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.

UP­DAT­ED: Mer­ck pulls Keytru­da in SCLC af­ter ac­cel­er­at­ed nod. Is the FDA get­ting tough on drug­mak­ers that don't hit their marks?

In what could be an early shot in the battle against drugmakers that whiff on confirmatory studies to support accelerated approvals, the FDA ordered Bristol Myers Squibb late last year to give up Opdivo’s approval in SCLC. Now, Merck is next on the firing line — are we seeing the FDA buckling down on post-marketing offenders?

Merck has withdrawn its marketing approval for PD-(L)1 inhibitor Keytruda in metastatic small cell lung cancer as part of what it describes as an “industry-wide evaluation” by the FDA of drugs that do not meet the post-marketing checkpoints on which their accelerated nods were based, the company said Monday.

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Michael Shpigelmacher

Khosla joins bet on un­con­ven­tion­al start­up look­ing to send drug de­liv­er­ing ro­bots in­to the brain

When Michael Shpigelmacher started the project, he knew he’d have to fund it himself. Every other effort of its kind was academic, rejected as too risky by investors.

Shpigelmacher, a robotics geek and entrepeneur who had drifted into consulting for pharma, wanted to build the real-life equivalent of technology from the 1960s film Fantastic Voyage, the one where a submarine crew is shrunk to “about the size of a microbe” and sent on a mission to repair a scientist’s brain. He scanned the literature, found the lab that was working on the most advanced project — at the Max Planck Institute in Germany, it turned out — and started funding them with money from his own account, along with some seed cash from friends and family.

Bob Nelsen (Photo by Michael Kovac/Getty Images)

With stars aligned and cash in re­serve, Bob Nelsen's Re­silience plans a makeover at 2 new fa­cil­i­ty ad­di­tions to its drug man­u­fac­tur­ing up­start

Bob Nelsen’s new, state-of-the-art drug manufacturing initiative is taking shape.

Just 3 months after gathering $800 million of launch money, a dream team board and a plan to shake up a field where he found too many bottlenecks and inefficiencies for the era of Covid-19, Resilience has snapped up a pair of facilities now in line for a retooling.

The company has acquired a 310,000-square-foot plant in Boston from Sanofi along with a 136,000-square-foot plant in Ontario to add to a network which CEO Rahul Singhvi says is just getting started on building his company’s operations up. The Sanofi deal comes with a contract to continue manufacturing one of its drugs.

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Mesoblast gets a $110M life­line from Surg­Cen­ter De­vel­op­ment; uniQure still un­sure if gene ther­a­py spurred can­cer event

Mesoblast faced rough waters in 2020, but on Monday were thrown a financial lifeline.

The Australian stem cell therapy player has raised $110 million in a private placement, the company announced, offering 60 million shares to the US investor group SurgCenter Development. SurgCenter received the shares at a 6.5% discount from Mesoblast’s closing price on Feb. 25.

Mesoblast plans to use the funds to boost supply of its lead candidate remestemcel-L ahead of what they hope is a potential approval in pediatric GvHD when they return to the FDA, as well as advancing manufacturing and development of their rexlemestrocel-L platform for chronic heart failure and chronic low back pain.

Af­ter bail­ing on Covid-19 vac­cines, Mer­ck will team up with J&J to pro­duce its shot as part of un­usu­al Big Phar­ma pact

Merck took a big gamble when it opted to jump into the Covid-19 vaccine race late, and made an equally momentous decision to back out in late January. Now, looking to chip in on the effort, Merck reportedly agreed to team up with one of the companies that has already crossed the finish line.

President Joe Biden on Tuesday is expected to announce a partnership between drugmakers Merck and Johnson & Johnson to jointly produce J&J’s recombinant protein Covid-19 vaccine that received the FDA’s emergency use authorization Saturday, the Washington Post reported.

Ab­b­Vie tees up a biotech buy­out af­ter siz­ing up their Parkin­son's drug spun out of Ke­van Shokat's lab

AbbVie has teed up a small but intriguing biotech buyout after looking over the preclinical work it’s been doing in Parkinson’s disease.

The company is called Mitokinin, a Bay Area biotech spun out of the lab of UCSF’s Kevan Shokat, whose scientific explorations have formed the academic basis of a slew of startups in the biotech hub. One of Shokat’s PhD students in the lab, Nicholas Hertz, co-founded Mitokinin using their lab work on PINK1 suggesting that amping up its activity could play an important role in regulating the mitochondrial dysfunction contributing to Parkinson’s disease pathogenesis and progression.

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Paul Sekhri

The next big biotech su­per­star? Paul Sekhri has some thoughts on that

It occasionally occurs to Paul Sekhri that if they pull this off, his company will be on the front page of the New York Times and a lead story in just about every major news outlet on the planet. He tries not to dwell on it, though.

“I just want to be laser-focused on getting to that point,” Sekhri says, before acknowledging, “Yes, it absolutely crossed my mind.”

Sekhri, a longtime biopharma executive with tenures at Sanofi and Novartis, is now entering year three as CEO of eGenesis, the biotech that George Church protégé Luhan Yang founded to genetically alter pigs so that they can be used for organ transplants. He led them through one megaround and has just closed another, raising $125 million from 17 different investors to push the first-ever (humanized) pig to human transplants into the clinic.

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Fi­bro­Gen shares skid low­er as a sur­prise ad­comm rais­es risks on roxa OK

FibroGen will likely have to delay its US rollout for roxadustat once again.

In an unexpected move, the FDA is convening its Cardiovascular and Renal Drugs Advisory Committee to review the NDA in an advisory committee meeting. The date is yet to be confirmed.

Just a few weeks ago, SVB Leerink analyst Geoffrey Porges predicted that the roxa approval could come ahead of the PDUFA date on March 20 — effusive despite already being let down once by the FDA’s extension of its review back in December. AstraZeneca, which is partnered with FibroGen on the chronic kidney disease-related anemia drug, disclosed regulators had requested further clarifying analyses of clinical data.

In­tro­duc­ing End­pointsF­DA+, our new pre­mi­um week­ly reg­u­la­to­ry news re­port led by Zachary Bren­nan

CRLs. 483s. CBER, CDER and RWE. For biopharma professionals, these acronyms command attention because of the fundamental role FDA plays in drug development. Now Endpoints is doubling down on regulatory coverage, and launching a weekly report focusing on developments out of White Oak, with analysis and insight into what it all means.

Coverage will be led by our new senior editor, Zachary Brennan. He joins Endpoints from POLITICO, where he covered pharma. Prior to that he was the managing editor for Regulatory Focus, a news publication from the Regulatory Affairs Professionals Society.