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.

In­side Track: Be­hind the Scenes of a Ma­jor Biotech SPAC

Dr. David Hung and Michelle Doig are no strangers to the SPAC phenomenon. As Founder and CEO of Nuvation Bio, a biotech company tackling some of the greatest unmet needs in oncology, Dr. Hung recently took the company public in one of this year’s biggest SPAC related deals. And as Partner at Omega Funds, Doig not only led and syndicated Nuvation Bio’s Series A, but is now also President of the newly formed, Omega-sponsored, Omega Alpha SPAC (Nasdaq: OMEG; oversubscribed $138m IPO priced January 6, 2021).

Aduhelm OK 'bit­ter­sweet' for ALS ad­vo­cates; Con­trast­ing Covid-19 vac­cine read­outs; GSK joins TIG­IT bat­tle; 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 the busiest days of June now behind us, we’re starting to think seriously about the second half of the year. In August, we have scheduled a special report where Endpoints will compile a list of the 20 most influential R&D executives in biopharma. Know a luminary who should definitely be included? Nominate them now.

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Who are the lu­mi­nar­ies dri­ving the biggest ad­vances in bio­phar­ma R&D? End­points News is ask­ing for your nom­i­na­tions for a spe­cial re­port

In biopharma, driving a drug to market is the ultimate goal — but none of that happens without a strong research and development program. At the most successful companies, those R&D efforts are spearheaded by true innovators in the field who are always looking for that next novel mechanism of action or breakthrough safety profile.

Now, Endpoints News is asking you to tell us who those guiding lights are.

Leen Kawas, Athira CEO

Biotech founder placed on leave as $400M Alzheimer's start­up idea comes un­der scruti­ny

Athira Pharma, the Alzheimer’s biotech that emerged out of obscurity last year and raised nearly $400 million for a dark-horse approach to treating neurodegeneration, has found itself in sudden turmoil.

On Tuesday evening, the company released a terse statement announcing that CEO and founder Leen Kawas had been placed on administrative leave while an independent review board investigated “actions stemming” from her doctoral research at Washington State University. Mark Litton, who joined the company as COO two years ago, will take over day-to-day operations, they said.

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Bris­tol My­ers breaks the bank on Ei­sai's fo­late re­cep­tor ADC drug, lay­ing out more than $3B+ for rights

For years, innovation in oncology has been a crapshoot with Big Pharma — the whales at the table — dropping the big bucks for the key to the next generation of tumor fighters. Bristol Myers Squibb hasn’t exactly made a name for being an innovator in the space, but that doesn’t mean it won’t splash in when it sees a potential winner.

Now, with a massive check in hand, the drugmaker is willing to put its intuition to the test.

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Michael Chambers (L) and John Ballantyne

Dana­her strikes deal to buy boom­ing next-gen man­u­fac­tur­er Alde­vron for $9.6B

Life sciences conglomerate Danaher Corp. $DHR has struck a deal to buy the fast-growing Aldevron, one of the world’s top manufacturers of hotly sought-after plasmid DNA, mRNA and recombinant proteins for the burgeoning world of vaccine and drugmakers pushing some game-changing technologies.

Buyout talks set the stage for Danaher to settle on a $9.6 billion cash pact to acquire the private Fargo, ND-based company — a key supplier for a disruptive new Covid vaccine as well as a host of gene and cell therapy and CRISPR gene editing players — founded by Michael Chambers and CSO John Ballantyne as a crew of 2 back in 1998.

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Christian Hogg, Hutchmed CEO

Hutchmed files for $600M+ IPO in Hong Kong as lead on­col­o­gy drug su­r­u­fa­tinib awaits FDA's good graces

In oncology, a flush of Chinese-developed drugs has the biopharma industry rethinking the poles of power in R&D as the blossoming nation continues to make a name for itself and pick up bundles of cash in the process. Now, as its lead drug faces a pivotal FDA review, the company formerly known as Chi-Med is planting its flag on home soil with a massive public offering.

Hutchmed — recently renamed from Chi-Med, or Hutchison China MediTech — will look to raise $603 million as part of a Hong Kong IPO that serves as a homecoming of sorts for the Chinese-based oncology player, which has listed on Nasdaq since 2016.

FDA's con­tro­ver­sial Aduhelm de­ci­sion leaves ALS pa­tients feel­ing spurned

The FDA’s controversial approval of Biogen’s Aduhelm drug for Alzheimer’s disease has been met with fierce resistance from all corners of the biopharma industry, but few seem to be as upset with the decision as ALS patients and advocacy groups.

For all that’s already been written and discussed about the agency’s announcement, from the drug’s exorbitantly high price of $56,000 per year to criticism over lowered standards, ALS patients see something more. ALS patients and associations say they largely regarded Aduhelm’s approval as a bittersweet double standard: happy that those with Alzheimer’s have a new drug available, but questioning how the FDA evaluated Biogen’s drug compared to the experimental programs being studied for their own disease.

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Spring reg­u­la­to­ry agen­da: What’s com­ing soon-ish from the FDA

The FDA’s lack of a permanent commissioner does not seem to be halting its progress to propose and finalize dozens of new regulations, with the latest batch covering everything from adverse event reporting to supplemental application submissions to annual reports for INDs.

Overall, FDA expects to release more than 40 new proposed regulations and finalize another 24 in the coming months and years.

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