Two months af­ter ink­ing a SPAC deal, Ren­o­va­cor taps new CMO; Cure­Vac reels in a new de­vel­op­ment chief from Mer­ck KGaA

Marc Sem­i­gran

Marc Sem­i­gran was at sleep­away camp in Hopewell Junc­tion, NY, when Neil Arm­strong took the first steps on the moon. He packed in­to a so­cial hall with a cou­ple of hun­dred kids whose eyes were glued to one small, stat­icky, black-and-white tele­vi­sion as Arm­strong de­scend­ed the lad­der.

It sparked an in­ter­est in physics for Sem­i­gran whose fo­cus lat­er turned to med­i­cine be­cause he want­ed to help peo­ple. That, and “I’m prob­a­bly too tall, I don’t think I would have made it as an as­tro­naut,” he quipped.

He went on to Har­vard Med­ical School, then an in­tern­ship and res­i­den­cy at the renowned Mass­a­chu­setts Gen­er­al Hos­pi­tal. His car­di­ol­o­gy work there even­tu­al­ly led to a gig as CMO of MyoKar­dia, where he stayed un­til the com­pa­ny was bought out by Bris­tol My­ers Squibb for a whop­ping $13.1 bil­lion last year. And now, he’s tak­ing the same role at gene ther­a­py-fo­cused Ren­o­va­cor, just as the com­pa­ny pre­pares to go pub­lic on the back of a SPAC.

“Some­thing that re­al­ly re­as­sured me about my de­ci­sion was that we will have the funds to be able to car­ry out the sci­en­tif­ic mis­sion,” he said. Up­on clos­ing its deal with the blank-check com­pa­ny Chardan Health­care Ac­qui­si­tion 2 Corp, Ren­o­va­cor is set to pock­et gross pro­ceeds of up to $116 mil­lion.

Sem­i­gran joined MyoKar­dia back in 2016, where he over­saw Phase I and II stud­ies and the de­sign of reg­is­tra­tional stud­ies, worked with reg­u­la­tors, and helped file the NDA for mava­camten — MyoKar­dia’s drug for ob­struc­tive car­diomy­opa­thy. In 2019, Sem­i­gran was pro­mot­ed to se­nior VP of med­ical sci­ences. The FDA set a de­ci­sion date of Jan. 28, 2022, for mava­camten, the same year that Ren­o­va­cor is hop­ing to get IND clear­ance for REN-001, its gene ther­a­py for BAG3-as­so­ci­at­ed di­lat­ed car­diomy­opa­thy (DCM).

“It would be great,” he said, if one of his drugs gets ap­proved in the same year that an­oth­er en­ters the clin­ic.

“So many of our ther­a­pies for heart fail­ure re­al­ly ad­dress man­i­fes­ta­tions of heart fail­ure, rather than the pri­ma­ry un­der­ly­ing prob­lem,” Sem­i­gran said. “Dif­fer­en­ti­at­ing by cause is re­al­ly what we need to do with heart fail­ure…  Both REN-001 and mava­camten ad­dress very dif­fer­ent seg­ments of the heart fail­ure pop­u­la­tion, and we need them both.”

BAG3 pro­tein is ex­pressed pre­dom­i­nant­ly in the heart, where it plays a role in the main­te­nance of sar­com­eres, nor­mal­iza­tion of pro­tein qual­i­ty con­trol, in­hi­bi­tion of pro­grammed cell death, and re­spon­sive­ness to adren­er­gic sig­nals. BAG3 DCM has an av­er­age on­set at 38 years old, and a sur­vival rate of less than 50% five years af­ter dis­cov­ery.

“Cer­tain­ly, our first and pri­ma­ry tar­get is to ad­dress the pa­tients with the ge­net­ic mu­ta­tions in BAG3. But as we learn more from treat­ing these pa­tients, there may be the pos­si­bil­i­ty of ex­pan­sion to oth­er heart fail­ure pa­tients,” Sem­i­gran said, or even oth­er or­gans. — Nicole De­Feud­is

Klaus Ed­vard­sen

Cure­Vac, the run­ner up mR­NA com­pa­ny mak­ing a new vac­cine for Covid-19, has poached their new de­vel­op­ment chief from Mer­ck KGaA.

The Ger­man biotech re­port­ed it re­cruit­ed Mer­ck KGaA’s Klaus Ed­vard­sen for chief de­vel­op­ment of­fi­cer. Ed­vard­sen had been head of on­col­o­gy for the Ger­man Mer­ck, mak­ing him a good cul­tur­al fit with Cure­Vac. He had ear­li­er served a stint as head of on­col­o­gy de­vel­op­ment at As­traZeneca and had worked at GSK and Gen­mab be­fore that.

