Martin Babler, Esker

Fore­site's im­munol­o­gy play gets a $200M megaround for TYK2 pro­gram, re­brand­ing as Alu­mis

A Fore­site-in­cu­bat­ed biotech that de­buted just eight months ago closed a new mega fi­nanc­ing round on Thurs­day, and with it comes a com­pa­ny re­brand­ing.

Es­ker Ther­a­peu­tics will now call it­self Alu­mis fol­low­ing the com­ple­tion of a $200 mil­lion Se­ries B, the biotech an­nounced Thurs­day. The funds are ex­pect­ed to go to­ward Alu­mis’ pipeline, in­clud­ing its lead pro­gram ESK-001, a TYK2 in­hibitor tar­get­ing the pan-JAK path­way that the com­pa­ny has tout­ed as po­ten­tial­ly safer than cur­rent JAK in­hibitors.

“The fund­ing re­al­ly serves for us to ad­vance the pro­gram in­to the clin­ic, and then we have al­so a pipeline build­ing be­hind it,” CEO Mar­tin Babler told End­points News in an in­ter­view. “And we want to al­so make sure that we can take full ad­van­tage of our da­ta an­a­lyt­ics plat­form to re­al­ly ex­plore ad­di­tion­al tar­gets and ad­di­tion­al in­di­ca­tions.”

The lead com­pound is be­ing eval­u­at­ed in pso­ri­a­sis, and a Phase I safe­ty and tol­er­a­bil­i­ty study was ex­pect­ed to read out by the end of 2021. Though the com­pa­ny hasn’t put out a press re­lease with the da­ta yet, Babler said Alu­mis is “ex­treme­ly pleased” with the mol­e­cule.

“The fea­tures that we see is re­al­ly that we have a great PK pro­file, and that we have good se­lec­tiv­i­ty,” he said. “We’re on track to re­al­ly un­der­stand how this mol­e­cule stacks up against oth­ers in the field.”

For­mer CEO and founder June Lee had pre­vi­ous­ly said she ex­pect­ed the pro­gram to serve as a proof-of-con­cept for the rest of Alu­mis’ plat­form. By aim­ing to iden­ti­fy cer­tain ge­net­ic tar­gets, Lee not­ed she want­ed to serve pa­tients she felt had been in the “come-one-come-all” im­munol­o­gy mar­ket.

ESK-001 will have plen­ty of com­pe­ti­tion as the JAK field has seen much crowd­ing in re­cent years. Though Lee said Alu­mis’ mol­e­cule sprout­ed from the same class as Bris­tol My­ers Squibb’s deu­cravac­i­tinib, that drug beat out Am­gen’s Ote­zla in a piv­otal head-to-head pso­ri­a­sis tri­al last year, and the FDA has set a PDU­FA date for Sep­tem­ber.

“Fun­da­men­tal­ly, TYK2 is a mem­ber of the class of the JAK in­hibitors, but it has re­al­ly a dif­fer­en­ti­at­ed pro­file,” Babler said. “And one of the things about this mol­e­cule, it’s one of sev­er­al al­losteric TYK2 in­hibitors that are in de­vel­op­ment. And those in­hibitors re­al­ly don’t have a lot of JAK phar­ma­col­o­gy. And so we don’t re­al­ly see at least so far from from the lead­ing mol­e­cule in this class, which is the BMS mol­e­cule, and our own and oth­ers, the same phar­ma­col­o­gy that you see with JAK in­hibitors.”

Out­side this mol­e­cule, the com­pa­ny is aim­ing to de­vel­op oth­er can­di­dates in the im­munol­o­gy space, with Babler say­ing in a re­lease Thurs­day the com­pa­ny may look to ac­quire oth­er as­sets in ad­di­tion to build­ing out its pipeline.

The JAK space has been shak­en in re­cent months by re­peat­ed safe­ty is­sues, fol­low­ing a post-mar­ket­ing study for Pfiz­er’s Xel­janz that el­e­vat­ed the con­cerns in ear­ly 2021. De­spite the re­newed scruti­ny, the FDA has waved through new JAK in­hibitors re­cent­ly, ap­prov­ing Xel­janz and Ab­b­Vie’s Rin­voq for new in­di­ca­tions last month.

But the drugs came with ex­pand­ed warn­ings and a key la­bel change, say­ing they can on­ly be tak­en af­ter a pa­tient has failed on one or more TNF block­ers such as Hu­mi­ra. The shift came af­ter reg­u­la­tors flagged the risk of car­dio­vas­cu­lar events in pa­tients old­er than 50 with boxed warn­ings on Xel­janz, Rin­voq and Eli Lil­ly’s Olu­mi­ant.

“While we have a lead as­set, this is al­so about build­ing an en­tire pipeline be­hind it,” Babler said. “And so we are ac­tive­ly work­ing on sev­er­al oth­er pro­grams that we will dis­close at the ap­pro­pri­ate time.”

IDC: Life Sci­ences Firms Must Em­brace Dig­i­tal Trans­for­ma­tion Now

Pre-pandemic, the life sciences industry had settled into a pattern. The average drug took 12 years and $2.9 billion to bring to market, and it was an acceptable mode of operations, according to Nimita Limaye, Research Vice President for Life Sciences R&D Strategy and Technology at IDC.

