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.

Brian Kaspar. AveXis via Twitter

AveX­is sci­en­tif­ic founder fires back at No­var­tis CEO Vas Narasimhan, 'cat­e­gor­i­cal­ly de­nies any wrong­do­ing'

Brian Kaspar’s head was among the first to roll at Novartis after company execs became aware of the fact that manipulated data had been included in its application for Zolgensma, now the world’s most expensive therapy.

But in his first public response, the scientific founder at AveXis — acquired by Novartis for $8.7 billion — is firing back. And he says that not only was he not involved in any wrongdoing, he’s ready to defend his name as needed.

I reached out to Brian Kaspar after Novartis put out word that he and his brother Allen had been axed in mid-May, two months after the company became aware of the allegations related to manipulated data. His response came back through his attorneys.

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UP­DAT­ED: Pay­back? An­a­lysts say Sarep­ta was blind­sided by an FDA re­jec­tion dri­ven by reg­u­la­to­ry re­venge

In one of the least anticipated moves of the year, the FDA has rejected Sarepta’s application for an accelerated approval of its Duchenne MD drug golodirsen after fretting over safety issues.

In a statement that arrived after the bell on Monday, Sarepta explained the CRL, saying:

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FDA de­ci­sion on Ver­tex's CF triple will come just ahead of planned CEO shake­up

Vertex has clinched a priority review for the all-important cystic fibrosis triple that will blaze the trail for treating a large group of patients unhelped by its current drugs.

FDA regulators have set a PDUFA date of March 19, 2020, just a year after the Boston biotech posted positive Phase III results showing that people with two F508del mutations experienced statistically significant improvements in lung function after a 4-week regimen of VX-445, tezacaftor and ivacaftor. After reviewing 24-week data among patients with one F508del mutation and one minimal function mutation — and thoroughly comparing the VX-445 triple with another combo featuring VX-659 on scores like safety, drug-drug interactions, and photosensitivity — Vertex ultimately went with VX-445.

An MIT spin­out kills one of its ‘liv­ing ther­a­peu­tics’ af­ter flunk­ing an ear­ly-stage study — shares rout­ed

Just a few weeks after bagging $80 million in a deal to collaborate with Gingko Bioworks on its special blend of engineered bacteria used for “living therapeutics,” little Synlogic in Boston $SYBX is tossing one of its two clinical programs after watching an early-stage study go down in defeat.

Their Phase Ib/IIa study for SYNB1020 to counter the accumulation of ammonia in the body, a condition called hyperammonemia or urea cycle disorder, floundered at the interim readout, forcing the biotech to kill it and reserve its cash for pipeline therapies with greater potential.

Elan­co to buy Bay­er's an­i­mal health busi­ness for $7.6B, as deal­mak­ing gath­ers steam in the sec­tor

Last week, Elanco explicitly dodged answering questions about its rumored interest in Bayer’s animal health business in its post-earnings call. On Tuesday, the Eli Lilly spinoff disclosed it was purchasing the German drug maker’s veterinary unit in a cash-and-stock deal worth $7.6 billion. 

Elanco $ELAN has been busy on the deal-making front. In April, it laid out plans to swallow its partner, Kansas-based pet therapeutics company Aratana $PETX. A July report by Reuters suggested a potential Bayer deal was being explored, and Bloomberg last week said the deal was imminent, citing sources. 

As­traZeneca's di­a­betes drug Farx­i­ga helps pa­tients with heart dis­ease and with­out di­a­betes in land­mark tri­al

Months ago, data on J&J’s $JNJ Invokana indicated the diabetes drug conferred cardiovascular (CV) benefit in patients who do and do not have preexisting CV disease. On Tuesday, AstraZeneca’s $AZN rival treatment, Farxiga, was shown to cut the risk of CV death or the worsening of heart failure in patients with heart disease, in a landmark trial.

The treatments, in addition to Jardiance from Eli Lilly $LLY, belong to a class of diabetes drugs called sodium-glucose co-transporter 2 (SGLT2) inhibitors, which work by curbing the absorption of glucose via the kidneys so that surplus glucose is excreted through urination.

Levi Garraway. Broad Institute via Youtube

Roche raids Eli Lil­ly for its next chief med­ical of­fi­cer as San­dra Horn­ing plans to step down

We found out Monday morning where Levi Garraway was headed after he left Eli Lilly as head of oncology R&D a few days ago. Roche named Garraway as their new chief medical officer, replacing Sandra Horning, who they say is retiring from the company.

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Af­ter a posse of Wall Street an­a­lysts pre­dict a like­ly new win for Sarep­ta, we're down to the wire on a crit­i­cal FDA de­ci­sion

As Bloomberg notes, most of the Wall Street analysts that cover Sarepta $SRPT are an upbeat bunch, ready to cheer on the team when it comes to their Duchenne MD drugs, or offer explanations when an odd setback occurs — as happened recently with a safety signal that was ‘erroneously’ reported last week.

Ritu Baral Cowen
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UP­DAT­ED: No­var­tis spin­off Nabri­va fi­nal­ly scores its first an­tibi­ot­ic ap­proval

In May, Nabriva Therapeutics suffered a setback after the FDA rejected its antibiotic for complicated urinary tract infections — the Novartis spinoff has now had some better luck with the US agency, which on Monday approved its other drug for community-acquired bacterial pneumonia.

The drug, lefamulin, has been developed as an intravenous and oral formulation and been tested in two late-stage clinical trials. The semi-synthetic compound, whose dosing can be switched between the two formulations, is engineered to inhibit the synthesis of bacterial protein by binding to a part of the bacterial ribosome.