He has a tremen­dous back­ground, hav­ing led both busi­ness de­vel­op­ment and clin­i­cal re­search on a glob­al scale for sev­er­al high-pro­file bio­phar­ma­ceu­ti­cal com­pa­nies. His great breadth of knowl­edge and ex­per­tise in re­search and dif­fer­ent ther­a­peu­tic ar­eas will serve Cure­Vac well as it con­tin­ues to evolve from a re­search-ori­ent­ed biotech­nol­o­gy to a ful­ly in­te­grat­ed bio­phar­ma­ceu­ti­cal com­pa­ny,” ob­served Jean Stéphenne, chair­man of the su­per­vi­so­ry board of Cure­Vac. — John Car­roll

Nurix Ther­a­peu­tics is cel­e­brat­ing the ad­di­tion of its newest board mem­ber, and it’s reeled in a high-pro­file biotech CEO.

Clay Sie­gall

Clay Sie­gall of Seagen is hop­ping on­to the board, Nurix an­nounced this week, join­ing the pro­tein degra­da­tion play­er that’s se­cured part­ner­ships with Gilead and Sanofi. The move comes as Nurix is ex­pect­ed to launch clin­i­cal stud­ies for three prod­uct can­di­dates some­time be­fore the end of the year.

Sie­gall made his name by found­ing Seagen as Seat­tle Ge­net­ics way back in 1998, and has trans­formed it in­to one of the larg­er biotechs in the US. Un­der Sie­gall’s lead­er­ship, Seagen has shep­herd­ed three drugs past the fin­ish line with the po­ten­tial for a fourth in Oc­to­ber.

It’s pinned block­buster hopes on one of its drugs, the Nectin-4 tar­get­ing ther­a­py Pad­cev, which saw sales more than dou­ble to $69.8 mil­lion in the first quar­ter in 2021 com­pared to 2020.

Sie­gall him­self has made a pret­ty pen­ny as the com­pa­ny’s chief ex­ec­u­tive, pulling in a $16.5 mil­lion pay pack­age last year — a fig­ure that ap­proach­es some of the biggest names in phar­ma. It’s al­so the largest pack­age for any CEO in the state of Wash­ing­ton, ac­cord­ing to an As­so­ci­at­ed Press re­port.

Nurix, mean­while, is con­tin­u­ing to charge ahead with its pipeline. The pro­grams ex­pect­ed to hit Phase I stud­ies soon com­prise a small mol­e­cule de­grad­er of BTK called NX-5948, and with it, Nurix hopes to tar­get au­toim­mune dis­eases. There are al­so two lig­ase in­hibitors where Nurix is go­ing af­ter an im­muno-on­col­o­gy tar­get and tu­mor in­fil­trat­ing lym­pho­cytes, re­spec­tive­ly.

Their lead can­di­date is a dual de­grad­er of both BTK and Aio­los, a pro­tein tar­get of IMiD drugs, known as NX-2127. It re­cent­ly be­gan its own clin­i­cal tri­al, the first Nurix has launched.

In ad­di­tion to Nurix’s board, Sie­gall al­so serves on the boards of Ul­tragenyx and Wash­ing­ton Round­table, a lob­by­ist group com­pris­ing sev­er­al ex­ec­u­tives from the state. — Max Gel­man

Ronald Martell

→ Pri­vate plat­form com­pa­ny Mor­phim­mune has se­lect­ed Ronald Martell as the com­pa­ny’s new CEO and pres­i­dent. The new stint at the San Fran­cis­co-based com­pa­ny isn’t Martell’s first rodeo in the CEO chair. Martell was pre­vi­ous­ly run­ning gigs at Nu­ve­la­tion Phar­ma, Achieve Life Sci­ences, Se­vion and Neu­ro­gesX. Ad­di­tion­al­ly, Martell was co-founder and ex­ec­u­tive chair­man of In­dap­ta and Or­ca Bio. Ear­li­er in his ca­reer, Martell was with Genen­tech and Im­Clone Sys­tems, where he was mak­ing deals with Bris­tol My­ers Squibb and Mer­ck KGaA.

