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.

The top 10 block­buster drugs in the late-stage pipeline — Eval­u­ate adds 6 new ther­a­pies to heavy-hit­ter list

Vertex comes in for a substantial amount of criticism for its no-holds-barred tactical approach toward wresting the price it wants for its commercial drugs in Europe. But the flip side of that coin is a highly admired R&D and commercial operation that regularly wins kudos from analysts for their ability to engineer greater cash flow from the breakthrough drugs they create.

Both aspects needed for success in this business are on display in the program backing Vertex’s triple for cystic fibrosis. VX-659/VX-445 + Tezacaftor + Ivacaftor — it’s been whittled down to 445 now — was singled out by Evaluate Pharma as the late-stage therapy most likely to win the crown for drug sales in 5 years, with a projected peak revenue forecast of $4.3 billion.

The latest annual list, which you can see here in their latest world preview, includes a roster of some of the most closely watched development programs in biopharma. And Evaluate has added 6 must-watch experimental drugs to the top 10 as drugs fail or go on to a first approval. With apologies to the list maker, I revamped this to rank the top 10 by projected 2024 sales, instead of Evaluate's net present value rankings.

It's how we roll at Endpoints News.

Here is a quick summary of the rest of the top 10:

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How small- to mid-sized biotechs can adopt pa­tient cen­tric­i­ty in their on­col­o­gy tri­als

By Lucy Clos­sick Thom­son, Se­nior Di­rec­tor of On­col­o­gy Pro­ject Man­age­ment, Icon

Clin­i­cal tri­als in on­col­o­gy can be cost­ly and chal­leng­ing to man­age. One fac­tor that could re­duce costs and re­duce bar­ri­ers is har­ness­ing the pa­tient voice in tri­al de­sign to help ac­cel­er­ate pa­tient en­roll­ment. Now is the time to adopt pa­tient-cen­tric strate­gies that not on­ly fo­cus on pa­tient needs, but al­so can main­tain cost ef­fi­cien­cy.

John Reed at JPM 2019. Jeff Rumans for Endpoints News

Sanofi's John Reed con­tin­ues to re­or­ga­nize R&D, cut­ting 466 jobs while boost­ing can­cer, gene ther­a­py re­search

The R&D reorganization inside Sanofi is continuing, more than a year after the pharma giant brought in John Reed to head the research arm of the Paris-based company.
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John Chiminski, Catalent CEO - File Photo

'It's a growth play': Catal­ent ac­quires Bris­tol-My­er­s' Eu­ro­pean launch pad, ex­pand­ing glob­al CD­MO ops

Catalent is staying on the growth track.

Just two months after committing $1.2 billion to pick up Paragon and take a deep dive into the sizzling hot gene therapy manufacturing sector, the CDMO is bouncing right back with a deal to buy out Bristol-Myers’ central launchpad for new therapies in Europe, acquiring a complex in Anagni, Italy, southwest of Rome, that will significantly expand its capacity on the continent.

There are no terms being offered, but this is no small deal. The Anagni campus employs some 700 staffers, and Catalent is planning to go right in — once the deal closes late this year — with a blueprint to build up the operations further as they expand on oral solid, biologics, and sterile product manufacturing and packaging.

This is an uncommon deal, Catalent CEO John Chiminski tells me. But it offers a shortcut for rapid growth that cuts years out of developing a green fields project. That’s time Catalent doesn’t have as the industry undergoes unprecedented expansion around the world.

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Arc­turus ex­pands col­lab­o­ra­tion, adding $30M cash; Ku­ra shoots for $100M raise

→  Rare dis­ease play­er Ul­tragenyx $RARE is ex­pand­ing its al­liance with Arc­turus $ARCT, pay­ing $24 mil­lion for eq­ui­ty and an­oth­er $6 mil­lion in an up­front as the two part­ners ex­pand their col­lab­o­ra­tion to in­clude up to 12 tar­gets. “This ex­pand­ed col­lab­o­ra­tion fur­ther so­lid­i­fies our mR­NA plat­form by adding ad­di­tion­al tar­gets and ex­pand­ing our abil­i­ty to po­ten­tial­ly treat more dis­eases,” said Emil Kakkis, the CEO at Ul­tragenyx. “We are pleased with the progress of our on­go­ing col­lab­o­ra­tion. Our most ad­vanced mR­NA pro­gram, UX053 for the treat­ment of Glyco­gen Stor­age Dis­ease Type III, is ex­pect­ed to move in­to the clin­ic next year, and we look for­ward to fur­ther build­ing up­on the ini­tial suc­cess of this part­ner­ship.”

