptive Advisors, T. Rowe Price and Associates and Viking Global Investors. Existing investors in Canaan, Access Biotechnology and Atlas Venture also participated in the round.