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. 

At the In­flec­tion Point for the Next Gen­er­a­tion of Can­cer Im­munother­a­py

While oncology researchers have long pursued the potential of cellular immunotherapies for the treatment of cancer, it was unclear whether these therapies would ever reach patients due to the complexity of manufacturing and costs of development. Fortunately, the recent successful development and regulatory approval of chimeric antigen receptor-engineered T (CAR-T) cells have demonstrated the significant benefit of these therapies to patients.

Stéphane Bancel, Moderna CEO

'This is not go­ing to be good': Mod­er­na CEO Ban­cel warns of a 'ma­te­r­i­al drop' in vac­cine ef­fi­ca­cy as Omi­cron spreads

Even as public health officials remain guarded about their comments on the likelihood Omicron will escape the reach of the currently approved Covid-19 vaccines, there’s growing scientific consensus that we’re facing a variant that threatens to overwhelm the vaccine barricades that have been erected.

Stéphane Bancel, the CEO of Moderna, one of the leading mRNA players whose quick vault into the markets with a highly effective vaccine created an instant multibillion-dollar market, added his voice to the rising chorus early Tuesday. According to Bancel, there will be a significant drop in efficacy when the average immune system is confronted by Omicron. The only question now is: How much?

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With on­ly burns to show in gene ther­a­py, Astel­las inks deal with AAV spe­cial­ist Dyno in push for a bet­ter cap­sid

On the hunt for a better AAV capsid for gene therapy, Eric Kelsic’s Dyno Therapeutics has set itself apart with its focus on machine learning to help speed discovery. Now, Japanese drugmaker Astellas — fresh off a slate of gene therapy burns — is taking a bet on Dyno as it looks to the future.

Astellas and Dyno will work together as part of an R&D pact to develop next-gen AAV vectors for gene therapy using Dyno’s CapsidMap platform directed at skeletal and cardiac muscle, the companies said Wednesday. Under the terms of the deal, Dyno will design AAV capsids for gene therapy, while Astellas will be responsible for conducting preclinical, clinical and commercialization activities for gene therapy product candidates using the capsids.

Philip Dormitzer, new GSK global head of vaccines R&D

Glax­o­SmithK­line poach­es Pfiz­er's vi­ral vac­cines lead in rush to cap­i­tal­ize on fu­ture of mR­NA

GlaxoSmithKline has appointed Philip Dormitzer, formerly chief scientific officer of Pfizer’s viral vaccines unit, as its newest global head of vaccines R&D, looking to leverage one of the leading minds behind Pfizer and BioNTech’s RNA collaboration that led to Covid-19 jab Comirnaty, the British drug giant said Tuesday.

Dormitzer had been with Pfizer for a little more than six years, joining up after a seven-year stint with Novartis, where he reached the role of US head of research and head of global virology for the company’s vaccines and diagnostics unit.

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In­tro­duc­ing End­points Stu­dio, a new way to ad­ver­tise with End­points-craft­ed brand­ing cam­paigns

Since our start in 2016, Endpoints has grown fast while executing our mission to cover biopharma’s most critical developments for industry pros worldwide. As readership has grown, our advertising business has too. Endpoints advertising partners support the mission and engage their desired audiences through announcements on our email and web platforms, brand recognition in our event coverage and sponsorships of Endpoints daily and weekly reports.

Paul Hudson, Sanofi CEO (Cyril Marcilhacy/Bloomberg via Getty Images)

Sanofi snaps up new vac­cine can­di­date and de­vis­es mR­NA game plan around it — but not for what you think

Paul Hudson has spotlighted vaccines, immunology and dermatology as some of the top R&D focuses at Sanofi. His latest deal brings all of them together.

The French pharma giant isn’t sharing any financial details about the buyout of Origimm, a low-profile, private Austrian biotech whose technology promises to identify antigens causing skin disease and build vaccines against them. Their lead candidate targets acne vulgaris.

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As first Omi­cron case in US crops up, re­searchers won­der: which an­ti­bod­ies, vac­cines will hold up?

As Covid-19 drug and vaccine developers race to figure out which of their products might be hampered by the new variant, the CDC on Wednesday afternoon announced the first confirmed case of the Omicron variant (B.1.1.529) in the US, found in San Francisco.

The unidentified individual was a traveler who returned from South Africa on Nov. 22, 2021, was fully vaccinated, and had mild symptoms that the CDC described as improving. All close contacts have been contacted and have tested negative, the centers said.

Mod­er­na los­es lat­est bat­tle in key vac­cine de­liv­ery patent fight as fed­er­al ap­peal falls flat

The US Court of Appeals for the Federal Circuit on Wednesday rejected Moderna’s attempt to overturn key patents related to the delivery vehicle for its Covid-19 vaccine after the biotech sought to preempt a potentially risky infringement lawsuit.

For years, Moderna has been battling a tiny Pennsylvania biotech known as Arbutus over patents for a technology required to deliver its mRNA drugs and vaccines, known as lipid nanoparticles or LNP. Moderna is concerned there’s a substantial risk that Arbutus will assert the ’069 patent in an infringement suit targeting Moderna’s Covid-19 vaccine, particularly as Arbutus has boasted of its patent protection and refused to grant a covenant not to sue Moderna.

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Lan Huang, BeyondSpring CEO

Months af­ter shock­ing in­vestors with lung can­cer win, Be­yond­Spring's lead drug hits road­block at the FDA

BeyondSpring shocked investors in early August after its once-marginal lead drug suddenly showed a lot of promise in a common form of lung cancer. With hopes high, the FDA has now slammed the door on that drug in another indication — does that spell bad news for BeyondSpring’s Cinderella story?

The FDA issued BeyondSpring a complete response letter for its plinabulin in combination with granulocyte colony-stimulating factor (G-CSF) for the prevention of chemotherapy-induced neutropenia, effectively shutting down the drug’s immediate chances at a marketing approval, the biotech said Wednesday.

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