UP­DAT­ED: Chica­go biotech ar­gues blue­bird, Third Rock 'killed' its ri­val, pi­o­neer­ing tha­lassemia gene ther­a­py in law­suit

Blue­bird bio $BLUE chief Nick Leschly court­ed con­tro­ver­sy last week when he re­vealed the com­pa­ny’s be­ta tha­lassemia treat­ment will car­ry a jaw-drop­ping $1.8 mil­lion price tag over a 5-year pe­ri­od in Eu­rope — mak­ing it the plan­et’s sec­ond most ex­pen­sive ther­a­py be­hind No­var­tis’ $NVS fresh­ly ap­proved spinal mus­cu­lar at­ro­phy ther­a­py, Zol­gens­ma, at $2.1 mil­lion. A Chica­go biotech, mean­while, has been fum­ing at the side­lines. In a law­suit filed ear­li­er this month, Er­rant Gene Ther­a­peu­tics al­leged that blue­bird and ven­ture cap­i­tal group Third Rock un­law­ful­ly prised a vi­ral vec­tor, de­vel­oped in part­ner­ship with the Memo­r­i­al Sloan Ket­ter­ing Can­cer Cen­ter (MSK), from its grasp, and thwart­ed the de­vel­op­ment of its sem­i­nal gene ther­a­py.

Neil Woodford. Woodford Investment Management via YouTube

Wood­ford braces po­lit­i­cal storm as UK fi­nan­cial reg­u­la­tors scru­ti­nize fund sus­pen­sion

The shock of Neil Wood­ford’s de­ci­sion to block with­drawals for his flag­ship fund is still rip­pling through the rest of his port­fo­lio — and be­yond. Un­der po­lit­i­cal pres­sure, UK fi­nan­cial reg­u­la­tors are now tak­ing a hard look while in­vestors con­tin­ue to flee.

In a re­sponse let­ter to an MP, the Fi­nan­cial Con­duct Au­thor­i­ty re­vealed that it’s opened an in­ves­ti­ga­tion in­to the sus­pen­sion fol­low­ing months of en­gage­ment with Link Fund So­lu­tions, which tech­ni­cal­ly del­e­gat­ed Wood­ford’s firm to man­age its funds.

Gilead baits new al­liance with $45M up­front, div­ing in­to the busy pro­tein degra­da­tion field

Gilead is jump­ing on board the pro­tein degra­da­tion band­wag­on. And they’re turn­ing to a low-pro­file Third Rock start­up for the ex­per­tise. But if you were look­ing for a trans­for­ma­tion­al deal to kick up fresh en­thu­si­asm for Gilead, you’ll have to re­main pa­tient.

This one will have a long way to go be­fore they get in­to the clin­ic.

The big biotech said Wednes­day morn­ing that it is pay­ing $45 mil­lion up­front and re­serv­ing a whop­ping $2.3 bil­lion in biotech bucks if San Fran­cis­co-based Nurix can point the way to new can­cer ther­a­pies, as well as drugs for oth­er, un­spec­i­fied dis­eases.

A new num­ber 1 drug? Keytru­da tapped to top the 10 biggest block­busters on the world stage by 2024

Analysts may be fretting about Keytruda’s longterm prospects as a host of rival therapies elbow their way to the market. But the folks at Evaluate Pharma are confident that last year’s $7 billion earner is headed for glory, tapping it to beat out the current #1 therapy Humira as AbbVie watches that franchise swoon over the next 5 years.

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