Trou­bled Unum re­brands as Co­gent Bio­sciences, re­places CEO Chuck Wil­son with An­drew Rob­bins; Jen­nifer Fox ap­point­ed as CFO at David Hung-led Nu­va­tion Bio

An­drew Rob­bins

→ Rife with tur­moil and hit with a bar­rage of FDA holds as it spi­raled in­to pen­ny-stock ter­ri­to­ry, Unum Ther­a­peu­tics hopes a new name — Co­gent Bio­sciences — and a new CEO can turn its for­tunes around. An­drew Rob­bins takes con­trol now and suc­ceeds Chuck Wil­son, who found­ed Unum in 2014.

The cell ther­a­py biotech stum­bled out of the gate when it de­buted on Nas­daq in 2018 and re­vealed that 2 of its 9 pa­tients died in one arm of their AC­TR087 tri­al. The FDA would hand down 3 dif­fer­ent holds, two for AC­TR087 and an­oth­er for its ex­per­i­men­tal ther­a­py AC­TR707. Adding in­sult to in­jury, Unum shed around 60% of its work­force and jet­ti­soned its old pipeline in fa­vor of a new one a few months ago.

Wil­son, whose last of­fi­cial day at work is to­day, is get­ting $860,737.50 in sev­er­ance pay, ac­cord­ing to an SEC fil­ing, payable over 18 months. And Rob­bins gets an op­tion on 7,442,421 shares $COGT at the cur­rent price which vest over 4 years along with an an­nu­al salary of $575,000 and a bonus up to 60% of that.

Rob­bins makes his way to Co­gent Bio­sciences from Ar­ray Bio­Phar­ma, where he was their COO from 2012 un­til Pfiz­er pur­chased the com­pa­ny in 2019. He’s al­so on the board of di­rec­tors at Har­poon Ther­a­peu­tics.

Jen­nifer Fox

Nu­va­tion Bio, whose CEO David Hung has just fash­ioned an $850 mil­lion SPAC deal merg­ing with Panacea, has brought on Jen­nifer Fox as their CFO. Fox has held lead­er­ship roles in in­vest­ment bank­ing with Deutsche Bank, Bear Stearns, Bank of Amer­i­ca and Pru­den­tial, and is join­ing Nu­va­tion Bio af­ter her tenure with Cit­i­Group as man­ag­ing di­rec­tor and co-head of their health­care cor­po­rate and in­vest­ment bank­ing group.

Richard Ad­cock

Patrick Soon-Sh­iong has hand­ed the CEO reins at Nan­tK­west to Richard Ad­cock, a first-time biotech ex­ec who was at the helm of Ver­i­ty Health Sys­tems be­fore mak­ing the switch. Soon-Sh­iong, a man whose lofty am­bi­tions are of­ten jux­ta­posed with un­even re­sults through­out his ca­reer, steps aside from the top job 5 years af­ter he took Nan­tK­west pub­lic, but he will stay on as ex­ec­u­tive chair­man. Our Ja­son Mast has more per­spec­tive on the tran­si­tion here and on Soon Sh­iong’s Covid-19 cru­sade here.

→ Speak­ing of Nan­tk­west, David Pyrce has been giv­en the nod as CEO of De­va­Cell, a syn­thet­ic vec­tor ther­a­peu­tics play­er out of San Diego. Pyrce was pre­vi­ous­ly Nan­tK­west’s SVP, strat­e­gy, in­no­va­tions and chief com­mer­cial of­fi­cer, and the GSK and Bio­Marin vet found­ed Ge­nom­ic Prin­ci­ples, where he was al­so chair­man and CEO.

Stream Bio­med­ical — fo­cused on the treat­ment of acute stroke and Alzheimer’s dis­ease — has tapped William Schwi­eter­man as its CEO. Schwi­eter­man comes aboard suc­ceed­ing Gary Gage, the com­pa­ny’s founder, who will con­tin­ue to serve as COO. Schwi­eter­man for­mer­ly served at the FDA’s Cen­ter for Bi­o­log­ics and has held roles at Chelsea Ther­a­peu­tics (ac­quired by Lund­beck), Ma­teon Ther­a­peu­tics (merged with On­cotel­ic) and Per­cep­tive Ad­vi­sors.

