Castle Creek Biosciences chair Jeff Aronin

Scoop: Af­ter pulling IPO am­bi­tions last De­cem­ber, Jeff Aron­in's Cas­tle Creek turns to pri­vate back­ers

Jeff Aronin’s cell and gene ther­a­py biotech Cas­tle Creek Bio­sciences has raised $112 mil­lion in eq­ui­ty, End­points News has learned.

The Ex­ton, PA, biotech se­cured the fi­nanc­ing from 54 in­vestors, ac­cord­ing to an SEC fil­ing dat­ed May 2. The late-stage start­up had last year con­sid­ered a $100 mil­lion Nas­daq de­but, but in a sign of the bear mar­ket that has plagued hun­dreds of new­ly mint­ed pub­lic biotechs, Cas­tle Creek pulled those am­bi­tions in the last few weeks of 2021.

This time around, the biotech has re­turned to pri­vate back­ing, and it comes just three months af­ter the com­pa­ny raised near­ly $12 mil­lion in debt fi­nanc­ing. Cas­tle Creek had pre­vi­ous­ly raised $25 mil­lion in debt fi­nanc­ing last year, ac­cord­ing to an SEC fil­ing, and $71.8 mil­lion from Fi­deli­ty Man­age­ment and Val­or Eq­ui­ty Part­ner in 2018.

End­points has reached out to Aronin and a Cas­tle Creek com­pa­ny spokesper­son, and will up­date this sto­ry ac­cord­ing­ly.

If Cas­tle Creek is still fol­low­ing the same strate­gic route as at the time of its S-1 fil­ing, the biotech will like­ly de­ploy the pro­ceeds on the Phase III tri­al of its ex vi­vo gene ther­a­py dabo­cema­gene aut­ofi­cel, al­so dubbed FCX-007 and D-Fi, for pa­tients with chron­ic wounds due to re­ces­sive dy­s­troph­ic epi­der­mol­y­sis bul­losa.

The con­di­tion leads to blis­ter­ing and tear­ing of the skin due to a lack of col­la­gen pro­tein. It’s some­times been re­ferred to as a “but­ter­fly” dis­ease be­cause of how frag­ile it can make an in­fant’s skin. Oth­er biotechs ex­plor­ing the rare dis­ease in­clude Phase III-stage Abeona Ther­a­peu­tics and Eloxx Phar­ma­ceu­ti­cals.

Cas­tle Creek’s study is still re­cruit­ing and is ex­pect­ed to col­lect fi­nal pri­ma­ry out­come da­ta in April 2023, ac­cord­ing to the fed­er­al clin­i­cal tri­als data­base. When Cas­tle Creek ac­quired the drug from Fi­bro­cell in 2019, the orig­i­nal own­er said a mar­ket­ing ap­pli­ca­tion would be shipped off in 2021.

D-Fi is al­so slat­ed to en­ter a late-stage tri­al in a dom­i­nant form of the con­di­tion, ac­cord­ing to the biotech’s pipeline page on its web­site.

Cas­tle Creek’s oth­er clin­i­cal-stage ex vi­vo au­tol­o­gous gene ther­a­py, FCX-013, is in a Phase I/II study in pa­tients with mod­er­ate to se­vere lo­cal­ized scle­ro­der­ma, which leads to hard­en­ing and tight­en­ing of the skin.

The fi­nanc­ing comes four months af­ter Cas­tle Creek bought up gene ther­a­py mak­er No­vavi­ta Thera, which adds pre­clin­i­cal as­sets tar­get­ing rare liv­er and meta­bol­ic dis­ease to the com­pa­ny’s pipeline. As part of the deal, No­vavi­ta co-founder Joseph Lil­le­gard took on the post of sci­ence chief.

Last year, when con­sid­er­ing the Wall Street en­trance, Cas­tle Creek ter­mi­nat­ed a six-year-old li­cense agree­ment with TWI Biotech­nol­o­gy last June for de­vel­op­ment of CCP-020, a com­pound known as di­ac­ere­in.

Aronin is chair of Cas­tle Creek’s orig­i­na­tor, in­vest­ment en­gine Paragon Bio­sciences, be­hind the likes of Har­mo­ny Bio­sciences and Evozyne. He’s al­so founder and chair of Chica­go health-tech in­cu­ba­tor MAT­TER and was pre­vi­ous­ly CEO of Marathon Phar­ma­ceu­ti­cals.

Vas Narasimhan (Photographer: Jason Alden/Bloomberg via Getty Images)

No­var­tis de­tails plans to axe 8,000 staffers as Narasimhan be­gins sec­ond phase of a glob­al re­org

We now know the number of jobs coming under the axe at Novartis, and it isn’t small.

The pharma giant is confirming a report from Swiss newspaper Tages-Anzeiger that it is chopping 8,000 jobs out of its 108,000 global staffers. A large segment will hit right at company headquarters in Basel, as CEO Vas Narasimhan axes some 1,400 of a little more than 11,000  jobs in Switzerland.

The first phase of the work is almost done, the company says in a statement to Endpoints News. Now it’s on to phase two. In the statement, Novartis says:

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Bob Nelsen (Lyell)

UP­DAT­ED: As bear mar­ket con­tin­ues to beat down biotech, ARCH clos­es a $3B ear­ly-stage fund

One of the biggest names in biotech investing has a whole lot of new money to spend.

