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.

A new chap­ter in the de­cen­tral­ized clin­i­cal tri­al ap­proach

Despite the promised decentralized trial revolution, we haven’t yet moved the needle in a significant way, although we are seeing far bolder commitments to this as we continue to experience the pandemic restrictions for some time to come. The vision of grandeur is one thing, but operationalizing and execution are another and recognising that change, particularly mid-flight on studies, is worthy of thorough evaluation and consideration in order to achieve success. Here we will discuss one of the critical building blocks of a Decentralized and Remote Trial strategy: TeleConsent; more than paper under glass, it is a paradigm change and key digital enabler.

Su­per-se­cre­tive an­ti-ag­ing biotech Cal­i­co tees up the first vis­i­ble clin­i­cal tri­al of an ex­per­i­men­tal drug. And it’s for can­cer?

Over the past 7 years, Calico has been so much more than your average, run-of-the-mill secretive biotech players. It’s a riddle, wrapped in a mystery, inside an enigma, to repurpose an old Winston Churchill line dating from the time he confronted the Iron Curtain surrounding Stalin’s thoughts.

Launched by industry legend Art Levinson of Genentech fame, with the infinitely deep pockets of Google for support, one of the few big headlines the anti-aging biotech has sparked focused on a major alliance with AbbVie — a giant outfit that conversely likes to show off its drug prospects whenever it can. Together, they’ve been focused on diseases that limit life span — quite an arc of ailments.

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RBC's Bri­an Abra­hams holds a mock ad­comm on Bio­gen's iffy ad­u­canum­ab da­ta — and most of these ex­perts don't see a path to an ap­proval

As catalysts go, few loom larger than the aducanumab adcomm slated for Nov. 6.

With its big franchise under assault, Biogen is betting the ranch that its mixed late-stage Alzheimer’s data can squeak past the experts and regulators and get onto the market. And the topic — after a decade of Alzheimer’s R&D disasters in what still represents the El Dorado of drug markets — remains in the center ring of discussions around late-stage pipeline prospects.

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Af­ter near­ly a year of de­bate, the Covid-19 vac­cine chal­lenge tri­als are of­fi­cial­ly com­ing

After nearly a year of public advocacy and often rancorous ethical debate, human challenge trials for Covid-19 vaccines are getting off the ground in London.

The UK government’s Covid-19 Vaccine Taskforce and the contract research firm Open Orphan announced today £10 million ($13 million) plan to test experimental Covid-19 vaccines in volunteers whintentionally exposed to the novel coronavirus. The studies, which won’t launch until early 2021, come after 9 months of debate over whether such studies were safe and would actually hasten vaccine development, and they follow a long history of researchers using challenge models to study other respiratory viruses, including flu and the coronaviruses that cause the common cold.

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Derek Chalmers, Cara Ther

Cara lines up a $440M deal for US rights to its late-stage drug for se­vere itch, with $150M cash on the ta­ble

With plans afoot to file an NDA for what could be its first approved drug, Cara Therapeutics is pivoting its focus to commercialization. And Swiss company Vifor Pharma is willing to surrender up to $440 million to market the candidate in the US.

Cara $CARA CEO Derek Chalmers said an NDA submission is coming this quarter for their intravenous drug Korsuva in chronic kidney disease-associated pruritus (CKD-aP), a severe itching condition. The Stamford, CT-based biotech read out positive topline data from a Phase III pivotal study back in April, and announced plans to approach EMA regulators shortly after filing with the FDA.

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Covid-19 roundup: Pars­ing Bourla, a top an­a­lyst sees im­proved chances for Pfiz­er vac­cine; Fau­ci: No sur­prise that Trump was hit by Covid-19

With a medley of adverse events hobbling the late-stage development of vaccines and drugs, Pfizer CEO Albert Bourla’s latest — extended — timeline for the mRNA approach they’re working on with BioNTech is giving some top analysts added confidence that the pharma giant can come up with the regulatory goods next month.

Parsing Bourla’s language in his comments last week, SVB Leerink’s Geoffrey Porges notes that Bourla’s decision to say they “may” be able to nail down the positive efficacy of their vaccine in a matter of days — a big change from his earlier certainty — may also indicate a delay on that to early November.

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Daniel O'Day, Gilead CEO (Kevin Dietsch/UPI/Bloomberg via Getty Images)

Gilead feels the heat as close al­ly Gala­pa­gos re­ports a big set­back on one of their top ex­per­i­men­tal drugs

The bad news keeps stacking up at Galapagos — which quite likely just lost control of a billion-dollar deal — and by extension their close partners at Gilead.

The biotech $GLPG reported after the bell Thursday that GLPG1972, one of their top development programs, flat failed a mid-stage study for osteoarthritis, flunking the primary and all secondary endpoints.

Testing 3 different doses of their drug, which relies on ADAMTS-5 inhibition, investigators concluded that none of them triggered a statistically significant response — as measured by cartilage thickness.

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IN8bio CEO William Ho (IN8bio)

Bring­ing their ge­net­i­cal­ly mod­i­fied gam­ma delta T cells to Nas­daq, IN8bio files for $86M IPO

The biotech IPO parade continues marching forward as 2020 turns toward the fourth quarter.

IN8bio, a New York-based company focused on genetically modified gamma delta T cell therapies, filed to go public Friday seeking an $86 million raise. The company has two clinical-stage candidates being studied in glioblastoma and leukemia, respectively.

By any stretch of the imagination, 2020 has already been a huge year for biotech, and nowhere does it appear more obvious than the vast amounts of companies hitting the public market.

News brief­ing: Ab­b­Vie and Roche's Ven­clex­ta scores an­oth­er FDA OK; Im­muno­Gen nabs Chi­na deal with $40M cash

AbbVie and Roche’s Venclexta has gotten a new FDA thumbs up.

The pair announced Monday that regulators have approved the drug in combination with azacitidine or low-dose cytarabine for newly-diagnosed acute myeloid leukemia in adults who are 75 or older or those who can’t undergo intensive chemotherapy. This follows the drug’s accelerated approval in 2018 and positive data from two Phase III confirmatory trials.