C4 Ther­a­peu­tics bumps An­drew Phillips to CEO; Milind Desh­pande ex­its Achillion; Leena Gand­hi to head up I/O at Eli Lil­ly

An­drew Phillips has been div­ing deep in­to the biotech side of things ever since he left the acad­e­mia to join C4 Ther­a­peu­tics — he start­ed off lead­ing the sci­en­tif­ic ef­forts but soon af­ter as­sumed cor­po­rate and man­age­ment du­ties as pres­i­dent. Now, he’s tak­ing an­oth­er step up to be­come CEO of the pro­tein degra­da­tion biotech. That leaves his pre­vi­ous CSO po­si­tion avail­able for Stew­art Fish­er, for­mer­ly C4T’s head of dis­cov­ery, to fill. Like Phillips, he had a brief stint at the Broad In­sti­tute be­fore join­ing the Wa­ter­town, MA-based biotech; but un­like the new CEO, who was a pro­fes­sor at Yale, Fish­er worked at As­traZeneca for more than 10 years. To­geth­er, they are ex­pect­ed to build on the tar­get­ed pro­tein degra­da­tion plat­form and al­liances they’ve es­tab­lished to re­al­ize C4T’s po­ten­tial in ar­eas like can­cer, in­fec­tious dis­ease and au­toim­mune dis­or­ders.

Am­ber Salz­man

→ Now that it’s in clin­i­cal stage, Ad­verum Biotech­nolo­gies $AD­VM has de­cid­ed the arrange­ment where CEO Am­ber Salz­man com­mutes week­ly from the East Coast to its Men­lo Park, CA of­fices will no longer work. Salz­man, who’s al­so the pres­i­dent, is step­ping down from her roles so the board can re­cruit a full-time chief ex­ec­u­tive based out of its head­quar­ters. CFO Leone Pat­ter­son is tak­ing over her re­spon­si­bil­i­ties ad in­ter­im. Al­so head­ed out the door, but with­out an ex­pla­na­tion: CMO Athena Coun­tou­ri­o­tis, who will be re­placed by VP of clin­i­cal de­vel­op­ment Lin­da Neu­man for now.

→ As Berlin-based Ome­icos Ther­a­peu­tics moves in­to the US mar­ket, it has brought on Alexan­der Gebauer to lead clin­i­cal de­vel­op­ment for its car­dio­vas­cu­lar as­sets and dis­cov­ery ef­forts in oph­thal­mol­o­gy. Gebauer will take on two roles: man­ag­ing di­rec­tor for Ome­icos Ther­a­peu­tics, and CEO of US-based Ome­icos Oph­thalmics, which re­cent­ly formed. In the for­mer, he will over­see Ome­icos’ lead com­pound for rhythm con­trol in pa­tients with atri­al fib­ril­la­tion, steer­ing the plan­ning and tri­al de­sign for an up­com­ing Phase II. For the new ven­ture, he will head up col­lab­o­ra­tions with ex­ter­nal ex­perts in es­tab­lish­ing pre­clin­i­cal proof of con­cept for po­ten­tial drug can­di­dates. While the Ger­man ex­ec had not worked in the US since lead­ing a clin­i­cal tri­al in New Jer­sey ear­ly in his ca­reer, he had ac­crued some in­ter­na­tion­al ex­pe­ri­ence while work­ing for In­dia’s Ran­baxy Lab­o­ra­to­ries and Sun Phar­ma.

Milind Desh­pande

→ Milind Desh­pande is step­ping down from Achillion $ACHN, the biotech he’s led for the bet­ter part of the last two decades, first as CSO and then as CEO. His de­par­ture leaves the fad­ed hep C star in the hands of for­mer COO Joseph Tru­itt, who al­ready has the pres­i­dent ti­tle. Dur­ing his tenure, Desh­pande steered a pipeline re­struc­tur­ing that re­brand­ed Achillion from an in­fec­tious dis­ease play­er to a spe­cial­ist in com­ple­ment bi­ol­ogy, ax­ing staff just a few months ago. Tru­itt, who joined the com­pa­ny in 2009, emerged as a key fig­ure in that come­back nar­ra­tive. Hav­ing led com­mer­cial strat­egy and busi­ness de­vel­op­ment, he will now prep Achillion for a se­ries of read­outs from its com­ple­ment fac­tor D in­hi­bitor pro­gram in rare dis­eas­es.

