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.

Regeneron CEO Leonard Schleifer speaks at a meeting with President Donald Trump, members of the Coronavirus Task Force, and pharmaceutical executives in the Cabinet Room of the White House (AP Photo/Andrew Harnik)

OWS shifts spot­light to drugs to fight Covid-19, hand­ing Re­gen­eron $450M to be­gin large scale man­u­fac­tur­ing in the US

The US government is on a spending spree. And after committing billions to vaccines defense operations are now doling out more of the big bucks through Operation Warp Speed to back a rapid flip of a drug into the market to stop Covid-19 from ravaging patients — possibly inside of 2 months.

The beneficiary this morning is Regeneron, the big biotech engaged in a frenzied race to develop an antibody cocktail called REGN-COV2 that just started a late-stage program to prove its worth in fighting the virus. BARDA and the Department of Defense are awarding Regeneron a $450 million contract to cover bulk delivery of the cocktail starting as early as late summer, with money added for fill/finish and storage activities.

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Noubar Afeyan, Flagship CEO and Tessera chairman (Victor Boyko/Getty Images)

Flag­ship ex­ecs take a les­son from na­ture to mas­ter ‘gene writ­ing,’ launch­ing a star-stud­ded biotech with big am­bi­tions to cure dis­ease

Flagship Pioneering has opened up its deep pockets to fund a biotech upstart out to revolutionize the whole gene therapy/gene editing field — before gene editing has even made it to the market. And they’ve surrounded themselves with some marquee scientists and execs who have crowded around to help shepherd the technology ahead.

The lead player here is Flagship general partner Geoff von Maltzahn, an MIT-trained synthetic biologist who set out in 2018 to do CRISPR — a widely used gene editing tool — and other rival technologies one or two better. Von Maltzahn has been working with Sana co-founder Jake Rubens, another synthetic biology player out of MIT who he describes as his “superstar,” who’s taken the CSO role.

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Covid-19 roundup: Squab­bles with gov­ern­ment de­lay Mod­er­na’s PhI­II — re­ports; No­vavax se­cures largest Warp Speed deal yet: $1.6B

A much-anticipated Phase III trial for Moderna’s Covid-19 vaccine is being held up as the company delayed submitting trial protocols and sparred with government scientists on how to run the study and even what the benchmark for success should be, Reuters reported.

Moderna, the first US company to put their vaccine into human testing, was supposed to enter a 30,000-person study this month in partnership with the NIH to determine whether it can prevent infection. STAT reported last week that the trial was facing delays over the protocol, but that a July start was still possible. Neither the NIH nor Moderna ever disclosed a specific date the trial should start, but Reuters reported that the agency had hoped to begin on July 10.

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Donald and Melania Trump watch the smoke of fireworks from the South Lawn of the White House on July 4, 2020 (via Getty)

Which drug de­vel­op­ers of­fer Trump a quick, game-chang­ing ‘so­lu­tion’ as the pan­dem­ic roars back? Eli Lil­ly and Ab­Cellera look to break out of the pack

We are unleashing our nation’s scientific brilliance and will likely have a therapeutic and/or vaccine solution long before the end of the year.

— Donald Trump, July 4

Next week administration officials plan to promote a new study they say shows promising results on therapeutics, the officials said. They wouldn’t describe the study in any further detail because, they said, its disclosure would be “market-moving.”

— NBC News, July 3

Something’s cooking. And it’s not just July 4 leftovers involving stale buns and uneaten hot dogs.

Over the long weekend observers picked up signs that the focus in the Trump administration may swiftly shift from the bright spotlight on vaccines being promised this fall, around the time of the election, to include drugs that could possibly keep patients out of the hospital and take the political sting out of the soaring Covid-19 numbers causing embarrassment in states that swiftly reopened — as Trump cheered along.

So far, Gilead has been the chief beneficiary of the drive on drugs, swiftly offering enough early data to get remdesivir an emergency authorization and into the hands of the US government. But their drug, while helpful in cutting stays, is known for a limited, modest effect. And that won’t tamp down on the hurricane of criticism that’s been tearing at the White House, and buffeting the president’s most stalwart core defenders as the economy suffers.

