Cell Med­ica scoops Kite Phar­ma's Chris Now­ers as CEO; Shire vet jumps to Edi­Gene as CEO

→ With sev­er­al of Cell Med­ica’s pro­grams on track for clin­i­cal tri­als, Gregg San­do has de­cid­ed it’s time to pass the reins at the biotech he found­ed 12 years ago. The new CEO is Chris Now­ers, a Bris­tol-My­ers vet and one-time biotech CEO who jumps from Kite Phar­ma. In that role, he head­ed up the Eu­ro­pean op­er­a­tion and com­mer­cial­iza­tion ef­forts for Kite’s Yescar­ta. He is now ex­pect­ed to lever­age that ex­pe­ri­ence to dri­ve Cell Med­ica’s own CAR and TCR pro­grams, some of which are de­vel­oped in col­lab­o­ra­tion with aca­d­e­m­ic part­ners in Lon­don (where it’s head­quar­tered) and Hous­ton (where it has of­fices).

→ An­oth­er Chi­nese banker is mak­ing the jump to biotech as Shang­hai-based I-Mab Bio­phar­ma woos Jef­feries’ Asia head Jielun Zhu to be its CFO. Zhu has a cov­et­ed re­sume: he led a num­ber of IPOs and M&A deals at Jef­feries’ Hong Kong of­fice at a time Chi­na’s fledg­ling biotech scene is ma­tur­ing and the city in par­tic­u­lar is gar­ner­ing in­ter­est as a nascent biotech IPO des­ti­na­tion. Be­fore mov­ing in­to bank­ing, he had a ca­reer in strat­e­gy con­sul­tant which led him to bio­phar­ma clients in the US. That’s all rel­e­vant for I-Mab, which re­cent­ly closed a $220 mil­lion C round to fund its in-li­cens­ing busi­ness mod­el.

Dong Wei

→ Hong Kong-based Edi­Gene has ap­point­ed for­mer Shire R&D ex­ec Dong Wei to serve as the com­pa­ny’s new CEO. The com­pa­ny, which has a US pres­ence in Cam­bridge, MA, is de­vel­op­ing a pipeline in ge­net­ic dis­eases and can­cer, along with CRISPR/Cas 9-based drug dis­cov­ery ser­vices.

“Genome edit­ing is rev­o­lu­tion­iz­ing drug de­vel­op­ment in mul­ti­ple as­pects,” Wei said in a state­ment. “With its deep sci­ence and pro­pri­etary plat­forms, Edi­Gene is unique­ly po­si­tioned in this rapid ad­vanc­ing field. It is a priv­i­lege to work with such an ex­cel­lent team to de­vel­op in­no­v­a­tive op­tions for pa­tients in Chi­na and the world.”

Wei comes from Tre­os Bio, where he was COO. Be­fore that, he was the glob­al de­vel­op­ment leader of late-stage de­vel­op­ment pro­grams at Shire, se­nior di­rec­tor of busi­ness op­er­a­tion and pro­gram man­age­ment at John­son & John­son In­no­va­tion Cen­ter and held var­i­ous R&D and busi­ness po­si­tions at com­pa­nies in­clud­ing Bio­MarinElan, and Janssen.

Lawrence Keny­on has of­fi­cial­ly been ap­point­ed the pres­i­dent and CEO of On­co­bi­o­log­ics af­ter fill­ing the role ad in­ter­im for two months. In ad­di­tion to spear­head­ing the biotech’s new lead pro­gram in­to the clin­ic and di­rect­ing strat­e­gy, Keny­on will con­tin­ue ex­er­cis­ing his CFO du­ties — the po­si­tion he first took when he joined the com­pa­ny in 2015 — un­til a re­place­ment is found. Dou­bling up shouldn’t be a chal­lenge for Keny­on, who’s pre­vi­ous­ly had stints as CFO/COO at Arno Ther­a­peu­tics and CEO/CFO at Tamir Biotech­nol­o­gy. Cran­bury, NJ-based On­co­bi­o­log­ics, which was found­ed as a biosim­i­lar de­vel­op­er, re­cent­ly added a nov­el mon­o­clon­al an­ti­body to its pipeline.

→ South San Fran­cis­co’s Tenaya Ther­a­peu­tics has tapped Gen­zyme vet Faraz Ali to take over the start­up as CEO. JJ Kang, the Col­umn Group prin­ci­pal who served as found­ing pres­i­dent, will re­main on the board. Like Re­genxbio, where Ali most re­cent­ly worked as chief busi­ness of­fi­cer, Tenaya has a lead pro­gram in gene ther­a­py. Un­like Re­genxbio, it’s laser fo­cused on de­vel­op­ing re­gen­er­a­tive ther­a­pies for heart fail­ure, based on sci­ence out of the Glad­stone In­sti­tute of Car­dio­vas­cu­lar Dis­ease.