→ Gre­go­ry Madi­son has re­signed from Keryx Bio­phar­ma $KERX on the same day he be­came its CEO and pres­i­dent three years ago. Jodie Mor­ri­son, a cur­rent board mem­ber and for­mer chief ex­ec­u­tive at Tokai Phar­ma, will lead the Au­ryx­ia mak­er in the in­ter­im. The Boston com­pa­ny thanked Madi­son but did not give a rea­son for Madi­son’s de­par­ture in its state­ment, choos­ing in­stead to fo­cus on its out­looks for Au­ryx­ia, its on­ly drug, cur­rent­ly ap­proved for iron de­fi­cien­cy ane­mia and hy­per­phos­phatemia in pa­tients with chron­ic kid­ney dis­ease. The ther­a­py ac­count­ed for $20 to 21 mil­lion out of $21 to $22.5 mil­lion in first quar­ter rev­enue.

→ Two weeks ago, Leena Gand­hi was in the spot­light at AACR with the lat­est land­mark da­ta on Mer­ck’s Keytru­da/chemo com­bo for front­line lung can­cer. That pack­age end­ed up out­shin­ing a ri­val play from Bris­tol-My­ers Squibb as Mer­ck con­tin­ued to con­sol­i­date its lead po­si­tion in the field. This week, we find out that Gand­hi, an in­ves­ti­ga­tor at the Perl­mut­ter Can­cer Cen­ter at NYU Lan­gone Health and a Dana-Far­ber vet, has been re­cruit­ed by none oth­er than Eli Lil­ly to head up its im­muno-on­col­ogy re­search work. Or per­haps, more to the point, the I/O work that Lil­ly plans to get start­ed on. And she’s the lat­est in a se­ries of new hires that points to Lil­ly’s brew­ing in­ter­est in forg­ing new on­col­ogy deals. As of now, Lil­ly has been large­ly by­passed on the glob­al I/O su­per high­way as it pairs up its tar­get­ed can­cer agents with the lead play­ers. But in its Q1 call a few days ago, new R&D chief Dan Skovron­sky and the ex­ec­u­tive team made it clear that the com­pa­ny is prepar­ing to hatch some I/O deals to beef up its can­cer drug pipeline. And Gand­hi is clear­ly cen­tral to that process. She ar­rives at Lil­ly June 25.

→ Fol­low­ing a brief stint at di­ag­nos­tics com­pa­ny Eu­rofins, Amit Kohli is back in the drug de­vel­op­ment busi­ness — and in his long­time home of Paris. His newest ti­tle is COO of Pharnext, a biotech fo­cused on neu­rode­gen­er­a­tive dis­eases. The Sanofi vet is ex­pect­ed to lead cor­po­rate strat­e­gy and op­er­a­tions, with a spe­cial fo­cus on cross-func­tion­al lead­er­ship as Pharnext pre­pares to re­lease Phase III da­ta on PXT3003, an or­phan drug for the treat­ment of Char­cot-Marie-Tooth dis­ease type 1A.

→ Af­ter get­ting to know CytRx $CYTR as a strate­gic con­sul­tant for the past few months, Er­ic Cur­tis has been tapped to run the com­pa­ny’s on­col­o­gy pro­grams as its pres­i­dent and COO. A sea­soned com­mer­cial­iza­tion ex­ec — with roles span­ning Glax­o­SmithK­line, Bay­er and Aege­ri­on — Cur­tis said his fo­cus will be on part­ner­ship op­por­tu­ni­ties for CytRx’s Link­er Ac­ti­vat­ed Drug Re­lease tech­nol­o­gy. Hav­ing out-li­censed its most ad­vanced drug con­ju­gate to Nant­Cell, CytRx is cur­rent­ly plan­ning INDs for sev­er­al un­named pre­clin­i­cal as­sets, to be sub­mit­ted lat­er this year, and work­ing on dis­cov­er­ing more.

