Art Krieg moves from CEO post to CSO at Check­mate; In­di­v­ior breathes sigh of re­lief af­ter court rul­ing

Art Krieg

→ Art Krieg is turn­ing in his spot in the CEO’s suite in ex­change for the CSO’s job at Check­mate Phar­ma­ceu­ti­cals. Bar­ry Labinger, for­mer CEO at Bio­thera, will take the top job as Krieg — who found­ed the com­pa­ny — spends a lot more time in the lab. Along with the switch-up in the ex­ec­u­tive of­fices, Check­mate al­so raised $22 mil­lion in a round led by Decheng Cap­i­tal. Ex­ist­ing in­vestors Sofinno­va, ven­Bio, and F-Prime all par­tic­i­pat­ed as well. “My ini­tial goal in found­ing Check­mate was to de­ter­mine if in­tra­tu­moral TLR9 ac­ti­va­tion could in­duce tu­mor re­gres­sion in an­ti-PD-1 re­frac­to­ry ad­vanced can­cer pa­tients,” Krieg com­ment­ed. “Now that we have achieved that goal, I am de­light­ed to turn over Check­mate’s lead­er­ship to Bar­ry, so that I can fo­cus my own ef­forts on the fur­ther sci­en­tif­ic de­vel­op­ment of our plat­form.” 

→ Opi­oid ad­dic­tion treat­ment mak­er In­di­v­ior has an­oth­er lease of life af­ter a US court de­nied In­dia’s Dr. Red­dy’s Labs from launch­ing a gener­ic ver­sion of the Lon­don-list­ed com­pa­ny’s (LON: $IN­DV) top-sell­ing drug, Sub­ox­one film. The on­go­ing saga in­ten­si­fied last month when Dr. Red­dy’s ap­peal to void a pre­lim­i­nary in­junc­tion thwart­ing it from sell­ing its Sub­ox­one gener­ic was ac­cept­ed by a US ap­peals court, evis­cer­at­ing In­di­v­ior’s shares. On Wednes­day, how­ev­er, a sep­a­rate rul­ing has man­dat­ed the pre­lim­i­nary in­junc­tion re­main in place pro­tect­ing the drug, which ac­counts for a bulk of In­di­v­ior’s rev­enue.

→ On a roll, WuXi Bi­o­log­ics has con­vinced its part­ners at Ox­ford Bio­Ther­a­peu­tics to ex­pand their im­muno-on­col­o­gy al­liance to cov­er the de­vel­op­ment of five bis­pe­cif­ic an­ti­bod­ies us­ing the CRO’s WuX­i­Body plat­form and the biotech’s tar­get dis­cov­ery ex­per­tise. The un­spec­i­fied up­front plus de­vel­op­ment, reg­u­la­to­ry and com­mer­cial mile­stones could rack up as much as $450 mil­lion for WuXi. “Com­bin­ing OBT’s nov­el sec­ond gen­er­a­tion IO med­i­cines with a ma­jor check-point path­way in­to a sin­gle en­ti­ty, with po­ten­tial broad util­i­ty across many sol­id and liq­uid tu­mor types, is de­signed to gen­er­ate nov­el ther­a­pies for pa­tients who do not ben­e­fit from ex­ist­ing IO med­i­cines,” said OBT CEO Chris­t­ian Rohlff in a state­ment.

→ As­traZeneca $AZN is not wast­ing pre­cious time. Faced with two sig­nif­i­cant set­backs with its check­point in­hibitor Imfinzi in com­bi­na­tion with its in-house CT­LA-4, the com­pa­ny is con­tin­u­ing to shop for an­oth­er drug that could vault its im­muno-on­col­o­gy pro­gram to greater heights. On Wednes­day, the British drug­mak­er an­nounced its plan to test Imfinzi with Aveo On­col­o­gy’s $AVEO Fo­tiv­da in a Phase I/II study in­volv­ing treat­ment-naive pa­tients with liv­er can­cer.

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.

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.

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 more than a week 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.

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.