→ On­corus, a Cam­bridge, MA-based biotech fo­cused on on­colyt­ic virus­es, has snagged Mod­er­na’s chief of on­col­o­gy de­vel­op­ment for the helm. Ted Ash­burn is tak­ing the CEO’s spot while On­corus’ co-founder and MPM Cap­i­tal man­ag­ing di­rec­tor Mitchell Fin­er will call the strate­gic shots as ex­ec­u­tive chair­man. Ash­burn got his MD at Har­vard Med and went on to work at sev­er­al big or­ga­ni­za­tions, in­clud­ing Pfiz­er and Sanofi/Gen­zyme.

→ Con­tract man­u­fac­tur­er Cy­to­vance Bi­o­log­ics has named Yan Wang, who’s al­so lead­ing its sis­ter com­pa­ny Sci­en­tif­ic Pro­tein Lab­o­ra­to­ries, to the top job. With a back­ground in both re­search and busi­ness de­vel­op­ment, Wang has been on Cy­to­vance’s board since 2015 and in fact re­cent­ly be­came its in­ter­im CEO be­fore go­ing of­fi­cial.

→ As CAN­bridge Life Sci­ences gears up for a piv­ot to com­mer­cial­iza­tion — with its new­ly ap­proved ther­a­py for can­cer treat­ment-re­lat­ed oral mu­cosi­tis — it’s poached long­time Pfiz­er ex­ec May Or­fali to lead its clin­i­cal op­er­a­tions. While the Bei­jing-based biotech is plan­ning sev­er­al tri­als in Chi­na, the new CMO will stay in Cam­bridge, MA and over­see drug de­vel­op­ment on both sides of the Pa­cif­ic from CAN­bridge’s US out­post. Can­bridge ex­ecs like her track record in a sim­i­lar role at Pfiz­er’s rare dis­ease unit, and are count­ing on her to bring Ner­l­ynx, the breast can­cer drug they re­cent­ly in-li­censed from Puma, to the Chi­na mar­ket. Or­fali suc­ceeds Mark Gold­berg, who was brought in by his old col­league and Can­bridge founder, James Xue. Gold­berg will con­tin­ue to ad­vise the com­pa­ny.

Dan Chen, who at Genen­tech led the de­vel­op­ment of Tecen­triq from start to post-mar­ket star­dom, has tak­en the CMO’s job at IgM Bio­sciences in Moun­tain View, CA. Chen wasn’t just in charge of the Tecen­triq pro­gram, which Roche de­vout­ly be­lieves is a block­buster in the mak­ing, he al­so helped guide a se­ries of al­liances with key an­ti­body de­vel­op­ers around the world. That added ex­pe­ri­ence that could come in handy on his new job. He is join­ing an­oth­er Genen­tech vet, Bruce Heyt, who serves as chief sci­en­tif­ic of­fi­cer at IgM.

Chen told End­points News in an in­ter­view Thurs­day that when he first start­ed work­ing on Tecen­triq, he was a team of 1. And af­ter watch­ing the clin­i­cal de­vel­op­ment team alone ex­pand in­to the hun­dreds of staffers at Genen­tech over the years, he’s back at an N of 1, ready to start build­ing a new team. Once again, he is look­ing to make some biotech his­to­ry.

→ Hav­ing lined up two Phase III and sev­er­al oth­er stud­ies, Retrophin $RTRX is now hand­ing all of that re­spon­si­bil­i­ty to Noah Rosen­berg, the new CMO they re­cruit­ed from der­ma­tol­ogy spe­cial­ist Medimetriks Phar­ma­ceu­ti­cals. At his new of­fices in San Diego, he will be look­ing at a pipeline of ther­a­pies tar­get­ing rare dis­eases such as the neu­ro­log­i­cal dis­or­der fos­met­pan­tote­nate for pan­tothen­ate ki­nase-as­so­ci­at­ed neu­rode­gen­er­a­tion (PKAN).

→ A decade af­ter co-found­ing Sir­naomics and lay­ing the foun­da­tion for its siR­NA dis­cov­ery plat­form, David Evans is re­turn­ing full-time to take on the role of chief sci­en­tif­ic of­fi­cer. His man­date cov­ers pre­clin­i­cal pro­grams for an­tifi­bro­sis and an­ti­cancer RNAi ther­a­pies — the lat­ter of which he’s al­ready been con­sult­ing for. The ap­point­ment like­ly means he will leave his job man­ag­ing the In Vit­ro Screen­ing labs for the Fred­er­ick Na­tion­al Lab for Can­cer Re­search, but the se­r­i­al en­tre­pre­neur said he’s ready to get more in­ti­mate­ly en­gaged in de­liv­er­ing in­no­v­a­tive ther­a­peu­tics.

