IPOs con­tin­ue to bus­tle as three more biotechs pre­pare to make the Nas­daq leap

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The biotech IPO mar­ket con­tin­ues to charge full-steam ahead, with three more com­pa­nies sub­mit­ting their Nas­daq pitch­es to the SEC late Fri­day.

The lead­ers among the pack are Ada­gio Ther­a­peu­tics and Cas­tle Creek Bio­sciences, each pen­cil­ing in $100 mil­lion ini­tial­ly. Fol­low­ing up the rear is Eliem Ther­a­peu­tics, jot­ting down $80 mil­lion for its raise es­ti­mate less than six months af­ter launch­ing out of RA Cap­i­tal’s in­cu­ba­tor.

Fri­day’s fil­ings come a week af­ter End­points News’ con­ver­sa­tion with Nas­daq of­fi­cial Jor­dan Saxe, who said the in­sti­tu­tion is in con­ver­sa­tions with about 250 biotechs over the next 12 to 18 months. Per the End­points tal­ly, the biotechs that have al­ready priced have raised more than $10 bil­lion com­bined.

In ad­di­tion to the three fil­ings, French biotech Dy­nacure with­drew its ap­pli­ca­tion for an IPO af­ter not pric­ing last week.

Our own John Car­roll took a deep look in­to Ada­gio’s high-pro­file quest for Nas­daq, which pre­mi­um sub­scribers can read here. For the best of the rest, check out the news be­low.

Cas­tle Creek takes for­mer Fi­bro­cell pro­grams pub­lic

Ahead of a high-stakes Phase III read­out in the sec­ond half of next year, Cas­tle Creek is seek­ing to join the Nas­daq ranks.

The Ex­ton, PA-based biotech is fo­cus­ing its ef­forts around a pro­gram called dabo­cema­gene aut­ofi­cel, or D-Fi, to treat re­ces­sive dy­s­troph­ic epi­der­mol­y­sis bul­losa, a some­times fa­tal rare dis­ease caused by a lack of col­la­gen in the skin re­sult­ing in un­con­trol­lable blis­ter­ing. It’s a pro­gram that comes from the small ac­qui­si­tion of the biotech Fi­bro­cell back in Sep­tem­ber 2019.

Cas­tle Creek has been work­ing on rare dis­eases in­volv­ing the skin since in­cep­tion, with a for­mer lead pro­gram in a broad­er epi­der­mol­y­sis bul­losa pop­u­la­tion. But that can­di­date, a top­i­cal re­for­mu­la­tion of the IL-1 be­ta an­ti-in­flam­ma­to­ry drug di­ac­ere­in, failed a Phase II study in Oc­to­ber 2018.

Jeff Aronin

Co-founder Michael Der­by had told End­points at the time that Cas­tle Creek planned to ad­vance the pro­gram in­to Phase III de­spite the fail­ure, but it’s un­clear if those plans ever came to fruition. Di­ac­ere­in is no longer list­ed among the biotech’s pipeline, and its on­ly men­tions in the S-1 re­volve around the old li­cens­ing agree­ments Cas­tle Creek signed to re-en­gi­neer it as a top­i­cal drug.

The biotech will con­tin­ue to charge for­ward with the new­er can­di­date, and plans to launch a sec­ond Phase III study be­fore the end of 2021 in the dom­i­nant ver­sion of dy­s­troph­ic epi­der­mol­y­sis bul­losa. Though Cas­tle Creek did not di­vulge ex­act fig­ures in its SEC pa­per­work, it’s ex­pect­ed a sig­nif­i­cant por­tion of these funds will go to­ward the two stud­ies and “pre-com­mer­cial” ac­tiv­i­ties for D-Fi.

There’s al­so an­oth­er Fi­bro­cell gene ther­a­py for mod­er­ate to se­vere lo­cal­ized scle­ro­der­ma in the works, and some IPO funds will be used to wrap up an on­go­ing Phase I/II tri­al, Cas­tle Creek not­ed. The biotech comes from maven Jeff Aronin and his port­fo­lio of com­pa­nies un­der the Paragon um­brel­la. Once it prices, Cas­tle Creek ex­pects to trade un­der the tick­er $CCBS.

Eliem for a dream: From stealth to Nas­daq in four months

Eliem Ther­a­peu­tics is aim­ing to com­plete a quick rise to Nas­daq af­ter launch­ing at the end of March.

There had been signs of an IPO af­ter the biotech’s $60 mil­lion Se­ries B, when com­pa­ny spokes­peo­ple de­clined in­ter­view re­quests ahead of the fil­ing. Eliem like­ly rep­re­sents one of the fastest Nas­daq push­es for biotech in re­cent mem­o­ry, go­ing from launch to fil­ing for an IPO in less than four months.

Should it price, Eliem will have a pipeline of four neu­ro as­sets led by a pro­drug of an en­do­cannabi­noid known as palmi­toylethanolamide, or PEA. The can­di­date is known as ETX-810, and CSO Va­lerie Moris­set pre­vi­ous­ly told End­points the biotech is look­ing at a va­ri­ety of chron­ic pain in­di­ca­tions.

ETX-810 is cur­rent­ly in two Phase IIa stud­ies look­ing at di­a­bet­ic pe­riph­er­al neu­ro­path­ic pain and lum­bosacral radic­u­lar pain. Da­ta read­outs are ex­pect­ed for the first half of 2022.

Eliem is al­so de­vel­op­ing a GA­BA-pos­i­tive al­losteric mod­u­la­tor, which the com­pa­ny is call­ing ETX-155. Re­searchers plan to take this pro­gram in­to two Phase IIa stud­ies for ma­jor de­pres­sive dis­or­der and hor­mone-re­lat­ed de­pres­sive dis­or­ders, as well as a Phase Ib tri­al for epilep­sy. Da­ta here are ex­pect­ed in the sec­ond half of 2022 and the first half of 2023, re­spec­tive­ly.

