The next few months are im­por­tant for Macro­Gen­ics. They may soon have their first ap­proved drug. They could even de­feat moun­tain­ous odds and eclipse Keytru­da in a head to head tri­al.

But what­ev­er they do, they’ll do it with­out long­time CMO Jon Wig­gin­ton.

Jon Wig­gin­ton

The can­cer biotech an­nounced yes­ter­day that af­ter 7 years, Wig­gin­ton will leave the com­pa­ny at the end of the month to pur­sue a new op­por­tu­ni­ty. CSO Ezio Bon­vi­ni will as­sume his role while Macro­Gen­ics search­es for a re­place­ment.

Wig­gin­ton came to Macro­Gen­ics in 2013 as VP of clin­i­cal de­vel­op­ment, af­ter help­ing run Bris­tol-My­ers Squibb’s im­muno-on­col­o­gy pro­gram. Be­fore that, he worked at Mer­ck and spent 14 years do­ing trans­la­tion­al re­search at the Na­tion­al Can­cer In­sti­tute.

The com­pa­ny Wig­gin­ton joined had re­cent­ly piv­ot­ed from an an­ti­body de­vel­op­er whose tar­gets ranged from di­a­betes to West Nile virus to one prin­ci­pal­ly fo­cused on can­cer. With a Pfiz­er part­ner­ship and a plat­form ac­quired from Raven Ther­a­peu­tics, they had just pre­sent­ed their first Phase I AS­CO da­ta on mar­ge­tux­imab, the Raven-de­vel­oped chimeric HER2 an­ti­body that would be­come their lead drug. It was de­signed to give the ben­e­fits of Her­ceptin while al­so trig­ger­ing an im­mune at­tack.

The an­ti­body had just gone in­to Phase II tri­als. Macro­Gen­ics, about to go pub­lic, brought him in, tout­ing his clin­i­cal ex­pe­ri­ence in im­muno-on­col­o­gy.

”In par­tic­u­lar, his lead­er­ship in the in­no­v­a­tive de­sign of clin­i­cal stud­ies for rapid­ly ad­vanc­ing the field of im­mune check­point ther­a­peu­tics will prove valu­able in max­i­miz­ing the po­ten­tial of our on­col­o­gy port­fo­lio,” CEO Scott Koenig said at the time.

Wig­gin­ton has since helped ush­er mar­ge­tux­imab through a Phase III tri­al that showed it was su­pe­ri­or — al­beit not ma­jor­ly so —  to Her­ceptin and a sub­se­quent BLA fil­ing last year. Mean­while, af­ter work­ing on PD-1 and PD-L1 at Bris­tol-My­ers, he helped de­vel­op Macro­Gen­ics’ PD-1 in­hibitor MGA012. In part­ner­ship with In­cyte, that drug is now in sev­er­al late-stage tri­als, in­clud­ing against Keytru­da.

There are lin­ger­ing ques­tions about the pipeline Wig­gin­ton helped build. Com­mer­cial­ly, the best op­por­tu­ni­ties for mar­ge­tux­imab will come with fu­ture da­ta on ear­li­er lines of gas­tric and breast can­cer, SVB Leerink’s Jonathan Chang re­cent­ly wrote. And the read­outs on MGA012 and some ear­li­er stage as­sets could al­ways come up bust (it’s un­like­ly to beat out Keytru­da, for in­stance).

Still, Chang was op­ti­mistic.

“Be­yond mar­ge­tux­imab, MGNX has one of the broad­est and deep­est pipelines of pro­pri­etary and part­nered bis­pe­cif­ic an­ti­bod­ies in clin­i­cal de­vel­op­ment,” he wrote. “We are im­pressed with MGNX’s pro­lif­ic R&D en­gine.”

Microcap biotech Seelos Therapeutics is halting enrollment of its study in spinocerebellar ataxia type 3 (also known as Machado-Joseph disease) because of “financial considerations,” and in order to focus on other studies, the company said today, adding that the pause would be temporary.

The study will continue with the patients who have already enrolled, and the data from them will be used to decide whether to continue enrolling others in the future.

Paul McKenzie took over as CEO of Australian pharma giant CSL this month, following in the footsteps of long-time CSL vet Paul Perreault.

With an eye on mRNA, and quickly commercializing its new, $3.5 million-per-shot gene therapy for hemophilia B, McKenzie and chief medical officer Bill Mezzanotte answered some questions from Endpoints News this afternoon about where McKenzie is going to take the company and what advances may be coming to market from CSL’s pipeline. Below is a lightly edited transcript.

Otonomy may be shutting down, but the lessons learned there will live on at another biotech working on new treatments for hearing loss.

San Francisco-based Spiral Therapeutics has bought certain assets related to three of Otonomy’s programs, ranging from data, patent rights, and know-how to inventory. That includes data around Otonomy’s twice-failed lead program, OTO-104 (Otividex), a sustained-exposure formulation of dexamethasone.