J&J says a com­bi­na­tion of Er­lea­da and Zyti­ga, two of its big prostate can­cer drugs, has met the pri­ma­ry end­point of ra­di­ograph­ic pro­gres­sion-free sur­vival in a Phase III study — but fell short of help­ing pa­tients live longer.

Specif­i­cal­ly, the ACIS study re­cruit­ed pa­tients with chemother­a­py-naïve metasta­t­ic cas­tra­tion-re­sis­tant prostate can­cer re­ceiv­ing an­dro­gen de­pri­va­tion ther­a­py. In­ves­ti­ga­tors found that adding Er­lea­da to a reg­i­men of Zyti­ga plus pred­nisone ex­tend­ed me­di­an rPFS by 6 months (22.6 ver­sus 16.6 months).

At a me­di­an fol­low-up of 54.8 months, J&J re­port­ed at AS­CO GU, they ob­served a 30% re­duc­tion in the risk of ra­di­ograph­ic pro­gres­sion or death.

When it comes to the sec­ondary end­points, though, no sta­tis­ti­cal­ly sig­nif­i­cant dif­fer­ence be­tween treat­ment arms was demon­strat­ed, ei­ther on OS, time to ini­ti­a­tion of cy­to­tox­ic chemother­a­py, chron­ic opi­oid use or pain pro­gres­sion.

For its part, J&J not­ed that among the het­ero­ge­neous over­all pop­u­la­tion, cer­tain co­horts — in­clud­ing pa­tients aged 75 or old­er, those with vis­cer­al metas­ta­sis, lu­mi­nal type in PAM50 test and tu­mors with av­er­age or high AR ac­tiv­i­ty — had bet­ter rPFS and bet­ter OS re­sults, sug­gest­ing they may de­rive clin­i­cal ben­e­fit from the new com­bo.

“In­sights from the ACIS study re­gard­ing dif­fer­ences in ben­e­fit for spe­cif­ic pa­tient sub­groups treat­ed with the com­bi­na­tion war­rant ad­di­tion­al eval­u­a­tion,” Dana Rathkopf, prin­ci­pal in­ves­ti­ga­tor and a med­ical on­col­o­gist at Memo­r­i­al Sloan Ket­ter­ing, said in a state­ment. — Am­ber Tong

Tar­go­v­ax los­es prostate can­cer part­ner af­ter en­roll­ment strug­gles

Nor­we­gian biotech Tar­go­v­ax said Tues­day that its part­ner on a prostate can­cer pro­gram has dropped out of the col­lab­o­ra­tion.

The Czech biotech com­pa­ny So­tio had been run­ning a Phase I safe­ty study for ON­COS-102 to see if it could en­hance the ef­fi­ca­cy of its den­drit­ic cell vac­cine. How­ev­er, due to the strict in­clu­sion cri­te­ria in the study and chal­lenges re­lat­ed to the Covid-19 pan­dem­ic, the duo was not able to com­plete en­roll­ment.

As such, So­tio de­cid­ed to walk away from the part­ner­ship. On­ly four pa­tients end­ed up en­rolling, and Tar­go­v­ax said the de­ci­sion will not im­pact fur­ther de­vel­op­ment of ON­COS-102.

Tar­go­v­ax is al­so re­search­ing the pro­gram’s use in treat­ing melanoma and mesothe­lioma. In da­ta re­leased last No­vem­ber, the com­pa­ny said an 18-month analy­sis showed that me­di­an over­all sur­vival was at least 18.2 months for first-line mesothe­lioma pa­tients re­ceiv­ing the drug plus chemother­a­py. That com­pared to 14.2 months or less for the con­trol group. — Max Gel­man

WuXi backs $56M launch round of trans-Pa­cif­ic biotech

Transpa­cif­ic biotech start­up Drug Farm is launch­ing with $56 mil­lion, a fo­cus on he­pati­tis B virus, and promis­es to un­cloak new tar­gets and path­ways in in­nate im­mu­ni­ty.

Du­al­ly based in Shang­hai and Guil­ford, CT, the com­pa­ny says its tech plat­form al­lows it to gen­er­ate and di­rect­ly as­sess ge­net­ic mu­ta­tions in liv­ing an­i­mals with in­tact im­mune sys­tems. The AI-di­rect­ed med­i­c­i­nal chem­istry then points them to first-in-class small mol­e­cule im­mune-mod­u­lat­ing can­di­dates, added Tian Xu, founder and chair­man.