COVID-19 changed that, and served as a proof-of-concept for how technology can truly help life sciences companies succeed and grow, Limaye said. She recently spoke about industry trends at Egnyte’s Life Sciences Summit 2022. You should watch the entire session, free and on-demand, but here’s a brief recap of why she’s urging life sciences companies to embrace digital transformation.

Martin Landray, Protas CEO (Illustration: Assistant Editor Kathy Wong for Endpoints News)

Those big bil­lion-dol­lar PhI­II stud­ies? Mar­tin Lan­dray says they can be done for a tiny frac­tion of the cost

Martin Landray knows what controversy in clinical drug development feels like, from first-hand experience.

Landray was the chief architect of RECOVERY, a study that pitted a variety of drugs against Covid-19. And he offered some landmark data that would help push dexamethasone out into broader use as a cheap treatment, while helping ice hydroxy’s reputation as a clear misfire.

“Lots of people told us we shouldn’t use it,” Landray says about dexamethasone and Covid-19. “It was dangerous. We shouldn’t even do a trial. They also cared about hydroxychloroquine and lots of people said we shouldn’t do a trial because it must be used. I’ve got the letters from both sets of people.”

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FDA ap­proves one of the prici­est new treat­ments of all time — blue­bird's gene ther­a­py for be­ta tha­lassemia

The FDA on Wednesday approved the first gene therapy for a chronic condition — bluebird bio’s new Zynteglo (beti-cel) as a potentially curative treatment for those with transfusion-dependent thalassemia.

The thumbs-up from the FDA follows a unanimous adcomm vote in June, with outside experts pointing to extraordinary efficacy, with 89% of subjects with TDT who received beti-cel having achieved transfusion independence.

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Geoffrey Porges, new Schrödinger CFO

Long­time an­a­lyst Ge­of­frey Porges de­parts SVB to lead fi­nances at a drug dis­cov­ery shop

Geoffrey Porges has ended his two-decade run as a biotech analyst, as the former SVB Securities vice chair began as CFO of Schrödinger on Thursday.

The long-running analyst, who previously headed up vaccines marketing at Merck before the turn of the millennium, will lead the financial operations of the 700-employee company as Schrödinger broadens its focus from a drug discovery partner to also building out an in-house pipeline, with clinical trial No. 1 set to begin next quarter.

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James Dentzer, Curis CEO

FDA lifts par­tial hold on Curis' lym­phoma study -- shares spike

Four months after the FDA put two clinical trials from Curis on clinical hold, the FDA is now apparently content with how the biotech will change up managing one of the studies.

The Massachusetts oncology biotech put out word early Thursday that the federal regulator lifted a partial clinical hold of the company’s Phase I/II study of emavusertib in lymphoma, following a new data package that the biotech recently submitted to the agency. Shares of the biotech $CRIS, hovering just above penny stock territory, shot up more than 55% in early trading before settling at close to a 30% share price boost.

Astel­las' hot flash­es drug will get speedy re­view at FDA; US opts out of Val­ne­va vac­cine

The FDA will decide on Astellas’ menopausal symptom drug by Feb. 22 of next year, as the Japanese pharma disclosed it had paid about $97 million to get a priority review voucher to speed up the review.

Astellas said the agency has accepted the pharma’s application for fezolinetant for the treatment of moderate to severe vasomotor symptoms (VMS) associated with menopause. VMS includes hot flashes and/or night sweats. The company said as many as 80% of women in the US experience those symptoms during or after the menopausal transition.

Joel Dudley, new partner at Innovation Endeavors (Bosch Health Campus)

For­mer Google CEO’s VC is mak­ing a big­ger push in­to the biotech world, hir­ing promi­nent Ther­a­nos skep­tic

Venture capital firm Innovation Endeavors has mainly had its focus on investments across the tech space, but it has been slowly turning its attention to the biotech world. Now, a new partner is coming into the fold showing that its interest in biotech is likely to grow further.

The Silicon Valley-based company, which is headed up by former Google CEO Eric Schmidt, has brought on Joel Dudley as a partner. According to Dudley’s LinkedIn page, he is joining Innovation Endeavors after serving as the chief science officer of biotech startup Tempus Labs since 2020.

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Bayer's first DTC ad campaign for chronic kidney disease drug Kerendia spells out its benefits

Bay­er aims to sim­pli­fy the com­plex­i­ties of CKD with an ABC-themed ad cam­paign

Do you know the ABCs of CKD in T2D? Bayer’s first ad campaign for Kerendia tackles the complexity of chronic kidney disease with a play on the acronym (CKD) and its connection to type 2 diabetes (T2D).

Kerendia was approved last year as the first and only non-steroidal mineralocorticoid receptor antagonist to treat CKD in people with type 2 diabetes.

In the TV commercial launched this week, A is for awareness, B is for belief and C is for cardiovascular, explained in the ad as awareness of the connection between type 2 and kidney disease, belief that something can be done about it, and cardiovascular events that may be reduced with treatment.

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James Mock, incoming CFO at Moderna

Mod­er­na taps new CFO from PerkinElmer af­ter for­mer one-day CFO oust­ed

When Moderna hired a new CFO last year,  it didn’t expect to see him gone after only one day. Today the biotech named his — likely much more vetted — replacement.

The mRNA company put out word early Wednesday that after the untimely departure of then brand-new CFO Jorge Gomez, it has now found a replacement in James Mock, the soon-to-be former CFO at diagnostics and analytics company PerkinElmer.

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