CEO Jeremy Bender (Day One)

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.

The Big Phar­ma dis­card pile; Lay­offs all around while some biotechs bid farewell; New Roche CEO as­sem­bles top team; and more

Welcome back to Endpoints Weekly, your review of the week’s top biopharma headlines. Want this in your inbox every Saturday morning? Current Endpoints readers can visit their reader profile to add Endpoints Weekly. New to Endpoints? Sign up here.

With earnings seasons in full swing, we’ve listened in on all the calls so you don’t have to. But news is popping up from all corners, so make sure you check out our other updates, too.

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Sen. Ron Wyden (D-OR) (Francis Chung/E&E News/Politico via AP Images)

In­fla­tion re­bates in­com­ing: Wyden calls on CMS to move quick­ly as No­var­tis CEO pledges re­ver­sal

Senate Finance Chair Ron Wyden (D-OR) this week sent a letter to the head of the Centers for Medicare & Medicaid Services seeking an update on how and when new inflation-linked rebates will take effect for drugs that see major price spikes.

The newly signed Inflation Reduction Act requires manufacturers to pay a rebate to Medicare when they increase drug prices faster than the rate of inflation.

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Raymond Stevens, Structure Therapeutics CEO

Be­hind Fri­day's $161M IPO: A star sci­en­tist, GPCR drug dis­cov­ery and a plan to chal­lenge phar­ma in di­a­betes

What does it take to pull off a $161 million biotech IPO these days?

In Structure Therapeutics’ case, it means having a star scientist co-founder paired with the computational drug discovery company Schrödinger, $198 million in private funding from blue-chip investors, almost six years of research work on G protein-coupled receptors and a slate of oral, small-molecule drugs, with an eye on the huge and growing diabetes and weight-loss market.

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Trodelvy notch­es a win in most com­mon form of breast can­cer

Following a promise last year to go “big and fast in breast cancer,” Gilead has secured a win for Trodelvy in the most common form.

The drug was approved to treat HR-positive, HER2-negative breast cancer patients who’ve already received endocrine-based therapy and at least two other systemic therapies for metastatic cancer, Gilead announced on Friday.

Trodelvy won its first indication in metastatic triple-negative breast cancer back in 2020, and has since added urothelial cancer to the list. HR-positive HER2-negative breast cancer accounts for roughly 70% of new breast cancer cases worldwide per year, according to senior VP of oncology clinical development Bill Grossman, and many patients develop resistance to endocrine-based therapies or worsen on chemotherapy.

Af­ter 13 years, Ramy Mah­moud steps in­to CEO seat at Opti­nose; Ru­pert Vessey set to ex­it Bris­tol My­ers in Ju­ly

After 13 years as president and COO at Optinose, Ramy Mahmoud has stepped into a new role as its CEO. He is taking the place of Peter Miller, who stepped down earlier this week, though Miller is still staying with the company as a consultant.

In 2010, the two business partners joined Optinose to take it in a new direction, transforming it from a delivery platform to product company. They previously worked together at Johnson & Johnson, when Miller was president at Janssen and Mahmoud headed medical affairs. Miller said after he learned about Optinose, “I did what I always do, which is find people smarter than me to talk with about the idea. And the first person I called was Ramy … and I said, ‘Hey, Ramy, what do you think of this technology?’”

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Te­va drops out of in­dus­try trade group PhRMA

Following in AbbVie’s footsteps, Teva confirmed on Friday that it’s dropping out of the industry trade group Pharmaceutical Research and Manufacturers of America (PhRMA).

Teva didn’t give a reason for its decision to leave, saying only in a statement to Endpoints News that it annually reviews “effectiveness and value of engagements, consultants and memberships to ensure our investments are properly seated.”

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Sanofi CFO Jean-Baptiste de Chatillon (L) and CEO Paul Hudson (Romuald Meigneux/Sipa via AP Images)

Sanofi sees downtick in flu sales as it preps for launch of RSV an­ti­body

Sanofi expects its RSV antibody jointly developed with AstraZeneca will be available next season, executive VP of vaccines Thomas Triomphe announced on the company’s quarterly call.

Beyfortus, also known as nirsevimab, was approved in the EU back in November and is currently under FDA review with an expected decision coming in the third quarter of this year. The news comes as the FDA plans to hold advisory committee meetings over the next couple months to review RSV vaccines from Pfizer and GSK.

Christophe Weber, Takeda CEO (Photographer: Shoko Takayasu/Bloomberg via Getty Images)

Take­da fo­cus­es on ‘di­verse’ pipeline prospects on heels of two ac­qui­si­tions

After a whopping $4 billion asset buy from Nimbus Therapeutics, along with a $400 million deal with Hutchmed for a colorectal cancer drug, Takeda executives touted pipeline optimism on its latest earnings call this week.

That’s because the TYK2 inhibitor for psoriasis Takeda is getting from Nimbus, along with the Hutchmed fruquintinib commercialization outside of China, are just two of what it reports are 10 late-stage development programs of promising candidates.

Regeneron CSO George Yancopoulos (L) and CEO Len Schleifer at a groundbreaking for its new Tarrytown, NY facility, June 2022 (Lev Radin/Pacific Press/LightRocket via Getty Images)

In show­down with Roche, Re­gen­eron gears up for po­ten­tial Eylea ex­pan­sion amid Covid de­cline

Regeneron faced a substantial slump in overall revenue last year, but the focus still remains on some of its biggest blockbusters.

The pharma with several high-profile partnerships — Sanofi and Bayer among them — said Friday that Q4 revenue was down 31% for the quarter, and down 24% for the entire year. However, that won’t stop blockbuster expansion plans.

One of those is Eylea, the Bayer-partnered eye disease drug that has been in major competition with Roche’s Vabysmo. While Eylea is currently only approved in a 2 mg dose, the company recently filed for approval to give a 8 mg dose, in hopes of making a longer-lasting treatment.