UPDATED: Xencor says goodbye to its former lead drug, selling all rights to Lonnie Moulder’s new startup

Lonnie Moulder (L) and Hua Mu

More than three years af­ter its lead pro­gram failed a Phase II study, Xen­cor is pass­ing off the drug to an up-and-com­ing Hong Kong biotech.

Xen­cor sold ex­clu­sive world­wide rights for obex­e­limab, a bis­pe­cif­ic tar­get­ing FcγRI­Ib and CD19 to treat au­toim­mune dis­eases, to Lon­nie Moul­der’s Zenas Bio­Phar­ma, the com­pa­nies an­nounced Sun­day evening. In ex­change, Xen­cor gets a slice of eq­ui­ty equal­ing 15% of Zenas’ shares fol­low­ing its next fi­nanc­ing round, up to $480 mil­lion in mile­stones and roy­al­ties. In a state­ment, Xen­cor CEO Bassil Dahiy­at said the deal al­lows the biotech to fo­cus more on oth­er pro­grams with­in its ‘bis­pe­cif­ic an­ti­body and cy­tokine pipeline,’ though he did not pro­vide more specifics.

Re­gard­less, Xen­cor once had high hopes for obex­e­limab. It was the com­pa­ny’s lead in-house pro­gram back in the mid-2010s, with Xen­cor hold­ing on­to rights even while sign­ing multi­bil­lion deals with phar­ma pow­er­house No­var­tis.

Sun­day’s news comes a lit­tle over a week af­ter an­oth­er set­back in the No­var­tis deal, as the Swiss phar­ma hand­ed back most of its rights to an­oth­er bis­pe­cif­ic at the cen­ter­piece of that col­lab­o­ra­tion, though it re­mains on­go­ing.

Xen­cor had hoped this can­di­date could prove dif­fer­ent from pre­vi­ous au­toim­mune ther­a­pies, tout­ing its abil­i­ty to tar­get B cell ac­ti­va­tion with­out de­plet­ing them. Obex­e­limab, though, missed the pri­ma­ry end­point in a Phase II lu­pus study in Oc­to­ber 2018, as re­searchers did not see a sta­tis­ti­cal­ly sig­nif­i­cant dif­fer­ence be­tween the place­bo and treat­ment arms in con­tin­ued im­prove­ment af­ter 225 days.

De­spite the miss, the biotech has tried to high­light the ‘pos­i­tive treat­ment ef­fect’ it saw in the study and, at the time, said it would ei­ther launch a Phase III study or find a part­ner for the pro­gram. Xen­cor is now hand­ing off the drug, how­ev­er, em­pha­siz­ing Sun­day that Zenas will have ‘sole re­spon­si­bil­i­ty’ for all R&D and com­mer­cial­iza­tion ac­tiv­i­ties.

Mean­while, the pro­gram is Zenas’ first to un­der­go any clin­i­cal stud­ies af­ter the com­pa­ny launched ear­li­er this year. Moul­der got the biotech start­ed in March with sev­en pre­clin­i­cal pro­grams, leap­ing back in­to biotech af­ter steer­ing MGI Phar­ma to a $4 bil­lion sale in 2007 to Ei­sai and Tesaro to a $5 bil­lion buy­out with Glax­o­SmithK­line in 2018.

So far, Zenas has fo­cused large­ly on au­toim­mune and rare dis­ease can­di­dates, in­clud­ing a lead drug with Chi­na rights in thy­roid eye dis­ease. It orig­i­nal­ly came from Im­muno­gen and changed hands mul­ti­ple times. There are al­so three oth­er mon­o­clon­al an­ti­bod­ies in an old­er Xen­cor deal, in which the lat­ter pre­vi­ous­ly re­ceived a slice of eq­ui­ty.

Though Moul­der helped get Zenas’ feet off the ground, he soon hand­ed the CEO role to Hua Mu. The two de­vel­oped a work­ing re­la­tion­ship while Moul­der was get­ting Tesaro run­ning and Mu served as the CMO of HutchMed.

It’s not yet clear where Zenas will aim to specif­i­cal­ly de­vel­op its new as­set, with Mu say­ing on­ly in a press re­lease it has the ‘po­ten­tial to treat nu­mer­ous au­toim­mune dis­eases.’ In a fol­low-up re­quest for com­ment, com­pa­ny spokesper­son Lau­ren Bartlett told End­points News Zenas is not cur­rent­ly dis­clos­ing any par­tic­u­lars about dis­ease ar­eas.

This ar­ti­cle has been up­dat­ed to in­clude com­ment from Zenas’ spokesper­son Lau­ren Bartlett. 

Joan Perelló, Sanifit CEO

Joan Perelló beat all the odds with his little Spanish biotech startup Sanifit.