Ste­fan König, the for­mer Take­da VP and glob­al fran­chise head, in­flam­ma­to­ry bow­el dis­ease, has hopped in­to the CEO seat at George Med­i­cines. In his most re­cent role at Take­da, König was re­spon­si­ble for En­tyvio (vedolizum­ab). König’s ear­li­er roles at Take­da in­clud­ed re­gion­al man­ag­ing di­rec­tor for a clus­ter of coun­tries in Cen­tral and East­ern Eu­rope. In ad­di­tion, König spent 10 years in Mex­i­co and Latin Amer­i­ca work­ing in busi­ness and cor­po­rate de­vel­op­ment and mar­ket­ing for Mer­ck and No­var­tis.

Deci­bel Ther­a­peu­tics has added a new chair­man as it con­tin­ues a now-more-than-year­long piv­ot to gene ther­a­py and re­gen­er­a­tion.

William Car­son

The Cam­bridge biotech named William Car­son, for­mer CEO of Ot­su­ka Phar­ma­ceu­ti­cals, as chair. Car­son will serve as a de­layed re­place­ment for for­mer Bio­gen CEO George Scan­gos, a long­time col­league of Steve Holtz­man, Deci­bel’s for­mer chief ex­ec­u­tive. Deci­bel qui­et­ly dis­closed in their S-1 this Jan­u­ary that Scan­gos had re­signed from the board in June 2020, five months af­ter Holtz­man re­tired and the com­pa­ny shift­ed fo­cus.

Car­son, a psy­chi­a­trist, served on the board at Pre­vail be­fore its buy­out by Eli Lil­ly and is now on the boards at Saa­ma Tech­nolo­gies, An­nex­on, Ot­su­ka and Ex­ci­sion Bio­ther­a­peu­tics. His ap­point­ment comes amid a se­ries of changes Deci­bel has made to bur­nish its cre­den­tials, most re­cent­ly ex­pand­ing its sci­en­tif­ic ad­vi­so­ry board with a clutch of well-re­gard­ed gene ther­a­py and hear­ing ex­perts.

Patrick Flani­gan is hop­ping aboard Nan­cy Thorn­ber­ry’s gut-brain ax­is biotech Kally­ope as CFO. Flani­gan joins the crew from Ich­nos Sci­ences, where he al­so served as CFO. Flani­gan jump­start­ed his ca­reer at Gen­zyme, where he served as VP of in­vestor re­la­tions be­fore hop­ping over to Cel­gene as SVP.

Nanobi­otix has ush­ered in a new CFO two days pri­or to pre­sent­ing some pos­i­tive ear­ly da­ta at #AS­CO21 for their tu­mor-shrink­ing tech. Bart Van Rhi­jn, who joins the com­pa­ny af­ter a stint as CFO of Servi­er Phar­ma­ceu­ti­cals, will be suc­ceed­ing out­go­ing CFO Philippe Mauber­na. Pri­or to his role at Servi­er, Van Rhi­jn was with Price­wa­ter­house­C­oop­ers, Philips and Gal­der­ma. Ad­di­tion­al­ly, Van Rhi­jn has been ap­point­ed to the com­pa­ny’s ex­ec­u­tive board.

Mol­ly Gib­son

→ AI biotech Gen­er­ate Bio­med­i­cines has reeled in Mike No­haile as CSO. No­haile hails from Flag­ship Pi­o­neer­ing, where he served as op­er­at­ing part­ner. Pri­or to Flag­ship, No­haile was with Am­gen, where he served as SVP of strat­e­gy, com­mer­cial­iza­tion, and in­no­va­tion.

In ad­di­tion to No­haile’s ap­point­ment, Mol­ly Gib­son — who was hon­ored in our 2020 20 un­der 40 spe­cial — will be ex­pand­ing her role at Gen­er­ate, tack­ing on new re­spon­si­bil­i­ties as chief strat­e­gy and in­no­va­tion of­fi­cer. Pri­or to Gen­er­ate, Gib­son, who is a prin­ci­pal of Flag­ship Pi­o­neer­ing, led com­pu­ta­tion­al bi­ol­o­gy at Kalei­do Bio­sciences.

Valen­z­aBio — whose on­col­o­gy is­land of mis­fit toys snared $70 mil­lion in April — has waved in Gre­go­ry Keenan as CMO. Keenan joins the Bethes­da, MD-based team from Avro­bio, where he served as SVP, glob­al head of med­ical and drug safe­ty. Pri­or to that, he served in stints at As­traZeneca, Med­im­mune, Hu­man Genome Sci­ences and Cen­to­cor Or­tho­Biotech.