Min Wang

Ver­sant-backed Monte Rosa Ther­a­peu­tics, fly­ing high with $96 mil­lion in a Se­ries B an­nounced last month, has three new ap­point­ments with Min Wang, COO; Ajim Tam­boli, CFO; and Jul­lian Jones, SVP, head of busi­ness de­vel­op­ment. Wang, who just held the same po­si­tion at Blue­Rock Ther­a­peu­tics, was al­so SVP, gen­er­al coun­sel at Agios and se­nior patent coun­sel at Genen­tech and Mer­ck. Tam­boli helped guide the sale of Rodin Ther­a­peu­tics to Alk­er­mes when he was Rodin’s CFO. And Jones was pre­vi­ous­ly the se­nior di­rec­tor of on­col­o­gy busi­ness de­vel­op­ment at Eli Lil­ly. Be­fore that, she was in busi­ness de­vel­op­ment and li­cens­ing at Boehringer In­gel­heim.

→ Amass­ing a nice chunk of change ($133 mil­lion) over 3 rounds — in­clud­ing one for $50 mil­lion that was an­nounced in June — South San Fran­cis­co biotech Sur­rozen has brought on Charles Williams as CFO. Since 2013, Williams had been the head of cor­po­rate de­vel­op­ment at Jazz Phar­ma­ceu­ti­cals, and he oc­cu­pied lead­er­ship roles in cor­po­rate de­vel­op­ment and fi­nance at MAP Phar­ma­ceu­ti­cals and CV Ther­a­peu­tics. Sur­rozen has 2 IND can­di­dates, one for liv­er dis­ease and the oth­er for IBD.

Michael Amoroso

→ It didn’t take long for Michael Amoroso to earn a pro­mo­tion in the wake of João Sif­fert’s de­par­ture at Abeona Ther­a­peu­tics. In Ju­ly, Amoroso head­ed to Abeona as their chief com­mer­cial of­fi­cer, and this week, he gets the bump to COO. Be­fore the Cel­gene and Sanofi vet got to the gene and cell ther­a­py biotech, Amoroso led com­mer­cial­iza­tion ef­forts for Yescar­ta at Kite and was Ei­sai’s SVP, Amer­i­c­as for the com­mer­cial on­col­o­gy busi­ness group.

→ Long­time Mer­ck vet Jef­frey Fu is em­bark­ing on a new chap­ter as CBO of New York biotech Coda­genix, which bagged a $20 mil­lion Se­ries B round in Jan­u­ary and is prepar­ing a Phase I tri­al for their Covid-19 vac­cine can­di­date CDX-005. Dur­ing his 30 years at the phar­ma gi­ant, Fu held var­i­ous lead­er­ship po­si­tions in busi­ness de­vel­op­ment, R&D and mar­ket­ing and sales. Fu wraps up his Mer­ck tenure as cor­po­rate fi­nance ex­ec­u­tive di­rec­tor, busi­ness de­vel­op­ment and as a mem­ber of the US mar­ket and glob­al vac­cines lead­er­ship teams.

Cather­ine Thut

Adel Na­da’s Boston start­up Gen­tiBio, which launched in Au­gust with $20 mil­lion worth of fund­ing, is fill­ing out its C-suite with Cather­ine Thut as CBO and Thomas Wick­ham as CSO. Thut, a No­var­tis and Mer­ck alum, moves on from her CEO post at Makana Ther­a­peu­tics, a xe­ro­trans­plan­ta­tion biotech that merged with gene edit­ing com­pa­ny Re­com­bi­net­ics ear­li­er this month. Wick­ham has been an R&D ex­ec with Mer­ri­mack Phar­ma­ceu­ti­cals and more re­cent­ly Ru­bius Ther­a­peu­tics. He was al­so se­nior di­rec­tor of pre­clin­i­cal phar­ma­col­o­gy at EMD Serono.

