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 top 100 bio­phar­ma VCs, Bob Brad­way places $2B bet in can­cer, gene edit­ing pi­o­neer's new big idea, 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.

Before diving in, we had some news to share: Endpoints is launching a premium weekly report focusing on all things regulatory. Coverage will be led by our new senior editor, Zachary Brennan, who joins us from POLITICO. Arsalan Arif has more details in his Publisher’s Note.

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Robert Bradway (Photographer: Scott Eisen/Bloomberg via Getty Images)

UP­DAT­ED: Am­gen snaps up can­cer drug play­er Five Prime, adding PhI­II-ready FGFR2b drug in $2B M&A play

Amgen is making a long-awaited move on the M&A side, buying South San Francisco-based Five Prime $FPRX for close to $2 billion and adding a slate of new cancer drugs to the pipeline.

Amgen is paying $38 a share, putting the deal value at $1.9 billion. The stock closed at $21.26 last night, giving investors a 78% premium.

The jewel in the crown of this deal is bemarituzumab, which Amgen describes as a first-in-class, Phase III-ready anti-FGFR2b antibody. Amgen was drawn to the bargaining table by Five Prime’s mid-stage data on gastric cancer, satisfied by PFS and OS data helping to validate FGFR2b as a target. Amgen researchers will now expand on the R&D program in other epithelial cancers, including lung, breast, ovarian and other cancers.

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David Liu (Casey Atkins Photography courtesy Broad Institute)

David Liu has a new big idea: pro­teome edit­ing. It could one day shred tau, RAS and some of the worst dis­ease-caus­ing pro­teins

Before David Liu became famous for inventing new forms of gene editing, he was known around academia in part for a more obscure innovation: a Rube Goldberg-esque system that uses bacteria-infecting viruses to take one protein and turn it into another.

Since 2011, Liu’s lab has used the system, called PACE, to dream up fantastical new proteins: DNA base editors far more powerful than the original; more versatile forms of the gene editor Cas9; insecticides that kill insecticide-resistant bugs; enzymes that slide synthetic amino acids into living organisms. But they struggled throughout to master one of the most common and powerful proteins in the biological world: proteases, a set of Swiss army knife enzymes that cut, cleave or shred other proteins in everything from viruses to humans.

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The 2021 top 100 bio­phar­ma in­vestors: As the pan­dem­ic hit and IPOs boomed, VCs swung in­to ac­tion like nev­er be­fore

The global pandemic may have roiled economies, killed hundreds of thousands and throttled entire industries, but the only effect it had on biopharma venture investing was to help turbocharge the field to giddy new heights.

Below you’ll find the new top 100 venture investors in the industry, ranked by the number of deals they were publicly involved in, as tracked by DealForma chief Chris Dokomajilar. The numbers master then calculated the estimated amount of money they put into each deal — divvying up the cash by the number of players — to indicate how they managed their syndicates.

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UP­DAT­ED: Not 3 weeks af­ter tak­ing Hu­ma­cyte pub­lic, Ra­jiv Shuk­la launch­es an­oth­er blank check com­pa­ny

One of biotech’s earliest SPAC investors is back with another blank-check company, less than a month after his last effort announced its intent to merge.

Rajiv Shukla is intending to take a third lucky winner public with Alpha Healthcare Acquisition III, filing to go public Thursday with a $150 million raise penciled in. The move comes just a couple of weeks after Shukla’s second SPAC said it would jump to Nasdaq in tandem with Laura Niklason’s Humacyte in a $255 million new investment.

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Bruce Cozadd, Jazz CEO (Jazz Pharmaceuticals)

Jazz CEO Bruce Cozadd cam­paigned for 6 months to buy GW Phar­ma. A 90% pre­mi­um sealed the deal — along with $17.6M in ‘re­ten­tion’ in­cen­tives

Jazz CEO Bruce Cozadd didn’t beat around the bush.

In his first video meeting with GW Pharma chief Justin Gover last July 8, he offered to pay $172 a share to get the company, which had beaten the odds in getting its remarkable cannabinoid drug Epidiolex across the regulatory finish line for epilepsy. GW’s stock closed at $129 that day.

Cozadd had already done his homework on the financing to make sure he could swing it the way he wanted. He just needed to do some due diligence before making the non-binding bid firm.

Paul Hudson, Getty Images

How does Paul Hud­son's $13.5M comp pack­age stack up against oth­er CEOs? He's in the 'first quar­tile'

Paul Hudson arrived at Sanofi like a hurricane, chopping off duds in the pipeline, shaking up the C-suite, striking big M&A deals and jumping into the Covid-19 vaccine race — all in an attempt to reboot a pharma giant notorious for its setbacks.

Now, we’re getting a look at what the CEO brought home in his first year on the job.

When all is said and done, Hudson will have made about $6.7 million in 2020, about $2.5 million of which has already been paid. The bigger figure includes a $2.3 million bonus that’s subject to approval at an April meeting, and another $1.8 million in variable compensation that has yet to be paid.

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An Ar­ray co-founder re-emerges as CEO of a small aca­d­e­m­ic spin­out, look­ing to re­make an old class of can­cer drugs

Tony Piscopio hadn’t worked as a bench scientist in years when, around 2011, he got put in touch with a team at the University of Colorado trying to revitalize an old approach to treating cancer.

Piscopio, who had co-founded Array Biopharma before heading to South Korea to launch a new company, was back in the states, unattached and intrigued. He founded a three-person company with two professors, Xuedong Liu and Gail Eckhardt, and while they worked on the biology side, he returned to his old chemist chair and began drawing up potential compounds on a computer, along with manufacturing processes to make them. Outsourcing companies synthesized or analyzed the results.

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Af­ter three years of courtship (and turn­downs), Mer­ck pounced on the first glance of clin­i­cal da­ta in $1.85B Pan­dion takeover

It’s almost become cliché for biotech executives to talk about the importance of keeping your options open and being prepared to go all the way. But when it comes to negotiating with a giant like Merck, a little patience can indeed go a long way.

Just ask Pandion Therapeutics.

Days ago we already learned that Merck is shelling out $1.85 billion to pick up the biotech and its slate of autoimmune hopefuls. What we didn’t know until the SEC disclosure dropped Thursday is that the deal comes after Pandion turned down two other proposals from Merck over the past three years and held out until the last minute for a sweetened deal.

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