In ad­di­tion to Keenan’s ap­point­ment, the crew has al­so wel­comed CEO of Ri­bometrix Mike Solomon in­to the fold as part of its board of di­rec­tors. Solomon was a for­mer ven­ture part­ner of SV Health In­vestors; COO of Deci­bel Ther­a­peu­tics, and en­tre­pre­neur in res­i­dence at Third Rock Ven­tures among oth­er stints.

Michael MacLean

→What bet­ter way to prep for an IPO than adding a well-re­gard­ed CFO to your board? Verve Ther­a­peu­tics, Sekar Kathire­san’s car­dio­vas­cu­lar gene-edit­ing start­up, an­nounced they had named Michael MacLean, for­mer CFO of Avid­i­ty Bio­sciences, to its board. In ad­di­tion to Avid­i­ty, MacLean has al­so worked as CFO of PureTech and Io­n­is spin­out Akcea. Verve has pen­ciled in $100 mil­lion for their pub­lic of­fer­ing, al­though they are wide­ly ex­pect­ed to raise sig­nif­i­cant­ly more.

David Hung has re­cruit­ed a sup­ply chain ex­pert to en­sure that the can­cer drugs he’s de­vel­op­ing at Nu­va­tion Bio will be ready when­ev­er he needs them. As chief tech­ni­cal op­er­a­tions of­fi­cer, David Han­ley is tasked with over­see­ing every­thing from prod­uct de­vel­op­ment to man­u­fac­tur­ing, while al­so work­ing on com­mer­cial plan­ning with oth­er teams — in short, ded­i­cat­ed to prod­uct readi­ness at all stages, whether it be pre­clin­i­cal or mar­ket­ing. He joins from Ra­dius Health just as Nu­va­tion is push­ing a Phase I/II study of the lead can­di­date, which tar­gets CDK 2/4/6, and lin­ing up five oth­ers for the clin­ic.

Wayne God­frey

→ While aim­ing for an IPO af­ter com­ing off the press­es with a $1 bil­lion deal with Mer­ck, Janux Ther­a­peu­tics has se­lect­ed Wayne God­frey as CMO. God­frey comes from IGM Bio­sciences, where he served as VP of clin­i­cal de­vel­op­ment. Be­fore that, he was with Kite Phar­ma, Etubics, Gilead and Bavar­i­an-Nordic.

→ Be­lea­guered biotech On­cono­va Ther­a­peu­tics — which axed its high-risk MDS pro­gram af­ter an­oth­er PhI­II flop — has named Mark Gelder as CMO. Gelder hops aboard from El­e­var Ther­a­peu­tics, where he served in the same role. Pri­or to El­e­var, Gelder was work­ing with Pier­ian Bio­sciences, Ac­celo­vance, Heron Ther­a­peu­tics, Pfiz­er, Wyeth and Bay­er.

→ Launched by Fra­zier Health­care Part­ners last May with a $15 mil­lion Se­ries A, San Diego-based on­col­o­gy drug de­vel­op­er Lengo Ther­a­peu­tics has made Di­ana Haus­man CMO. Haus­man comes aboard af­ter a stint as CMO for Zymeworks. Pri­or to that, she served at Zy­mo­Ge­net­ics, Berlex and Im­munex. Haus­man’s ap­point­ment comes three weeks af­ter Lengo snagged the CEO of Velos­Bio Dave John­son as chair­man of the board.

Di­ana Haus­man

Evelo Bio­sciences has ap­point­ed Mark Plinio as CCO. Plinio comes to Evelo from Iron­wood Phar­ma­ceu­ti­cals, where he was CCO and SVP, mar­ket­ing and sales. Pri­or to his gig at Iron­wood, Plinio spent near­ly two decades at No­var­tis in a va­ri­ety of roles in­clud­ing head of der­ma­tol­ogy and rheuma­tol­ogy mar­ket­ing for Cosen­tyx.

JSR Life Sci­ences com­pa­ny Se­lex­is has named Roland Hoff­mann-Hecht as CBO. Hoff­mann-Hecht hails from Pol­phar­ma Bi­o­log­ics, where he was head of busi­ness de­vel­op­ment, CD­MO Eu­rope. Pri­or to that, he held roles at Hal­ix, BIO­ME­VA GmbH, CMC Bi­o­log­ics and Rentschler Biotech­nolo­gie GmbH.