Flo­rence Lor­get

→ A French biotech that launched last week is adding to their per­son­nel as their AAV gene ther­a­py tar­gets re­tini­tis pig­men­tosa: Spar­ingVi­sion has fo­cused their eyes on Flo­rence Lor­get as chief de­vel­op­ment sci­ences of­fi­cer and Ra­jiv Gan­gurde as chief tech­nol­o­gy of­fi­cer. Lor­get, who got her start at Am­gen and was a se­nior sci­en­tist at Bio­Marin and Genen­tech, leaves her role at Sang­amo as se­nior di­rec­tor of non­clin­i­cal safe­ty eval­u­a­tion. Gan­gurde heads over to Spar­ingVi­sion from Voy­ager Ther­a­peu­tics, where he was the Cam­bridge biotech’s se­nior di­rec­tor and head of CMC.

QurAlis, fo­cused on the de­vel­op­ment of treat­ments for ALS and oth­er neu­ro­log­ic dis­eases, has en­list­ed An­gela Genge as CMO. Genge pre­vi­ous­ly served as a clin­i­cal in­ves­ti­ga­tor in No­var­tis‘ Glob­al Neu­ro­science Clin­i­cal De­vel­op­ment Unit in ad­di­tion to di­rect­ing clin­ics at Mon­tre­al Neu­ro­log­i­cal Hos­pi­tal.

→ Plug­ging away in the hema­tol­ogy and on­col­o­gy spaces, with its PLK1 in­hibitor CYC140 for pa­tients with ad­vanced leukemias and MDS among those in the pipeline, NJ-based Cy­cla­cel Phar­ma­ceu­ti­cals has named Mark Kirschbaum CMO. He was pre­vi­ous­ly Ar­Qule’s VP of hema­tol­ogy and on­col­o­gy and has been a se­nior med­ical di­rec­tor in glob­al clin­i­cal de­vel­op­ment with Dai­ichi Sankyo, Tai­ho Phar­ma­ceu­ti­cals and BeiGene.

Jane Robert­son

→ Can­cer and fi­bro­sis-fo­cused Redx Phar­ma has re­cruit­ed Jane Robert­son as its CMO. Robert­son is tak­ing over for An­drew Saun­ders, who’s hit­ting the ex­it to pur­sue oth­er op­por­tu­ni­ties. Cur­rent­ly, Robert­son serves as CMO at Achilles Ther­a­peu­tics and has pre­vi­ous­ly held a stint at As­traZeneca On­col­o­gy.

→ France’s ERY­TECH Phar­ma — which teamed up for a $57 mil­lion cell ther­a­py deal with SQZ Biotech last June — has named Stew­art Craig as its chief tech­ni­cal of­fi­cer. Craig joins the com­pa­ny with ex­pe­ri­ence as chief man­u­fac­tur­ing of­fi­cer at Or­chard Ther­a­peu­tics, as well as roles at Stem­cells, PCT Cell Ther­a­py Ser­vices and Xcyte Ther­a­pies.

Josefin-Beate Holz

Tol­ga Has­san and Josefin-Beate Holz have been in­stalled at Dan­ish biotech Syn­kli­no as CFO and CMO, re­spec­tive­ly. Has­san makes his way to Syn­kli­no, de­vel­op­ing drugs to treat cy­tomegalovirus (CMV) in­fec­tions, af­ter 7 years at F-star Ther­a­peu­tics, first as CFO and then as COO. Holz brings CMO ex­pe­ri­ence from Storm Ther­a­peu­tics, Ca­lyp­so Biotech and Abl­ynx, and she was a project man­age­ment VP at LEO Phar­ma.

