→ Ay­ala Ther­a­peu­tics — which fo­cus­es on rare can­cers that oc­cur due to dys­reg­u­la­tion of the Notch-ac­ti­vat­ing path­way — has raised $30 mil­lion in a round of fi­nanc­ing led by part­ner No­var­tis.

The funds, which al­so came from in­vestors in­clud­ing SBI JI In­no­va­tion Fund, Is­rael Biotech Fund, aMoon and Harel In­sur­ance & Fi­nance Group, will be used to fu­el the de­vel­op­ment of its lead drug, AL101. The pan-Notch in­hibitor is cur­rent­ly be­ing eval­u­at­ed for ade­noid cys­tic car­ci­no­ma (ACC) in a Phase II tri­al, and the com­pa­ny is al­so plan­ning to in­ves­ti­gate its use in a mid-stage study in triple neg­a­tive breast can­cer.

In 2017, Ay­ala inked a deal with Bris­tol-My­ers Squibb $BMY to de­vel­op treat­ments for can­cers with al­tered Notch genes. The fol­low­ing year, it joined forces with No­var­tis to de­vel­op and mar­ket an­oth­er drug, AL102, in com­bi­na­tion with BC­MA-tar­get­ing agents for mul­ti­ple myelo­ma pa­tients.

The Is­raeli biotech raised $17 mil­lion in its first round of fi­nanc­ing in April 2018.

→ The FDA grant­ed Bay­er’s Aliqopa (co­pan­lis­ib) — used for the treat­ment of adult pa­tients with re­lapsed mar­gin­al zone lym­phoma (MZL) who have re­ceived at least two oth­er ther­a­pies pri­or — break­through ther­a­py des­ig­na­tion based on over­all re­sponse rate (ORR) from its piv­otal Phase II CHRONOS-1 study. The com­pa­ny says that it “is con­duct­ing two ad­di­tion­al Phase III stud­ies to eval­u­ate the ef­fi­ca­cy and safe­ty of Aliqopa in com­bi­na­tion with oth­er ther­a­pies with iNHL (in­clud­ing MZL) who have re­lapsed fol­low­ing one or more pri­or ther­a­pies.”

→ Ger­man-based Bay­er $BAYRY and Foun­da­tion Med­i­cine $FMI are en­ter­ing a glob­al col­lab­o­ra­tion for the de­vel­op­ment and com­mer­cial­iza­tion of NGS-based com­pan­ion di­ag­nos­tic tests, which help find a pos­si­ble can­cer treat­ment ther­a­py via mol­e­c­u­lar in­for­ma­tion from a pa­tient’s tu­mor genome. Bay­er will al­so have ac­cess to Foun­da­tionOne CDx — Foun­da­tion Med­i­cine’s se­quenc­ing based in vit­ro di­ag­nos­tic de­vice.

The first project that will be un­der­tak­en is de­vel­op­ing a com­pan­ion di­ag­nos­tic for Vi­t­rakvi (larotrec­tinib), the first and on­ly TRK in­hibitor ap­proved in the US for adult and pe­di­atric pa­tients with “sol­id tu­mors that have a neu­rotroph­ic tropomyosin re­cep­tor ki­nase (NTRK) gene fu­sion with­out a known ac­quired re­sis­tance mu­ta­tion that are ei­ther metasta­t­ic or where sur­gi­cal re­sec­tion will like­ly re­sult in se­vere mor­bid­i­ty, and have no sat­is­fac­to­ry al­ter­na­tive treat­ments or that have pro­gressed fol­low­ing treat­ment.”

→ As­traZeneca spin­out Viela Bio has notched a com­mer­cial deal with sea­soned Chi­nese phar­ma Han­soh cen­tered around inebi­lizum­ab, the lead drug among six as­sets from the phar­ma gi­ant. The an­ti-CD19 drug treats neu­romyelitis op­ti­ca spec­trum dis­or­der, a rare dis­ease that af­fects the eye and spine. All told, the deal is worth up to $220 mil­lion in­clud­ing up­front and mile­stones.

→ The Park­er In­sti­tute is em­bark­ing on a new re­search jour­ney to find out why some pa­tients de­vel­op au­toim­mune dis­or­ders fol­low­ing can­cer im­munother­a­py. To­geth­er with two oth­er non­prof­its (ded­i­cat­ed to di­a­betes and health­care re­spec­tive­ly), it’s pledg­ing $10 mil­lion over three years to sup­port re­searchers at Yale, UCSF, Vir­ginia Ma­son and Dana-Far­ber. The hope is to both ad­vance can­cer treat­ment and bet­ter un­der­stand how type 1 di­a­betes de­vel­ops in gen­er­al.

