Cor­bus brags about an­oth­er PhII suc­cess for its lead drug, but shares slide ear­ly

Yu­val Co­hen, Cor­bus CEO

Cor­bus Phar­ma­ceu­ti­cals has plucked out some pos­i­tive da­ta from its mid-stage cys­tic fi­bro­sis study. But it didn’t help its stock price this morn­ing.

While the Phase II goal for its add-on drug an­aba­sum (JBT-101 or Re­sunab) was safe­ty and tol­er­a­bil­i­ty — which the biotech says they hit — it was an ef­fi­ca­cy sig­nal they picked up in a high-dose group that drew most of the at­ten­tion. There, the com­pa­ny says, a twice dai­ly 20 mg dose of the drug trig­gered a 75% re­duc­tion in the an­nu­al­ized rate of pul­monary ex­ac­er­ba­tions re­quir­ing IV an­tibi­otics com­pared to place­bo co­hort.

While Cor­bus tout­ed the da­ta as an­oth­er sign of clin­i­cal progress, there was con­sid­er­able chat­ter on Twit­ter at­tack­ing the re­sults, which ex­plains why shares are down 13% in pre-mar­ket trad­ing.

TheStreet’s Adam Feuer­stein, a fre­quent crit­ic of Cor­bus, launched a full scale as­sault on the com­pa­ny, say­ing the da­ta shows no signs of a clin­i­cal ben­e­fit and that re­searchers just got lucky on pul­monary ex­ac­er­ba­tions with a hand­ful of cas­es to com­pare.

In this four-month study of cys­tic fi­bro­sis pa­tients, the Cor­bus drug failed to im­prove lung func­tion com­pared to a place­bo. Over­all res­pi­ra­to­ry symp­toms, mea­sured by a cys­tic fi­bro­sis pa­tient ques­tion­naire, al­so showed no dif­fer­ence be­tween an­aba­sum and place­bo.

Cor­bus CEO Yu­val Co­hen re­spond­ed:

We don’t com­ment on stock move­ments but it is note­wor­thy that there is a siz­able short po­si­tion in our stock that is prob­a­bly hav­ing a bad hair day this morn­ing…

There were a to­tal of 85 pa­tients re­cruit­ed for this study, and the high dose was test­ed in the sec­ond part of the Phase II, weeks 5 through 12, with 30 pa­tients get­ting a 20 mg sin­gle dose per day and 31 get­ting the twice dai­ly dose. Eleven pa­tients in the place­bo arm were as­signed to the drug groups and 24 pa­tients con­tin­ued on place­bo.

Five pa­tients with­drew due to ad­verse events — five on place­bo, three on an­aba­sum. And the re­searchers al­so high­light­ed some pos­i­tive bio­mark­er re­sults as well.

The lat­est batch of mid-stage da­ta fol­lows an­oth­er small Phase II for sys­temic scle­ro­sis, an au­toim­mune dis­ease of con­nec­tive tis­sue, that helped add some pos­i­tive at­ten­tion for the com­pa­ny, which has been un­der an in­tense short at­tack. Us­ing a com­pos­ite score to gauge a re­sponse on a slate of key mea­sures like lung func­tion, the com­bined drug arm in­clud­ing pa­tients on a range of dos­es of re­sunab (JBT-101) post­ed a me­di­an 33% CRISS score af­ter 16 weeks of ther­a­py, com­pared to 0% in the place­bo group. And that marks a sig­nif­i­cant ben­e­fit for pa­tients, says the biotech, with a p-val­ue of 0.044 — not a great num­ber, but with­in the mar­gin need­ed to de­clare a win.

These small stud­ies and sub­group analy­ses leave a lot to be de­sired, but Cor­bus CEO Co­hen — nev­er re­luc­tant to boast about suc­cess­es — be­lieve it helps show that the com­pa­ny is on track to de­liv­er in piv­otal stud­ies.

“The re­duc­tion in acute pul­monary ex­ac­er­ba­tions along with re­duc­tions in in­flam­ma­to­ry cells and in­flam­ma­to­ry me­di­a­tors in spu­tum demon­strate the po­ten­tial for an­aba­sum as a new in­flam­ma­tion-tar­get­ing ther­a­peu­tic in cys­tic fi­bro­sis that can broad­ly tar­get pa­tients with­out re­gard to their spe­cif­ic CFTR mu­ta­tions. The out­comes of this 16-week study in­di­cate that an­aba­sum has the po­ten­tial to ad­dress the im­por­tant un­met need for treat­ments that tar­get in­flam­ma­tion in CF,” com­ment­ed prin­ci­pal in­ves­ti­ga­tor James Chmiel.

Most of these pa­tients were al­ready tak­ing Orkam­bi, a com­bo drug from Ver­tex which has proved to have a mod­est but ef­fec­tive im­pact on CF.

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.

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.

Bris­tol-My­ers star Op­di­vo fails sur­vival test in a matchup with Nex­avar aimed at shak­ing up the big HCC mar­ket

Bris­tol-My­ers Squibb has suf­fered an­oth­er painful set­back in its years-long quest to ex­pand the reach of Op­di­vo. The phar­ma gi­ant this morn­ing not­ed that their Check­mate-459 study com­par­ing Op­di­vo with Bay­er’s Nex­avar in front­line cas­es of he­pa­to­cel­lu­lar car­ci­no­ma — the most com­mon form of liv­er can­cer — failed to hit the pri­ma­ry end­point on over­all sur­vival.

This was a sig­nif­i­cant mile­stone in Bris­tol-My­ers’ tal­ly of PD-1 cat­a­lysts this year. Nex­avar (so­rafenib) has been the stan­dard of care in front­line HCC for the past decade, though Op­di­vo has been mak­ing head­way in sec­ond-line HCC cas­es, where it’s go­ing toe-to-toe with Bay­er’s Sti­var­ga (re­go­rafenib) af­ter re­cent ap­provals shook up the mar­ket.

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.