Working on the far perimeter of the big US/European drug development scene, he took a drug born out of his PhD work and got enough seed cash to get started. That’s one near miracle. In the second near miracle he gathered a previously unheard of venture raise in Spain — helping build an industry ecosystem from scratch — to pursue a successful search for solid human data for his drug, SNF472. And while gathering a virtual team of developers from Europe and the US, the CEO/co-founder steered it into the late-stage arena.

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Most people know if they’re ‘Team Pfizer’ or ‘Team Moderna,’ but few know if they got the Comirnaty or Spikevax Covid-19 vaccine. Those are the brand names of Pfizer and Moderna vaccines, respectively, however they have yet to take hold with consumers, media or even medical professionals.

And there are others. Covid vaccine brand names also include AstraZeneca’s Vaxzevria, Novovax’s Nuvaxovid, and Sanofi and GlaxoSmithKline’s Vidprevtyn. J&J’s Janssen-developed Covid vaccine is the lone major holdout and is still yet to be named, if ever. In EMA filings approving its conditional use, the brand name is listed simply as ‘Covid-19 Vaccine Janssen.’

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Emily Leproust, Twist CEO

Twist Bioscience has come a long way since dipping its toes into the antibody discovery space a couple years ago, spinning out its first company just last week to take a Covid-19 antibody into the clinic. There’s plenty more where that came from, CEO Emily Leproust says — and she thinks a small biotech’s mice are the key to getting there.

Leproust is putting down up to $10 million in cash and another $140 million in stock to buy out Massachusetts-based Abveris (formally known as AbX Biologics) and its family of hyperimmune mouse models, she announced on Monday morning. If Abveris hits an internal revenue target next year, it’s eligible for up to another $40 million in Twist shares.

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We are wrapping up this year’s special report on 20 trailblazing women in biopharma R&D, and can’t be more excited to share their stories on December 7, both through the written profiles and a live event, followed by a panel on gender issues moderated by Nicole DeFeudis and myself. Learn more and sign up here.

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Ugur Sahin (L) and Özlem Türeci (Bernd von Jutrczenka/picture-alliance/dpa/AP Images)

Pfizer and BioNTech are planning to file for full approval of their Covid-19 vaccine for all of those over the age of 12 after they said longer-term analysis of the vaccine in teens continued to show strong protection against symptomatic cases of Covid-19 more than four months after the second dose.

With no serious safety concerns at least 6 months after the second dose for those ages 12 through 15, the companies said the data will form the basis for a planned upgrade from EUA to supplemental Biologics License Application (sBLA).

Now that the PD-(L)1 craze has (largely) swept through China, resulting in the approval of more than a dozen drugs with more to come, two of the top domestic oncology players are teaming up to go after the other checkpoint target.

Hengrui is licensing exclusive China rights to CStone’s CTLA-4 inhibitor, CS1002, in a deal worth up to $200 million, which covers research, development, registration, manufacturing and commercialization.

GlaxoSmithKline’s newest TV ads for Trelegy (screenshot above) embrace the realities of living with COPD.

When GlaxoSmithKline launched its first campaign for three-drug combo Trelegy inhaler, it used a catchy ‘1-2-3’ pop song. A customized version of a 1970s Jackson Five hit, GSK’s custom lyrics repeated the power of ‘Trelegy 1-2-3’ throughout a series of four TV ads that first debuted in 2018.

The strategy made sense. As the first three-in-one COPD drug, the upbeat song reinforced the product message. And it worked. Trelegy awareness soared, and the campaign climbed the ranks to GSK’s best performing respiratory ad. GSK employees were humming the ad in the hallways and Trelegy sales began climbing.

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Douglas Fambrough, Dicerna CEO (Dicerna via YouTube)

Early this year researchers at Novo Nordisk were beaming as they announced the first drug identified in their RNAi alliance with Dicerna was headed into the clinic. And now they’re coming back for the whole thing.

This morning the Copenhagen-based pharma giant put out word that it is buying Dicerna $DRNA — an RNAi pioneer that has had its up and downs over the years — for $3.3 billion. Novo is paying $38.25 a share — an 80% premium.

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Gilead is going all in — hook, line and sinker — on its oncology alliance with Arcus. And they are going for broke.

The big biotech unveiled a deal that now delivers $725 million in opt-in payments covering the clinical development programs for Arcus, ranging from their closely watched anti-TIGIT programs for domvanalimab and AB308 to etrumadenant (the A2a/A2b adenosine receptor antagonist) and quemliclustat, the small molecule CD73 inhibitor. Gilead will also cover half of the development costs, handing Terry Rosen’s biotech a deal that gives them a clear cash runway to achieving all its goals in oncology.

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https://endpts.com/xencor-says-goodbye-to-its-former-lead-drug-selling-all-rights-to-lonnie-moulders-new-startup/