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.”

2023 Spot­light on the Fu­ture of Drug De­vel­op­ment for Small and Mid-Sized Biotechs

In the context of today’s global economic environment, there is an increasing need to work smarter, faster and leaner across all facets of the life sciences industry.  This is particularly true for small and mid-sized biotech companies, many of which are facing declining valuations and competing for increasingly limited funding to propel their science forward.  It is important to recognize that within this framework, many of these smaller companies already find themselves resource-challenged to design and manage clinical studies themselves because they don’t have large teams or in-house experts in navigating the various aspects of the drug development journey. This can be particularly challenging for the most complex and difficult to treat diseases where no previous pathway exists and patients are urgently awaiting breakthroughs.

Rick Modi, Affinia Therapeutics CEO

Ver­tex-part­nered gene ther­a­py biotech Affinia scraps IPO plans

Affinia Therapeutics has ditched its plans to go public in a relatively closed-door market that has not favored Nasdaq debuts for the drug development industry most of this year. A pandemic surge in 2020 and 2021 opened the doors for many preclinical startups, which caught Affinia’s attention and gave the gene therapy biotech confidence in the beginning days of 2022 to send in its S-1.

But on Friday, Affinia threw in the S-1 towel and concluded now is not the time to step onto Wall Street. The biotech has put out few public announcements since the spring of this year. Endpoints News picked the startup as one of its 11 biotechs to watch last year.

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Albert Bourla, Pfizer CEO (Efren Landaos/Sipa USA/Sipa via AP Images)

Pfiz­er makes an­oth­er bil­lion-dol­lar in­vest­ment in Eu­rope and ex­pands again in Michi­gan

Pfizer is continuing its run of manufacturing site expansions with two new large investments in the US and Europe.

The New York-based pharma giant’s site in Kalamazoo, MI, has seen a lot of attention over the past year. As a major piece of the manufacturing network for Covid-19 vaccines and antivirals, Pfizer is gearing up to place more money into the site. Pfizer announced it will place $750 million into the facility, mainly to establish “modular aseptic processing” (MAP) production and create around 300 jobs at the site.

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Up­dat­ed: FDA re­mains silent on or­phan drug ex­clu­siv­i­ty af­ter last year's court loss

Since losing a controversial court case over orphan drug exclusivity last year, the FDA’s Office of Orphan Products Development has remained entirely silent on orphan exclusivity for any product approved since last November, leaving many sponsors in limbo on what to expect.

That silence means that for more than 70 orphan-designated indications for more than 60 products, OOPD has issued no public determination on the seven-year orphan exclusivity in the Orange Book, and no new listings of orphan exclusivity appear in OOPD’s searchable database, as highlighted recently by George O’Brien, a partner in Mayer Brown’s Washington, DC office.

Yuling Li, Innoforce CEO

In­no­force opens new man­u­fac­tur­ing site in Chi­na

Innoforce is off to the races at its new site in the city of Hangzhou, China.

The Chinese CDMO announced last week that it has started manufacturing at the new facility, which was built to offer process development and manufacturing operations for RNA, plasmid DNA, viral vectors and other cell therapeutics. It will also serve as Innoforce’s corporate HQ.

The company said it’s investing more than $200 million in the 550,000-square-foot manufacturing base for advanced therapies. The GMP manufacturing facility features space for producing plasmids with three 30-liter bioreactors. For viral vector manufacturing, Innoforce also has 200- and 500-liter bioreactors at its disposal, along with eight suites to make cell therapies. The site also includes several labs and warehouse spaces.

Vas Narasimhan, Novartis CEO (Thibault Camus/AP Images, Pool)

No­var­tis bol­sters Plu­vic­to's case in prostate can­cer with PhI­II re­sults

The prognosis is poor for metastatic castration-resistant prostate cancer (mCRPC) patients. Novartis wants to change that by making its recently approved Pluvicto available to patients earlier in their course of treatment.

The Swiss pharma giant unveiled Phase III results Monday suggesting that Pluvicto was able to halt disease progression in certain prostate cancer patients when administered after androgen-receptor pathway inhibitor (ARPI) therapy, but without prior taxane-based chemotherapy. The drug is currently approved for patients after they’ve received both ARPI and chemo.

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Pfiz­er-backed Me­di­ar Ther­a­peu­tics ropes in an­oth­er Big Phar­ma in­vestor

A biotech centered on treating fibrosis — born out of Mass General and Brigham and Women’s Hospital — has received a financial boost.

According to an SEC filing, the company has raised $31,761,186 in its latest funding round, which includes 17 investors. The filing lists six names attached to the company, including Meredith Fisher, a partner at Mass General Brigham Ventures and Mediar’s acting CEO.

Ken Greenberg, SonoThera CEO

Gene ther­a­py goes acoustic as ARCH-backed biotech launch­es with ul­tra­sound gene de­liv­ery plat­form

After co-founding two biotechs off virus-based therapies, one for pain and one for cancer, Ken Greenberg decided to go in a different direction for his newest biotech, SonoThera.

Based out of San Francisco, SonoThera announced Monday morning that it raised $60.75 million to develop new gene therapies — but delivered by ultrasound, which Greenberg says can address the major challenges facing more conventional viral gene therapies.

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Af­ter M&A fell through, Ther­a­peu­tic­sMD sells hor­mone ther­a­py, con­tra­cep­tive ring for $140M cash plus roy­al­ties

TherapeuticsMD, a women’s health company whose one-time billion-dollar valuation seems a distant memory as its blockbuster aspirations petered out, is finally cashing out.

Australia’s Mayne Pharma is paying $140 million upfront to license essentially TherapeuticsMD’s whole portfolio, including two prescription drugs that treat conditions relating to menopause, a contraceptive vaginal ring as well as its prescription prenatal vitamin brands.

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