→ As Log­icBio inch­es to­ward clin­i­cal de­vel­op­ment, it has re­cruit­ed COO San­dra Poole and se­nior di­rec­tor of man­u­fac­tur­ing Paul Herzich to make sure every­thing is ready. Both bring plen­ty of ex­pe­ri­ence to the high­ly tech­ni­cal genome edit­ing work that Log­icBio is do­ing on treat­ments for pe­di­atric in­di­ca­tions. Poole led bi­o­log­ics man­u­fac­tur­ing at Gen­zyme for 15 years be­fore tak­ing up a tech­ni­cal op­er­a­tions role at Im­muno­Gen. In her new po­si­tion, she will take charge of both in­ter­nal op­er­a­tions and li­ais­ing with part­ners. Herzich joins the Cam­bridge, MA-based biotech from Pfiz­er’s Bam­boo Ther­a­peu­tics, where he served as di­rec­tor of clin­i­cal gene ther­a­py man­u­fac­tur­ing.

David Thomp­son has left the helm of a biotech he co-found­ed to join In­ozyme, where he sees “com­pelling sci­ence” and ear­ly-stage re­search show­ing that its ENPP1 en­zyme re­place­ment ther­a­py has po­ten­tial in rare meta­bol­ic dis­eases. As the first CSO and SVP, Thomp­son will over­see sci­en­tif­ic and trans­la­tion­al ef­forts as In­ozyme tran­si­tions from dis­cov­ery to clin­i­cal stage. In­ozyme is cur­rent­ly ex­plor­ing lead prod­uct can­di­date in treat­ing gen­er­al­ized ar­te­r­i­al cal­ci­fi­ca­tion of in­fan­cy (GACI) and au­to­so­mal re­ces­sive hy­pophos­phatemic rick­ets type 2 (ARHR2) — both square­ly with­in Thomp­son’s ex­per­tise in min­er­al­iza­tion and bone dis­or­ders. Pri­or to found­ing Azure Biotech, he’s led pre­clin­i­cal and clin­i­cal de­vel­op­ment at Alex­ion, Pfiz­er and Mer­ck Re­search Labs.

→ South San Fran­cis­co-based Vaxart $VXRT has tapped David Tay­lor to lead its quest to de­vel­op oral re­com­bi­nant vac­cine tablets as CMO. In Tay­lor, Vaxart gets a spe­cial­ist who has ded­i­cat­ed much of his ca­reer to vac­cines, lead­ing pro­grams at Take­da, Vax­In­nate and the non­prof­it PATH. The com­pa­ny is par­tic­u­lar­ly im­pressed by his ex­pe­ri­ence in norovirus and in­fluen­za vac­cines, as it con­tin­ues on ear­ly-stage stud­ies for its own prod­ucts in those in­di­ca­tions.

Tarek Sah­moud’s decades-long in­volve­ment in on­col­o­gy drug de­vel­op­ment has tak­en him to Hu­mani­gen, the biotech that dropped its pro­gram in Cha­gas dis­ease to pur­sue CAR-T op­ti­miza­tion. Be­fore join­ing H3 Bio­med­i­cine, Sah­moud’s re­sume was es­sen­tial­ly a who’s who in big phar­ma: As­traZeneca, No­var­tis, Cel­gene and ul­ti­mate­ly Boehringer In­gel­heim. But his short run in H3 fa­mil­iar­ized him with the CMO role, which he is tak­ing at Hu­mani­gen. He will now be­come in cen­tral fig­ure in push­ing clin­i­cal work for lenzilum­ab, the mon­o­clon­al an­ti­body that Hu­mani­gen be­lieves will make CAR-T safer and bet­ter.