→ Three months af­ter NewLink Ge­net­ics scrapped a com­bi­na­tion pro­gram for its IDO path­way drug in­dox­i­mod in the gen­er­al rout that fol­lowed the fail­ure of In­cyte’s big IDO project for epaca­do­stat, the biotech has slashed close to a third of its staff and re­or­ga­nized the C-suite in a last stand ef­fort to prove their ther­a­py can work. CFO Jack Hen­ne­man re­signed his po­si­tion to be­come chief ad­min­is­tra­tive of­fi­cer as he plans his de­par­ture for lat­er in the year. Chief com­mer­cial of­fi­cer Bri­an Wi­ley left a few days ago. The Iowa-based com­pa­ny has made sev­er­al pro­mo­tions to fill the gap: Carl Lan­gren to CFO; Lori Law­ley to VP, fi­nance and con­troller; and Brad Pow­ers to gen­er­al coun­sel.

→ Fol­low­ing a 10-year run around Bris­tol My­ers Squibb’s var­i­ous fi­nan­cial de­part­ments, Joshua Reed is start­ing fresh at Aldeyra Ther­a­peu­tics $ALDX. Reed was brought in to re­place out­go­ing CFO Stephen Tuli­pano as the Lex­ing­ton, MA-based biotech an­tic­i­pates some late-stage da­ta in the com­ing year to prove its lead drug’s worth in treat­ing var­i­ous con­di­tions aris­ing from oc­u­lar in­flam­ma­tion. Be­fore join­ing Bris­tol-My­ers, Reed spent sev­er­al years at JP­Mor­gan Chase and Cred­it Su­isse.

BioDe­liv­ery Sci­ences $BD­SI has hired Thomas Smith away from pain man­age­ment ri­val Charleston Lab­o­ra­to­ries, putting him in charge of med­ical af­fairs re­lat­ed to its ap­proved prod­ucts as well as its film de­liv­ery tech­nol­o­gy. Based in Raleigh, NC, the com­pa­ny mar­kets, ei­ther it­self or through out-li­cens­ing part­ners, three drugs for chron­ic pain, opi­oid de­pen­dence and can­cer pain, re­spec­tive­ly.

→ Mark­ing an­oth­er mile­stone in its en­try to Japan, Bel­gium’s Promethera Bio­sciences has snatched for­mer Mit­sui Glob­al In­vest­ment VC Mut­su­ki Takano to head up the Tokyo branch of­fice it opened a few months ago. As gen­er­al branch man­ag­er, Takano is tasked with dri­ving prod­uct and cor­po­rate de­vel­op­ment in both Japan and the wider Asian re­gion. Backed by Eu­ro­pean and Japan­ese VCs, Promethera is de­vel­op­ing cell-based med­i­cines for liv­er dis­eases.

→ Fol­low­ing a 20-year ca­reer in in­vest­ment bank­ing (span­ning Stifel, UBS, Leerink and Mor­gan Stan­ley), Marc Gras­so has tak­en a job (or two?) as CFO and CBO of Ku­ra On­col­o­gy $KU­RA. He will head a fi­nance team built up by Hei­di Hen­son in the four years since the biotech’s in­cep­tion. On the verge of a piv­otal tri­al for its far­ne­syl trans­ferase in­hibitor tip­i­farnib, San Diego-based Ku­ra has just re­cent­ly hired a new COO from Cel­gene.

Bern­stein’s long­time Big Phar­ma an­a­lyst Tim An­der­son is head­ed to a new re­search firm that’s been at­tract­ing some at­ten­tion re­cent­ly. An­der­son left Bern­stein re­cent­ly and is head­ed to Wolfe Re­search, where he will be­gin in Sep­tem­ber. The web­site cites their cov­er­age of “about 36 sub-sec­tors through 15 se­nior re­search an­a­lysts,” along with a 2016 and 2017 win as a top 15 group — by In­sti­tu­tion­al In­vestor. The scut­tle­butt around the an­a­lyst com­mu­ni­ty is that Wolfe now wants to build the next Bern­stein.

