From part­ner to knight in shin­ing ar­mor: Cas­tle Creek to buy Fi­bro­cell

In April, Cas­tle Creek swooped in to part­ner with the em­bat­tled gene and cell ther­a­py Fi­bro­cell to shep­herd its lead gene ther­a­py for a type of “but­ter­fly” dis­ease in­to late-stage de­vel­op­ment. Now, the New Jer­sey-based der­ma­tol­ogy com­pa­ny is ac­quir­ing its part­ner in a deal worth $63.3 mil­lion.

Cas­tle Creek CEO Greg Wu­jek

Penn­syl­va­nia-based Fi­bro­cell last year ini­ti­at­ed a re­view of strate­gic al­ter­na­tives, in­clud­ing a sale.

Its lead drug FCX-007 is en­gi­neered to treat the un­der­ly­ing cause of re­ces­sive dy­s­troph­ic epi­der­mol­y­sis bul­losa, which is caused by the de­fi­cien­cy of the pro­tein COL7. Cells are ex­tract­ed from the pa­tient, ge­net­i­cal­ly mod­i­fied, and then used to treat wounds by lo­cal in­jec­tion, avoid­ing sys­temic dis­tri­b­u­tion.

A late-stage study for FCX-007 was kicked off in Ju­ly, and if all goes well, a mar­ket­ing ap­pli­ca­tion for the treat­ment is ex­pect­ed to be sub­mit­ted in 2021, Fi­bro­cell said on Thurs­day. The com­pa­ny, which al­so counts In­trex­on $XON as a part­ner, has an ex­per­i­men­tal gene ther­a­py FCX-013 in ear­ly-stage de­vel­op­ment for mod­er­ate to se­vere lo­cal­ized scle­ro­der­ma.

Epi­der­mol­y­sis Bul­losa (EB) is a group of ge­net­ic skin con­di­tions that cause the skin to blis­ter and tear due to min­i­mal con­tact — in­fants born with the dis­ease are called ‘but­ter­fly chil­dren’ as their skin is con­sid­ered as frag­ile as a wing of a but­ter­fly.

Cas­tle Creek Phar­ma­ceu­ti­cals — one of for­mer Marathon chief Jeff Aronin’s port­fo­lio com­pa­nies un­der his flag­ship in­vest­ment en­gine Paragon Bio­sciences — has its own EB drug in de­vel­op­ment: CCP-020 is a late-stage top­i­cal oint­ment un­der de­vel­op­ment for use in epi­der­mol­y­sis bul­losa sim­plex. The drug is a re­pur­posed an oral or­phan treat­ment called di­ac­ere­in, which is ap­proved to treat joint swelling or pain in the EU, but its use is re­strict­ed due to the risks of di­ar­rhea and liv­er prob­lems.

“Fol­low­ing our li­cens­ing agree­ment to de­vel­op and com­mer­cial­ize FCX-007, our ex­pe­ri­ence work­ing to­geth­er on rare der­ma­to­log­i­cal con­di­tions caused us to quick­ly re­al­ize that Cas­tle Creek and Fi­bro­cell could achieve even greater syn­er­gies by com­bin­ing the com­pa­nies in­to one,” said Greg Wu­jek, CEO of Cas­tle Creek Phar­ma­ceu­ti­cals, in a state­ment.

Cas­tle Creek has agreed to pay $3 per Fi­bro­cell share $FC­SC, which is a near­ly 64% pre­mi­um to the com­pa­ny’s Thurs­day clos­ing. The deal, in which Cas­tle Creek will ab­sorb Fi­bro­cell’s debt, is ex­pect­ed to close by the fourth quar­ter.

Tal Zaks, Moderna CMO (Moderna via YouTube)

UP­DAT­ED: NI­AID and Mod­er­na spell out a 'ro­bust' im­mune re­sponse in PhI coro­n­avirus vac­cine test — but big ques­tions re­main to be an­swered

The NIAID and Moderna have spelled out positive Phase I safety and efficacy data for their Covid-19 vaccine mRNA-1273 — highlighting the first full, clear sketch of evidence that back-to-back jabs at the dose selected for Phase III routinely produced a swarm of antibodies to the virus that exceeded levels seen in convalescent patients — typically in multiples indicating a protective response.

Moderna execs say plainly that this first stage of research produced exactly the kind of efficacy they hoped to see in humans, with a manageable safety profile.

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Trans­port Sim­u­la­tion Test­ing for Your Ther­a­py is the Best Way to As­sure FDA Ex­pe­dit­ed Pro­gram Ap­proval

Modality Solutions is an ISO:9001-registered biopharmaceutical cold chain engineering firm with unique transport simulation capabilities that support accelerated regulatory approval for biologics and advanced therapeutic medicinal products (ATMP). Our expertise combines traditional validation engineering approaches with regulatory knowledge into a methodology tailored for the life sciences industry. We provide insight and execution for the challenges faced in your cold chain logistics network.

