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.

ZS Per­spec­tive: 3 Pre­dic­tions on the Fu­ture of Cell & Gene Ther­a­pies

The field of cell and gene therapies (C&GTs) has seen a renaissance, with first generation commercial therapies such as Kymriah, Yescarta, and Luxturna laying the groundwork for an incoming wave of potentially transformative C&GTs that aim to address diverse disease areas. With this renaissance comes several potential opportunities, of which we discuss three predictions below.

Allogenic Natural Killer (NK) Cells have the potential to displace current Cell Therapies in oncology if proven durable.

Despite being early in development, Allogenic NKs are proving to be an attractive new treatment paradigm in oncology. The question of durability of response with allogenic therapies is still an unknown. Fate Therapeutics’ recent phase 1 data for FT516 showed relatively quicker relapses vs already approved autologous CAR-Ts. However, other manufacturers, like Allogene for their allogenic CAR-T therapy ALLO-501A, are exploring novel lymphodepletion approaches to improve persistence of allogenic cells. Nevertheless, allogenic NKs demonstrate a strong value proposition relative to their T cell counterparts due to comparable response rates (so far) combined with the added advantage of a significantly safer AE profile. Specifically, little to no risk of graft versus host disease (GvHD), cytotoxic release syndrome (CRS), and neurotoxicity (NT) have been seen so far with allogenic NK cells (Fig. 1). In addition, being able to harness an allogenic cell source gives way to operational advantages as “off-the-shelf” products provide improved turnaround time (TAT), scalability, and potentially reduced cost. NKs are currently in development for a variety of overlapping hematological indications with chimeric antigen receptor T cells (CAR-Ts) today, and the question remains to what extent they will disrupt the current cell therapy landscape. Click for more details.

Graphic: Kathy Wong for Endpoints News

What kind of biotech start­up wins a $3B syn­di­cate, woos a gallery of mar­quee sci­en­tists and re­cruits GSK's Hal Bar­ron as CEO in a stun­ner? Let Rick Klaus­ner ex­plain

It started with a question about a lifetime’s dream on a walk with tech investor Yuri Milner.

At the beginning of the great pandemic, former NCI chief and inveterate biotech entrepreneur Rick Klausner and the Facebook billionaire would traipse Los Altos Hills in Silicon Valley Saturday mornings and talk about ideas.

Milner’s question on one of those mornings on foot: “What do you want to do?”

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Hal Barron, Endpoints UKBIO20 (Jeff Rumans)

'Al­tos was re­al­ly a once-in-a-life­time op­por­tu­ni­ty': Hal Bar­ron re­flects on his big move

By all accounts, Hal Barron had one of the best jobs in Big Pharma R&D. He made more than $11 million in 2020, once again reaping more than his boss, Emma Walmsley, who always championed him at every opportunity. And he oversaw a global R&D effort that struck a variety of big-dollar deals for oncology, neurodegeneration and more.

Sure, the critics never let up about what they saw as a rather uninspiring late-stage pipeline, where the rubber hits the road in the Big Pharma world’s hunt for the next big near-term blockbuster, but the in-house reviews were stellar. And Barron was firmly focused on bringing up the success rate in clinical trials, holding out for the big rewards of moving the dial from an average 10% success rate to 20%.

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Executive Director of the EMA Emer Cooke (AP Photo/Geert Vanden Wijngaert)

Eu­ro­pean Par­lia­ment signs off on strength­en­ing drug reg­u­la­tor's abil­i­ty to tack­le short­ages

The European Parliament on Thursday endorsed a plan to increase the powers of the European Medicines Agency, which will be better equipped to monitor and mitigate shortages of drugs and medical devices.

By a vote of 655 to 31, parliament signed off on a provisional agreement reached with the European Council from last October, in which the EMA will create two shortage steering groups (one for drugs, the other for devices), a new European Shortages Monitoring Platform to facilitate data collection and increase transparency, and on funding for the work of the steering groups, task force, working parties and expert panels that are to be established.

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FDA+ roundup: FDA's neu­ro­science deputy de­parts amid on­go­ing Aduhelm in­ves­ti­ga­tions; Califf on the ropes?

Amid increased scrutiny into the close ties between FDA and Biogen prior to the controversial accelerated approval of Aduhelm, the deputy director of the FDA’s office of neuroscience has called it quits after more than two decades at the agency.

Eric Bastings will now take over as VP of development strategy at Ionis Pharmaceuticals, the company said Wednesday, where he will provide senior clinical and regulatory leadership in support of Ionis’ pipeline.

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Sec­ondary patents prove to be key in biosim­i­lar block­ing strate­gies, re­searchers find

While the US biosimilars industry has generally been a disappointment since its inception, with FDA approving 33 biosimilars since 2015, just a fraction of those have immediately followed their approvals with launches. And more than a handful of biosimilars for two of the biggest blockbusters of all time — AbbVie’s Humira and Amgen’s Enbrel — remain approved by FDA but still have not launched because of legal settlements.

Hal Barron (GSK via YouTube)

GSK R&D chief Hal Bar­ron jumps ship to run a $3B biotech start­up, Tony Wood tapped to re­place him

In a stunning switch, GlaxoSmithKline put out word early Wednesday that R&D chief Hal Barron is exiting the company after 4 years — a relatively brief run for the man chosen by CEO Emma Walmsley in late 2017 to turn around the slow-footed pharma giant.

Barron is being replaced by Tony Wood, a close associate of Barron’s who’s taking one of the top jobs in Big Pharma R&D. He’ll be closer to home, though, for GSK. Barron has been running a UK and Philadelphia-based research organization from his perch in San Francisco.

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Chamath Palihapitiya and Pablo Legorreta

Bil­lion­aires Chamath Pal­i­hapi­tiya and Pablo Legor­re­ta hatch an $825M SPAC for cell ther­a­py biotech

Three years after Royalty Pharma chief Pablo Legorreta led a group of investors to buy up a pair of biotechs and create a new startup called ProKidney, the biotech is jumping straight into an $825 million public shell created by SPAC king and tech billionaire Chamath Palihapitiya.

ProKidney was founded 6 years ago but really got going at the beginning of 2019 with the $62 million acquisition of inRegen, which was working on an autologous — from the patient — cell therapy for kidney disease. After extracting kidney cells from patients, researchers expand the cells in the lab and then inject them back into patients, aiming to restore the kidneys of patients suffering from CKD.

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Troy Wilson, Kura CEO

FDA lifts par­tial hold on Ku­ra's Phase Ib AML pro­gram as biotech re­dou­bles mit­i­ga­tion ef­forts

Kura Oncology is clear to resume studies for its early-stage leukemia program after the FDA lifted a clinical hold Thursday afternoon.

Regulators had placed the hold on a Phase Ib study of KO-539, an experimental oral treatment for some genetic subsets of acute myeloid leukemia last November after a patient died while taking the drug. Kura expects to begin enrolling patients again imminently, CEO Troy Wilson told Endpoints News.