Wan-Jen Hong

Blood can­cer play­er Ima­go Bio­sciences has ap­point­ed Wan-Jen Hong as CMO. Hong hails from Genen­tech, where she served as group med­ical di­rec­tor. Hong pre­vi­ous­ly was a clin­i­cal in­struc­tor in hema­tol­ogy at Stan­ford Uni­ver­si­ty School of Med­i­cine and is the cur­rent ad­junct clin­i­cal fac­ul­ty mem­ber in its di­vi­sion of hema­tol­ogy.

→ Af­ter emerg­ing from stealth mode last June with $118 mil­lion in its pock­et from Red­mile Group and over 10 oth­er in­vestors, Shat­tuck Labs has bagged Ab­hi­nav Shuk­la as chief tech­ni­cal of­fi­cer. Shuk­la joins the Austin, TX-based team from Red­pin Ther­a­peu­tics, hav­ing served as chief tech­ni­cal op­er­a­tions of­fi­cer. Pri­or to that, Shuk­la was with CRISPR Ther­a­peu­tics, Shire, Bris­tol My­ers, Am­gen and KBI Bio­phar­ma.

→  A cou­ple of months af­ter emerg­ing from stealth mode with a $100 mil­lion Se­ries B round and a mis­sion to out­smart can­cer re­sis­tance, The­seus Phar­ma­ceu­ti­cals has tapped Brad Dahms as its new CFO. The for­mer in­vest­ment banker is com­ing from Se­lec­ta Bio­sciences, where he re­cent­ly led a $730 mil­lion agree­ment to li­cense the com­pa­ny’s chron­ic re­frac­to­ry gout treat­ment to So­bi. Be­fore that, Dahms was a se­nior VP in the health­care group at Can­tor Fitzger­ald & Co., and held roles at RBC Cap­i­tal Mar­kets and JP Mor­gan. The­seus, backed by Or­biMed, says it will use the Se­ries B to ad­vance a suite of “pan-vari­ant” TKIs, in­clud­ing a lead com­pound tar­get­ing KIT-mu­tant gas­troin­testi­nal stro­mal tu­mors.

John Maslows­ki

→ Forge Bi­o­log­ics has reeled in John Maslows­ki in­to the new role of CCO. Maslows­ki jumps aboard from Cas­tle Creek Bio­sciences, where he was pres­i­dent and CEO. He served in the same role at Fi­bro­cell Sci­ence and had gigs at Wyeth, Mer­ck and Te­va. Maslows­ki was al­so the for­mer chair­man of the board of di­rec­tors at Fal­con Ther­a­peu­tics.

Ovid Ther­a­peu­tics is ex­pand­ing CBO’s Jef­frey Rona’s re­spon­si­bil­i­ties to in­clude the role of CFO. Rona joined the com­pa­ny in Oc­to­ber 2020. Pri­or to Ovid, Rona was head­ing op­er­a­tions at Dan­forth Ad­vi­sors as West­ern re­gion man­ag­ing di­rec­tor. Be­fore that, he was run­ning gigs as an ex­ec at GlobeIm­mune, Al­go­Rx Phar­ma­ceu­ti­cals and Great Basin Sci­en­tif­ic.

Jeff Rona

→ AI-based di­ag­nos­tic soft­ware in pathol­o­gy com­pa­ny Paige has ap­point­ed co-founder David Klim­stra as CMO. Klim­stra is cur­rent­ly the chair of the de­part­ment of pathol­o­gy at Memo­r­i­al Sloan Ket­ter­ing Can­cer Cen­ter.

→  NEXGEL, a provider of hy­dro­gels for health­care and con­sumer ap­pli­ca­tions, has brought in Adam Drapczuk as CFO. Pri­or to his new role at NEXGEL, Drapczuk was fi­nan­cial con­troller for R-Pharm US. Drapczuk has al­so had stints at In­pel­lis, Tris Phar­ma and West-Ward Phar­ma­ceu­ti­cals.

→ Mer­ck KGaA has wel­comed a fresh slate of faces with the ap­point­ments of Amy Ma­h­ery as SVP, head of the neu­rol­o­gy and im­munol­o­gy glob­al busi­ness fran­chise; Jan Klatt as SVP, head of the de­vel­op­ment unit neu­rol­o­gy & im­munol­o­gy; and Amy Kao as head of trans­la­tion­al in­no­va­tion plat­form im­munol­o­gy.

Ma­h­ery pre­cious­ly served on the glob­al mar­ket ac­cess team at Mer­ck KGaA and serves as the health­care rep­re­sen­ta­tive on the Mer­ck di­ver­si­ty coun­cil. Mean­while, Klatt comes to the team from No­var­tis, where he most re­cent­ly served as glob­al pro­gram head, heart fail­ure. Fi­nal­ly, Kao comes aboard from Bio­gen, where she worked in ear­ly clin­i­cal de­vel­op­ment in im­munol­o­gy.

