As­traZeneca vet Jen­nifer But­ler takes charge of In­nate Phar­ma's US biz; C4 raids NI­BR

→ France’s In­nate Phar­ma has wooed As­traZeneca vet Jen­nifer But­ler to lead the US op­er­a­tions it has set up af­ter ac­quir­ing Lu­mox­i­ti from the British drug­mak­er in a rich add-on col­lab­o­ra­tion deal. But­ler’s of­fi­cial ti­tle will be EVP and gen­er­al man­ag­er of In­nate Phar­ma US. Most re­cent­ly, she was chief busi­ness of­fi­cer, chief com­mer­cial of­fi­cer and head of US op­er­a­tions at Tes­sa Ther­a­peu­tics.

→ Af­ter cel­e­brat­ing the ap­proval of a Parkin­son’s ther­a­py he helped ac­quired for Acor­da Ther­a­peu­tics, chief busi­ness of­fi­cer An­drew Hind­man has de­cid­ed to step down. Hind­man, who joined Acor­da in 2014, is now “in­ter­est­ed in pur­su­ing op­por­tu­ni­ties in the wider bio­phar­ma in­dus­try,” CEO Ron Co­hen said. Over the next few tran­si­tion­ing months, he will con­tin­ue to help eval­u­ate ex-US com­mer­cial part­ner­ships for In­bri­ja as the com­pa­ny awaits a Eu­ro­pean reg­u­la­to­ry de­ci­sion.

→ C4 Ther­a­peu­tics has raid­ed the No­var­tis In­sti­tutes of Bio­med­ical Re­search for its chief med­ical of­fi­cer. The biotech re­port­ed to­day that it’s hired on Adam Crys­tal for the spot, fol­low­ing a stint as a se­nior di­rec­tor at NI­BR. C4 is one of sev­er­al biotechs work­ing on pro­tein de­graders, which has al­so been a keen in­ter­est of NI­BR chief Jay Brad­ner. “Dr. Crys­tal’s deep un­der­stand­ing of the sci­ence of tar­get­ed pro­tein degra­da­tion, cou­pled to his proven clin­i­cal lead­er­ship and un­der­stand­ing of the pa­tient com­mu­ni­ty, will be in­stru­men­tal to ad­vanc­ing C4T’s pipeline,” said Andy Phillips, the CEO of C4.

John Lea­man is quit­ting his job as CFO and head of cor­po­rate strat­e­gy at Se­lec­ta Bio, a year and a half af­ter join­ing the Wa­ter­town, MA-based biotech. His res­ig­na­tion comes in the wake of a re­vamp that claimed 36% of the staff — most of them work­ing on a now de­funct on­col­o­gy team — and pro­mot­ed a gout drug to the lead po­si­tion.

→ San Diego-based Escient has tapped William Hod­der as its chief busi­ness of­fi­cer, adding a sea­soned BD ex­ec and one-time en­tre­pre­neur to its start­up lead­er­ship team. Less than a year in­to its of­fi­cial ex­is­tence, the biotech is still busy trans­lat­ing in­sights on Mas-re­lat­ed G-pro­tein re­cep­tors to a new class of GCPR-tar­get­ed drugs, and Hod­der will play a hand in the plan­ning and grow­ing process, CEO Alain Baron said. Be­fore a re­cent run as a con­sul­tant, Hod­der has worked for Pro­tag­o­nist Ther­a­peu­tics and Fi­bro­Gen, as well as found­ing and lead­ing Tren­ovus.

In­cyte’s head of clin­i­cal de­vel­op­ment in Eu­rope has jumped ship to shape a nascent pipeline at iOnc­tura, a Mer­ck KGaA spin­out based in Gene­va. As CMO, Michael Lahn will lead first-in-hu­man stud­ies of the biotech’s next-gen PI3Kδ in­hibitor and po­ten­tial first-in-class au­to­tax­in (ATX) in­hibitor. Lahn, an alum­ni of As­traZeneca and Eli Lil­ly, will work close­ly with Zoë John­son, who’s re­cent­ly been pro­mot­ed to CSO.

→ Is­rael’s burn and wound man­age­ment biotech Medi­Wound is part­ing ways with CEO Gal Co­hen af­ter 12 years. Sharon Mal­ka, who helped steer the com­pa­ny to a 2014 Nas­daq de­but along­side Co­hen dur­ing this time as CFO and COO, is step­ping up to the role. Co­hen’s tenure was marked by Eu­rope and Is­rael ap­provals for Nexo­Brid, Medi­Wound’s flag­ship, non-sur­gi­cal prod­uct for burn treat­ment. Now fi­nanced un­der a con­tract with BAR­DA, the ther­a­py has com­plet­ed a sec­ond Phase III that will hope­ful­ly prop up the case for an FDA ap­proval — some­thing that Mal­ka will over­see while sup­port­ing an “on­go­ing strate­gic process.”

