23andMe finds a buy­er for its IL-36 bis­pe­cif­ic in Almi­rall; Neu­ro­crine, Idor­sia re­vise epilep­sy drug deal

→ The first fruits of 23andMe’s ef­forts to gen­er­ate new drugs off the in­sights it gained from a mas­sive amount of ge­net­ic da­ta are tak­ing shape, and Almi­rall is sign­ing up to ripen one of them. The Span­ish der­ma­tol­ogy drug­mak­er has li­censed a bis­pe­cif­ic an­ti­body that blocks three cy­tokines in the IL-36 cy­tokine fam­i­ly, which are tied to skin con­di­tions such as pso­ri­a­sis and lu­pus, in ad­di­tion to oth­er in­flam­ma­to­ry ail­ments such as ul­cer­a­tive col­i­tis, in­flam­ma­to­ry bow­el dis­ease, and Crohn’s dis­ease.

“As a leader in med­ical der­ma­tol­ogy, we felt Almi­rall was the best com­pa­ny to take this pro­gram for­ward and ul­ti­mate­ly de­vel­op an ef­fec­tive ther­a­py for pa­tients,” Ken­neth Hillan, who suc­ceed­ed Genen­tech vet Richard Scheller as head of ther­a­peu­tics at 23andMe, said in a state­ment.

While it start­ed out as a di­rect-to-con­sumer test­ing ser­vice, 23andMe has moved deep­er in­to the ther­a­peu­tic space in re­cent years, most no­tably through a $300 mil­lion part­ner­ship with Glax­o­SmithK­line.

→ We now know the iden­ti­ty of Idor­sia’s mys­tery part­ner from last year. The Swiss biotech — spun out from J&J’s Acte­lion buy­out — had an­nounced that it pock­et­ed a $5 mil­lion pay­ment from an undis­closed par­ty to score a li­cens­ing op­tion on ACT-709478, a brain pen­e­trat­ing T-type cal­ci­um chan­nel block­er. Now we learn that Neu­ro­crine will pay $45 mil­lion if it ex­er­cis­es the op­tion and up to $365 mil­lion in mile­stones.

“We are ex­cit­ed to lever­age the sci­en­tif­ic ex­per­tise of Idor­sia in T-type cal­ci­um chan­nel in­hi­bi­tion to po­ten­tial­ly ad­vance a Phase 2 ready com­pound to help peo­ple suf­fer­ing from epilep­sy. In ad­di­tion to the treat­ment of epilep­sy, the mod­u­la­tion of the cal­ci­um chan­nel may be use­ful for the treat­ment of oth­er dis­or­ders such as es­sen­tial tremor and pain,” Kevin Gor­man, the CEO at Neu­ro­crine, said in a state­ment.

Phase­Bio has found a deep-pock­et­ed be­liev­er in its blood thin­ner re­ver­sal agent: SFJ Phar­ma­ceu­ti­cals, which has of­fered up to $120 mil­lion to sup­port the clin­i­cal de­vel­op­ment of PB2452. First li­censed from As­traZeneca, the “break­through” drug is de­signed to can­cel the ef­fects of tica­grelor, an an­ti­co­ag­u­lant, in ur­gent or sur­gi­cal sit­u­a­tions. Backed by Black­stone Life Sci­ences and Abing­worth, SFJ will al­so take over the bulk of the clin­i­cal and reg­u­la­to­ry work out­side of the US. In ex­change, Phase­Bio will pay an­nu­al lump sums once (and if) they win ap­provals.

Boehringer In­gel­heim Ven­ture Fund and Dutch in­vestor PPF are lead­ing a $22 mil­lion Se­ries C round for Basel, Switzer­land-based NBE Ther­a­peu­tics to bankroll ear­ly clin­i­cal tri­als of its lead as­set. Rid­ing on re­newed en­thu­si­asm for an­ti­body-drug con­ju­gates, NBE said their plat­form tech is both more pow­er­ful and safer than the ear­li­er gen­er­a­tions of ADC, be­ing im­mune-stim­u­la­to­ry and em­ploy­ing an an­thra­cy­cline pay­load. NBE-002 tar­gets ROR1 in triple-neg­a­tive breast can­cer and lung can­cer, to be fol­lowed by oth­er sol­id can­cer types and lym­phomas.

→ While await­ing an FDA de­ci­sion on its sec­ond shot at an ap­proval, Aca­cia Phar­ma has in-li­censed a short-act­ing, re­versible in­tra­venous seda­tive/anes­thet­ic from Cos­mo Phar­ma. The €10 mil­lion up­front pay­ment will take the form of an eq­ui­ty sale, with an­oth­er €30 mil­lion due up­on US ap­proval of the drug, By­Fa­vo, and more com­mer­cial mile­stones. “Hav­ing a sec­ond prod­uct that shares the same call­ing points and at­trac­tive com­mer­cial mes­sage as Barhem­sys will make the in­vest­ment in our sales and mar­ket­ing teams more ef­fi­cient,” CEO Mike Bolin­der said in a state­ment.

→ Eye-fo­cused gene ther­a­py de­vel­op­er Eye­ven­sys has scored $30 mil­lion in Se­ries B fund­ing with the help of lead in­vestor Boehringer In­gel­heim Ven­ture Fund. Pon­tif­ax, Bpifrance, CapDe­cisif, In­serm Trans­fert, the Glob­al Health Sci­ences Fund and Pure­os Bioven­tures al­so joined to boost their R&D ef­forts, fea­tur­ing a lead Phase II-ready pro­gram for chron­ic non-in­fec­tious uveitis.

