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.

UP­DAT­ED: In sur­prise switch, Bris­tol-My­ers is sell­ing off block­buster Ote­zla, promis­ing to com­plete Cel­gene ac­qui­si­tion — just lat­er

Apart from revealing its checkpoint inhibitor Opdivo blew a big liver cancer study on Monday, Bristol-Myers Squibb said its plans to swallow Celgene will require the sale of blockbuster psoriasis treatment Otezla to keep the Federal Trade Commission (FTC) at bay.

The announcement — which has potentially delayed the completion of the takeover to early 2020 — irked investors, triggering the New York-based drugmaker’s shares to tumble Monday morning in premarket trading.

Celgene’s Otezla, approved in 2014 for psoriasis and psoriatic arthritis, is a rising star. It generated global sales of $1.6 billion last year, up from the nearly $1.3 billion in 2017. Apart from the partial overlap of Bristol-Myers injectable Orencia, the company’s rival oral TYK2 psoriasis drug is in late-stage development, after the firm posted encouraging mid-stage data on the drug, BMS-986165, last fall. With Monday’s decision, it appears Bristol-Myers is favoring its experimental drug, and discounting Otezla’s future.

The move blindsided some analysts. Credit Suisse’s Vamil Divan noted just days ago:

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Novotech CEO Dr. John Moller

Novotech CRO Award­ed Frost & Sul­li­van Best Biotech CRO Asia-Pa­cif­ic 2019

Known in the in­dus­try as the Asia-Pa­cif­ic CRO, Novotech is now lead CRO ser­vices provider for the grow­ing num­ber of in­ter­na­tion­al biotechs se­lect­ing the re­gion for their stud­ies.

Re­flect­ing this Asia-Pa­cif­ic growth, Novotech staff num­bers are up 20% since De­cem­ber 2018 to 600 in-house clin­i­cal re­search peo­ple across a full range of ser­vices, across the re­gion.

Novotech’s ca­pa­bil­i­ties have been rec­og­nized by an­a­lysts like Frost & Sul­li­van, most re­cent­ly with the pres­ti­gious Asia-Pa­cif­ic CRO Biotech of the year award for best prac­tices in clin­i­cal re­search for biotechs for the fifth year. See oth­er awards here.

Fol­low­ing news of job cuts in Eu­ro­pean R&D ops, Sanofi con­firms it’s of­fer­ing US work­ers an 'ear­ly ex­it'

Ear­li­er in the week we learned that Sanofi was bring­ing out the bud­get ax to trim 466 R&D jobs in Eu­rope, re­tool­ing its ap­proach to car­dio as re­search chief John Reed beefed up their work in can­cer and gene ther­a­pies. And we’re end­ing the week with news that the phar­ma gi­ant has al­so been qui­et­ly re­duc­ing staff in the US, tar­get­ing hun­dreds of jobs as the com­pa­ny push­es vol­un­tary buy­outs with a fo­cus on R&D sup­port ser­vices.

Suf­fer­ing No­var­tis part­ner Cona­tus is pack­ing it in on NASH af­ter a se­ries of un­for­tu­nate tri­al events

The NASH par­ty is over at No­var­tis-backed Cona­tus. And this time they’re turn­ing off the lights.

More than 2 years af­ter No­var­tis sur­prised the biotech in­vest­ment com­mu­ni­ty with its $50 mil­lion up­front and promise of R&D sup­port to part­ner with the lit­tle biotech on NASH — ig­nit­ing a light­ning strike for the share price — Cona­tus $CNAT is back with the lat­est bit­ter tale to tell about em­ri­c­as­an, which once in­spired con­fi­dence at the phar­ma gi­ant.

Dean Hum. Nasdaq via YouTube

Gen­fit goes to Chi­na with a deal worth up to $228M for NASH drug

Fresh off the high of its Nas­daq IPO de­but, and the low of com­par­isons to Cymabay — whose NASH drug re­cent­ly stum­bled — Gen­fit on Mon­day un­veiled an up to $228 mil­lion deal with transpa­cif­ic biotech Terns Phar­ma­ceu­ti­cals to de­vel­op its flag­ship ex­per­i­men­tal liv­er drug — elafi­bra­nor — in Greater Chi­na.