Tillman Gerngross, Adagio Therapeutics CEO

An­ti­body leg­end Till­man Gern­gross is el­bow­ing his way in­to the Covid-19 R&D cru­sade: 'I don’t see this end­ing any­time soon'

One of the most influential — and outspoken — scientists at work in the field of antibody discovery is jumping into the frenzied race to create new therapeutics to treat and prevent Covid-19. And he’s operating with the conviction that the current outbreak now once again spreading like wildfire will create plenty of demand for what he has in mind.

Dartmouth professor and Adimab CEO Tillman Gerngross tells me he’s raised $50 million from a group of close VCs to spin out a new company — Adagio Therapeutics — with a full C-suite team assembled to hire up a staff and keep rolling toward the clinic.

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Who are the women blaz­ing trails in bio­phar­ma R&D and lead­ing the fight against Covid-19? Nom­i­nate them for End­points' spe­cial re­port

One of the many inequalities the pandemic has laid bare is the gender imbalance in biomedical research. A paper examining Covid-19 research authorship wondered out loud: Where are the women?

It’s a question that echoes beyond our current times. In the biopharma world, not only are women under-represented in R&D roles (particularly at higher levels), their achievements and talents could also be undermined by stereotypes and norms of leadership styles. The problem is even more dire for women of color.

Jeff Albers, Blueprint CEO

Di­ag­nos­tic champ Roche buys its way in­to the RET ti­tle fight with Eli Lil­ly, pay­ing $775M in cash to Blue­print

When Roche spelled out its original $1 billion deal — $45 million of that upfront — with Blueprint to discover targeted therapies against immunokinases, the biotech partner’s RET program was still preclinical. Four years later, pralsetinib is on the cusp of potential approval and the Swiss pharma giant is putting in much more to get in on the commercial game.

Roche gains rights to co-develop and co-commercialize the drug, with sole marketing responsibility for places outside the US and China (where CStone has staked its claim).

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Norbert Bischofberger, Kronos CEO

Gilead­'s ex-R&D chief Bischof­berg­er heads back to the biotech gi­ant to pick up a pair of late-stage drugs that had been put aside

Norbert Bischofberger knows entospletinib well.

Back during his long, blockbuster run as head of R&D at Gilead, researchers had once held some high hopes for this drug. But to make it work, he and the team felt it would need a new companion diagnostic to identify patients. There was talk of a combo approach to give it more punch. But the market was small, making them wonder if it would be worth going through a lengthy development cycle to get it through a pivotal.

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GSK’s Shin­grix leader Guil­laume Pfe­fer has jumped on board Flag­ship to helm a biotech hy­brid as Afeyan’s lat­est CEO-part­ner

After spending 4 years in a senior post with GlaxoSmithKline’s star team positioning Shingrix for a blockbuster approval, Guillaume Pfefer is headed back to the biotech world — in style.

Pfefer has signed on to join Noubar Afeyan’s busy group of partners at Flagship, and he’s taking the helm of an upstart — which today is being merged with another Flagship startup — with some grand plans of its own. The announcement this morning notes that Pfefer will run Kintai Therapeutics, one of the grads of the Flagship labs.

Donald Trump and Anthony Fauci (AP Images)

Covid-19 roundup: Rus­sia hack­ers tar­get US, UK vac­cine and drug re­searchers; Fau­ci fires back at White House cam­paign to un­der­mine him

Russia has tried to steal a Covid-19 vaccine and therapeutics researcher from pharmaceutical and academic institutions in the US, UK and Canada, Britain’s National Cyber Security Centre said Thursday.

The NCSC said that hacking attempts came from a group known as APT129, also known as “Cozy Bear,” that “almost certainly operate as part of Russian intelligence services.” The Canadian Communication Security Establishment, US Department for Homeland Security, the Cybersecurity Infrastructure Security Agency, and the National Security Agency shared the assessment, the NCSC said.

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John Furey, Imvax CEO

A neu­ro­sur­geon spent the past 30 years de­vel­op­ing a neoanti­gen tu­mor vac­cine. Now he has $112M for a piv­otal test

As a neurosurgeon, David Andrews knew there wasn’t much he could do for his glioma patients after resecting — rarely fully — their tumor. Even with the best treatment and care available, median overall survival is just somewhere between 14 and 16 months.

Then in the 1990s, his mentor at Thomas Jefferson University introduced him to Renato Baserga, a pathologist who had been studying the effect of using antisense oligonucleotide to knock out the insulin-like growth factor type 1 receptor in cancers. As IGF-R1 drives tumor growth and metastasis, the preclinical reasoning went, implanting a molecule targeting the receptor together with the tumor material near lymph nodes can slow down the spread of the cancer.

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