Both pro­grams come from RA Cap­i­tal, where the biotech was in­cu­bat­ed. Both will al­so be the pri­ma­ry fo­cus­es for the IPO raise.

Once Eliem goes pub­lic, it will trade un­der the tick­er $ELYM.

No­var­tis reshuf­fles its wild cards; Tough sell for Bio­gen? Googling pro­teins; Ken Fra­zier's new gig; 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.

If you enjoy the People section in this report, you may also want to check out Peer Review, my colleagues Alex Hoffman and Kathy Wong’s comprehensive compilation of comings and goings in biopharma.

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Demis Hassabis, DeepMind CEO (Qianlong/Imaginechina via AP Images)

Google's Deep­Mind opens its pro­tein data­base to sci­ence — po­ten­tial­ly crack­ing drug R&D wide open

Nearly a year ago, Google’s AI outfit DeepMind announced they had cracked one of the oldest problems in biology: predicting a protein’s structure from its sequence alone. Now they’ve turned that software on nearly every human protein and hundreds of thousands of additional proteins from organisms important to medical research, such as fruit flies, mice and malaria parasite.

The new database of roughly 350,000 protein sequences and structures represents a potentially monumental achievement for the life sciences, one that could hasten new biological insights and the development of new drugs. DeepMind said it will be free and accessible to all researchers and companies.

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In­side Bio­gen's scram­ble to sell Aduhelm: Pro­ject 'Javelin' and pres­sure to ID as many pa­tients as pos­si­ble

In anticipation of Aduhelm’s approval for Alzheimer’s in June, Biogen employees were directed to identify and guarantee treatment centers would administer the drug through a program called “Javelin,” a senior Biogen employee told Endpoints News.

The program identified about 800 centers for use, he said, and Biogen now pays for the use of bioassays to identify beta amyloid in potential patients having undergone a lumbar puncture procedure, the employee said — and one center preparing to administer the drug confirmed its participation in the bioassay program.

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Vas Narasimhan, Novartis CEO (Jason Alden/Bloomberg via Getty Images)

No­var­tis dis­cards one of its ‘wild card’ drugs af­ter it flops in key study. But it takes one more for the hand

Always remember just how risky it is to gamble big on small studies.

A little more than 4 years ago, Novartis reportedly put up a package worth up to $1 billion for the dry eye drug ECF843 after a small biotech called Lubris put it through its paces in a tiny study of 40 moderate to severe patients, tracking some statistically significant markers of efficacy.

By last fall, the program had risen up to become one of CEO Vas Narasimhan’s top “wild card” programs in line for a potential breakthrough year in 2021. These drugs were all considered high-risk, high-reward efforts. And in this case, risk won.

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UP­DAT­ED: Three biotechs price hefty IPOs just be­fore the week­end, while a fourth and a SPAC seek spots on Wall Street

Editor’s note: Interested in following biopharma’s fast-paced IPO market? You can bookmark our IPO Tracker here.

A handful of biotechs are hitting Wall Street just before the start of the weekend, with three companies — Caribou Biosciences, Sophia Genetics and Absci — all pricing big raises Wednesday and Thursday. Gamma delta T cell-focused IN8bio relaunched its IPO campaign months after postponing it last November, seeking a slightly lower raise. And another SPAC has filed for a public debut.

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Victor Perlroth, Kodiak Sciences CEO

Ko­di­ak turns down $125M pay­ment from Bak­er Bros. deal, slash­es roy­al­ty cap by 55%

Following a massive public raise last November, Kodiak Sciences has re-worked a royalty sale agreement with an old partner — and declined new funds in the process.

Kodiak is turning down a planned $125 million payment from Baker Bros. Advisors, according to an SEC filing, cutting short an agreement that saw the biotech hand over a 4.5% stream of royalty sales on its experimental anti-VEGF therapy KSI-301 for retinal vascular diseases. In conjunction with the move, Kodiak is shrinking the royalty cap from just over $1 billion to $450 million.

EMA re­jects FDA-ap­proved Parkin­son's drug, signs off on Mod­er­na vac­cine use in ado­les­cents ahead of FDA

The European Medicines Agency on Friday rejected Kyowa Kirin’s Parkinson’s disease drug Nouryant (istradefylline), which the US FDA approved in 2019 under the brand name Nourianz.

EMA said it considered that the results of the clinical studies used to support the application “were inconsistent and did not satisfactorily show that Nouryant was effective at reducing the ‘off’ time. Only four out of the eight studies showed a reduction in ‘off’ time, and the effect did not increase with an increased dose of Nouryant.”

6 top drug­mak­ers of­fer per­spec­tives on FDA's new co­vari­ates in RCTs guid­ance

Back in May, the FDA revised and expanded a 2019 draft guidance that spells out how to adjust for covariates in the statistical analysis of randomized controlled trials.

Building on the ICH’s E9 guideline on the statistical principles for clinical trials, the 3-page draft was transformed into an 8-page draft, with more detailed recommendations on linear and nonlinear models to analyze the efficacy endpoints in RCTs.

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Mol­e­c­u­lar Di­ag­nos­tics Can Trans­form Can­cer Care. Let’s Make It Hap­pen.

Like so many people around the world, my life has been profoundly shaped by cancer. Those personal experiences, along with a deep love of clinical laboratory science and a passion to apply the power of genomics in medicine, motivated me to launch a company that would improve cancer care through better diagnostics. Thirteen years later, I am proud that we are delivering more accurate information at multiple points along the patient journey, with a focus on eight of the 10 cancers that are most commonly diagnosed in the United States.