The deal comes weeks af­ter Gen­fit $GN­FT is­sued a fiery de­fense of its dual PPAR ag­o­nist elafi­bra­nor, when com­peti­tor Cymabay’s PPARδ ag­o­nist, se­ladel­par, fiz­zled in a snap­shot of da­ta from an on­go­ing mid-stage tri­al. The main goal at the end of 12 weeks was for se­ladel­par to in­duce a sta­tis­ti­cal­ly sig­nif­i­cant im­prove­ment in liv­er fat con­tent, but da­ta showed that pa­tients on the place­bo ac­tu­al­ly per­formed bet­ter.

Alex­ion wins pri­or­i­ty re­view for Ul­tomiris' aHUS in­di­ca­tion; FDA ex­pands ap­proval of Ver­tex's Symdeko

→ Alex­ion $ALXN has scored a speedy re­view for Ul­tomiris for pa­tients with atyp­i­cal he­molyt­ic ure­mic syn­drome (aHUS) af­ter post­ing pos­i­tive da­ta from a piv­otal study in Jan­u­ary. The drug is the rare dis­ease com­pa­ny’s shot at pro­tect­ing its block­buster blood dis­or­der fran­chise that is cur­rent­ly cen­tered around its flag­ship drug, Soliris, which is a com­ple­ment in­hibitor typ­i­cal­ly ad­min­is­tered every two weeks. Ul­tomiris has a sim­i­lar mech­a­nism of ac­tion but re­quires less-fre­quent dos­ing — every eight weeks. The de­ci­sion date has been set to Oc­to­ber 19. Late last year, Ul­tomiris se­cured ap­proval for noc­tur­nal he­mo­glo­bin­uria (PNH) pa­tients.

Bet­ter than Am­bi­en? Min­er­va soars on PhI­Ib up­date on sel­torex­ant for in­som­nia

A month af­ter roil­ing in­vestors with what skep­tics dis­missed as cher­ry pick­ing of its de­pres­sion da­ta, Min­er­va is back with a clean slate of da­ta from its Phase IIb in­som­nia tri­al.

In a de­tailed up­date, the Waltham, MA-based biotech said sel­torex­ant (MIN-202) hit both the pri­ma­ry and sev­er­al sec­ondary end­points, ef­fec­tive­ly im­prov­ing sleep in­duc­tion and pro­long­ing sleep du­ra­tion. In­ves­ti­ga­tors made a point to note that the ef­fects were con­sis­tent across the adult and el­der­ly pop­u­la­tions, with the lat­ter more prone to the sleep dis­or­der.

Gene ther­a­py biotech sees its stock rock­et high­er on promis­ing re­sults for rare cas­es of but­ter­fly dis­ease

Shares of Krys­tal Biotech took off this morn­ing $KRYS af­ter the lit­tle biotech re­port­ed promis­ing re­sults from its gene ther­a­py to treat a rare skin dis­ease called epi­der­mol­y­sis bul­losa.

Fo­cus­ing on an up­date with 4 new pa­tients, re­searchers spot­light­ed the suc­cess of KB103 in clos­ing some stub­born wounds. Krys­tal says that of 4 re­cur­ring and 2 chron­ic skin wounds treat­ed with the gene ther­a­py, the KB103 group saw the clo­sure of 5. The 6th — a chron­ic wound, de­fined as a wound that had re­mained open for more than 12 weeks — was par­tial­ly closed. That brings the to­tal so far to 8 treat­ed wounds, with 7 clo­sures.

Ab­b­Vie gets a green light to re­sume re­cruit­ing pa­tients for one myelo­ma study — but Ven­clex­ta re­mains un­der a cloud

Three months af­ter reg­u­la­tors at the FDA forced Ab­b­Vie to halt en­rolling pa­tients in its tri­als of a com­bi­na­tion us­ing Ven­clex­ta (vene­to­clax) to treat drug-re­sis­tant cas­es of mul­ti­ple myelo­ma, the agency has green-light­ed the re­sump­tion of one of those stud­ies, while keep­ing the rest on the side­lines.

The CANO­VA (M13-494) study can now get back in busi­ness re­cruit­ing pa­tients to test the drug for a pop­u­la­tion that shares a par­tic­u­lar ge­net­ic bio­mark­er. To get that per­mis­sion, Ab­b­Vie — which is part­nered with Roche on this pro­gram — was forced to re­vise the pro­to­col, mak­ing un­spec­i­fied changes in­volv­ing risk mit­i­ga­tion mea­sures, pro­to­col-spec­i­fied guide­lines and an up­dat­ed fu­til­i­ty cri­te­ria.