→ Up­ping his com­mit­ment with oph­thal­mol­o­gy biotech View­Point Ther­a­peu­tics, Robert Kim has tak­en a full-time role as CMO. Kim had served as a con­sul­tant and ad­vi­sor to the com­pa­ny while teach­ing at UCSF, and he’s been con­vinced to spear­head pre­clin­i­cal and clin­i­cal plans for VP1-001, the lead drug for age-re­lat­ed cataracts. Through­out his aca­d­e­m­ic ca­reer, Kim had as­sumed a slate of roles at first med­ical de­vice, then bio­phar­ma, com­pa­nies, with stints at Genen­tech, Al­con and most re­cent­ly Apel­lis Phar­ma­ceu­ti­cals.

→ With its promis­es of ap­ply­ing ma­chine learn­ing to drug dis­cov­ery, Re­cur­sion Phar­ma­ceu­ti­cal has wooed Kevin Lynch from Ab­b­Vie, where he’s worked for the past 22 years. There’s plen­ty for the new chief busi­ness of­fi­cer to do, says the Salt Lake City-based biotech, as its ther­a­peu­tic reach has now been ex­tend­ed in­to ar­eas like im­munol­o­gy and in­flam­ma­tion, im­muno-on­col­o­gy, and in­fec­tious dis­ease, be­yond its ini­tial fo­cus on ge­net­ic dis­ease. The next step will be to ex­pand its pre­clin­i­cal pipeline and pur­sue strate­gic part­ner­ships — some­thing that Lynch has done plen­ty of while do­ing busi­ness de­vel­op­ment at Ab­b­Vie.

→ In a sign of growth, Cari­bou Bio­sciences — the gene edit­ing com­pa­ny co-found­ed by CRISPR pi­o­neer Jen­nifer Doud­na — has cre­at­ed a new chief busi­ness of­fi­cer role and in­vit­ed a big phar­ma vet to fill it. Tim­o­thy Her­pin joins the Berke­ley, CA-based biotech from As­traZeneca, where as head of trans­ac­tions he over­saw deals with fel­low gi­ants like Mer­ck as well as biotechs like Ac­er­ta Phar­ma. A par­tic­u­lar fo­cus in his broad man­date will be to seek op­por­tu­ni­ties for Cari­bou’s off-the-shelf CAR-T can­di­dates and mi­cro­bio­me-based ther­a­pies.

Curt Her­berts has re­signed from gene edit­ing com­pa­ny Sang­amo $SG­MO to pur­sue “a lead­er­ship op­por­tu­ni­ty” with a pri­vate biotech, leav­ing with the bless­ings of ex­ecs grate­ful for the phar­ma col­lab­o­ra­tions he’s ex­e­cut­ed dur­ing his eight-year tenure. The com­pa­ny has yet to name his suc­ces­sor, but it did pro­mote Michael Holmes to chief tech­nol­o­gy of­fi­cer from VP of re­search. A long­time em­ploy­ee — he joined in 2001 — Holmes played a cru­cial role in us­ing zinc fin­ger nu­cle­as­es for gene edit­ing, a feat that the com­pa­ny is now known for.

AM­AG Phar­ma­ceu­ti­cals $AM­AG may be launch­ing sev­er­al prod­ucts this year, but it al­so wants to make sure its port­fo­lio will keep grow­ing. And it’s hired Alan Butch­er to do that as the chief busi­ness of­fi­cer. For­mer­ly of Shire, Butch­er jumps from a sim­i­lar role in li­cens­ing and busi­ness de­vel­op­ment at Pur­due Phar­ma. In ad­di­tion to scout­ing new prod­ucts, he will al­so lead an al­liance man­age­ment team and lead cor­po­rate strat­e­gy for the com­pa­ny, which is cur­rent­ly fo­cused on women’s health and can­cer care.

Jen­nifer Doud­na, one of the most promi­nent sci­en­tif­ic pi­o­neers be­hind CRISPR/Cas9 gene edit­ing tech, has qui­et­ly joined the J&J $JNJ board.

Xi­aobin Wu has jumped from Pfiz­er to BeiGene, lend­ing his Chi­na op­er­a­tions ex­per­tise to the im­muno-on­col­o­gy biotech as its gen­er­al man­ag­er and pres­i­dent. Wu, who’s worked for Wyeth and Bay­er in the coun­try, said he’s drawn to BeiGene’s “en­tre­pre­neur­ial spir­it, the qual­i­ty of its sci­ence and its em­ploy­ees, and its dri­ve to be­come a glob­al leader.”