And An­der­son tells End­points Ed­i­tor John Car­roll via LinkedIn that he’s look­ing for­ward to the move, not­ing:

Yes, I am mov­ing on. Fun­da­men­tals are tough on the sell-side, but the place I am go­ing to (Wolfe Re­search) has man­aged to find it­self in the sweet spot where they are gain­ing share, and are able to grow the busi­ness at a time when many oth­ers oth­ers are hav­ing to con­tract. Good to be in growth mode! I will not of­fi­cial­ly emerge at Wolfe un­til late Sep­tem­ber.

Roy Baynes has tak­en a board seat at DNA-test­ing com­pa­ny Nat­era, con­tribut­ing his on­col­o­gy ex­per­tise out­side his day job as CMO of Mer­ck.

Robert Ash­worth is the new VP, reg­u­la­to­ry, at On­coSec, ar­riv­ing at a time the mi­cro­cap biotech $ONCS preps for sev­er­al de­vel­op­ment mile­stones in the near-term. One of them will be a Phase II tri­al that tests its in­ves­ti­ga­tion­al Im­munoPulse IL-12 com­bined with Keytru­da, which showed ear­ly promise in a pre­vi­ous read­out. With the ex­pe­ri­ence and skills he gained at Ad­vax­is, NPS Phar­ma and Ot­su­ka, Ash­worth will lead On­coSec’s reg­u­la­to­ry strat­e­gy in ad­di­tion to in­ter­act­ing with reg­u­la­tors and part­ners world­wide.

→ Now that it’s ini­ti­at­ed its first BLA sub­mis­sion, En­zy­vant — the rare dis­ease-fo­cused mem­ber of Vivek Ra­maswamy’s ever-ex­pand­ing Vant fam­i­ly — has hired two ex­ecs to help lead what they see as a pe­ri­od of growth. Shire vet An­drew Daw­son has been named SVP of hu­man re­sources. while Alex Tra­cy will be­come VP of phar­ma­ceu­ti­cal de­vel­op­ment and man­u­fac­tur­ing. Be­fore join­ing En­zy­vant’s moth­er com­pa­ny Roivant, Tra­cy de­vel­oped both small mol­e­cules and bi­o­log­ics at No­var­tis Vac­cines and Hos­pi­ra/Pfiz­er.

→ New­ly pub­lic Proven­tion Bio $PRVB now wants to turn its at­ten­tion to its pipeline, and has ap­point­ed Mark Rig­by to over­see clin­i­cal de­vel­op­ment of the type 1 di­a­betes treat­ments it had picked up from J&J. The new VP jumps from a role in the ear­ly de­vel­op­ment and trans­la­tion­al med­i­cine unit at J&J sub­sidiary Janssen.

→ Hav­ing pitched in at Tri­ci­da $TC­DA as a con­sul­tant in the past few years, Dawn Parsell has been hired has SVP of clin­i­cal de­vel­op­ment, tasked with see­ing the chron­ic kid­ney dis­ease drug TRC-101 through an NDA as the com­pa­ny preps an ac­cel­er­at­ed ap­proval pitch. If that goes through, she will al­so be in charge of run­ning the post­mar­ket­ing tri­al.

Mer­ck is tak­ing the ax to its US op­er­a­tions, cut­ting 500 jobs in its lat­est re­or­ga­ni­za­tion

Merck is cutting 500 jobs in its US sales and headquarters commercial teams in its latest effort to find new ways to streamline the operation.

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Alice Shaw, Lung Cancer Foundation of America

Top ALK ex­pert and can­cer drug re­searcher Al­ice Shaw bids adieu to acad­e­mia, hel­lo to No­var­tis

Jay Bradner has recruited a marquee oncology drug researcher into the ranks of the Novartis Institutes for BioMedical Research. Alice Shaw is jumping from prestigious posts intertwined through Mass General, Harvard and Dana-Farber to take the lead of NIBR’s translational clinical oncology group.

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Mi­rati preps its first look at their KRAS G12C con­tender, and they have to clear a high bar for suc­cess

If you’re a big KRAS G12C fan, mark your calendars for October 28 at 4:20 pm EDT.

That’s when Mirati $MRTX will unveil its first peek at the early clinical data available on MRTX849 in presentations at the AACR-NCI-EORTC International Conference on Molecular Targets and Cancer Therapeutics in Boston.

Mirati has been experiencing the full effect of a rival’s initial success at targeting the G12C pocket found on KRAS, offering the biotech some support on the concept they’re after — and biotech fans a race to the top. Amgen made a big splash with its first positive snapshot on lung cancer, but deflated sky-high expectations as it proved harder to find similar benefits in other types of cancers.