→ Irish drug de­vel­op­er Avadel Phar­ma­ceu­ti­cals — which saw its stock shoot up near­ly 33% on nar­colep­sy da­ta last April — has made a slew of new hires with the ap­point­ments of Jeff Cruik­shank as VP, sales; Denise Strauss as VP, mar­ket­ing and new prod­uct strat­e­gy and An­gela Woods as VP, peo­ple and cul­ture.

Denise Strauss

Cruik­shank comes to the com­pa­ny with ex­pe­ri­ence from Iron­wood Phar­ma­ceu­ti­cals, No­var­tis and Janssen Phar­ma­ceu­ti­cals un­der his belt. Mean­while, Strauss brings in her own ex­per­tise from her times at Gen­fit, Pfiz­er, Scher­ing-Plough and Boehringer In­gel­heim. Last but not least, Woods for­mer­ly served as VP, hu­man re­sources at Mallinck­rodt.

Athi­ra Phar­ma, go­ing af­ter one of phar­ma’s trick­i­est fields in Alzheimer’s dis­ease, has a new top lawyer. The Seat­tle-based biotech has tapped Mark Wor­thing­ton as their gen­er­al coun­sel, where he comes af­ter a 24-year stint at Sum­mit Law Group. Athi­ra went pub­lic in a $200 mil­lion-plus IPO in Sep­tem­ber 2020, and CEO Leen Kawas said in a state­ment that Wor­thing­ton will be in­volved in “busi­ness growth and strate­gic plans.”

Im­mu­nic — whose lead drug failed to im­press in 2 sep­a­rate tri­als — has ap­point­ed In­der­pal Singh as gen­er­al coun­sel. Singh joins the com­pa­ny from San­doz In­ter­na­tion­al GmbH, where he was glob­al le­gal head of bio­phar­ma. Pri­or to San­doz, Singh was with Mer­ck KGaA, Bio­gen Idec, Pfiz­er Deutsch­land GmbH and Pfiz­er.

→ Health­care in­vestor Gilde Health­care has snagged Joep Mui­jr­ers to the in­vest­ment team of its Ven­ture & Growth cap­i­tal fund. Mui­jr­ers will be re­spon­si­ble for Gilde’s in­vest­ments in pub­licly-trad­ed com­pa­nies fo­cused on ther­a­peu­tics, healthtech and med­ical de­vices in Eu­rope and the US. Mui­jr­ers for­mer­ly served as CFO and chief of port­fo­lio strat­e­gy at PureTech Health.

→ Med­ical de­vice Co Avisa Di­ag­nos­tics has added Bar­bara Bunger to its ex­ec­u­tive team in the new­ly cre­at­ed po­si­tion of VP, clin­i­cal de­vel­op­ment. Pri­or to her new role, Bunger served in roles at Clin­i­cal De­vel­op­ment and Reg­u­la­to­ry Ser­vicesBeck­ton Dick­in­son and Medtron­ic Spine & Bi­o­log­ics among oth­ers.

Mic­ki Klear­man

→ San Fran­cis­co’s Kezar Life Sci­ences — which bagged an $86.3 IPO back in 2018 — has en­list­ed Mic­ki Klear­man to its board of di­rec­tors. Klear­man brings to the board her ex­pe­ri­ence from her time at Genen­tech/Roche, where she served as group med­ical di­rec­tor in im­munol­o­gy.

→ Mel­bourne-based Opthea is bring­ing in Ju­lia Haller and Ju­dith Robert­son as in­de­pen­dent non-ex­ec­u­tive di­rec­tors to its board of di­rec­tors. Haller serves as pro­fes­sor and chair of the de­part­ment of oph­thal­mol­o­gy at Sid­ney Kim­mel Med­ical Col­lege at Thomas Jef­fer­son Uni­ver­si­ty. She al­so sits on the board of Bris­tol My­ers and is pres­i­dent of the John Hop­kins Med­ical and Sur­gi­cal As­so­ci­a­tion. Mean­while, Robert­son most re­cent­ly served as CCO of Eleu­sis and was the for­mer CCO of Aerie Phar­ma­ceu­ti­cals. Be­fore Arie, Robert­son was serv­ing at J&J, Janssen, BMS and No­var­tis.