→ Or­phan drug de­vel­op­er Mi­no­ryx Ther­a­peu­tics has re­cruit­ed Di­di­er Le Nor­mand to be CFO of its op­er­a­tions across Eu­rope and the gen­er­al man­ag­er of a new­ly es­tab­lished Bel­gian sub­sidiary. The ap­point­ment adds an­oth­er C-suite role to Le Nor­mand’s re­sume, which has been packed with sim­i­lar roles in phar­ma and medtech com­pa­nies.

→ Biotech vet Tony Fior­i­no — per­haps best known as the for­mer CEO of Brain­storm Ther­a­peu­tics — is tak­ing up the CMO post at elec­tro­Core $ECOR as it seeks FDA clear­ance of its non-in­va­sive bio­elec­tron­ic va­gus nerve stim­u­la­tor gam­ma­Core. Com­ing from an in­ter­im CEO role at strug­gling Im­mune Phar­ma, he re­places Pe­ter Staats, who will be­come a se­nior ex­ec­u­tive ad­vis­er. Al­so join­ing the com­pa­ny: Phar­ma­copeia vet Bri­an Pos­ner, elec­tro­Core’s new CFO.

→ While re­searchers at Sang­amo Ther­a­peu­tics $SG­MO con­tin­ue to tweak its gene edit­ing tech for its lead rare dis­ease pro­grams, the biotech is beef­ing up its cell ther­a­py team to grow the CAR-Tregs port­fo­lio. Ja­son Fontenot will now lead that ef­fort, in­clud­ing a part­ner­ship with Sanofi and a pact with Gilead’s Kite for he­mo­glo­binopathies and can­cer re­spec­tive­ly. He comes to his new role of SVP, cell ther­a­py by way of Im­mu­soft, Juno and Bio­gen.

→ Ex­pe­ri­enced medtech ex­ec Kevin Kalish has been re­cruit­ed to lead the R&D ef­fort at En­Clear Ther­a­pies, a neu­rode­gen­er­a­tion-fo­cused start­up that’s just raised $2 mil­lion in seed fund­ing to take a de­vice-based amy­otroph­ic lat­er­al scle­ro­sis ther­a­py to the clin­ic in two years. De­vel­oped by Kevin Eggan of the Broad In­sti­tute, the treat­ment would re­move tox­ic pro­teins be­lieved to dri­ve the dis­ease.

Cold Spring Har­bor Lab’s Mick­ey At­w­al has teased on Twit­ter that he will “soon be join­ing Re­gen­eron to head their ma­chine learn­ing and mol­e­c­u­lar pro­fil­ing ef­forts.” Hav­ing re­searched the in­ter­sec­tion of pop­u­la­tion ge­net­ics, ma­chine learn­ing and can­cer bi­ol­o­gy, de­vel­op­ing math­e­mat­i­cal and com­pu­ta­tion­al tools, he’s mov­ing on­to a new po­si­tion with “di­rect trans­la­tion­al op­por­tu­ni­ties ahead,” At­w­al said.

Tri­umvi­ra Im­muno­log­ics has named Cyn­thia Moli­na as VP of reg­u­la­to­ry af­fairs to dri­ve sub­mis­sions and in­ter­ac­tions with health agen­cies around the world. Moli­na has been im­mersed in the T cell can­cer ther­a­py world while serv­ing in a sim­i­lar role at Hous­ton-based Cell Med­ica for the past six years.

Cell and Gene Con­tract Man­u­fac­tur­ers Must Em­brace Dig­i­ti­za­tion

The Cell and Gene Industry is growing at a staggering 30% CAGR and is estimated to reach $14B by 20251. A number of cell, gene and stem cell therapy sponsors currently have novel drug substances and products and many rely on Contract Development Manufacturing Organizations (CDMO) to produce them with adherence to stringent regulatory cGMP conditions. Cell and gene manufacturing for both autologous (one to one) and allogenic (one to many) treatments face difficult issues such as: a complex supply chain, variability on patient and cellular level, cell expansion count and a tight scheduling of lot disposition process. This complexity affects quality, compliance and accountability in the entire vein-to-vein process for critically ill patients.

Cal­lid­i­tas bets up to $102M on a biotech buy­out, snag­ging a once-failed PBC drug

After spending years developing its oral formulation of the corticosteroid budesonide, Sweden’s Calliditas now has its sights set on the primary biliary cholangitis field.

The company will buy out France-based Genkyotex, and it’s willing to bet up to €87 million ($102 million) that Genkyotex’s failed Phase II drug, GKT831, will do better in late-stage trials.

