ADC Ther­a­peu­tics beefs up mon­ster $200M round with fresh $76M haul

Days af­ter Roche se­cured ac­cel­er­at­ed ap­proval for its an­ti­body-drug con­ju­gate, Lau­sanne, Switzer­land-based ADC Ther­a­peu­tics has clinched an­oth­er $76 mil­lion to its al­ready hefty $200 mil­lion round of fi­nanc­ing un­veiled in 2017.

The fresh in­jec­tion brings ADC’s ven­ture haul to $531 mil­lion.

Chris Mar­tin ADC

The funds will set the on­col­o­gy com­pa­ny up with “a strong bal­ance sheet to fund prepa­ra­tions for a po­ten­tial Bi­o­log­ic Li­cense Ap­pli­ca­tion (BLA) for AD­CT-402 (lon­cas­tux­imab tesirine) in re­lapsed or re­frac­to­ry dif­fuse large B-cell lym­phoma (DL­B­CL) in the sec­ond half of 2020, as well as prepa­ra­tions for a piv­otal Phase II tri­al of AD­CT-301 (cami­dan­lum­ab tesirine) in Hodgkin lym­phoma based on our re­cent end of Phase I meet­ing with the U.S. Food and Drug Ad­min­is­tra­tion,” said ADC chief Chris Mar­tin, in a state­ment on Wednes­day.

An­ti­body-drug con­ju­gates are a class of ther­a­peu­tics in which a can­cer-killing tox­in is at­tached to a spe­cif­ic an­ti­body us­ing a biodegrad­able link­er. They are de­signed to min­i­mize the ef­fects of the chemother­a­py on healthy cells while max­i­miz­ing tu­mor cell death, which is why the tech­nol­o­gy is some­times likened to a tro­jan horse as it is en­gi­neered to go un­no­ticed, de­liv­er­ing chemother­a­pies to cells ex­press­ing the anti­gen tar­get.

Un­like the first gen­er­a­tion of an­ti­body-drug con­ju­gates that were steered to the mar­ket by Seat­tle Ge­net­ics and oth­ers, ADC Ther­a­peu­tics is us­ing pyrroloben­zo­di­azepine-based war­heads that it sus­pects will be more po­tent and mit­i­gate drug re­sis­tance, even in hard-to-treat tu­mors.

Mar­tin served as one of the orig­i­nal board mem­bers at ADC back in 2011 when the biotech was launched. In 2013, he en­gi­neered the sale of UK’s Spirogen — where he was CEO — to As­traZeneca in a $440 mil­lion deal, which the British drug­mak­er paired with a $20 mil­lion in­vest­ment in ADC. ADC and Spirogen al­so share the pyrroloben­zo­di­azepine-based war­head tech­nol­o­gy.

ADC’s two lead pro­grams (402 and 301) first re­port­ed pos­i­tive ear­ly-stage da­ta in 2016, and the com­pa­ny has since up­dat­ed its da­ta. The com­pa­ny’s re­searchers, led by CMO Jay Fein­gold —  for­mer VP of can­cer re­search at Wyeth — pre­sent­ed up­dat­ed Phase I da­ta at Amer­i­can So­ci­ety of Hema­tol­ogy (ASH) meet­ing on the 402 pro­gram, which takes aim at a tar­get fa­vored by the CAR-T crowd: CD19. In 139 evalu­able pa­tients with re­lapsed or re­frac­to­ry DL­B­CL, the sci­en­tists reg­is­tered an over­all re­sponse rate (ORR) was 43.3% — com­pris­ing 23.6% com­plete re­spons­es and 19.7% par­tial re­spons­es.

ADC al­so pub­lished fresh phase I da­ta on its ex­per­i­men­tal 301 drug at ASH. In 113 pa­tients with Hodgkin’s lym­phoma, who have failed mul­ti­ple lines of ther­a­py, re­searchers doc­u­ment­ed an ORR of 86.5%, in­clud­ing a lofty 43% com­plete re­sponse rate.

The piv­otal (Phase II) 402 DL­B­CL tri­al is ex­pect­ed to read­out in the third quar­ter of 2019 — and a piv­otal (Phase II) 301 study in Hodgkin lym­phoma pa­tients is ex­pect­ed to kick off in the com­ing months. Last year, the com­pa­ny aban­doned an ear­ly-stage study in pa­tients with HER2-pos­i­tive can­cers eval­u­at­ing its drug, AD­CT-502, af­ter it failed to im­press.