→ Af­ter bring­ing in Yann Maz­abraud as their EVP, head of in­ter­na­tion­al last month, Boston biotech Rhythm Phar­ma­ceu­ti­cals is now reel­ing in Jen­nifer Chien as EVP, head of North Amer­i­ca. Chien joins the com­pa­ny af­ter a stint as CCO at Krys­tal Biotech. Pri­or to her time at Krys­tal, Chien served in a va­ri­ety of roles at Sanofi Gen­zyme, in­clud­ing VP, head of ge­net­ic dis­eases.

→ It’s been a busy few months of fill­ing lead­er­ship po­si­tions at Chi­na-based rare dis­ease and on­col­o­gy play­er CAN­bridge Phar­ma­ceu­ti­cals. Af­ter nail­ing down an act­ing CSO in Richard Gre­go­ry and a glob­al head of BD in Car­rie Ann Cook, CAN­Bridge has ap­point­ed Yunx­i­ang Zhu as their head of glob­al re­search. Zhu has spent the last 2 years as an SVP at Shenogen Phar­ma Group out of Bei­jing, and he is a long­time Gen­zyme vet whose re­search was in­stru­men­tal in de­vel­op­ing aval­glu­cosi­dase al­fa, Sanofi’s en­zyme re­place­ment ther­a­py for Pompe dis­ease. The EMA just ac­cept­ed for re­view a mar­ket­ing au­tho­riza­tion ap­pli­ca­tion for the ther­a­py ear­li­er this month.

Don Healey

→ A month af­ter nab­bing Nick Har­vey as their CFO, Adicet Bio has tapped Don Healey as their chief tech­nol­o­gy of­fi­cer. Be­fore mov­ing to the Men­lo Park, CA-based biotech start­up, which de­vel­ops al­lo­gene­ic gam­ma delta T cell ther­a­pies, Healey was SVP, op­er­a­tions and site head at KBI Bio­phar­ma. Be­fore this, he spent more than 10 years at Opexa Ther­a­peu­tics, in­clud­ing 7 as their CSO.

→ Dutch biotech Sapreme, fo­cused on macro­mol­e­cule ther­a­peu­tics, has wel­comed Miri­am Bu­jny as their chief de­vel­op­ment of­fi­cer. Bu­jny was re­cent­ly at Dutch RNA play­er Pro­QR Ther­a­peu­tics, where she was their se­nior di­rec­tor of R&D. She was al­so at Janssen from 2012-16, lead­ing the pre­dic­tive bio­mark­er de­part­ment at the Janssen Pre­ven­tion Cen­ter.

Mi­na Pasta­gia

Mi­na Pasta­gia has been cho­sen as VP of clin­i­cal de­vel­op­ment at Ar­ma­ta Phar­ma­ceu­ti­cals, which is de­vel­op­ing bac­te­rio­phage ther­a­peu­tics such as AP-PA02 for Pseudomonas aerug­i­nosa in­fec­tions in pa­tients with cys­tic fi­bro­sis. Pasta­gia has just com­plet­ed 3 years at Janssen as se­nior med­ical di­rec­tor, in­fec­tious dis­eases and vac­cines, and be­fore that, she was the trans­la­tion­al med­i­cine leader in in­fec­tious dis­eases, im­munol­o­gy and in­flam­ma­tion at Roche.

→ Austin-based gene ther­a­py biotech Gen­prex has pro­mot­ed Er­ic Chapde­laine to VP of man­u­fac­tur­ing. Chapde­laine jumped aboard last year at Gen­prex, where he start­ed as their se­nior di­rec­tor of phar­ma­ceu­ti­cal sci­ences and man­u­fac­tur­ing. He’s al­so been in qual­i­ty con­trol, CMC and man­u­fac­tur­ing at Al­ny­lam and Gen­zyme.

