Lonnie Moulder (L) and Hua Mu

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

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.

Bassil Dahiy­at

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. 

Op­ti­miz­ing Cell and Gene Ther­a­py De­vel­op­ment and Pro­duc­tion: How Tech­nol­o­gy Providers Like Corn­ing Life Sci­ences are Spurring In­no­va­tion

Remarkable advances in cell and gene therapy over the last decade offer unprecedented therapeutic promise and bring new hope for many patients facing diseases once thought incurable. However, for cell and gene therapies to reach their full potential, researchers, manufacturers, life science companies, and academics will need to work together to solve the significant challenges facing the industry.

David Baker working with a student on their protein design (Jason Mast)

Sci­en­tists are fi­nal­ly learn­ing how to de­sign pro­teins from scratch. Drug de­vel­op­ment may nev­er be the same

SEATTLE — It’s a cloudy Thursday afternoon in mid-July and David Baker is reclining into the futon in his corner office at the University of Washington, arms splayed out like a daytime talk show host as he coaches another one of his postdocs through the slings and arrows of scientific celebrity.

“Be jealous of your time,” he says, before plotting ways of sneaking her out of Zooms. “It’s this horrible cost to science that you’re tied up in some stupid meeting.”

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Pre­sent­ing a live End­points News event: Man­ag­ing a biotech in tur­bu­lent times

Biotech is one of the smartest, best educated industries on the planet. PhDs abound. We’ve had a long enough track record to see a new generation of savvy, experienced execs coming together to run startups.

And in these times, they are being tested as never before.

Biotech is going through quite a rough patch right now. For 2 years, practically anyone with a decent resume and some half-baked ideas on biotech could start a company and get it funded. The pandemic made it easy in many ways to pull off an IPO, with traditional road shows shut down in exchange for a series of quick Zoom meetings. Generalist investors flocked as the numbers raised soared into the stratosphere.

Patty Murray, D-WA (Graeme Sloan/Sipa USA)(Sipa via AP Images)

Sen­ate user fee reau­tho­riza­tion bill omits ac­cel­er­at­ed ap­proval re­forms, shows wide gaps with House ver­sion

The Senate health committee on Tuesday released its first version of the bill to reauthorize all the different FDA user fees. But unlike the House version, there are only a few controversial items in the Senate’s version, which does not address either accelerated approval reforms or clinical trial diversity (as the House did).

While it’s still relatively early in the process of finalizing this legislation (the ultimate statutory deadline is the end of September), the House and Senate, at least initially, appear to be starting off in different corners on what should be included.

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Warren Buffett, Berkshire Hathaway CEO

Berk­shire Hath­away pulls out of Ab­b­Vie, Bris­tol My­ers Squibb in­vest­ments

It looks like Warren Buffett is sticking to ice cream and railroads for the moment.

The billionaire CEO of Berkshire Hathaway backed out of two major holdings in the pharma industry, Forexlive first reported, including a $410 million investment in AbbVie and a $324.4 million stake in Bristol Myers Squibb.

The move comes after Berkshire abandoned its Teva shares just last quarter, Bloomberg reported.

Clay Siegall (Photo by Dimitrios Kambouris/Getty Images for Gabrielle's Angel Foundation)

UP­DAT­ED: Clay Sie­gall re­signs from Seagen amid in­ves­ti­ga­tion in­to do­mes­tic vi­o­lence claims

A week after Seagen revealed that longtime CEO Clay Siegall was on leave due to an allegation of domestic violence, he has resigned.

Since that shocking revelation, more details about the claims have emerged into the public eye. As Endpoints News reported, Siegall was arrested on April 23. A police report about that night and a subsequent temporary restraining order described a pattern of abusive behavior against his wife and a physical altercation that left her with multiple bruises. Siegall denied the claims.

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Long-ex­pect­ed UK lay­offs im­mi­nent for No­var­tis fol­low­ing sale

Nearly a year ago, more than 200 workers at Novartis’ Grimsby, UK, facility were able to hang on to their jobs after the pharma closed a Switzerland site as a part of its workforce restructuring plan. Now, it looks like those employees’ time is up, as the site has been sold, Grimsby Telegraph reported today.

The manufacturing site has been sold to Humber Industrials, a subsidiary of International Process Plants. None of the current staff members will be working with the new owners, however.

FDA lob­bies Con­gress over rare dis­ease court rul­ing with wide im­pli­ca­tions

Usually reserved for making decisions on drug applications or enforcing what Congress stipulates, the FDA is now dipping its toe into the wild world of congressional politics as it attempts to fix a major court decision that could have a chilling effect on rare disease R&D.

The case in question from last October saw a US appeals court overturn a prior FDA court win, saying that the agency never should’ve approved a rare disease drug because a previously approved but more expensive drug with the same active ingredient has orphan drug exclusivity barring such an approval.

Peter Marks (Greg Nash/Pool via AP)

Even FDA's Pe­ter Marks is wor­ried about the com­mer­cial vi­a­bil­i­ty of gene and cell ther­a­pies

When bluebird bio’s gene therapy to treat beta thalassemia won European approval in 2019, the nearly $2 million per patient price tag for the potential cure seemed like a surmountable hurdle.

Fast forward two years later, and bluebird has withdrawn Zynteglo, the beta thal drug, along with the rest of its gene therapy portfolio from Europe, which the company said is generally unwilling to pay a fair price for the treatment.