The com­pa­ny — which has a work­force of 120 and op­er­a­tions in Lon­don, New Jer­sey and San Fran­cis­co — an IPO is al­so on the cards, Mar­tin told End­points News.

Nick Leschly via Getty

UP­DAT­ED: Blue­bird shares sink as an­a­lysts puz­zle out $1.8M stick­er shock and an un­ex­pect­ed de­lay

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.

Bain’s biotech team has cre­at­ed a $1B-plus fund — with an eye to more Big Phar­ma spin­outs

One of the biggest investors to burst onto the biotech scene in recent years has re-upped with more than a billion dollars flowing into its second fund. And this next wave of bets will likely include more of the Big Pharma spinouts that highlighted their first 3 years in action.

Adam Koppel and Jeff Schwartz got the new life sciences fund at Bain Capital into gear in the spring of 2016, as they were putting together a $720 million fund with $600 million flowing in from external investors and the rest drawn from the Bain side of the equation. This time the external investors chipped in $900 million, with Bain coming in for roughly $180 million more.

They’re not done with Fund I, with plans to add a couple more deals to the 15 they’ve already posted. And once again, they’re estimating another 15 to 20 investments over a 3- to 5-year time horizon for Fund II.

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Neil Woodford, Woodford Investment Management via YouTube

Un­der siege, in­vest­ment man­ag­er Wood­ford faces an­oth­er in­vest­ment shock

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.

Ted Love. HAVERFORD COLLEGE

Glob­al Blood Ther­a­peu­tics poised to sub­mit ap­pli­ca­tion for ac­cel­er­at­ed ap­proval, with new piv­otal da­ta on its sick­le cell dis­ease drug

Global Blood Therapeutics is set to submit an application for accelerated approval in the second-half of this year, after unveiling fresh data from a late-stage trial that showed just over half the patients given the highest dose of its experimental sickle cell disease drug experienced a statistically significant improvement in oxygen-wielding hemoglobin, meeting the study's main goal.

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Gene ther­a­pies seize the top of the list of the most ex­pen­sive drugs on the plan­et — and that trend has just be­gun

Anyone looking for a few simple reasons why the gene therapy field has caught fire with the pharma giants need only look at the new list of the 10 most expensive therapies from GoodRx.

Two recently approved gene therapies sit atop this list, with Novartis’ Zolgensma crowned the king of the priciest drugs at $2.1 million. Right below is Luxturna, the $850,000 pioneer from Spark, which Roche is pushing hard to acquire as it adds a gene therapy group to the global mix.

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Adding mar­quee in­vestors, Black­Thorn bags $76M to back an AI-dri­ven strat­e­gy for pre­ci­sion neu­ro med­i­cine

As ar­ti­fi­cial in­tel­li­gence and ma­chine learn­ing loom ever larg­er in drug dis­cov­ery and de­vel­op­ment, a biotech op­er­at­ing at the “nexus” of tech­nol­o­gy and neu­ro­sciences has cashed in with $76 mil­lion in fresh fi­nanc­ing.

The big idea at Black­Thorn Ther­a­peu­tics is to do for neu­robe­hav­ioral dis­or­ders what ge­net­i­cal­ly tar­get­ed ther­a­py has done for on­col­o­gy: Re­de­fine pa­tient pop­u­la­tions by the un­der­ly­ing bi­ol­o­gy — dys­reg­u­lat­ed brain cir­cuits, or neu­rotypes — in­stead of symp­toms, there­by find­ing the pa­tients who are most like­ly to ben­e­fit at en­roll­ment phase.

Fol­low­ing CAR-T pi­o­neer­s' foot­steps, Tes­sa launch­es Chi­na JV in $120M deal

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.

News­mak­ers at #EHA19: Re­gen­eron, Ar­Qule track progress on re­sponse rates

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.

In a boost to Rit­ux­an fran­chise, Roche nabs quick ap­proval for po­latuzum­ab ve­dotin

Roche’s lat­est an­ti­body-drug con­ju­gate has crossed the FDA fin­ish line, gain­ing an ac­cel­er­at­ed ap­proval a full two months ahead of sched­ule.

Po­livy, or po­latuzum­ab ve­dotin, is a first-in-class drug tar­get­ing CD79b — a pro­tein promi­nent in B-cell non-Hodgkin lym­phoma. It will now be mar­ket­ed for dif­fuse large B-cell lym­phoma as part of a reg­i­men that al­so in­cludes the chemother­a­py ben­damus­tine and a ver­sion of rit­ux­imab (Rit­ux­an).