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.”

Forge Bi­o­log­ics’ cGMP Com­pli­ant and Com­mer­cial­ly Vi­able Be­spoke Affin­i­ty Chro­matog­ra­phy Plat­form

Forge Biologics has developed a bespoke affinity chromatography platform approach that factors in unique vector combinations to streamline development timelines and assist our clients in efficiently entering the clinic. By leveraging our experience with natural and novel serotypes and transgene conformations, we are able to accelerate affinity chromatography development by nearly 3-fold. Many downstream purification models are serotype-dependent, demanding unique and time-consuming development strategies for each AAV gene therapy product1. With the increasing demand to propel AAV gene therapies to market, platform purification methods that support commercial-scale manufacturing of high-quality vectors with excellent safety and efficacy profiles are essential.

Mathai Mammen, FogPharma's next CEO

Math­ai Mam­men hands in J&J's R&D keys to lead Greg Ver­dine’s Fog­Phar­ma 

In the early 1990s, Mathai Mammen was a teaching assistant in Greg Verdine’s Science B46 course at Harvard. In June, the former R&D head at Johnson & Johnson will succeed Verdine as CEO, president and chair of FogPharma, the same month the seven-year-old biotech kickstarts its first clinical trial.

After leading R&D at one of the largest drugmakers in the world, taking the company through more than half a dozen drug approvals in the past few years, not to mention a Covid-19 vaccine race, Mammen departed J&J last month and will take the helm of a Cambridge, MA biotech attempting to go after what Verdine calls the “true emperor of all oncogenes” — beta-catenin.

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Sen­ate Fi­nance Com­mit­tee lobs more bi­par­ti­san pres­sure on­to PBMs

Congress is honing in on how it wants to overhaul the rules of the road for pharmacy benefit managers, with a Senate Finance Committee hearing Thursday serving as the latest example of the Hill’s readiness to make changes to how pharma middlemen operate.

While pledging to ensure patients and pharmacies “don’t get a raw deal,” Finance Committee Chair Ron Wyden (D-OR) laid out the beginning of what looks like a major bipartisan effort — moves the PBM industry is likely to challenge vigorously.

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Nicklas Westerholm, Egetis Therapeutics CEO

Ac­qui­si­tion talks on­go­ing for Swedish rare dis­ease biotech Egetis, shares up al­most 40%

Shares of the Sweden-based rare disease biotech Egetis Therapeutics skyrocketed on Thursday afternoon as the company said it’s engaged in “ongoing discussion” with external parties regarding a “potential acquisition.”

Egetis confirmed rumors with a statement on Thursday while noting that there is no certainty that a takeover offer will be made.

Nonetheless, the possibility of an acquisition has shot up Egetis’ share price. By the afternoon on Thursday, its stock price was {$EGTX.ST} up over 38%. An Egetis spokesperson told Endpoints News in an email that it has no further comments.

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Lu­pus drug de­vel­op­ment mar­ket heat­ing up, while FDA links with ad­vo­ca­cy group to fur­ther ac­cel­er­ate re­search

The long-underserved systemic lupus erythematosus (SLE) market is suddenly buzzing with treatment possibilities. Less than two years after AstraZeneca’s approval for Saphnelo — the first new SLE drug in a decade and joining just one other approved in GSK’s Benlysta – the pipeline of potential drugs numbers in the dozens.

Although most are very early stage — Spherix Global Insights estimates five in Phase II/III — the pharma R&D enthusiasm is catching on among doctors, patients and advocacy groups. On Wednesday, the Lupus Research Alliance and the FDA formed a novel private-public partnership called Lupus Accelerating Breakthroughs Consortium (Lupus ABC) to help advance lupus clinical trial success.

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Stéphane Bancel, Moderna CEO (AP Photo/Markus Schreiber)

Mod­er­na so­lid­i­fies deal with Kenya to build mR­NA man­u­fac­tur­ing fa­cil­i­ty

The mRNA player Moderna is further cementing its presence on the African continent.

Moderna announced on Thursday that it has finalized an agreement with Kenya’s government to partner up and bring an mRNA manufacturing facility to the east African nation. The new facility aims to manufacture up to 500 million doses of vaccines annually. Moderna also said the new facility will have the ability to spike its production capabilities to respond to public health emergencies on the continent or globally.

Luke Miels, GSK chief commercial officer

GSK picks up Scynex­is' FDA-ap­proved an­ti­fun­gal drug for $90M up­front

GSK is dishing out $90 million cash to add an antifungal drug to its commercial portfolio, in a deal spotlighting the pharma giant’s growing focus on infectious diseases.

The upfront will lock in an exclusive license to Scynexis’ Brexafemme, which was approved in 2021 to treat a yeast infection known as vulvovaginal candidiasis, except in China and certain other countries where Scynexis already out-licensed the drug.

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Deborah Waterhouse, ViiV Healthcare CEO

MPP re­cruits three gener­ic man­u­fac­tur­ers to ex­pand use of Vi­iV's in­jectable PrEP drug

ViiV Healthcare has teamed up with the UN-backed Medicines Patent Pool and three generic manufacturers to expand access to medicine that can prevent HIV.

ViiV and the Medicines Patent Pool jointly announced Thursday that the MPP signed sub-licensing agreements with Aurobindo, Cipla and Viatris to manufacture generics of a long-acting form of cabotegravir for HIV pre-exposure prophylaxis (PrEP). As a result of the agreement, the manufacturers will be able to develop, manufacture and supply generic versions of cabotegravir LA in 90 countries — subject to regulatory approvals.

CSL CEO Paul McKenzie (L) and CMO Bill Mezzanotte

Q&A: New­ly-mint­ed CSL chief ex­ec­u­tive Paul McKen­zie and chief med­ical of­fi­cer Bill Mez­zan­otte

Paul McKenzie took over as CEO of Australian pharma giant CSL this month, following in the footsteps of long-time CSL vet Paul Perreault.

With an eye on mRNA, and quickly commercializing its new, $3.5 million-per-shot gene therapy for hemophilia B, McKenzie and chief medical officer Bill Mezzanotte answered some questions from Endpoints News this afternoon about where McKenzie is going to take the company and what advances may be coming to market from CSL’s pipeline. Below is a lightly edited transcript.