Amgen’s Otezla bags expanded FDA nod in psoriasis; I-Mab CEO hits the exit amid shakeup at Chinese firm

Just a few weeks af­ter Ote­zla notched a Phase III win and hit all pri­ma­ry and sec­ondary end­points for a tri­al in gen­i­tal pso­ri­a­sis, Am­gen’s block­buster drug Ote­zla gets yet an­oth­er OK from the FDA.

The biotech an­nounced this morn­ing the FDA ap­proved Ote­zla (apremi­last) for an ex­pand­ed in­di­ca­tion: the treat­ment of adult pa­tients with plaque pso­ri­a­sis who are can­di­dates for pho­tother­a­py or sys­temic ther­a­py.

Ote­zla is now the first and on­ly oral treat­ment ap­proved in adult pa­tients with plaque pso­ri­a­sis across all sever­i­ties, in­clud­ing mild, mod­er­ate and se­vere, Am­gen said in a state­ment.

The FDA ap­proval is based on find­ings from the Phase III AD­VANCE tri­al, where 21% of pa­tients on the drug in the tri­al achieved the tri­al’s pri­ma­ry end­point of Sta­t­ic Physi­cian’s Glob­al As­sess­ment re­sponse af­ter 16 weeks, com­pared to on­ly 4% on place­bo.

Ad­verse events ob­served in the tri­al were con­sis­tent with Ote­zla’s known safe­ty pro­file, Am­gen added.

This is Ote­zla’s third ap­proval it’s re­ceived in the US — the oth­ers are for adult pa­tients with ac­tive pso­ri­at­ic arthri­tis and for adult pa­tients with oral ul­cers as­so­ci­at­ed with Be­hçet’s dis­ease.

I-Mab CEO Joan Shen hits the ex­it

I-Mab is go­ing through a shake­up with cur­rent CEO Joan Shen step­ping down on Dec. 31 to ‘pur­sue oth­er in­ter­ests,’ ac­cord­ing to a state­ment. The com­pa­ny’s founder and chair­man Jing­wu Zang will be­come act­ing CEO as of Jan. 1.

The Chi­nese biotech an­nounced fur­ther changes yes­ter­day while im­ple­ment­ing a new gov­er­nance ini­tia­tive de­signed to fa­cil­i­tate glob­al pipeline de­vel­op­ment and ac­cel­er­ate its on­go­ing trans­for­ma­tion to­wards an in­te­grat­ed glob­al bio­phar­ma com­pa­ny. An­drew Zhu will be I-Mab’s new pres­i­dent and a mem­ber of the board of di­rec­tors. Zhu will lead their R&D di­vi­sion, fo­cus­ing on pipeline mile­stones and im­prov­ing clin­i­cal de­vel­op­ment ca­pa­bil­i­ties in Chi­na and in the US.

Zhu is a pro­fes­sor at Har­vard Med­ical School and was the CSO at Ji­ahui Health.

Menar­i­ni Group signs in-li­cens­ing deal to com­mer­cial­ize Karyopharm’s MM drug

Karyopharm Ther­a­peu­tics and Ital­ian phar­ma Menar­i­ni Group said they’re go­ing in on an ex­clu­sive li­cens­ing agree­ment for an on­col­o­gy drug.

Menar­i­ni will com­mer­cial­ize Karyopharm’s oral Se­lec­tive In­hibitor of Nu­clear Ex­port (SINE) com­pound Nex­povio in Eu­rope and oth­er glob­al ter­ri­to­ries.

Nex­povio is de­signed to treat mul­ti­ple myelo­ma, and un­der tight lim­i­ta­tions, giv­en con­di­tion­al ap­proval in the EU.

While Menar­i­ni re­ceives ex­clu­sive rights to com­mer­cial­ize Nex­povio for the treat­ment of on­col­o­gy in­di­ca­tions in the EU and oth­er Eu­ro­pean coun­tries, Latin Amer­i­ca and oth­er key coun­tries, Karyopharm will re­ceive in ex­change an up­front pay­ment of $75 mil­lion by year’s end, and is el­i­gi­ble to re­ceive up to an ad­di­tion­al $202.5 mil­lion in fu­ture mile­stones, plus tiered dou­ble-dig­it roy­al­ties on net sales of the drug.

Nex­povio has re­ceived mar­ket­ing au­tho­riza­tion from the Eu­ro­pean Com­mis­sion un­der the fol­low­ing con­di­tions:

in com­bi­na­tion with steroid dex­am­etha­sone for the treat­ment of mul­ti­ple myelo­ma in adult pa­tients who;

have re­ceived at least four pri­or ther­a­pies and whose dis­ease is re­frac­to­ry to at least;

two pro­tea­some in­hibitors,

two im­munomod­u­la­to­ry agents,

an an­ti-CD38 mon­o­clon­al an­ti­body,

and who have demon­strat­ed dis­ease pro­gres­sion on the last ther­a­py.

