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.

The Fac­tors Dri­ving a Rapid Evo­lu­tion of Gene & Cell Ther­a­py and CAR-T Clin­i­cal Re­search in APAC

APAC is the fastest growing region globally for cell & gene therapy trials representing more than a third of all cell & gene studies globally, with China leading in the region. 

APAC is the leading location globally for CAR-T trials with China attracting ~60% of all CAR-T trials globally between 2015-2022. The number of CAR-T trials initiated by Western companies has rapidly increased in recent years (current CAGR of about 60%), with multiple targets being explored including CD19, CD20, CD22, BCMA, CD30, CD123, CD33, CD38, and CD138.

The End­points 11; blue­bird's $3M gene ther­a­py; Bio­gen tout new neu­ro da­ta; Harsh re­views for can­cer drugs; 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.

Reading about John Carroll’s pick of biotech’s most promising startups has become a treasured tradition. If you ever get curious about previous classes of the Endpoints 11, you can find all of them (plus a number of our other regular specials) here.

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EMA warns of short­ages of two Boehringer heart drugs due to a spike in de­mand

The EMA is putting EU member states on alert over the shortage of two drugs that counter heart attacks due to an uptick in demand.

On Friday, the EMA sent out a warning that two Boehringer Ingelheim drugs are experiencing a shortage: Actilyse and Metalyse. The drugs are used as emergency treatments for adults experiencing acute myocardial infarction, or a heart attack, by dissolving blood clots that have formed in the blood vessels.

The End­points 11: The top pri­vate biotechs in pur­suit of new drugs. Push­ing the en­ve­lope with pow­er­ful new tech­nolo­gies

Right around the beginning of the year, we got a close-up look at what happens after a boom ripples through biotech. The crash of life sciences stocks in Q1 was heard around the world.

In the months since, we’ve seen the natural Darwinian down cycle take effect. Reverse mergers made a comeback, with more burned out shells to go public at a time IPOs and road shows are out of favor. And no doubt some of the more recent arrivals on the investing side of the business are finding greener pastures.

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As­traZeneca, Mer­ck cull one Lyn­parza in­di­ca­tion in heav­i­ly pre­treat­ed ovar­i­an can­cer pa­tients

Just one day after blockbuster Lynparza got access to another indication in China, its Big Pharma owners have decided to withdraw it in certain patients after reviewing Phase III data.

The two companies that work together on Lynparza decided to recall one of the indications several weeks ago in a specific type of ovarian cancer, Lynparza’s first indication when it was first FDA-approved in 2014. Initial data showed that rates of overall survival in patients with at least three rounds of chemo before getting on the PARP inhibitor were lower than in patients with less previous chemo treatment.

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Fu­ji­film con­tin­ues CD­MO ex­pan­sion, break­ing ground on $435M UK site

Fujifilm’s CDMO arm, Fujifilm Diosynth, has been on a roll this month as the company has recently broken ground on a major project in Europe and it appears to be keeping up the momentum.

Fujifilm Diosynth announced that it has kicked off an expansion project for its microbial manufacturing facility at its campus in the town of Billingham, UK, in the northeast of England.

The 20,000 square-foot, £400 million ($435 million) expansion will add clean rooms, purification suites and a packing area along with more space for the manufacturing itself.

An­oth­er Cipla site lands a Form 483 over clean­ing is­sues and QC con­trols

A Cipla drug manufacturing site in India has once again landed in the crosshairs of FDA inspectors.

The facility in question is Cipla’s drug manufacturing facility in the village of Verna, in the state of Goa in India’s southwest. In a sign that foreign inspections might ramp up again, the FDA’s visit from Aug. 16 to Aug. 22 uncovered six observations.

The 11-page report noted that environmental monitoring at the site did not properly ensure that microbial contaminants were not making any impact in the aseptic filling areas. It also found that procedures meant to stop microbial contamination were not adequately conducted in aseptic areas of the facility.

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Solicitor General Elizabeth Prelogar

Should SCO­TUS hear Am­gen's Repatha case? So­lic­i­tor gen­er­al says no

Back in April, Amgen said it was encouraged by the solicitor general’s anticipated review of its Supreme Court petition to rehear a Repatha patent case. They’re likely much less optimistic about the outcome now.

Solicitor General Elizabeth Prelogar wrote in a recent 27-page brief that Amgen’s arguments “lack merit and further review is not warranted.”

The case traces back to a suit filed in 2014 against Sanofi and Regeneron’s Praluent, which ended up beating Amgen’s PCSK9 blockbuster Repatha to market by a month just a year later.

Klick Health gath­ers biotech and phar­ma lu­mi­nar­ies to dis­cuss in­dus­try in­no­va­tions, in­vest­ments and fu­ture

At Klick Health’s first Ideas Exchange conference with biotech and pharma industry insiders since before the pandemic began, it was no surprise many conversations included Covid topics. Yet while vaccines and treatments were discussed, so too were the effects on drug development, federal responses, health inequities — and what to do now and next.

George Yancopoulos, chief scientist and cofounder of Regeneron, opened the conference responding to a question from Acorda CEO Ron Cohen about the spotlight on the industry during Covid and some of the “flak” biopharma has taken in the past.