We’ve had positive early-stage vaccine data, most recently from Pfizer and BioNTech, playing catchup on an mRNA race led by Moderna — where every little sign of potential trouble is magnified into a lethal threat, just as every advance excites a frenzy of support. But that race still has months to play out, with more Phase I data due ahead of the mid-stage numbers looming ahead. A vaccine may not be available in large enough quantities until well into 2021, which is still wildly ambitious.

So what about a drug solution?

Trump’s initial support for a panacea focused on hydroxychloroquine. But that fizzled in the face of data underscoring its ineffectiveness — killing trials that aren’t likely to be restarted because of a recent population-based study offering some support. And there are a number of existing drugs being repurposed to see how they help hospitalized patients.

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Cel­lec­tis slammed af­ter pa­tient dies and FDA slaps a hold on their tri­al for an off-the-shelf CAR-T for mul­ti­ple myelo­ma

Cellectis was slammed after the market close on Monday as the biotech reported that the FDA demanded it hit the brakes on their MELANI-01 trial for their off-the-shelf cell therapy UCARTCS1A after one of the patients in the study died of treatment-related cardiac arrest.

The multiple myeloma patient had previously been treated unsuccessfully with various therapies, noted the biotech, and had been given dose level two (DL2) of their allogeneic CAR-T.

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Shoshanna Shendelman, Applied Therapeutics CEO (Applied Therapeutics)

A lit­tle biotech slaps back at a 'crim­i­nal' short at­tack, vow­ing to pur­sue a pros­e­cu­tion of their case

As short attacks go, Biotech Research Partners’ assault on Applied Therapeutics’ “cherry picked” data and a variety of so-called red flags didn’t cause a whole lot of damage. Ahead of the July 4 holiday, its shares $APLT were dinged and showed signs of quick recovery.

But that didn’t stop an incendiary response, as the biotech swung into action bright and early Monday morning.

Applied Therapeutics accused the authors of the short report of manipulating graphs and figures, misrepresenting data and included factual misrepresentations — all of which added up, in their view, to fraud.

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Bill Haney, Dragonfly CEO (Dave Pedley/Getty Images for SXSW)

A boom­ing Drag­on­fly is tak­ing its TriN­KETs to Copen­hagen as the lat­est Bris­tol My­ers pact spurs ex­pan­sion plans — out­side the US

Bristol Myers Squibb is making a habit out of collaborating with the crew at Dragonfly, adding their 3rd deal in a series that now will take them into newly charted R&D territory. And the fast-growing team at the Cambridge-based biotech is adding a facility in Copenhagen for its next growth spurt, where the government is making it easy to recruit scientists internationally as the U.S. throttles back.

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Covid-19 roundup: Teamed up with NIH, Re­gen­eron launch­es PhI­II pre­ven­tion tri­al for an­ti­body cock­tail

As Regeneron moves its antibody cocktail into Phase II/III trials testing REGN-COV2 as a treatment for both hospitalized and non-hospitalized patients with Covid-19, the biotech is also starting a Phase III in the prevention setting.

The National Institute of Allergy and Infectious Diseases — which orchestrated the large, randomized study for remdesivir that produced positive results — will jointly run the study.

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Douglas Love, Annexon CEO (Annexon)

IPO bound? Ac­tu­al­ly, An­nex­on was al­ready prepped and primed to toss its S-1 to Wall Street as in­vestors ral­lied

The Wall Street IPO shuffle generally calls for a little distance between the crossover ante and the Wall Street double, but with the window on the street wide open and biotech sizzling hot, who’s waiting?

The crew at Annexon didn’t leave anyone in suspense for long about their IPO plans. A day after the Bay Area biotech with clinical plans to target neurodegeneration quietly unveiled a $100 million raise, they were back with an S-1 outlining a pitch to double that — or more.

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