Out­side of its lead drug, DF-006, which is al­so be­ing po­si­tioned for oth­er liv­er dis­eases, Drug Farm has al­so set its sights on au­toim­mune dis­eases and can­cer.

BioVe­da Chi­na Fund, WuXi AppTec’s cor­po­rate ven­ture fund, South Chi­na Ven­ture Cap­i­tal, Detong Cap­i­tal and Zhe­jiang Unit­ed In­vest­ment Group in­vest­ed in the round. — Am­ber Tong

Cam­bridge ex­pan­sion gets the OK for £65 mil­lion project

The Cam­bridge Bio­med­ical Cam­pus, the largest cen­ter of med­ical re­search and health sci­ence in Eu­rope, has been giv­en the green light on a £65 mil­lion ex­pan­sion project.

Cam­bridge an­nounced the plans last Fri­day, not­ing that this is part of a mas­sive ex­pan­sion planned to in­crease the to­tal area of the cam­pus by 400,000 square feet. Fri­day’s project specif­i­cal­ly will pro­vide 103,000 square feet of lab­o­ra­to­ry and of­fice space in a five-sto­ry build­ing.

The go-ahead was grant­ed to de­vel­op­ers Lib­er­ty Prop­er­ty Trust and Coun­try­side Prop­er­ties, who had been in charge of the pre­vi­ous ren­o­va­tions as well.

“The new de­vel­op­ment will be the lat­est build­ing on the bio­med­ical cam­pus which has seen ex­tra­or­di­nary growth with the de­liv­ery of over 1.7 mil­lion square feet of new space for oc­cu­piers in less than 10 years,” Lib­er­ty man­ag­ing di­rec­tor An­drew Blevins said in a state­ment. — Max Gel­man

Hen­grui bets $20M on fel­low Chi­nese biotech and its PI3kδ in­hibitor

Af­ter vault­ing it­self to the ranks of glob­al bio­phar­ma, Hen­grui Med­i­cine is scout­ing the lo­cal biotech scene for new as­sets.

Its lat­est bet is on fel­low Shang­hai biotech Yingli Phar­ma, which is scor­ing a $20 mil­lion eq­ui­ty in­vest­ment in ex­change for joint de­vel­op­ment and com­mer­cial­iza­tion rights for its PI3kδ in­hibitor in Chi­na.

“This col­lab­o­ra­tion will fur­ther en­rich the lay­out of Hen­grui Med­i­cine in the field of hema­to­log­i­cal tu­mor and on­col­o­gy and sup­ple­ment the ex­ist­ing prod­uct line,” Zhang Lian­shan, se­nior deputy gen­er­al man­ag­er and pres­i­dent of glob­al R&D of Hen­grui Med­i­cine, said.

Like a num­ber of peers in its gen­er­a­tion, Yingli has a lofty vi­sion to go glob­al with its small mol­e­cule drug re­search, eye­ing both can­cer and kid­ney-re­lat­ed meta­bol­ic dis­eases. — Am­ber Tong

Once a promising $725 million play in immunology, Gilead’s big bet on filgotinib effectively disintegrated in December when the drugmaker reworked its partnership with Galapagos. Now, Galapagos is sporting safety data that will come as a relief — but will it make a difference on filgotinib’s chances in the US?

In a study designed to compare filgotinib’s effect on sperm count with placebo, Galapagos’ JAK inhibitor saw fewer patients post a 50% or more reduction in sperm concentration after 13 weeks of treatment, according to data from the MANTA and MANTA-RAy studies unveiled Thursday.

CRLs. 483s. CBER, CDER and RWE. For biopharma professionals, these acronyms command attention because of the fundamental role FDA plays in drug development. Now Endpoints is doubling down on regulatory coverage, and launching a weekly report focusing on developments out of White Oak, with analysis and insight into what it all means.

Coverage will be led by our new senior editor, Zachary Brennan. He joins Endpoints from POLITICO, where he covered pharma. Prior to that he was the managing editor for Regulatory Focus, a news publication from the Regulatory Affairs Professionals Society.