ARCH Venture Partners closed its 12th venture fund early Wednesday morning, the firm said, bringing in almost $3 billion to invest in early-stage biotechs. The move comes about a year and a half after ARCH announced its previous fund, for almost $2 billion back in January 2021.

In an interview with Endpoints News, ARCH managing director and co-founder Bob Nelsen brushed off concerns about the broader market troubles, saying the downturn that’s seen several biotechs downsize and the XBI fall back to almost pre-pandemic levels won’t impact ARCH’s mindset too much because it typically focuses on company formation.

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Peter Marks (Jim Lo Scalzo/Pool via AP Images)

FDA's VRB­PAC votes in fa­vor of adapt­ing the Covid-19 vac­cine to the lat­est Omi­cron vari­ant

The FDA’s Vaccine and Related Biological Products Advisory Committee on Tuesday gave the thumbs up — by a vote of 19-2 — that the FDA should require an Omicron-related component in this next season’s booster dose for Covid-19, which both Pfizer/BioNTech and Moderna are hard at work on.

And while neither booster will likely be ready to go with adequate supplies for all American adults by the beginning of the next school year, the situation is still complex and fluid, with CBER Director Peter Marks telling the committee that it’ll take companies at least three months to ready their supplies for this expected next wave.

Lina Gugucheva, NewAmsterdam Pharma CBO

Phar­ma group bets up to $1B-plus on the PhI­II res­ur­rec­tion of a once dead-and-buried LDL drug

Close to 5 years after then-Amgen R&D chief Sean Harper tamped the last spade of dirt on the last broadly focused CETP cholesterol drug — burying their $300 million upfront and the few remaining hopes for the class with it — the therapy has been fully resurrected. And today, the NewAmsterdam Pharma crew that did the Lazarus treatment on obicetrapib is taking another big step on the comeback trail with a €1 billion-plus regional licensing deal, complete with close to $150 million in upfront cash.

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How pre­pared is bio­phar­ma for the cy­ber dooms­day?

One of the largest cyberattacks in history happened on a Friday, Eric Perakslis distinctly remembers.

Perakslis, who was head of Takeda’s R&D Data Sciences Institute and visiting faculty at Harvard Medical School at the time, had spent that morning completing a review on cybersecurity for the British Medical Journal. Moments after he turned it in, he heard back from the editor: “Have you heard what’s going on right now?”

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Sanofi to cut in­sulin prices for unin­sured from $99 to $35, match­ing the in­sulin cap com­ing through Con­gress

As the House-passed bill to cap the monthly price of insulin at $35 nationwide makes its way for a Senate vote soon, Sanofi announced Wednesday morning that beginning next month it will cut the monthly price of its insulins for uninsured Americans to $35, down from $99 previously.

The announcement from Sanofi, which allows the uninsured to buy one or multiple Sanofi insulins (Lantus, Insulin Glargine U-100, Toujeo, Admelog, and Apidra) at $35 for a 30-day supply effective July 1, follows House passage (232-193) of the monthly cap in March, with just 12 Republicans voting in favor of the measure.

Shehnaaz Suliman, ReCode Therapeutics CEO (Photo by Jennifer Leahy)

Pfiz­er, Sanofi-backed LNP out­fit goes back to the well and draws $120M for its trek to the clin­ic

A preclinical biotech touting a five-lipid drug delivery platform is looking to break out of its preclinical mold, and it just secured a sizable raise to do just that.

ReCode Therapeutics reported Wednesday morning that Leaps by Bayer and Matrix Capital Management affiliate AyurMaya co-led a Series B extension round, adding $120 million to the biotech’s previous Series B haul of $80 million. The biotech has been backed by several players in Big Pharma, notably Pfizer and Sanofi from its original Series B close last fall. And in this extension — featuring all new investors, CEO Shehnaaz Suliman tells Endpoints News — Amgen’s VC arm jumped on board.

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Eliot Charles, MiroBio executive chairman

Ox­ford spin­out nabs al­most $100M in new cash to test PD-1 in au­toim­mune dis­eases and hunt for a CEO

After about 15 years in an Oxford lab and three more years in the upstart world following a 2019 spinout, MiroBio is ready to enter UK clinical trials and, en route to the clinic, the biotech has picked up $97 million in Series B funds.

The £80 million financing round kicked off in earnest last September and includes a transatlantic consortium — led by Medicxi — ready to bankroll that first clinical trial, beginning “imminently,” as well as the debut study of a second program thereafter, executive chair Eliot Charles, an SR One venture partner, told Endpoints News.

Hank Safferstein, Generian CEO

Astel­las sub­sidiary to part­ner with Pitts­burgh up­start in search for 'un­drug­gable' pro­teins

As Astellas continues its drive to build out its gene therapy portfolio and capabilities, a subsidiary of the Japanese pharma company has entered into a collaboration with a little-known Pittsburgh biotech.

Astellas-owned Mitobridge and Generian Pharmaceuticals announced on Wednesday that they will work together in a new deal for “undruggable” protein targets. Generian will net an undisclosed upfront payment and could get up to $180 million in milestones, should anything from its platform prove successful, as well as single-digit royalties on global net sales.