→ In 2015, In­ovio joined forces with As­traZeneca’s $AZN Med­Im­mune unit for $27.5 mil­lion up­front, as well as an­oth­er po­ten­tial $700 mil­lion in mile­stone pay­ments — for the ex­clu­sive rights to In­ovio’s im­munother­a­py, de­signed to tar­get can­cers caused by hu­man pa­pil­lo­mavirus (HPV), in ad­di­tion to two ad­di­tion­al DNA-based can­cer vac­cine prod­ucts. On Wednes­day, In­ovio in a fil­ing dis­closed that Med­Im­mune was re­tain­ing its rights to the HPV im­munother­a­py, ME­DI0457 (pre­vi­ous­ly called INO-3112), but walk­ing away from the rest.

Blue­bird bio $BLUE has un­veiled its price for the new­ly ap­proved gene ther­a­py Zyn­te­glo (Lenti­Glo­bin), which came as a big sur­prise. And it wasn’t the on­ly un­ex­pect­ed twist in to­day’s sto­ry.

With some an­a­lysts bet­ting on a $900,000 price for the β-tha­lassemia treat­ment in Eu­rope, where reg­u­la­tors pro­vid­ed a con­di­tion­al ear­ly OK, blue­bird CEO Nick Leschly said Fri­day morn­ing that the pa­tients who are suc­cess­ful­ly treat­ed with their drug over 5 years will be charged twice that — $1.8 mil­lion — on the con­ti­nent. That makes this drug the sec­ond most ex­pen­sive ther­a­py on the plan­et, just be­hind No­var­tis’ new­ly ap­proved Zol­gens­ma at $2.1 mil­lion, with an­a­lysts still wait­ing to see what kind of pre­mi­um can be had in the US.

→ Ab­b­Vie is tout­ing new pos­i­tive da­ta com­par­ing their ag­ing block­buster Hu­mi­ra with their hoped-for block­buster upadac­i­tinib. Over 48 weeks a larg­er pro­por­tion of pa­tients tak­ing the ex­per­i­men­tal drug ex­pe­ri­enced clin­i­cal re­mis­sion than in the con­trol arm with Hu­mi­ra. Their drug brought in $20 bil­lion last year, top­ping the scales in the num­ber 1 slot.

→ Gilead has turned to Van­cou­ver-based Ab­Cellera for its lat­est dis­cov­ery deal. Ab­Cellera will use its know-how in “sin­gle-cell screen­ing of nat­ur­al im­mune sources” to find an­ti­body can­di­dates for Gilead to pur­sue in the in­fec­tious dis­ease field. The deal in­cludes an up­front and mile­stones.

These days just about every biotech se­ri­ous about glob­al de­vel­op­ment — and not just com­mer­cial­iza­tion — has a Chi­na strat­e­gy. Tes­sa Ther­a­peu­tics, a Bay­lor as­so­ci­at­ed out­fit based out of Sin­ga­pore, is no ex­cep­tion.

Tak­ing a page out of the CAR-T pi­o­neers’ play­book, Tes­sa is es­tab­lish­ing a joint ven­ture with Chi­na-Sin­ga­pore Guangzhou Knowl­edge City, which is ini­tial­ly putting down $40 mil­lion for a 13% stake with $40 mil­lion more to come in a sec­ond stage. The biotech, which now re­tains an 87% con­trol, is al­so rolling out its own con­tri­bu­tions in two phas­es, start­ing with $20 mil­lion and all its tech­nol­o­gy li­cense rights for Chi­na.

Re­gen­eron’s close­ly-watched bis­pe­cif­ic con­tin­ues to ring up high re­sponse rates

Re­gen­eron’s high-pro­file bis­pe­cif­ic REGN1979 is back in the spot­light at the Eu­ro­pean Hema­tol­ogy As­so­ci­a­tion sci­en­tif­ic con­fab. And while the stel­lar num­bers we saw at ASH have erod­ed some­what as more blood can­cer pa­tients are eval­u­at­ed, the re­sponse rates for this CD3/CD20 drug re­main high.

A to­tal of 13 out of 14 fol­lic­u­lar lym­phomas re­spond­ed to the drug, a 93% ORR, down from 100% at the last read­out. In 10 out of 14, there was a com­plete re­sponse. In dif­fuse large B-cell lym­phoma the re­sponse rate was 57% among pa­tients treat­ed at the 80 mg to 160 mg dose range. They were all com­plete re­spons­es. And 2 of these Cars were for pa­tients who had failed CAR-T ther­a­py.

Em­bat­tled UK fund man­ag­er Neil Wood­ford — who has con­tro­ver­sial­ly blocked in­vestors from pulling out from his flag­ship fund to stem the blood­let­ting, af­ter a slew of dis­ap­point­ed in­vestors fled fol­low­ing a se­ries of sour bets — is now pay­ing the price for his ac­tions via an in­vestor ex­o­dus on an­oth­er fund.

Har­g­reaves Lans­down, which has in the past sold and pro­mot­ed the Wood­ford funds via its re­tail in­vest­ment plat­form, has re­port­ed­ly with­drawn £45 mil­lion — its en­tire po­si­tion — from the in­vest­ment man­ag­er’s In­come Fo­cus Fund.