→ Af­ter choos­ing a new CBO, CFO and CMO in short or­der, Boul­der, CO biotech Edge­wise Ther­a­peu­tics keeps the new per­son­nel com­ing with John Moore as gen­er­al coun­sel. Moore jumps to Edge­wise from Pelo­ton Ther­a­peu­tics, where he was gen­er­al coun­sel and sec­re­tary, and for 15 years he held the same posts at Ar­ray Bio­Phar­ma.

James Cor­nelius

James Cor­nelius has been elect­ed to the board of di­rec­tors at drug dis­cov­ery play­er MBX Bio­sciences, which tar­gets rare en­docrine dis­eases. Un­til 2015, Cor­nelius was non-ex­ec­u­tive chair­man at Bris­tol My­ers Squibb af­ter his 2010 re­tire­ment as the Big Phar­ma’s CEO.

→ Ef­fec­tive Sun­day, Robert Ti­jan will re­sign from the board of di­rec­tors at Nurix Ther­a­peu­tics in or­der to chair their sci­en­tif­ic ad­vi­so­ry board. Ti­jan, the for­mer pres­i­dent of the Howard Hugh­es Med­ical In­sti­tute, is a pro­fes­sor of bio­chem­istry and mol­e­c­u­lar bi­ol­o­gy at Cal-Berke­ley.

Brett Mo­nia

Cog­ni­tion Ther­a­peu­tics, which fo­cus­es on neu­rode­gen­er­a­tive and neu­ro-oph­thalmic dis­or­ders and re­ceived a $76 mil­lion grant from the NIH in June, has added Brett Mo­nia to its board of di­rec­tors. Mo­nia was pro­mot­ed to CEO of Io­n­is this year af­ter 2 years as their COO.

Duke spin­out Evecx­ia has brought on Thomas Aasen to its board of di­rec­tors.  Pre­vi­ous­ly, Aasen served as EVP, CFO, CBO and trea­sur­er of ACA­DIA.

→ Mi­cro­bial im­munother­a­py biotech Prokar­i­um out of Lon­don has brought in Hyam Lev­it­sky as a mem­ber of their board if di­rec­tors. A Roche and Juno vet, Lev­it­sky leads R&D at Cen­tu­ry Ther­a­peu­tics.

Roger Perl­mut­ter’s new gig, Covid-19 IP dra­ma, Vivek Ra­maswamy's coach on the SPAC train, and more

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The DCT-OS: A Tech­nol­o­gy-first Op­er­at­ing Sys­tem - En­abling Clin­i­cal Tri­als

As technology-enabled clinical research becomes the new normal, an integrated decentralized clinical trial operating system can ensure quality, deliver consistency and improve the patient experience.

The increasing availability of COVID-19 vaccines has many of us looking forward to a time when everyday things return to a state of normal. Schools and teachers are returning to classrooms, offices and small businesses are reopening, and there’s a palpable sense of optimism that the often-awkward adjustments we’ve all made personally and professionally in the last year are behind us, never to return. In the world of clinical research, however, some pandemic-necessitated adjustments are proving to be more than emergency stopgap measures to ensure trial continuity — and numerous decentralized clinical trial (DCT) tools and methodologies employed within the last year are likely here to stay as part of biopharma’s new normal.

Onno van de Stolpe, Galapagos CEO (Thierry Roge/Belga Mag/AFP via Getty Images)

Gala­pa­gos chops in­to their pipeline, drop­ping core fields and re­or­ga­niz­ing R&D as the BD team hunts for some­thing 'trans­for­ma­tive'

Just 5 months after Gilead gutted its rich partnership with Galapagos following a bitter setback at the FDA, the Belgian biotech is hunkering down and chopping the pipeline in an effort to conserve cash while their BD team pursues a mission to find a “transformative” deal for the company.

The filgotinib disaster didn’t warrant a mention as Galapagos laid out its Darwinian restructuring plans. Forced to make choices, the company is ditching its IPF molecule ’1205, while moving ahead with a Phase II IPF study for its chitinase inhibitor ’4617.

