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.

From left to right: Lilian Kim, Associate Director Business Development; John Moller, CEO; Yooni Kim, Executive Director, Asia Operations; Michelle Park, Director South Korea Operations.

Novotech CRO sees 26% growth in Asia tri­al ac­tiv­i­ty from biotechs, but still plen­ty of ca­pac­i­ty

As the Asia-Pacific clinical trials sector continues to grow rapidly, Novotech the Asia-Pacific-based CRO is seeing biotech clinical activity up by 26%. But says there is still plenty of capacity in the region that features advanced medical facilities, supportive regulatory environments, and more than 2.3 billion people, largely treatment naïve, living in urban areas.

China, South Korea and Australia have the most studies registered as recruiting or about to recruit according to ClinicalTrials.Gov.

Pfizer, South San Francisco — Jeff Rumans for Endpoints News

UP­DAT­ED: Pfiz­er takes aim at a flag­ship fran­chise at Sanofi and Re­gen­eron — and scores a few di­rect hits

Count Pfizer in as a top player in the blockbuster game of JAK1 inhibitors.

Over the weekend the pharma giant posted some stellar Phase III efficacy data for their heavyweight contender abrocitinib in atopic dermatitis (eczema) that lines up ahead of a booming Dupixent (dupilumab), a blockbuster in the portfolios of Regeneron and Sanofi. And they put some real distance ahead of Eli Lilly’s trailing Olumiant, which made a delayed initial arrival on the market for rheumatoid arthritis after the FDA hobbled it with some additional hurdles on safety concerns.

JADE-MONO-1 scores well for Pfizer, teeing up what will be an intensely followed breakdown of the JADE MONO-2 data, which the pharma giant recently top-lined as “similar” to the first Phase III when tested against a placebo — a control group that has been easily outclassed by all the drugs in this market niche.

As of now, Pfizer looks to be equipped to run into the review stage — advantaged by a breakthrough therapy designation that is intended to speed up the regulatory process.

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A preda­tor's world? Top an­a­lyst sees the 'haves' and the 'haven't­s' di­verge as biotech bub­bles form — and col­lapse

Josh Schimmer

We’ve all seen the deluge of cash that’s been pouring into biotech from every angle: VCs, IPOs and follow-ons have generated billions in capital for new and emerging drug developers with ready access to some powerful new tech. But Evercore ISI’s Josh Schimmer is asking where we’re headed from here.

His answer is neither apocalyptic nor universally blissful, but if he’s right — and this is a discussion we’re hearing much, much more about at a time of growing economic and industry uncertainty — we may well be at a crossroads that could affect valuations, M&A and the entire global industry that has formed over the past 5 years.

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US mulls tar­iffs on Swiss drug ex­ports, weigh­ing on No­var­tis and Roche –  re­port

The leading Swiss newspaper has reported that the US is considering placing tariffs on pharmaceuticals from Switzerland. Roche and Novartis stock each fell 1% after the news broke.

Neue Zürcher Zeitung reported that US Trade Representative Robert Lighthizer told pharmaceutical representatives the Trump administration was considering the move. Tariffs do not appear to be in the immediate offing, but they would potentially affect Swiss giants Novartis and Roche along with other companies that manufacture in Switzerland, including Merck KGaA and US biotech Biogen, which is currently constructing a new facility in the country.

Neil Kumar, Endpoints

Bridge­Bio drops bid to re­claim Ei­dos af­ter di­rec­tors spurn 3 of­fers

A couple of months ago a newly public BridgeBio turned some heads by disclosing that it had made a bid for subsidiary Eidos Therapeutics in hopes of gobbling up the 34% stake that it doesn’t already own. Two offers later, the parties are calling it off.

A special committee of independent directors at the smaller biotech led by RA Capital’s Rajeev Shah and ex-Portola CEO William Lis first rejected the parent company’s initial offer — which would swap 1.3 BridgeBio shares for each Eidos share — on September 12. In the latest announcement, BridgeBio revealed that it eventually raised the offer to 1.5 shares and made $110 million available for all-cash or mixed consideration options, but Eidos still wasn’t interested.

Mark Foley, Revance

HR vi­o­la­tion push­es Re­vance co-founder out, vault­ing for­mer Zel­tiq chief to the helm

Months after Revance amended the terms of its Botox biosimilar collaboration with Mylan, the Newark, California-based drug developer disclosed its co-founder Dan Browne is stepping down, in what appears to be mysterious circumstances.

The company — which is also developing a rival to Allergan’s formidable Botox franchise — on Monday said Browne is departing “due to misjudgment in handling an employee matter,” that has also culminated in his resignation from Revance’s board of directors.

In-house FDA re­view flags a sus­pi­cious im­bal­ance in deaths as Sh­iono­gi hunts an OK for an­tibi­ot­ic

Shionogi has some big questions to answer if they plan to win an FDA panel’s backing for their new antibiotic.

While investigators have provided positive efficacy data for their new product to treat cases of complex urinary tract infections, an FDA review has flagged an imbalance of deaths between the antibiotic and a control arm. And they want the agency’s outside advisers to take a good hard look at that when they meet on Wednesday.

Cell ther­a­py start­up rais­es $16 mil­lion to fund its quest for the Holy Grail in re­gen­er­a­tive med­i­cine

In 2006, Shinya Yamanaka shook stem cell research with his discovery that mature cells can be converted into stem cells, relieving a longstanding political-ethical blockage and throwing open medical research on everything from curbing eye degeneration to organ printing.

But that process still has pitfalls, including in risk and scalability, and some researchers are exploring another way first hinted at years ago: new technology to convert mature cells directly into other mature cells without the complex and time-consuming process of first making them into stem cells.

Eye­ing $86M, Galera leads a pack of three mod­est biotech IPOs push­ing past high pro­file stum­bles

Exactly one year after kicking off a pivotal Phase III study for its lead drug — a companion for cancer patients receiving radiotherapy — Galera is looking to the Nasdaq for some new cash to complete the clinical work and fuel its commercial drive.

CEO Mel Sorensen has penciled in an $86 million ask, which was filed on the same day as liver disease company 89bio and rare disease diagnostics shop Centogene. The trio marks the first batch of IPO filings in the wake of two highly anticipated but ultimately disappointing public debuts by BioNTech and Vir, signaling dwindling biotech fervor on Wall Street. 89bio and Centogene are seeking $70 million and $69 million, respectively.