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.

In a stun­ning set­back, Amarin los­es big patent fight over Vas­cepa IP. And its high-fly­ing stock crash­es to earth

Amarin’s shares $AMRN were blitzed Monday evening, losing billions in value as reports spread that the company had lost its high-profile effort to keep its Vascepa patents protected from generic drugmakers.

Amarin had been fighting to keep key patents under lock and key — and away from generic rivals — for another 10 years, but District Court Judge Miranda Du in Las Vegas ruled against the biotech. She ruled that:
(A)ll the Asserted Claims are invalid as obvious under 35 U.S.C.§ 103. Thus, the Court finds in favor of Defendants on Plaintiff’s remaining infringementclaim, and in their favor on their counterclaims asserting the invalidity of the AssertedClaims under 35 U.S.C. § 103.

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UP­DAT­ED: Have a new drug that promis­es to fight Covid-19? The FDA promis­es fast ac­tion but some de­vel­op­ers aren't hap­py

After providing an emergency approval to use malaria drugs against coronavirus with little actual evidence of their efficacy or safety in that setting, the FDA has already proven that it has set aside the gold standard when it comes to the pandemic. And now regulators have spelled out a new approach to speeding development that promises immediate responses in no uncertain terms — promising a program offering the ultimate high-speed pathway to Covid-19 drug approvals.

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FDA puts pe­di­atric aGVHD drug on pri­or­i­ty re­view lane — will they go vir­tu­al with the ad­comm?

Despite worries about regulatory delays due to new work arrangements under Covid-19, the FDA appears intent to go full speed ahead with its everyday work, not only granting priority review to a stem cell therapy for acute graft versus host disease but also plotting an advisory committee meeting for it.

With a PDUFA date of September 30, the journey of the drug — remestemcel-L, or Ryoncil — could shed light on the agency’s capacity to facilitate drug development unrelated to Covid-19.

Covid 19 roundup: Trump push­es his new fa­vorite, untest­ed drug; CRISPR out­lines crip­pling im­pact of Covid-19

President Trump has a new favorite Covid-19 drug.

After a conversation with Japanese Prime Minister Shinzo Abe, Politico reports, the president is pressuring the FDA to issue emergency use authorization for favipiravir, a flu drug that showed glimpses of success in China but remains unproven and carries a list of worrying side effects. The push comes after a week-plus in which the White House touted a potentially effective but unproven malaria medication despite the concerns of scientific advisors such as NIAID director Anthony Fauci. And Trump ally Rudy Giuliani has been talking up unproven cell therapy efforts on Twitter.

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Once fu­ri­ous over No­var­tis’ da­ta ma­nip­u­la­tion scan­dal, the FDA now says it’s noth­ing they need to take ac­tion on

Back in the BP era — Before Pandemic — the FDA ripped Novartis for its decision to keep the agency in the dark about manipulated data used in its application for Zolgensma while its marketing application for the gene therapy was under review.

Civil and criminal sanctions were being discussed, the agency noted in a rare broadside at one of the world’s largest pharma companies. Notable lawmakers cheered the angry regulators on, urging the FDA to make an example of Novartis, which fielded Zolgensma at $2.1 million — the current record for a one-off therapy.

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Covid-19 roundup: GSK, Am­gen tai­lor R&D work to fit the coro­n­avirus age; Doud­na's ge­nomics crew launch­es di­ag­nos­tic lab

You can add Amgen and GSK to the list of deep-pocket drug R&D players who are tailoring their pipeline work to fit a new age of coronavirus.

Following in the footsteps of a lineup of big players like Eli Lilly — which has suspended patient recruitment for drug studies — Amgen and GSK have opted to take a more tailored approach. Amgen is intent on circling the wagons around key studies that are already fully enrolled, and GSK has the red light on new studies while the pandemic plays out.

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ITeos nabs $125M as they prep Keytru­da com­bi­na­tion tri­al — if Covid-19 will let them

For iTeos, it turned out, $75 million could only last so long.

Two years after announcing their eye-catching Series B raise, the Belgian biotech is back with an even larger Series B-2: $125 million.

The now $200 million financing illustrates the vast capital available for those with promising new immuno-oncology compounds, particularly those that might be used in combination with existing therapies. In December, iTeos announced a collaboration with Merck to test its lead compound with Keytruda this year. The proceeds will push forward that trial and help fund the ongoing Phase I/II trials for that compound, EOS-850, and a second one, EOS-448.

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Dai­ichi Sankyo sinks $200M in­to new gene ther­a­py tech from Ul­tragenyx

In a leap to the gene therapy space, Daiichi Sankyo has dropped $200 million to access Ultragenyx’s manufacturing technology, providing the rare disease biotech with plenty of cash and a stock boost amid a general cash crunch.

For $125 million in cash and a $75 million equity investment, Daiichi Sankyo has bought a non-exclusive license to the IP around two platforms with which it plans to develop AAV-based gene therapy products. The Japanese pharma is purchasing the stock $RARE at $60 per share, more than a third above its current price of $44.43.

It is 'kind of a proven tech­nol­o­gy': Hep B vac­cine mak­er joins glob­al hunt for coro­n­avirus vac­cine

Using lab-grown proteins that are engineered to mimic the architecture of viruses to induce an immune response, VBI Vaccines is joining the hunt for a coronavirus vaccine — harnessing technology that has initially been proved safe in early trials as a prophylactic for cytomegalovirus (CMV) infection.

Unlike the raft of the companies in the Covid-19 vaccine race — including Moderna, CureVac and J&J — VBI is taking a pan-coronavirus approach, by developing a vaccine that will encompass Covid-19, severe acute respiratory syndrome (SARS), and Middle East respiratory syndrome (MERS).