→ Days ago, Aca­dia saw its shares slide on news that the FDA has be­gun a re­view of its an­ti-psy­chosis drug Nu­plazid fol­low­ing CNN’s re­port ques­tion­ing the safe­ty of the drug. This week, the San Diego biotech has ap­point­ed Alex­ion vet Ele­na Ridloff as its first SVP of in­vestor re­la­tions. Aca­dia ex­ecs like the fi­nan­cial com­mu­ni­ty re­la­tion­ships Ridloff has built since her hedge fund and con­sult­ing days.

Jen­nifer Du­d­i­nak is the new SVP of glob­al reg­u­la­to­ry af­fairs at Cel­gene, join­ing days be­fore the trou­bled big biotech re­as­sured in­vestors that it will re-file the block­buster hope­ful ozan­i­mod in 2019. 

→ It took a few months, but Or­biMed’s Sam Isaly has fi­nal­ly stepped down from his top post at the ven­ture firm. Late last year STAT writer Dami­an Garde out­lined charges that Isaly had ha­rassed women at the firm for years, lead­ing to a quick state­ment that he would be re­tir­ing from the com­pa­ny and his high-pro­file po­si­tion. The firm’s five oth­er part­ners — Sven Borho, Carl Gor­don, Jonathan Sil­ver­stein, Carter Neild and Ge­of­frey Hsu — will con­tin­ue their own­er­ship.

Paul Hudson, Getty Images

UP­DAT­ED: Sanofi CEO Hud­son lays out new R&D fo­cus — chop­ping di­a­betes, car­dio and slash­ing $2B-plus costs in sur­gi­cal dis­sec­tion

Earlier on Monday, new Sanofi CEO Paul Hudson baited the hook on his upcoming strategy presentation Tuesday with a tell-tale deal to buy Synthorx for $2.5 billion. That fits squarely with hints that he’s pointing the company to a bigger future in oncology, which also squares with a major industry tilt.

In a big reveal later in the day, though, Hudson offered a slate of stunners on his plans to surgically dissect and reassemble the portfoloio, saying that the company is dropping cardio and diabetes research — which covers two of its biggest franchise arenas. Sanofi missed the boat on developing new diabetes drugs, and now it’s pulling out entirely. As part of the pullback, it’s dropping efpeglenatide, their once-weekly GLP-1 injection for diabetes.

“To be out of cardiovascular and diabetes is not easy for a company like ours with an incredibly proud history,” Hudson said on a call with reporters, according to the Wall Street Journal. “As tough a choice as that is, we’re making that choice.”

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Parkin­son's trans­plants emerge as stem cell pi­o­neer Jeanne Lor­ing joins race

Jeanne Loring hadn’t studied Parkinson’s in 22 years when she got an email from a local neurologist.

The neurologist, Melissa Houser, didn’t know Loring had ever published on the disease. She was just looking for a stem cell researcher who might hear her out. 

“I think I was just picked out a hat,” Loring told Endpoints News. 

At a meeting in Loring’s Scripps Research office, Houser and a Parkinson’s nurse practitioner, Sherrie Gould, asked her why there was so much research done in stem cell transplants for other neurodegenerative diseases but not Parkinson’s. They wanted to know if she would work on one. 

What does $6.9B buy these days in on­col­o­gy R&D? As­traZeneca has a land­mark an­swer

Given the way the FDA has been whisking through new drug approvals months ahead of their PDUFA date, AstraZeneca and their partners Daiichi Sankyo may not have to wait until Q2 of next year to get a green light on trastuzumab deruxtecan (DS-8201).

The pharma giant this morning played their ace in the hole, showing off why they were willing to commit to a $6.9 billion deal — with $1.35 billion in a cash upfront — to partner on the drug.

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Paul Hudson, Sanofi

Paul Hud­son promis­es a bright new fu­ture at Sanofi, kick­ing loose me-too drugs and fo­cus­ing on land­mark ad­vances. But can he de­liv­er?

