Orencia approved by FDA for new indication — graft vs host disease; Sosei and Twist announce antibody discovery deal

For the first time, doc­tors will have a drug to com­bat acute graft-ver­sus-host dis­ease — a dan­ger­ous side ef­fect of stem cell trans­plants in which donor cells at­tack the re­cip­i­ent — be­fore it oc­curs.

The FDA has ap­proved Bris­tol My­ers Squibb’s Oren­cia to pre­vent aGVHD in com­bi­na­tion with cer­tain im­muno­sup­pres­sants, the com­pa­ny an­nounced on Wednes­day. Adults and kids two years and old­er can take the drug if they’re un­der­go­ing hematopoi­et­ic stem cell trans­plan­ta­tion from an un­re­lat­ed re­cip­i­ent.

‘Acute graft ver­sus host dis­ease can af­fect dif­fer­ent parts of the body and be­come a se­ri­ous post-trans­plant com­pli­ca­tion,’ said Richard Paz­dur, di­rec­tor of the FDA’s On­col­o­gy Cen­ter of Ex­cel­lence. ‘By po­ten­tial­ly pre­vent­ing the dis­ease, more pa­tients may suc­cess­ful­ly un­der­go bone mar­row or stem cell trans­plan­ta­tion with few­er com­pli­ca­tions.’

Oren­cia was ini­tial­ly ap­proved in 2005 for the treat­ment of adult rheuma­toid arthri­tis and has since been ex­pand­ed to treat pol­yartic­u­lar ju­ve­nile id­io­path­ic arthri­tis and adult pso­ri­at­ic arthri­tis.

Its lat­est ap­proval was based on key clin­i­cal da­ta, plus re­al-world ev­i­dence. In one study, dubbed GVHD-1, pa­tients who re­ceived Oren­cia saw a 90% over­all sur­vival rate com­pared to 84% in the place­bo group. For mod­er­ate-se­vere aGVHD-free sur­vival, pa­tients who re­ceived Oren­cia saw a 50% rate com­pared to 32% for pa­tients who re­ceived a place­bo. How­ev­er, se­vere aGVHD-sur­vival was not sig­nif­i­cant­ly im­proved in pa­tients who re­ceived Oren­cia com­pared to place­bo.

GVHD-2, which made use of re­al world da­ta, showed a 98% over­all sur­vival rate in pa­tients who took Oren­cia on top of stan­dard of care im­muno­sup­pres­sants, com­pared to 75% for pa­tients who re­ceived stan­dard im­muno­sup­pres­sion alone six months af­ter trans­plan­ta­tion. — Nicole De­Feud­is 

Japan’s So­sei Hep­tares inks deal with Twist — to fo­cus on an­ti­body dis­cov­ery

Ear­li­er this year, Japan­ese biotech So­sei Hep­tares suf­fered a set­back when phar­ma gi­ant Ab­b­Vie backed out of a deal on So­sei’s G pro­tein-cou­pled re­cep­tors. But as of this morn­ing, So­sei has signed an­oth­er deal — this time with Twist Bio­sciences on an­ti­body dis­cov­ery against GPCR tar­gets iden­ti­fied by So­sei.

So­sei Hep­tares will bring its iso­lat­ed GPCR tar­get pro­teins to the col­lab­o­ra­tion, while Twist will lever­age its in-house an­ti­body li­braries and bioin­for­mat­ics as part of the deal, ac­cord­ing to a joint state­ment from the two biotechs.

So­sei Hep­tares will have ex­clu­sive and full glob­al rights to de­vel­op and com­mer­cial­ize any an­ti­body leads iden­ti­fied and di­rect­ed to the GPCR tar­gets in the deal. Twist will be el­i­gi­ble for an up­front pay­ment, R&D costs and fu­ture pay­ments based on pre­de­fined de­vel­op­ment mile­stones. The fi­nan­cial terms of the deal re­main undis­closed.

Twist co-founder and CEO Emi­ly Lep­roust ex­pressed op­ti­mism for the deal, and said in a state­ment ‘We are pleased to part­ner with So­sei Hep­tares.’ — Paul Schloess­er

Ox­ford AI soft­ware imag­ing firm Brain­omix clos­es Se­ries B worth $21.2M

British AI-soft­ware pre­ci­sion med­i­cine com­pa­ny Brain­omix has closed a Se­ries B round, adding $21.2 mil­lion to its cof­fers.

The funds will pay for Brain­omix’s ex­pan­sion in­to new mar­kets and new in­di­ca­tions such as lung fi­bro­sis and can­cer, the com­pa­ny said in a state­ment.

The fi­nanc­ing was co-led by ex­ist­ing in­vestors Boehringer In­gel­heim Ven­ture Fund and Park­walk Ad­vi­sors, along­side new in­vestor Ten­cent Hold­ings and par­tic­i­pa­tion from Ox­ford Uni­ver­si­ty In­no­va­tion Fund.

The com­pa­ny built an AI plat­form that au­to­mates imag­ing bio­mark­er analy­sis — which is de­signed to im­prove di­ag­no­sis and treat­ment de­ci­sions. The com­pa­ny has been fo­cused on imag­ing strokes via AI, but now Brain­omix can move be­yond stroke and de­vel­op nov­el imag­ing bio­mark­ers for bet­ter treat­ment of lung fi­bro­sis and can­cer.

‘We wel­come Ten­cent as a high­ly ex­pe­ri­enced new in­vestor and thank Park­walk and BIVF, as well as OUIF, for their con­tin­u­ing sup­port,’ said Brain­omix co-founder and CEO Michalis Pa­padakis in a pre­pared state­ment. — Paul Schloess­er

Cerev­el en­lists Herophilus for organoid-based schiz­o­phre­nia deal

Cerev­el Ther­a­peu­tics has found a new part­ner to de­vel­op neu­ropsy­chi­a­try drugs as organoid chat­ter heats up in in­vestor cir­cles.

The biotech is team­ing up with Herophilus, the com­pa­nies an­nounced Thurs­day, aim­ing to mar­ry Cerev­el’s drug R&D ca­pa­bil­i­ties with the lat­ter’s AI-en­abled deep phe­no­typ­ing. Herophilus’ plat­form us­es ‘pa­tient-de­rived brain organoids and neu­roim­mune ge­net­i­cal­ly en­gi­neered brain organoids,’ in the hopes of mak­ing an­i­mal mod­els ob­so­lete for schiz­o­phre­nia treat­ment.

‘Re­search and de­vel­op­ment for neu­ro­science dis­eases is dif­fi­cult, and schiz­o­phre­nia in par­tic­u­lar can be in­cred­i­bly chal­leng­ing to ad­dress,’ Cerev­el CSO John Renger said in a state­ment. ‘The sci­ence and cut­ting-edge ap­proach that this col­lab­o­ra­tion brings to the ta­ble has the po­ten­tial to re­veal core mech­a­nisms of schiz­o­phre­nia and dis­ease-mod­i­fy­ing ap­proach­es to treat it.’

Thurs­day’s deal comes a week af­ter Stan­ford spin­out Next­Vi­vo earned a seed round to flesh out its organoid tech­nol­o­gy. Where­as Cerev­el and Herophilus are re­search­ing schiz­o­phre­nia, Next­Vi­vo is go­ing af­ter im­mune sys­tem dis­or­ders. — Max Gel­man
https://endpts.com/orencia-approved-by-fda-for-new-indication-graft-vs-host-disease-sosei-and-twist-announce-antibody-discovery-deal/