Amgen – Concert crushed on PhII schizophrenia flop; Amgen’s sotorasib gets BTD in China – Endpoints News

Con­cert Phar­ma­ceu­ti­cals stock tanked near­ly 40% on Mon­day morn­ing when a ma­jor Phase II flop left the biotech no choice but to ax its schiz­o­phre­nia pro­gram.

The move leaves Con­cert with just one Phase III can­di­date for alope­cia area­ta in the pipeline, which CEO Roger Tung says is now the fo­cus of their ef­forts. Shares $CNCE hov­ered at around $6.90 on the news — a sharp drop from Fri­day’s close at $10.47.

The can­di­date, a deuter­at­ed form of the en­doge­nous amino acid D-ser­ine dubbed CTP-692, failed both the pri­ma­ry and sec­ondary end­points in a proof-of-con­cept study with 325 pa­tients, Con­cert said. The par­tic­i­pants, who were al­ready on a sta­ble course of an­tipsy­chot­ic med­ica­tion, ran­dom­ly re­ceived ei­ther 1, 2 or 4-gram dos­es of CTP-692 once dai­ly. The pri­ma­ry end­point was mea­sured as change in the Pos­i­tive and Neg­a­tive Symp­tom Scale (PANSS) to­tal score at 12 weeks com­pared to base­line. But un­for­tu­nate­ly, no sig­nif­i­cant im­prove­ment over place­bo was seen at any of the dos­es.

“Un­for­tu­nate­ly, we didn’t see the re­sults we hoped for to sup­port con­tin­u­a­tion of this pro­gram,” Tung said in a state­ment. He laid out plans to shelf CTP-692, and in­stead fo­cus on the com­pa­ny’s Phase III alope­cia area­ta can­di­date, CTP-543.

While CTP-543 has seen some set­backs, the JAK in­hibitor scored a win when it re­ceived break­through ther­a­py des­ig­na­tion back in Ju­ly. The drug, which blocks JAK1 and JAK2, was placed on a brief clin­i­cal hold back in 2017 so the FDA could re­view “cer­tain re­cent­ly com­plet­ed non-clin­i­cal tox­i­col­o­gy stud­ies.” Con­cert fixed the is­sue and com­plet­ed a Phase IIa study in 2018. It’s now rac­ing to beat Pfiz­er’s PF-06651600, which in­hibits JAK3, and PF-06700841, which tar­gets TYK2 and JAK1. — Nicole De­Feud­is

Am­gen’s so­tora­sib gets BTD in Chi­na af­ter lat­est KRAS da­ta

On­ly a day af­ter pre­sent­ing the lat­est round of da­ta for its KRAS in­hibitor so­tora­sib, Am­gen has re­ceived a good sign from the Chi­nese gov­ern­ment.

The in­ves­ti­ga­tion­al drug notched a break­through ther­a­py des­ig­na­tion from Chi­na’s NM­PA for the treat­ment of KRAS G12C-mu­tat­ed lo­cal­ly ad­vanced or metasta­t­ic non-small cell lung can­cer, Am­gen an­nounced Fri­day. The BTD is for pa­tients who have re­ceived at least one pri­or sys­temic ther­a­py.

Last week’s da­ta came in ad­vance of the sched­uled re­lease for the World Con­fer­ence on Lung Can­cer, cour­tesy of an em­bar­go break on the PR for the da­ta. Ac­cord­ing to Am­gen, their one-year fol­lowup on the piv­otal Phase II found a 37.1% over­all re­sponse rate among 126 pa­tients, with 3 com­plete re­spons­es and 43 par­tials. The me­di­an du­ra­tion of re­sponse was 10 months.

So­tora­sib had pre­vi­ous­ly re­ceived a break­through des­ig­na­tion from the FDA, and the Phase II da­ta lined up right along­side the Phase I num­bers. — Max Gel­man

Gilead fronts $220M for Ar­cus in ex­change for larg­er own­er­ship stake

Gilead is in­creas­ing its own­er­ship stake in Ar­cus Bio­sciences just a few weeks af­ter its stock price hit a record high.

The cash in­fu­sion will to­tal rough­ly $220 mil­lion, the com­pa­nies said Mon­day. Gilead’s stake will in­crease to 19.5%, from ap­prox­i­mate­ly 13%, with the pur­chase of 5,650,000 ad­di­tion­al Ar­cus shares at a price of $39 per share.

Some of the fund­ing will go to­ward Ar­cus’ CD73 in­hibitor for pan­cre­at­ic can­cer, for which Ar­cus pre­sent­ed new da­ta that earned rave re­views from an­a­lysts a few weeks ago. Re­searchers tracked a 41% over­all re­sponse rate across all dose-es­ca­la­tion co­horts, ac­cord­ing to Ar­cus. And on Mon­day, Mizuho’s Mara Gold­stein said the Gilead buy-in fur­ther val­i­dates the strength of the da­ta.

“We see the deal in­creas­ing our con­fi­dence for this to be an in­flec­tion-po­ten­tial year for RCUS ahead of key da­ta read­outs in 2021 from mul­ti­ple stud­ies,” Gold­stein wrote to in­vestors.

Gilead’s abil­i­ty to in­crease its stake stems from a May 2020 agree­ment that al­lows the com­pa­ny to raise its Ar­cus own­er­ship to 35% over a 5-year pe­ri­od. — Max Gel­man

Il­lu­mi­na and Se­quoia launch new ge­nomics-fo­cused in­cu­ba­tor 

Il­lu­mi­na and Se­quoia Cap­i­tal Na­tion­al are un­veil­ing an in­cu­ba­tor to build new Chi­nese com­pa­nies in the bustling ge­nomics field.

The com­pa­nies an­nounced on Mon­day the Se­quoia Cap­i­tal Chi­na In­tel­li­gent Health­care Ge­nomics In­cu­ba­tor, Pow­ered by Il­lu­mi­na, which will be­gin its in­au­gur­al fund­ing cy­cle this fall.

Dur­ing two six-month fund­ing cy­cles a year, se­lect­ed star­tups will get ac­cess to in­vest­ment and busi­ness guid­ance from Se­quoia Cap­i­tal Chi­na, and ac­cess to Il­lu­mi­na se­quenc­ing sys­tems and reagents and ful­ly op­er­a­tional lab space in Shang­hai.

“Il­lu­mi­na has a suc­cess­ful track record of cre­at­ing ven­ture-backed ge­nomics start­up com­pa­nies through Il­lu­mi­na Ac­cel­er­a­tor in the U.S. and UK,” Il­lu­mi­na CEO Fran­cis deS­ouza said in a state­ment. — Nicole De­Feud­is 

Ap­pli­ca­tions are open un­til June 1.