Paul Hudson was on a mission Tuesday morning as he stood up to address Sanofi’s new R&D and business strategy.

Still fresh into the job, the new CEO set out to convince his audience — including the legions of nervous staffers inevitably devoting much of their day to listening in — that the pharma giant is shedding the layers of bureaucracy that had held them back from making progress in the past, dropping the duds in the pipeline and reprioritizing a more narrow set of experimental drugs that were promised as first-in-class or best-in-class.  The company, he added, is now positioned to “go after other opportunities” that could offer a transformational approach to treating its core diseases.

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Large advertisements for the drug Vivitrol decorate the walls of Grand Central Station on June 15, 2017 in New York City. (Photo: Andrew Lichtenstein via Getty)

FDA slaps down Alk­er­mes for mis­lead­ing Viv­it­rol ads — don't for­get vul­ner­a­bil­i­ty to opi­oid over­dose

The ads piqued interest as soon as they started appearing in 2016: at Grand Central Station, on the Red Line in Cambridge, and on a billboard off the New Jersey Turnpike. All showed a young person, generally with his or her arms crossed, and the question, “what is Vivitrol?”

Vivitrol’s maker, Alkermes, was in the midst of a marketing and lobbying campaign to promote the anti-opioid addiction drug — a campaign that would face significant backlash for tarnishing competitors despite little evidence for Vivitrol’s superiority.

FDA in-house re­view spot­lights an is­sue with one of Hori­zon's end­points but notes ef­fi­ca­cy for lead drug

The FDA in-house review highlights a disagreement of investigators’ use of a key endpoint by Horizon Pharma in the late-stage trial for the top drug in its pipeline, but largely agreed that the antibody was effective.

Horizon submitted a BLA for thyroid eye disease (TED) drug teprotumumab in March, less than two years after they bought the drug (and the rest of a division) from Narrow River for $145 million upfront. With breakthrough status, priority review, orphan designation and in-house sales projections of up to $750 million, the one-time Roche reject became the marquee pipeline asset for a company that’s developed some of the world’s most expensive drugs.

Seat­tle Ge­net­ics de­tails pos­i­tive OS and PFS da­ta for tu­ca­tinib in breast can­cer

Seattle Genetics $SGEN is showing off more positive data around tucatinib, its pivotal-stage drug for HER2 positive breast cancer.

A month after hearing about solidly upbeat hazard ratios, we learned today that the estimated progression-free survival rate at one year was 33% in the tucatinib arm compared to 12% for patients taking trastuzumab and capecitabine alone.

Median PFS was 7.8 months (95% CI: 7.5, 9.6) in the tucatinib arm, compared to 5.6 months (95% CI: 4.2, 7.1) in the control arm.

Bat­tered, cash hun­gry In­tec feels the burn of No­var­tis re­jec­tion

It’s a case of some bad timing for Intec.

Just when a key trial testing the company’s Accordion drug delivery tech imploded in Parkinson’s disease, they handed Novartis data from a successful PK study of a custom Accordion pill engineered to deliver a Novartis compound to entice the Swiss drugmaker into signing a licensing agreement.

Novartis said thanks, but no thanks.

For the cash-strapped Israeli drug developer, the failure to clinch the deal marks a big blow. As of the third quarter, the company has $15.7 million in cash and equivalents, which HC Wainwright analysts estimate will keep the lights on into mid-2020.

Bris­tol-My­ers shows off a low-pro­file AML con­tender it gained from Cel­gene buy­out — and they’re tak­ing it straight to the FDA

Bristol-Myers Squibb reaped an enormous pipeline with its much-criticized $64 billion megadeal to buy Celgene. And it got a few hidden gems in the deal.

One of those gems was brought out for display on Tuesday, with a late-breaker at ASH on CC-486, which is now being prepped for regulatory filings at the FDA and elsewhere.

Celgene top-lined the positive results in a maintenance setting for acute myeloid leukemia a few months ago, but at ASH investigators pulled back the curtains on the all-important data they believe will give them an advantage in the commercial wars to come.

And it’s impressive.

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