Under the current agreement, Calliditas $CALT will initially pay €20.3 million in cash for 62.7% of Genkyotex (or €2.80 a piece for 7,236,515 shares) in early October, then circle back for the rest of Genkyotex’s shares under the same terms. If nothing changes, the whole buyout will cost Calliditas €32.3 million, plus up to  €55 million in contingent rights.

Qi­a­gen in­vestors spurn Ther­mo Fish­er’s takeover of­fer, de­rail­ing a $12B+ deal

Thermo Fisher Scientific had announced an $11.5 billion takeover of Dutch diagnostics company Qiagen back in March, but the deal apparently did not sit well with Qiagen investors.

After getting hammered by critics who contended that Qiagen $QGEN was worth a lot more than what Thermo Fisher wanted to spend, investors turned thumbs down on the offer — derailing the buyout even after Thermo Fisher increased its offer to $12.6 billion in July. Qiagen’s share price has been boosted considerably by Covid-19 as demand for its testing kits surged.

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Inside FDA HQ (File photo)

The FDA just ap­proved the third Duchenne MD drug. And reg­u­la­tors still don’t know if any of them work

Last year Sarepta hit center stage with the FDA’s controversial reversal of its CRL for the company’s second Duchenne muscular dystrophy drug — after the biotech was ambushed by agency insiders ready to reject a second pitch based on the same disease biomarker used for the first approval for eteplirsen, without actual data on the efficacy of the drug.

On Wednesday the FDA approved the third Duchenne MD drug, based on the same biomarker. And regulators were ready to act yet again despite the lack of efficacy data.

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A lab technician works during research on coronavirus at Johnson & Johnson subsidiary Janssen Pharmaceutical in Beerse, Belgium, Wednesday, June 17, 2020. (Virginia Mayo/AP Images)

UP­DAT­ED: End­points News ranks all 28 play­ers in the Covid-19 vac­cine race. Here's how it stacks up to­day

(This piece was last updated on August 13. Endpoints News will continue to track the latest developments through the FDA’s marketing decisions.)

The 28 players now in or close to the clinical race to get a Covid-19 vaccine over the finish line are angling for a piece of a multibillion-dollar market. And being first — or among the leaders — will play a big role in determining just how big a piece.

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Xuefeng Yu in Hong Kong, 2019 (Imaginechina via AP Images)

CanSi­no reaps $748M wind­fall from Shang­hai IPO — as it warns Covid-19 vac­cine won't be a huge mon­ey mak­er

CanSino began the year with a clear goal to secure a secondary listing on Shanghai’s STAR market. Then something more urgent came along: As a rising vaccine developer on a mission to bring global standard immunizations to China, it heeded the call to make a vaccine to protect against a virus that would paralyze the whole world.

Xuefeng Yu and his team managed to keep doing both.

More than a month after CanSino’s Covid-19 vaccine candidate is authorized for military use in China, the Hong Kong-listed company has made a roaring debut in Shanghai. It fetched $748 million (RMB$5.2 billion) by floating 24.8 million shares, and soared 88% on its first trading day.

James Wilson, WuXi Global Forum at JPM20

FDA puts up a red light for Pas­sage Bio’s first gene ther­a­py pro­gram, de­lay­ing a pro­gram from James Wilson's group at Penn

Gene therapy pioneer James Wilson spearheaded animal studies demonstrating the potential of new treatments injected directly into the brain, looking to jumpstart a once-and-done fix for an extraordinarily rare disease called GM1 gangliosidosis in infants. His team at the University of Pennsylvania published their work on monkeys and handed it over to Passage Bio, a Wilson-inspired startup building a pipeline of gene therapies — with an IND for PBGM01 to lead the way.

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Stéphane Bancel speaks to President Donald Trump at the White House meeting on March 2 (AP Images)

UP­DAT­ED: Mod­er­na of­fers steep dis­count in US sup­ply deal — but still takes the crown with close to $2.5B in vac­cine con­tracts

The US pre-order for Moderna’s Covid-19 vaccine is in.

Operation Warp Speed is reserving $1.525 billion for 100 million doses of Moderna’s Phase III mRNA candidate, rounding out to about $15 per dose — including $300 million in incentive payments for timely delivery. Given that Moderna has a two-dose regimen, it’s good for vaccinating 50 million people. The US government also has the option to purchase another 400 million doses for a total of $6.6 billion, or $16.5 per dose.

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How much has pre­ci­sion med­i­cine helped? A new NCI study of­fers clues

Does precision medicine work?

The approach, based on finding a drug to target a patient’s specific genes, has undoubtedly saved individual lives, spurring Lazarus-like reversals in health in once-terminally ill patients. But critics have pointed out that its pursuit has meant drug companies spending hundreds of millions of dollars to target mutations that affect narrow slices of the populations, and that many of the gains researchers thought it would bring have eroded as cancers evolve resistance.