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Hal Barron, GSK's president of R&D and CSO, speaks to Endpoints News founder and editor John Carroll in London at Endpoints' #UKBIO19 summit on October 8, 2019

[Video] Cel­e­brat­ing tri­al fail­ures, chang­ing the cul­ture and al­ly­ing with Cal­i­for­nia dream­ers: R&D chief Hal Bar­ron talks about a new era at GSK

Last week I had a chance to sit down with Hal Barron at Endpoints’ #UKBIO19 summit to discuss his views on R&D at GSK, a topic that has been central to his life since he took the top research post close to 2 years ago. During the conversation, Barron talked about changing the culture at GSK, a move that involves several new approaches — one of which involves celebrating their setbacks as they shift resources to the most promising programs in the pipeline. Barron also discussed his new alliances in the Bay Area — including his collaboration pact with Lyell, which we covered here — frankly assesses the pluses and minuses of the UK drug development scene, and talks about his plans for making GSK a much more effective drug developer.

This is one discussion you won’t want to miss. Insider and Enterprise subscribers can log-in to watch the video.

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Flu Virus (Source: CDC)

FDA ex­pands Xofluza ap­proval as Roche strug­gles to catch loom­ing flu mar­ket

As a potentially powerful flu season looms, so does a big test for Roche and its new flu drug, Xofluza. The Swiss giant just got a small boost in advance of that test as the FDA expanded Xofluza’s indication to include patients at high risk of developing flu-related complications.

Xofluza (baloxavir marboxil) was approved last October in the US, the first landmark flu drug approval in 20 years and a much-needed green light for a company that had watched its leading flu drug Tamiflu get eaten alive by generics. Like its predecessor, the pill offered a reduction in flu symptoms but not a cure.

EMA backs sev­en ther­a­pies, in­clud­ing Mer­ck­'s Ebo­la vac­cine

The first-ever Ebola vaccine is on the precipice of approval after the European Medicine’s Agency (EMA) backed the Merck product in this week’s roster of recommendations.

The drugmaker $MRK began developing the vaccine, christened Ervebo, during the West African outbreak that occurred between 2014 and 2016, killing more than 11,000.

The current outbreak in the Democratic Republic of Congo (DRC) has shown case fatality rates of approximately 67%, the agency estimated. Earlier this year, the WHO declared the outbreak — which so far has infected more than 3,000 people — a public health emergency of international concern.

Ronald Herb­st fol­lows Med­Im­mune ex­o­dus to Pyx­is CSO post; Jeff God­dard to suc­ceed CEO of AIT Bio­science

→ The outflow of top execs from MedImmune continues to fill the leadership ranks of smaller biotechs. The latest to take off is Ronald Herbst, the head of oncology research, who’s assuming the CSO post at Pyxis Oncology.  

Herbst was part of the old MedImmune organization AstraZeneca CEO Pascal Soriot restructured earlier this year, reorganizing the company and eliminating the storied subsidiary as a separate organization.

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Med­ical an­i­ma­tion: Mak­ing it eas­i­er for the site and the pa­tient to un­der­stand

Medical animation has in recent years become an increasingly important tool for conveying niche information to a varied audience, particularly to those audiences without expertise in the specialist area. Science programmes today, for example, have moved from the piece-to-camera of the university professor explaining how a complex disease mechanism works, to actually showing the viewer first-hand what it might look like to shrink ourselves down to the size of an ant’s foot, and travel inside the human body to witness these processes in action. Effectively communicating a complex disease pathophysiology, or the novel mechanism of action of a new drug, can be complex. This is especially difficult when the audience domain knowledge is limited or non-existent. Medical animation can help with this communication challenge in several ways.
Improved accessibility to visualisation
Visualisation is a core component of our ability to understand a concept. Ask 10 people to visualise an apple, and each will come up with a slightly different image, some apples smaller than others, some more round, some with bites taken. Acceptable, you say, we can move on to the next part of the story. Now ask 10 people to visualise how HIV’s capsid protein gets arranged into the hexamers and pentamers that form the viral capsid that holds HIV’s genetic material. This request may pose a challenge even to someone with some virology knowledge, and it is that inability to effectively visualise what is going on that holds us back from fully understanding the rest of the story. So how does medical animation help us to overcome this visualisation challenge?

UP­DAT­ED: J&J's Xarel­to, Amar­in's Vas­cepa are cost-ef­fec­tive, not bud­get friend­ly — ICER

ICER, an increasingly influential cost-effectiveness watchdog in the United States, has concluded in its review of treatments for cardiovascular disease that while the cost of J&J’s Xarelto and Amarin’s Vascepa meet its benchmark for value pricing — the two treatments will not likely treat as many patients as hoped without surpassing the annual budget threshold calculated by ICER for each therapy.