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.

Biotech in­vestors and CEOs see two paths to growth, but are they equal­ly vi­able?

The dynamic in the biotech market has been highly volatile in the last few years, from the high peaks immediately after the COVID vaccine in 2021, to the lowest downturns of the last 20 years in 2022. This uncertainty makes calling the exact timing of the market’s turn something of a fool’s errand, according to Dr. Chen Yu, Founder and Managing Partner of TCG Crossover (TCG X). He speaks with RBC’s Noël Brown, Head of US Biotechnology Investment Banking, about the market’s road ahead and two possible paths for growth.

Dave Marek, Myovant CEO

My­ovant board balks as ma­jor­i­ty own­er Sum­it­o­mo swoops in with a $2.5B deal to buy them out

Three years after Sumitomo scooped up Roivant’s 46% stake in the publicly traded Myovant $MYOV as part of a 5-company, $3 billion deal, they’re coming back for the whole thing.

But these other investors at Myovant want more than what the Japanese pharma company is currently offering to pay at this stage.

Sumitomo is bidding $22.75 a share for the outstanding stock, which now represents 48% of the company after Sumitomo bumped its ownership since the original deal with Roivant. Myovant, however, created a special committee on the board, and they’re shaking their heads over the offer.

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Justin Klee (L) and Joshua Cohen, Amylyx co-CEOs (Cody O'Loughlin/The New York Times; courtesy Amylyx)

Ad­vo­cates, ex­perts cry foul over Amy­lyx's new ALS drug, cit­ing is­sues with price, PhI­II com­mit­ment

Not 24 hours after earning the first ALS drug approval in five years, Amylyx Pharmaceuticals’ Relyvrio is already drawing scrutiny. And it’s coming from multiple fronts.

In an investor call Friday morning, Amylyx revealed that it would charge about $158,000 per year, a price point that immediately drew backlash from ALS advocates and some outside observers. The cost reveal had been highly anticipated in the immediate hours after Thursday evening’s approval, though Amylyx only teased Relyvrio would cost less than previously approved drugs.

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Albert Bourla, Pfizer CEO (Gian Ehrenzeller/Keystone via AP)

Can a smart­phone app de­tect Covid? Pfiz­er throws down $116M to find out

What can a cough say about a patient’s illness? Quite a bit, according to ResApp Health — and Pfizer’s listening.

The pharma giant is shelling out about $116 million ($179 million AUD) to scoop up the University of Queensland spinout and its smartphone technology that promises to diagnose Covid and other respiratory illnesses based on cough and breathing sounds, the university announced last week.

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Big Phar­ma heavy­weights seek tweaks to FDA's clin­i­cal out­come as­sess­ment guid­ance

Pfizer, GSK, Janssen, Regeneron, Boehringer Ingelheim and at least a half dozen other companies are calling on the FDA to provide significantly more clarity in its draft guidance from this summer on clinical outcome assessments, which are a type of patient experience.

The draft is the third in a series of four patient-focused drug development guidance documents that the FDA had to create as part of the 21st Century Cures Act, and they describe how stakeholders (patients, caregivers, researchers, medical product developers and others) can collect and submit patient experience data and other relevant information for medical product development and regulatory decision-making.

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Rob Etherington, Clene CEO

Star­tup's gold nanocrys­tal ALS drug flops a PhII tri­al, a re­minder of the dis­ease's ob­sta­cles de­spite Amy­lyx OK

Despite the FDA approving an ALS drug for the first time in five years last week, the disease continues to fluster researchers, and another biotech is feeling the pain of a mid-stage failure.

Clene Nanomedicine reported early Monday that its ALS program, which uses gold nanocrystals to try to catalyze intracellular reactions, did not achieve its Phase II primary or secondary endpoints. And in a press release, the company noted for the first time that it’s speaking with “potential strategic partners” about the program — language that typically indicates a biotech is preparing to sell off an asset.

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Marc Dunoyer, Alexion CEO (AstraZeneca via YouTube)

Up­dat­ed: As­traZeneca nabs a small rare dis­ease gene ther­a­py play­er for 667% pre­mi­um

AstraZeneca is kicking off the fourth quarter with a little M&A Monday for a gene editing player recently overcoming a second clinical hold to its only program in human studies.

The Big Pharma and its subsidiary Alexion are buying out little LogicBio for $2.07 per share. That’s good for a massive 667% premium over its Friday closing price, when it headed into the weekend at 27 cents and just weeks after Nasdaq said LogicBio would have to delist, which has been put on hold as the biotech requests a hearing. It’s one of two biotech deals to commence October, alongside the news of Incyte buying a vitiligo-focused biotech.

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Land­mark Amy­lyx OK spurs de­bate; Some... pos­i­tive? Alzheimer's da­ta; Can­cer tri­al bot­tle­neck; Sanofi's CRISPR bet; and more

Welcome back to Endpoints Weekly, your review of the week’s top biopharma headlines. Want this in your inbox every Saturday morning? Current Endpoints readers can visit their reader profile to add Endpoints Weekly. New to Endpoints? Sign up here.

After brief stops in Paris and Boston, John Carroll and the Endpoints crew are staying on the road in October with their return for a live/streaming EUBIO22 in London. The hybrid event fireside chats and panels on mRNA, oncology and the crazy public market. We hope you can join him there.

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An­oth­er warn­ing let­ter for Lupin as FDA iden­ti­fies de­fi­cien­cies at In­dia-based site

With few new details of what needs fixing, Lupin disclosed last week that the FDA recently sent a warning letter to its Tarapur, India-based site.

After an inspection from March 22 to April 4, Lupin disclosed in an April stock filing that it received a Form 483 with four observations, but it didn’t offer any details on the observations.

Similar to comments made in April, the company said last week it does not believe the FDA slap will disrupt its drug supplies or the existing revenues from operations of this facility.

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