The EMA ap­proved Nex­povio in com­bi­na­tion with chemo drug Vel­cade and low-dose dex­am­etha­sone for treat­ing mul­ti­ple myelo­ma fol­low­ing at least one pri­or ther­a­py. The MAA will be re­viewed by the CHMP, which will is­sue an opin­ion to the Eu­ro­pean Com­mis­sion re­gard­ing the po­ten­tial ap­proval for an ex­pand­ed in­di­ca­tion. This re­view is ex­pect­ed to be com­plet­ed dur­ing the first half of next year, ac­cord­ing to the two com­pa­nies.

North Car­oli­na-based Heat Bi­o­log­ics ac­quir­ing de­fense-fo­cused biotech

Heat Bi­o­log­ics is buy­ing up a com­pa­ny — Elusys Ther­a­peu­tics.

The ac­qui­si­tion an­nounced this morn­ing is ex­pect­ed to close some­time in Q1 2022 — and the biotech has one prod­uct: obil­tox­ax­imab, al­so known as An­thim for treat­ing an­thrax ex­po­sure.

While the num­bers on this deal re­main hid­den, Heat’s ac­qui­si­tion of Elusys en­hances Heat’s im­munother­a­py port­fo­lio, the biotech said. Elusys had been award­ed over $350 mil­lion in past R&D con­tracts with a host of gov­ern­ment agen­cies, such as BAR­DA, NI­AID and the DOD.

Af­ter the deal is fi­nal­ized, Elusys will con­tin­ue to op­er­ate as a whol­ly owned sub­sidiary of Heat, and Heat will ac­quire all out­stand­ing shares of Elusys.

Heat CEO Jeff Wolf said in a state­ment that this ac­qui­si­tion is part of Heat’s vi­sion to de­vel­op and com­mer­cial­ize bio­phar­ma­ceu­ti­cals and vac­cines for the ‘glob­al biode­fense mar­ket.’

Life sci­ences in­vestor Thu­ja closed its Fund III with $85M

Ear­ly-stage in­vestor Thu­ja Cap­i­tal has of­fi­cial­ly closed its third in­vest­ment fund.

The in­vest­ing firm based in the Nether­lands an­nounced to­day that the fund will fo­cus on in­vest­ing in ear­ly-stage com­pa­nies based in the Nether­lands, Bel­gium or Ger­many. And for more specifics: The firm wants to in­vest in ear­ly stage com­pa­nies that de­vel­op nov­el ther­a­peu­tics, med­ical de­vices (in­clud­ing dig­i­tal health) or nu­traceu­ti­cals.

Fund III will build a port­fo­lio of any­where be­tween 10 and 12 in­vest­ments, and the fund has al­ready made three in­vest­ments so far: Ales­ta Ther­a­peu­tics (based in Lei­den, The Nether­lands), Es­o­Biotec (from Gos­selies, Bel­gium) and Pan Can­cer T (al­so in the Nether­lands, but in Rot­ter­dam).

In­sight Part­ners soft­ware sub­sidiary to ac­quire pro­teomics soft­ware com­pa­ny Pro­tein Met­rics

In the sec­ond ac­qui­si­tion brief of the day, life sci­ence soft­ware com­pa­ny In­sight­ful Sci­ence an­nounced that it has com­plet­ed a trans­ac­tion to ac­quire soft­ware com­pa­ny Pro­tein Met­rics.

Ac­cord­ing to a com­pa­ny an­nounce­ment, the new ac­qui­si­tion ex­pands In­sight­ful Sci­ence’s R&D in­to the bio­phar­ma­ceu­ti­cal pro­tein analy­sis sphere.

What Pro­tein Met­rics does is pro­vide a plat­form for pro­tein analy­sis, ac­cord­ing to In­sight­ful Sci­ence — along with ‘help re­searchers min­i­mize am­bi­gu­i­ty, achieve re­pro­ducibil­i­ty, and elim­i­nate lab-to-lab vari­abil­i­ty.’

Pro­tein Met­rics is the newest mem­ber of In­sight­ful Sci­ence’s soft­ware port­fo­lio, which in­cludes Snap­Gene and Dog­mat­ics.

In­sight­ful Sci­ence CEO Thomas Swal­la ex­pressed op­ti­mism about the deal, say­ing in a pre­pared state­ment, ‘We are ex­cit­ed about our po­ten­tial to add to our ca­pa­bil­i­ties and fur­ther en­hance sci­en­tif­ic ex­e­cu­tion and col­lab­o­ra­tion.’
https://endpts.com/amgens-otezla-bags-expanded-fda-nod-in-psoriasis-i-mab-ceo-hits-the-exit-amid-shakeup-at-chinese-firm/