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.

Health­care Dis­par­i­ties and Sick­le Cell Dis­ease

In the complicated U.S. healthcare system, navigating a serious illness such as cancer or heart disease can be remarkably challenging for patients and caregivers. When that illness is classified as a rare disease, those challenges can become even more acute. And when that rare disease occurs in a population that experiences health disparities, such as people with sickle cell disease (SCD) who are primarily Black and Latino, challenges can become almost insurmountable.

Jacob Van Naarden (Eli Lilly)

Ex­clu­sives: Eli Lil­ly out to crash the megablock­buster PD-(L)1 par­ty with 'dis­rup­tive' pric­ing; re­veals can­cer biotech buy­out

It’s taken 7 years, but Eli Lilly is promising to finally start hammering the small and affluent PD-(L)1 club with a “disruptive” pricing strategy for their checkpoint therapy allied with China’s Innovent.

Lilly in-licensed global rights to sintilimab a year ago, building on the China alliance they have with Innovent. That cost the pharma giant $200 million in cash upfront, which they plan to capitalize on now with a long-awaited plan to bust up the high-price market in lung cancer and other cancers that have created a market worth tens of billions of dollars.

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David Meek, new Mirati CEO (Marlene Awaad/Bloomberg via Getty Images)

Fresh off Fer­Gene's melt­down, David Meek takes over at Mi­rati with lead KRAS drug rac­ing to an ap­proval

In the insular world of biotech, a spectacular failure can sometimes stay on any executive’s record for a long time. But for David Meek, the man at the helm of FerGene’s recent implosion, two questionable exits made way for what could be an excellent rebound.

Meek, most recently FerGene’s CEO and a past head at Ipsen, has become CEO at Mirati Therapeutics, taking the reins from founding CEO Charles Baum, who will step over into the role of president and head of R&D, according to a release.

FDA hands ac­cel­er­at­ed nod to Seagen, Gen­mab's so­lo ADC in cer­vi­cal can­cer, but com­bo stud­ies look even more promis­ing

Biopharma’s resident antibody-drug conjugate expert Seagen has scored a clutch of oncology approvals in recent years, finding gold in what are known as “third-gen” ADCs. Now, another of their partnered conjugates is ready for prime time.

The FDA on Monday handed an accelerated approval to Seagen and Genmab’s Tivdak (tisotumab vedotin-tftv, or “TV”) in second-line patients with recurrent or metastatic cervical cancer who previously progressed after chemotherapy rather than PD-(L)1 systemic therapy, the companies said in a release.

Rafaèle Tordjman (Jeito Capital)

Con­ti­nu­ity and di­ver­si­ty: Rafaèle Tord­j­man's women-led VC firm tops out first fund at $630M

For a first-time fund, Jeito Capital talks a lot about continuity.

Rafaèle Tordjman had spotlighted that concept ever since she started building the firm in 2018, promising to go the extra mile(s) with biotech entrepreneurs while pushing them to reach patients faster.

Coincidentally, the lack of continuity was one of the sore spots listed in a report about the European healthcare sector published that same year by the European Investment Bank — whose fund is one of the LPs, alongside the American pension fund Teacher Retirement System of Texas and Singapore’s Temasek, to help Jeito close its first fund at $630 million (€534 million). As previously reported, Sanofi had chimed in €50 million, marking its first investment in a French life sciences fund.

Dave Lennon, former president of Novartis Gene Therapies

Zol­gens­ma patent spat brews be­tween No­var­tis and Re­genxbio as top No­var­tis gene ther­a­py ex­ec de­parts

Regenxbio, a small licensor of gene therapy viral vectors spun out from the University of Pennsylvania, is now finding itself in the middle of some major league patent fights.

In addition to a patent suit with Sarepta Therapeutics from last September, Novartis, is now trying to push its smaller partner out of the way. The Swiss biopharma licensed Regenxbio’s AAV9 vector for its $2.1 million spinal muscular atrophy therapy Zolgensma.

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Time for round 2: Il­lu­mi­na-backed VC snags $325M for its next fund

Illumina Ventures closed off its second investment fund with a total commitment of $325 million, offering fresh fuel to back a slate of startups that have already included a smorgasbord of companies, covering everything from diagnostics to biotech drug development and genomics.

Fund II brings the total investment under Illumina Ventures’ oversight to $560 million, which has been focused on early-stage companies. And it has a transatlantic portfolio that includes SQZ, Twist and Encoded Therapeutics.

Volker Wagner (L) and Jeff Legos

As Bay­er, No­var­tis stack up their ra­dio­phar­ma­ceu­ti­cal da­ta at #ES­MO21, a key de­bate takes shape

Ten years ago, a small Norwegian biotech by the name of Algeta showed up at ESMO — then the European Multidisciplinary Cancer Conference 2011 — and declared that its Bayer-partnered targeted radionuclide therapy, radium-223 chloride, boosted the overall survival of castration-resistant prostate cancer patients with symptomatic bone metastases.

In a Phase III study dubbed ALSYMPCA, patients who were treated with radium-223 chloride lived a median of 14 months compared to 11.2 months. The FDA would stamp an approval on it based on those data two years later, after Bayer snapped up Algeta and christened the drug Xofigo.

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Raju Mohan, Ventyx Biosciences CEO

Months af­ter a mam­moth raise, Ven­tyx Bio­sciences dips back in­to ven­ture well

Several months after emerging from what CEO Raju Mohan called “quiet mode” with a mammoth $114 million raise, Ventyx Biosciences is now making its plans for the clinic loud and clear.

The California-based immune modulation player kicked the week off with a $51 million Series B, while also naming some key hires ahead of its big clinical push.

The CMO slot is going to Jörn Drappa, former CMO at Viela Bio before it was bought out by Horizon Therapeutics earlier this year. The AstraZeneca vet stayed on at Horizon for a while as executive VP of R&D before making the jump to Ventyx.