Macro­Gen­ics los­es CMO Jon Wig­gin­ton as com­mer­cial­iza­tion looms

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.”

Forge Bi­o­log­ics’ cGMP Com­pli­ant and Com­mer­cial­ly Vi­able Be­spoke Affin­i­ty Chro­matog­ra­phy Plat­form

Forge Biologics has developed a bespoke affinity chromatography platform approach that factors in unique vector combinations to streamline development timelines and assist our clients in efficiently entering the clinic. By leveraging our experience with natural and novel serotypes and transgene conformations, we are able to accelerate affinity chromatography development by nearly 3-fold. Many downstream purification models are serotype-dependent, demanding unique and time-consuming development strategies for each AAV gene therapy product1. With the increasing demand to propel AAV gene therapies to market, platform purification methods that support commercial-scale manufacturing of high-quality vectors with excellent safety and efficacy profiles are essential.

Feng Zhang (Susan Walsh/AP Images)

In search of new way to de­liv­er gene ed­i­tors, CRISPR pi­o­neer turns to mol­e­c­u­lar sy­ringes

Bug bacteria are ruthless.

Some soil bacteria have evolved tiny, but deadly injection systems that attach to insect cells, perforate them and release toxins inside — killing a bug in just a few days’ time. Scientists, on the other hand, want to leverage that system to deliver medicines.

In a paper published Wednesday in Nature, MIT CRISPR researcher Feng Zhang and his lab describe how they engineered these syringes made by bacteria to deliver potential therapies like toxins that kill cancer cells and gene editors. With the help of an AI program, they developed syringes that can load proteins of their choice and selectively target human cells.

Endpoints News

Keep reading Endpoints with a free subscription

Unlock this story instantly and join 163,800+ biopharma pros reading Endpoints daily — and it's free.

Luke Miels, GSK chief commercial officer

GSK picks up Scynex­is' FDA-ap­proved an­ti­fun­gal drug for $90M up­front

Editor’s note: This is a live story and will be updated.

GSK is dishing out $90 million cash to add an antifungal drug to its commercial portfolio, in a deal spotlighting the pharma giant’s growing focus on infectious diseases.

The upfront will lock in an exclusive license to Scynexis’ Brexafemme, which was approved in 2021 to treat a yeast infection known as vulvovaginal candidiasis, except in China and certain other countries where Scynexis already out-licensed the drug.

Endpoints News

Keep reading Endpoints with a free subscription

Unlock this story instantly and join 163,800+ biopharma pros reading Endpoints daily — and it's free.

See­los Ther­a­peu­tics 'tem­porar­i­ly' stops study in rare neu­ro dis­or­der for busi­ness rea­sons

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.

Alec­tor cuts 11% of work­force as it dou­bles down on late-stage neu­ro pro­grams part­nered with GSK, Ab­b­Vie

A month after revealing plans to concentrate on its late-stage immuno-neurology pipeline, Alector is trimming its headcount by 11%.

The layoffs will impact around 30 employees across the organization, the company disclosed in an SEC filing, adding that the plan will “better align the company’s resources” with the new strategy. With $712.9 million in cash, cash equivalents and investments as of the end of 2022, Alector believes the reserves will now get it through 2025.

Endpoints News

Keep reading Endpoints with a free subscription

Unlock this story instantly and join 163,800+ biopharma pros reading Endpoints daily — and it's free.

Mathai Mammen, FogPharma's next CEO

Math­ai Mam­men hands in J&J's R&D keys to lead Greg Ver­dine’s Fog­Phar­ma 

In the early 1990s, Mathai Mammen was a teaching assistant in Greg Verdine’s Science B46 course at Harvard. In June, the former R&D head at Johnson & Johnson will succeed Verdine as CEO, president and chair of FogPharma, the same month the seven-year-old biotech kickstarts its first clinical trial.

After leading R&D at one of the largest drugmakers in the world, taking the company through more than half a dozen drug approvals in the past few years, not to mention a Covid-19 vaccine race, Mammen departed J&J last month and will take the helm of a Cambridge, MA biotech attempting to go after what Verdine calls the “true emperor of all oncogenes” — beta-catenin.

Endpoints News

Keep reading Endpoints with a free subscription

Unlock this story instantly and join 163,800+ biopharma pros reading Endpoints daily — and it's free.

CSL CEO Paul McKenzie (L) and CMO Bill Mezzanotte

Q&A: New­ly-mint­ed CSL chief ex­ec­u­tive Paul McKen­zie and chief med­ical of­fi­cer Bill Mez­zan­otte

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.

J&J bows out of RSV vac­cine race, end­ing PhI­II study and ced­ing to Pfiz­er, GSK

Johnson & Johnson announced Wednesday morning it is ending development of its adult RSV vaccine that was in the middle of a 27,200-patient trial, giving up a big slice of what’s expected to be the next multibillion-dollar pharma market.

The decision came down to the shifting RSV “competitive landscape,” a company spokesperson tells Endpoints News, adding the “breadth of options” was much different than when J&J first started its pivotal study. The spokesperson declined to comment on the Phase III data, saying only the shot is undergoing an “ongoing assessment.”

Endpoints News

Keep reading Endpoints with a free subscription

Unlock this story instantly and join 163,800+ biopharma pros reading Endpoints daily — and it's free.

Hugo Peris, Spiral Therapeutics CEO

Hear­ing-fo­cused biotech grabs trio of pro­grams from Oton­o­my's fire sale

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.