Biospecimen M&A: Discovery acquires Albert Li’s hepatocyte project; PhIII trial on Bayer’s Nubeqa reached primary endpoint

Dis­cov­ery Life Sci­ences has ac­quired what claims to be the Mary­land-based host of the world’s largest he­pa­to­cyte in­ven­to­ry, known as IVAL, to help re­searchers se­lect more ef­fec­tive and safer drug can­di­dates in the fu­ture.

The com­bined com­pa­nies will now serve a wider range of drug re­search and de­vel­op­ment sci­en­tists, ac­cord­ing to Al­bert Li, who found­ed IVAL in 2004 and is set to join the Dis­cov­ery lead­er­ship team as the CSO of phar­ma­col­o­gy and tox­i­col­o­gy. Li has spent his ca­reer with IVAL sup­port­ing the sub­mis­sions and ap­provals of sev­er­al break­through ther­a­pies, carv­ing out a spe­cial­ty in the iso­la­tion, cry­op­reser­va­tion, and cul­tur­ing of hu­man he­pa­to­cytes and the ap­pli­ca­tion of hu­man he­pa­to­cytes to eval­u­ate drug me­tab­o­lism, drug-drug in­ter­ac­tions, and drug tox­i­c­i­ty.

‘I am grate­ful to my IVAL team mem­bers who have en­trust­ed me with their ca­reers and are in­stru­men­tal to our achieve­ments. I look for­ward to be part of the won­der­ful and tal­ent­ed DLS fam­i­ly,’ Li said in a LinkedIn post.

The com­pa­nies did not of­fer a dol­lar fig­ure on the ac­qui­si­tion.

The ac­qui­si­tion is Dis­cov­ery’s ninth in less than four years. In May, it ac­quired Tar­gos Mol­e­c­u­lar Pathol­o­gy GmbH out of Ger­many, to up its glob­al tis­sue bio­mark­er ser­vices. Be­fore that, it picked up San­ta Bar­bara, CA-based Qual­Tek, an im­muno­his­to­chem­istry provider. In March 2020, it an­nounced a sig­nif­i­cant ex­pan­sion of its cell bi­ol­o­gy and im­munol­o­gy ser­vices lab­o­ra­to­ry to speed up the de­vel­op­ment of cell ther­a­pies and im­munother­a­pies. — Josh Sul­li­van

Nube­qa reach­es pri­ma­ry end­point in PhI­II tri­al on new in­di­ca­tion for prostate can­cer

Bay­er’s prostate can­cer drug Nube­qa reached its pri­ma­ry end­point in a Phase III tri­al on a type of prostate can­cer, the com­pa­ny an­nounced ear­ly this morn­ing.

The Phase III Arasens tri­al, in­ves­ti­gat­ing what is al­so known as daro­lu­tamide on metasta­t­ic hor­mone-sen­si­tive prostate can­cer (mH­SPC), showed that the drug in com­bi­na­tion with chemother­a­py do­c­etax­el and an­dro­gen de­pri­va­tion ther­a­py (ADT) sig­nif­i­cant­ly in­creased over­all sur­vival rate, com­pared to do­c­etax­el and ADT by them­selves.

Nube­qa is cur­rent­ly in­di­cat­ed for the treat­ment of pa­tients with non-metasta­t­ic cas­tra­tion-re­sis­tant prostate can­cer (nm­CR­PC).

‘We are es­pe­cial­ly grate­ful to the pa­tients and in­ves­ti­ga­tors for par­tic­i­pat­ing in this im­por­tant tri­al and look for­ward to pre­sent­ing the full re­sults at an up­com­ing meet­ing,’ said Bay­er SVP and head phar­ma­ceu­ti­cal on­col­o­gy de­vel­op­ment Scott Fields.

In a state­ment, Bay­er said they plan to dis­cuss the da­ta from the tri­al with health au­thor­i­ties re­gard­ing the sub­mis­sion of Nube­qa for mar­ket­ing au­tho­riza­tion in this in­di­ca­tion. No time­line was giv­en. — Paul Schloess­er

BeiGene and part­ner get Syl­vant ap­proved for mul­ti­cen­tric Castle­man dis­ease (MCD) in Chi­na

BeiGene and col­lab­o­ra­tor EU­SA Phar­ma an­nounced last night that Chi­na’s NM­PA ap­proved mon­o­clon­al an­ti­body treat­ment Syl­vant to treat adult pa­tients with mul­ti­cen­tric Castle­man dis­ease (MCD) who are both HIV-neg­a­tive and neg­a­tive for her­pes — which is al­so known as id­io­path­ic MCD (iM­CD).

This fol­lows pre­vi­ous ap­proval in the US and the EU.

‘To­day’s ap­proval pro­vides a new treat­ment for pa­tients in Chi­na with this rare sys­temic dis­or­der,’ com­ment­ed Xi­aobin Wu, pres­i­dent, COO, and gen­er­al man­ag­er of Chi­na at BeiGene. ‘This ap­proval is our sec­ond prod­uct in our col­lab­o­ra­tion with EU­SA. We look for­ward to launch­ing sil­tux­imab in 2022 and to help­ing pa­tients with iM­CD in Chi­na.’

The ap­proval of sil­tux­imab for the treat­ment of iM­CD was sup­port­ed by clin­i­cal re­sults from a multi­na­tion­al, ran­dom­ized, dou­ble blind and place­bo-con­trolled Phase II tri­al con­duct­ed in 79 pa­tients from 19 coun­tries and re­gions. — Paul Schloess­er
https://endpts.com/biospecimen-m-phiii-trial-on-bayers-nubeqa-reached-primary-endpoint/