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'Chang­ing the whole game of drug dis­cov­ery': Leg­endary R&D vet Roger Perl­mut­ter leaps back in­to work as a biotech CEO

Roger Perlmutter needs no introduction to anyone remotely involved in biopharma. As the R&D chief first at Amgen and then Merck, he’s built a stellar reputation and a prolific career steering new drugs toward the market for everything from cancer to infectious diseases.

But for years, he’s also held a less known title: science partner at The Column Group, where he’s regularly consulted about the various ideas the VCs had for new startups.

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As­traZeneca, Dai­ichi Sankyo un­cork new TNBC da­ta for 2nd part­nered ADC — and it's adding more heat un­der Gilead­'s Trodelvy

After the approval of their partnered anti-HER2 antibody-drug conjugate earlier this year, AstraZeneca and Daiichi Sankyo are riding high on the promise of their blooming partnership. Now a second ADC is showing promise in hard-to-treat breast cancer, and the companies have their eyes set on their only approved competitor in the space.

AstraZeneca and Daiichi Sankyo’s next-gen ADC datopotamab deruxtecan posted a 43% response rate and five confirmed complete or partial responses among 21 patients with triple-negative breast cancer, according to cohort data from the TROPION-PanTumor01 Phase I study presented Saturday at the virtual ESMO Breast annual meeting.

Angela Merkel (AP Photo/Michael Sohn)

Covid-19 roundup: Pfiz­er sub­mits vac­cine for full ap­proval; Merkel op­pos­es Biden pro­pos­al to sus­pend IP for vac­cines

Pfizer and BioNTech said Friday that they’ve submitted a biologics license application to the FDA for full approval of their mRNA vaccine for those over the age of 16.

How long it will take the FDA to decide on the BLA will be set once it’s been formally accepted by the agency.

Peter Marks, director of the FDA’s Center for Biologics Evaluation and Research, previously told Endpoints News that the review of the BLA should take between three and four months, but it may be even faster than that.

Karyopharm taps long­time Pfiz­er, Am­gen vet to steer the ship; With Mer­ck in the rearview mir­ror, Roger Perl­mut­ter stakes his claim to a CEO job — and it's a sur­pris­ing choice

Like many who work in biopharma, Richard Paulson got started in the field because of a love of science.

Paulson had just finished business school and was looking to start a career that married his two passions. While looking for jobs, he thought of his grandmother who had struggled with Alzheimer’s disease, recalling how he saw first-hand what innovative medicines can do for patients. Ultimately, he started his first job in the space as a sales rep at Glaxo Wellcome, one of GlaxoSmithKline’s predecessors before its merger with SmithKline Beecham in 2000.

UP­DAT­ED: EMA safe­ty com­mit­tee seeks more in­fo on heart in­flam­ma­tion fol­low­ing Pfiz­er Covid-19 vac­cine

The European Medicines Agency’s safety committee said Friday that it’s aware of cases of inflammation of the heart muscle and inflammation of the membrane around the heart, mainly reported following vaccination with Pfizer’s Covid-19 vaccine, known in Europe as Comirnaty.

“There is no indication that these cases are due to the vaccine,” the EMA’s Pharmacovigilance Risk Assessment Committee said.

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As­traZeneca caps PD-L1/CT­LA-4/chemo com­bo come­back with OS win. Is treme­li­mum­ab fi­nal­ly ready for ap­proval?

AstraZeneca’s closely-watched POSEIDON study continues to be the rare bright spot in its push for an in-house PD-L1/CTLA-4 combo.

Combining Imfinzi and tremelimumab with physicians’ choice of chemotherapy helped patients with stage IV non-small cell lung cancer live longer, the company reported — marking the first time the still-experimental tremelimumab has demonstrated an OS benefit.

For AstraZeneca and CEO Pascal Soriot, the positive readout — which is devoid of numbers — offers much-needed validation for the big bet they made on Imfinzi plus tremelimumab, after the PD-L1/CTLA-4 regimen failed multiple trials in head and neck cancer as well as lung cancer.

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