→ The cell ther­a­py ex­perts at Jasper Ther­a­peu­tics have brought in an ex­tra $14.1 mil­lion for their Se­ries A, adding Roche Ven­ture Fund to their ros­ter of mar­quee in­vestors. The new cash will help ex­pand the lead clin­i­cal pro­gram, a CD117-tar­get­ed an­ti­body con­ceived as an al­ter­na­tive con­di­tion­ing reg­i­men be­fore stem cell trans­plants.

→ Fol­low­ing the close of its $1 bil­lion-plus sec­ond fund, GHO Cap­i­tal Part­ners has ac­quired Bel­gian CD­MO Ar­de­na, which is fo­cused on ear­ly-stage drug de­vel­op­ment, from Men­tha Cap­i­tal.

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.

Kristen Hege, Bristol Myers Squibb SVP, early clinical development, oncology/hematology and cell therapy (Illustration: Assistant Editor Kathy Wong for Endpoints News)

Q&A: Bris­tol My­er­s' Kris­ten Hege on cell ther­a­py, can­cer pa­tients and men­tor­ing the next gen­er­a­tion

Kristen Hege leads Bristol Myers Squibb’s early oncology discovery program carrying on from the same work at Celgene, which was acquired by BMS in 2019. She’s known for her early work in CAR-T, having pioneered the first CAR-T cell trial for solid tumors more than 25 years ago.

However, the eminent physician-scientist is more than just a drug developer mastermind. She’s also a practicing physician, mother to two young women, an avid backpacker and intersecting all those interests — a champion of young women and people of color in STEM and life sciences.

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Gossamer Bio CEO Faheem Hasnain at Endpoints' #BIO22 panel (J.T. MacMillan Photography for Endpoints News)

Gos­samer’s Fa­heem Has­nain de­fends a round of pos­i­tive PAH da­ta as a clear win. But can these PhII re­sults stand up to scruti­ny?

Gossamer Bio $GOSS posted a statistically significant improvement for its primary endpoint in the key Phase II TORREY trial for lead drug seralutinib on Tuesday morning. But CEO Faheem Hasnain has some explaining to do on the important secondary of the crucial six-minute walk distance test — which will be the primary endpoint in Phase III — as the data on both endpoints fell short of expectations, missing one analyst’s bar on even modest success.

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Eu­ro­pean Com­mis­sion lays ground­work to un­wind Il­lu­mi­na's $7B+ Grail merg­er

The European Commission has recommended steps that — though not yet final — would require Illumina to “swiftly” unwind its controversial $7.1 billion Grail buyout.

The Commission delivered a “statement of objections” on Monday, detailing the process Illumina would need to take in divesting Grail, its blood testing spinout launched in 2016. Illumina re-acquired Grail back in August, despite criticism from both the FTC and EU.

US sup­ports ex­ten­sion for Covid-19 IP waiv­er de­ci­sion

After much debate, the US government is now calling for a deadline extension to discuss a controversial potential IP waiver for Covid-19 diagnostics and therapeutics.

Over the last five months, the Office of the United States Trade Representative said it has consulted with members of Congress, public health advocates, organized labor groups, academics, think tanks, companies and trade associations on the WTO’s recent TRIPS agreement, which established a 5-year waiver of certain patent requirements on Covid-19 vaccines.

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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Mar­ket­ingRx roundup: Phar­mas lay off Twit­ter ads for an­oth­er week; WPP un­cov­ers LGBTQ+ mar­ket­ing find­ings

When Twitter’s new owner Elon Musk tweeted this weekend, “Just a note to thank advertisers for returning to Twitter,” he likely wasn’t talking about big pharma companies. The vast majority of the top spending pharma advertisers had not returned last week, according to updated tracking data Pathmatic for Endpoints News.

Only three pharma advertisers spent any money at all, which is about the same as the past several weeks. AstraZeneca rejoined the active advertiser list, although at $700 spent hardly worth a personal Musk expression of gratitude. GSK remained active with $3,500 spent ad much lower than its previous spending, according to the Pathmatics data. Only Bayer spent any significant amount in advertising, with $244,000 spent last week, but that’s a considerable drop from almost $500,000 spent on OTC, prescription and corporate Twitter ads in each of the previous two weeks.

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Bob Duggan, Summit Therapeutics co-CEO

Bounc­ing from ma­jor set­back, Sum­mit hands out $500M cash for can­cer drug — thanks to a loan from bil­lion­aire CEO

After hitting a dead end with Summit Therapeutics’ lead program, Bob Duggan has found the drug that he believes will usher into a compelling second act. So compelling, in fact, that it involves $500 million cash — and he’s taking money out of his own pocket to fund the deal.

Striking a partnership with Akeso Therapeutics out of China, Summit is bringing in a bispecific antibody that blocks both PD-1 and VEGF called ivonescimab. Akeso, which has a PD-1/CTLA-4 bispecific approved in China, has already taken ivonescimab into multiple clinical trials, including a Phase III in lung cancer.

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Jay Lichter, Arialys Therapeutics CEO (Avalon Ventures)

Scoop: Aval­on, MPM back new CNS biotech with sci­en­tif­ic chops from Astel­las

A preclinical central nervous system biotech is in the works in La Jolla, CA, and the drug developer has reeled in capital from a syndicate of investors, Endpoints News has learned.

Arialys Therapeutics filed incorporation documents in the Golden State last December and applied its name for trademark protection with the US Patent and Trademark Office the week prior to that. Paperwork with the SEC also outlines plans to offer up equity in exchange for $55 million.

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