Liz Cer­mak

Neu­rana Phar­ma­ceu­ti­cals — fo­cused on the treat­ment of neu­ro­mus­cu­lar con­di­tions — has brought in Geor­gia Er­bez and J&J vet Eliz­a­beth (Liz) Cer­mak to its board of di­rec­tors. Er­bez is the cur­rent CFO of Har­poon Ther­a­peu­tics and for­mer­ly head­ed lead­er­ship roles at Zosana Phar­ma, As­te­r­ias Bio­ther­a­peu­tics and Rap­tor Phar­ma­ceu­ti­cals. On the oth­er hand, Cer­mak cur­rent­ly sits on the boards of Mol­e­culin Biotech, Que On­col­o­gy and Clarus Ther­a­peu­tics. Cer­mak’s pre­vi­ous ex­pe­ri­ence in­cludes roles at SteadyMed Ther­a­peu­tics and POZEN.

Ab­b­Vie-part­nered I-Mab has tapped two ex­perts in Chi­na’s reg­u­la­to­ry land­scape to its board of di­rec­tors. Ruyi He, now CSO at Re­meGen, used to be the chief sci­en­tist at the Na­tion­al Med­ical Prod­ucts Ad­min­is­tra­tion’s Cen­ter for Drug Eval­u­a­tion, while Rong Shao is a pro­fes­sor drug ad­min­is­tra­tion poli­cies and reg­u­la­tions, Chi­na Phar­ma­ceu­ti­cal Uni­ver­si­ty.

Ruyi He

→ Men­lo Park, CA-based 180 Life Sci­ences has wel­comed Rus­sell Ray and Tere­sa DeLu­ca to its board of di­rec­tors. This is Ray’s sec­ond board seat, he al­so sits on the board of Mer­ri­mack Phar­ma­ceu­ti­cals. Ray for­mer­ly served as man­ag­ing di­rec­tor and co-head of glob­al health care at Cred­it Su­isse First Boston Cor­po­ra­tion. Mean­while, DeLu­ca comes aboard with ex­pe­ri­ence from GSK, Med­co, Wal­greens, Hu­mana and Mag­el­lan.

Bio­com Cal­i­for­nia, the as­so­ci­a­tion rep­re­sent­ing the Cal­i­for­nia life sci­ence in­dus­try, has re­cruit­ed Juli Moran to its board of gov­er­nors and Paul Mo­la to its board of di­rec­tors. Moran is man­ag­ing part­ner and man­ag­ing di­rec­tor of De­loitte Con­sult­ing, while Mo­la is pres­i­dent, CEO and founder of Roswell Biotech­nolo­gies.

In­side Track: Be­hind the Scenes of a Ma­jor Biotech SPAC

Dr. David Hung and Michelle Doig are no strangers to the SPAC phenomenon. As Founder and CEO of Nuvation Bio, a biotech company tackling some of the greatest unmet needs in oncology, Dr. Hung recently took the company public in one of this year’s biggest SPAC related deals. And as Partner at Omega Funds, Doig not only led and syndicated Nuvation Bio’s Series A, but is now also President of the newly formed, Omega-sponsored, Omega Alpha SPAC (Nasdaq: OMEG; oversubscribed $138m IPO priced January 6, 2021).

Janet Woodcock, acting FDA commissioner (Al Drago/Bloomberg via Getty Images)

New Alzheimer's drug ap­proval fall­out: Pub­lic Cit­i­zen seeks re­moval of FDA's Wood­cock, Cavaz­zoni and Dunn

As Capitol Hill begins to wake up to the financial and scientific mess behind the FDA’s approval of Biogen’s new controversial Alzheimer’s drug Aduhelm, nonprofit watchdog Public Citizen is now calling for the top three FDA officials who are responsible to be removed from their positions.

In a letter to HHS Secretary Xavier Becerra on Wednesday, the group highlighted the “litany of flaws” in the FDA’s approval of the new drug, including the “unprecedented, inappropriately close” collaboration between the FDA and Biogen in the analysis of key trial data, basing approval on an unvalidated surrogate endpoint, not following the advice of its expert advisory committee (3 members of which have since resigned), and the wide label that the agency granted.

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Aus­tralian spin­out eyes the clin­ic with a pro­phy­lac­tic nasal spray for Covid-19

Whether patients are immunocompromised or just don’t like needles, one fledgling Australian biotech says it has an alternative to Covid-19 vaccines that doesn’t involve a jab in the arm — and on Tuesday, it pulled in a fresh round of funding to take it into the clinic.

