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.

Im­ple­ment­ing re­silience in the clin­i­cal tri­al sup­ply chain

Since January 2020, the clinical trials ecosystem has quickly evolved to manage roadblocks impeding clinical trial integrity, and patient care and safety amid a global pandemic. Closed borders, reduced air traffic and delayed or canceled flights disrupted global distribution, revealing how flexible logistics and supply chains can secure the timely delivery of clinical drug products and therapies to sites and patients.

In fi­nal days at Mer­ck, Roger Perl­mut­ter bets big on a lit­tle-known Covid-19 treat­ment

Roger Perlmutter is spending his last days at Merck, well, spending.

Two weeks after snapping up the antibody-drug conjugate biotech VelosBio for $2.75 billion, Merck announced today that it had purchased OncoImmune and its experimental Covid-19 drug for $425 million. The drug, known as CD24Fc, appeared to reduce the risk of respiratory failure or death in severe Covid-19 patients by 50% in a 203-person Phase III trial, OncoImmune said in September.

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Pascal Soriot (AP Images)

UP­DAT­ED: As­traZeneca, Ox­ford on the de­fen­sive as skep­tics dis­miss 70% av­er­age ef­fi­ca­cy for Covid-19 vac­cine

On the third straight Monday that the world wakes up to positive vaccine news, AstraZeneca and Oxford are declaring a new Phase III milestone in the fight against the pandemic. Not everyone is convinced they will play a big part, though.

With an average efficacy of 70%, the headline number struck analysts as less impressive than the 95% and 94.5% protection that Pfizer/BioNTech and Moderna have boasted in the past two weeks, respectively. But the British partners say they have several other bright spots going for their candidate. One of the two dosing regimens tested in Phase III showed a better profile, bringing efficacy up to 90%; the adenovirus vector-based vaccine requires minimal refrigeration, which may mean easier distribution; and AstraZeneca has pledged to sell it at a fraction of the price that the other two vaccine developers are charging.

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News brief­ing: Gilead part­ner Gala­pa­gos sells off CRO for $37M; Polyphor bags $3.3M from CF Foun­da­tion

Close Gilead ally Galapagos is selling off one of its contract research organizations to a Polish pharma company.

Galapagos has agreed to sell 100% of the outstanding shares in the CRO Fidelta to Selvita, in a deal worth roughly $37 million expected to close in the first week of January. The acquisition is expected to nearly double Selvita’s revenues, the company says, as well as expand its drug discovery efforts.

Gen­mab ax­es an ADC de­vel­op­ment pro­gram af­ter the da­ta fail to im­press

Genmab $GMAB has opted to ax one of its antibody-drug conjugates after watching it flop in the clinic.

The Danish biotech reported Tuesday that it decided to kill their program for enapotamab vedotin after the data gathered from expansion cohorts failed to measure up. According to the company:

While enapotamab vedotin has shown some evidence of clinical activity, this was not optimized by different dose schedules and/or predictive biomarkers. Accordingly, the data from the expansion cohorts did not meet Genmab’s stringent criteria for proof-of-concept.

Michelle Longmire, Medable CEO (Jeff Rumans)

Med­able gets $91M for vir­tu­al clin­i­cal tri­als, bring­ing to­tal raise to $136M

As biotechs look to get clinical studies back on track amid the pandemic, Medable returned to the venture well for the second time this year, bagging a $91 million Series C to build out its virtual trial platform.

The software provider recently launched three new apps for decentralizing clinical trials, and saw a 500% revenue spike this year. And it isn’t alone. Back in August, Science 37 secured a $40 million round for its virtual trial tech, with support from Novartis, Sanofi Ventures and Amgen. Patients and researchers are taking a liking to the online approach, suggesting regulators could allow it to become a new normal even after the pandemic is over.

The ad­u­canum­ab co­nun­drum: The PhI­II failed a clear reg­u­la­to­ry stan­dard, but no one is cer­tain what that means any­more at the FDA

Eighteen days ago, virtually all of the outside experts on an FDA adcomm got together to mug the agency’s Billy Dunn and the Biogen team when they presented their upbeat assessment on aducanumab. But here we are, more than 2 weeks later, and the ongoing debate over that Alzheimer’s drug’s fate continues unabated.

Instead of simply ruling out any chance of an approval, the logical conclusion based on what we heard during that session, a series of questionable approvals that preceded the controversy over the agency’s recent EUA decisions has come back to haunt the FDA, where the power of precedent is leaving an opening some experts believe can still be exploited by the big biotech.

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PhRMA sues Trump gov­ern­ment over drug im­por­ta­tion rule — days be­fore it's set to be ef­fec­tive

Ever since President Donald Trump floated the idea of using state-sponsored importation to lower drug prices, PhRMA has made its opposition abundant. Not only is the proposal dangerous and futile,  but the trade group has also argued that it may even be illegal.

Now that the FDA has issued its final rule permitting states to bring certain drugs from Canada, PhRMA is taking the government to court — just a few days before the rule is slated to take effect.

Feng Tian, Ambrx CEO (Ambrx)

Af­ter 5 qui­et years, a for­mer Scripps spin­out rais­es $200M and an­nounces plans to try again at an IPO

The first time San Diego biotech Ambrx tried to go public in 2014, they failed and the company’s board switched to a radically different strategy: They sold themselves for an undisclosed amount to a syndicate of Chinese investors and pharma companies.

Now, after 5 quiet years, that syndicate has raised a mountain of cash and indicated they’ll soon make another bid to go public.

Earlier this month, Ambrx raised $200 million in what they billed as a crossover round financed by Fidelity, BlackRock, Cormorant Asset Management, HBM Healthcare Investments, Invus, Adage Capital Partners and Suvretta Capital Management. It’s the largest amount they’ve ever raised and, according to Crunchbase figures, more than doubles the total amount of VC capital collected since their launch 17 years ago.