J&J's Er­lea­da/Zyti­ga com­bo hits PhI­II end­point — but what about OS?; Tar­go­v­ax los­es prostate can­cer part­ner af­ter en­roll­ment strug­gles

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

Robert Bradway (Photographer: Scott Eisen/Bloomberg via Getty Images)

UP­DAT­ED: Am­gen snaps up can­cer drug play­er Five Prime, adding PhI­II-ready FGFR2b drug in $2B M&A play

Amgen is making a long-awaited move on the M&A side, buying South San Francisco-based Five Prime $FPRX for close to $2 billion and adding a slate of new cancer drugs to the pipeline.

Amgen is paying $38 a share, putting the deal value at $1.9 billion. The stock closed at $21.26 last night, giving investors a 78% premium.

The jewel in the crown of this deal is bemarituzumab, which Amgen describes as a first-in-class, Phase III-ready anti-FGFR2b antibody. Amgen was drawn to the bargaining table by Five Prime’s mid-stage data on gastric cancer, satisfied by PFS and OS data helping to validate FGFR2b as a target. Amgen researchers will now expand on the R&D program in other epithelial cancers, including lung, breast, ovarian and other cancers.

Endpoints News

Keep reading Endpoints with a free subscription

Unlock this story instantly and join 102,700+ biopharma pros reading Endpoints daily — and it's free.

David Liu (Casey Atkins Photography courtesy Broad Institute)

David Liu has a new big idea: pro­teome edit­ing. It could one day shred tau, RAS and some of the worst dis­ease-caus­ing pro­teins

Before David Liu became famous for inventing new forms of gene editing, he was known around academia in part for a more obscure innovation: a Rube Goldberg-esque system that uses bacteria-infecting viruses to take one protein and turn it into another.

Since 2011, Liu’s lab has used the system, called PACE, to dream up fantastical new proteins: DNA base editors far more powerful than the original; more versatile forms of the gene editor Cas9; insecticides that kill insecticide-resistant bugs; enzymes that slide synthetic amino acids into living organisms. But they struggled throughout to master one of the most common and powerful proteins in the biological world: proteases, a set of Swiss army knife enzymes that cut, cleave or shred other proteins in everything from viruses to humans.

Endpoints Premium

Premium subscription required

Unlock this article along with other benefits by subscribing to one of our paid plans.

The 2021 top 100 bio­phar­ma in­vestors: As the pan­dem­ic hit and IPOs boomed, VCs swung in­to ac­tion like nev­er be­fore

The global pandemic may have roiled economies, killed hundreds of thousands and throttled entire industries, but the only effect it had on biopharma venture investing was to help turbocharge the field to giddy new heights.

Below you’ll find the new top 100 venture investors in the industry, ranked by the number of deals they were publicly involved in, as tracked by DealForma chief Chris Dokomajilar. The numbers master then calculated the estimated amount of money they put into each deal — divvying up the cash by the number of players — to indicate how they managed their syndicates.

Endpoints Premium

Premium subscription required

Unlock this article along with other benefits by subscribing to one of our paid plans.

Gala­pa­gos posts a safe­ty win for fil­go­tinib, but is it too lit­tle, too late?; Bio-Techne inks $320M mol­e­c­u­lar di­ag­nos­tics buy­out

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.

In the lat­est big in­vest­ment in gene ther­a­py man­u­fac­tur­ing, Bio­gen com­mits $200M to a ma­jor new fa­cil­i­ty in NC

You’d be forgiven for thinking that the only R&D effort of any consequence at Biogen belongs to aducanumab, its controversial Alzheimer’s drug. But behind the uproar around that drug, the big biotech has a full scale pipeline in play that includes a growing focus on developing gene therapies.

Now Biogen plans to build up the kind of manufacturing muscle that will give it an advantage in gaining FDA approvals — where CMC is always key — and then marketing them around the world.

Endpoints News

Keep reading Endpoints with a free subscription

Unlock this story instantly and join 102,700+ biopharma pros reading Endpoints daily — and it's free.

Eli Lil­ly claims a TKO in its long-run­ning ti­tle fight with No­vo Nordisk for the block­buster di­a­betes mar­ket — but there’s a hitch

Eli Lilly isn’t just gunning for a better diabetes drug in tirzepatide. They want to cut ahead of Novo Nordisk’s blockbuster rival Ozempic (semaglutide) on the obesity front as well. But a newly-claimed win in a head-to-head Phase III showdown over reducing A1C while shedding pounds — complete with clear evidence of superiority over the approved rival — could prove a tough sell right now.

Let’s start with the latest data from Lilly.

Endpoints News

Keep reading Endpoints with a free subscription

Unlock this story instantly and join 102,700+ biopharma pros reading Endpoints daily — and it's free.

In­tro­duc­ing End­points FDA+, our new pre­mi­um week­ly reg­u­la­to­ry news re­port led by Zachary Bren­nan

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.

UP­DAT­ED: Mer­ck pulls Keytru­da in SCLC af­ter ac­cel­er­at­ed nod. Is the FDA get­ting tough on drug­mak­ers that don't hit their marks?

In what could be an early shot in the battle against drugmakers that whiff on confirmatory studies to support accelerated approvals, the FDA ordered Bristol Myers Squibb late last year to give up Opdivo’s approval in SCLC. Now, Merck is next on the firing line — are we seeing the FDA buckling down on post-marketing offenders?

Merck has withdrawn its marketing approval for PD-(L)1 inhibitor Keytruda in metastatic small cell lung cancer as part of what it describes as an “industry-wide evaluation” by the FDA of drugs that do not meet the post-marketing checkpoints on which their accelerated nods were based, the company said Monday.

Endpoints News

Keep reading Endpoints with a free subscription

Unlock this story instantly and join 102,700+ biopharma pros reading Endpoints daily — and it's free.

Hal Barron, Endpoints UKBIO19

GSK, Vir's hopes for a Covid-19 an­ti­body fall flat in NIH 'mas­ter pro­to­col' with no ben­e­fit in hos­pi­tal­ized pa­tients

GlaxoSmithKline and Vir Biotechnology were hopeful that one of their partnered antibodies would carve out a win after getting the invite to a major NIH study in hospitalized Covid-19 patients. But just like Eli Lilly, the pair’s drug couldn’t hit the mark, and now they’ll be left to take a hard look at the game plan.

The NIH has shut down enrollment for GSK and Vir’s antibody VIR-7831 in its late-stage ACTIV-3 trial after the drug showed negligible effect in achieving sustained recovery in hospitalized Covid-19 patients, the partners said Wednesday.

Endpoints News

Keep reading Endpoints with a free subscription

Unlock this story instantly and join 102,700+ biopharma pros reading Endpoints daily — and it's free.