ENA Respiratory, which spun out of ENA Therapeutics last year, has pulled in nearly $24.7 million (AU $30 million) to advance its nasal spray for respiratory viral infections, the company said Tuesday.

Someit Sidhu, JATT

An­oth­er life sci­ences SPAC has popped up from a small biotech CEO with the help of Take­da, No­var­tis vet­er­ans

Editor’s note: Interested in following biopharma’s fast-paced IPO market? You can bookmark our IPO Tracker here.

The SPAC train has slowed down since the extraordinarily high levels from late 2020 into early this year, but Tuesday saw the filing of a new blank-check company targeting the life sciences industry.

Jatt Acquisition submitted its SEC paperwork Tuesday, penciling in an estimated raise of $120 million as it sets its sights on a reverse merger partner. The SPAC is run by Someit Sidhu, a co-founder of Pathios Therapeutics, as well as CEO of Akaza Bioscience and Izana Bioscience. Sidhu will control about 97% of the blank-check company’s shares, per the S-1.

In a first, Re­gen­eron's an­ti­body cock­tail re­duces deaths for a sub­group of hos­pi­tal­ized Covid-19 pa­tients

Scientists have come up with the first evidence that Regeneron’s antibody cocktail, which has so far only been authorized for the outpatient setting, may reduce deaths of hospitalized Covid-19 patients — albeit only a subset.

The combination of casirivimab and imdevimab is the subject of the latest data cut from RECOVERY, the large-scale UK-based trial testing a variety of potential treatments. In total, 9,785 patients hospitalized with Covid-19 were enrolled in this arm of the study and were randomly assigned to receive either usual care plus the intravenous combo or usual care alone.

Barry Greene, Sage CEO

UP­DAT­ED: Sage's sec­ond chance at de­pres­sion hits the PhI­II pri­ma­ry, but ques­tions re­main over dura­bil­i­ty, side ef­fects

Looking to make a comeback after a big Phase III flop, Sage Therapeutics revealed data they believe could change the entire depression treatment landscape, given the vast array of failures in the field. But some results are spooking investors, sending Sage $SAGE shares down early Tuesday.

First, the primary: Sage and Biogen reported Phase III data for once-daily zuranolone Tuesday morning, saying the experimental drug hit its primary endpoint by spurring a statistically significant change from baseline in the 17-item Hamilton Rating Scale for Depression total score. After 15 days, patients in the drug arm saw an average change of -14.1 points, compared to -12.3 on placebo.

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Bio­gen sig­nals a big PhI­II fail­ure as the lead gene ther­a­py in their $800M Night­star buy­out goes down in flames

That $800 million buyout of Nightstar has turned into a bust for Biogen as the lead therapy in the deal failed a pivotal study, signaling a severe setback for the biotech’s ambitions in gene therapies.

The big biotech put out the word after the market closed on Monday that the gene therapy they picked up in the deal for a degenerative blindness called choroideremia failed the Phase III study, just a month after their #2 drug in the deal also flopped in a mid-stage study.

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CEO Harith Rajagopalan (Fractyl)

Af­ter a decade in the type 2 di­a­betes game, Fractyl Lab­o­ra­to­ries recharges with a fresh $100M and a new name

Harith Rajagopalan compared the way type 2 diabetes is managed to sticking your fingers in a dam that’s leaking from a number of places.

You can take drugs to lower your blood sugar, cholesterol, or blood pressure, but you’re not addressing what he says is the core issue — the metabolic abnormality that causes the disease.

“We’re so busy plugging the holes in the dam, we don’t have time to see that the whole infrastructure is at risk,” he said. “That infrastructure is a full-body systemic metabolic abnormality called metabolic syndrome, that we’re ignoring while we’re so busy trying to treat all of the individual symptoms of the condition.”

Michel Sade­lain puts his name and new cell en­gi­neer­ing tech be­hind 'ag­nos­tic' CAR-T start­up chas­ing epi­ge­net­ic anti­gens

It felt natural for Alain Maiore and Sebastian Amigorena to bring in Michel Sadelain as a co-founder of Mnemo Therapeutics. A CAR-T pioneer, Sadelain had been involved as an advisor since the early days — enthusiastic about Amigorena’s work in a genetic knockout that could enhance T cell memory and a new class of potential targets he’s discovered — and could introduce some well-known technologies to the toolbox. So they got the initial cash from Sofinnova Partners to plant roots in Paris and New York in early 2019; within a few months, they began to see more clearly just what the antigen discovery platform might unlock.

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