David Chang steps up to CEO spot at WuX­i's cell and gene ther­a­py CD­MO; David Meline is the new CFO at Mod­er­na

David Meline

David Meline didn’t stay re­tired for long. As re­port­ed yes­ter­day, the for­mer Am­gen ex­ec will re­place Lorence Kim as CFO of Mod­er­na as the Big Phar­ma has sprint­ed to the front of the Covid-19 vac­cine pack, get­ting se­lect­ed as one of the fi­nal­ists for Op­er­a­tion Warp Speed. Meline, who gets start­ed on Mon­day, an­nounced his re­tire­ment as Am­gen’s CFO in Oc­to­ber 2019, re­main­ing in the role un­til the end of the year. But he’s back in the sad­dle at a cru­cial time as Mod­er­na pre­pares for Phase III stud­ies of their SARS-CoV-2 vac­cine. Meline pre­vi­ous­ly held lead­er­ship po­si­tions at 3M and Gen­er­al Mo­tors.

WuXi AppTec has called up­on David Chang to be CEO of the WuXi Ad­vanced Ther­a­pies busi­ness unit, the com­pa­ny’s cell and gene ther­a­py CD­MO. Chang has held po­si­tions at sev­er­al ma­jor play­ers: At Cel­gene, he was cor­po­rate VP and head of cell ther­a­py glob­al man­u­fac­tur­ing; at Roche, he was the glob­al head of en­gi­neer­ing and strat­e­gy; and at Genen­tech, he was se­nior di­rec­tor of glob­al man­u­fac­tur­ing, sci­ence & tech­nol­o­gy, as well as the di­rec­tor of process de­vel­op­ment.

→ In 2017 Steven Da­mon joined the board of di­rec­tors at Mi­cron Bio­med­ical. Now, he’s sit­ting in the CEO chair at the At­lanta-based com­pa­ny, which de­vel­ops nee­dle patch tech­nol­o­gy for self-dos­ing of vac­cines and ther­a­peu­tics. Be­fore Da­mon as­sumed his new role, he was VP, busi­ness and com­mer­cial de­vel­op­ment at Fe­masys and al­so has di­rec­tor­ships at Tem­ple Ther­a­peu­tics and Nu­triband, which he found­ed as 4P Ther­a­peu­tics and sold two years ago. Pri­or to 4P Ther­a­peu­tics, Da­mon was the SVP of busi­ness and cor­po­rate de­vel­op­ment at Al­tea Ther­a­peu­tics.

Brent Ra­gans

Fer­ring Phar­ma­ceu­ti­cals CCO Brent Ra­gans has been pro­mot­ed to pres­i­dent. Ra­gans start­ed out at Par­sip­pa­ny, NJ-based Fer­ring as their VP of com­mer­cial op­er­a­tions in 2012. He al­so spent a dozen years at Sanofi in sev­er­al ca­pac­i­ties, even­tu­al­ly be­com­ing the phar­ma gi­ant’s SVP, con­sumer health­care strat­e­gy and cor­po­rate de­vel­op­ment for North Amer­i­ca.

→ Oslo biotech Ex­act Ther­a­peu­tics, a GE Health­care spin­out, has cho­sen Rafiq Hasan as CEO. In pre­vi­ous years, Hasan steered Eylea from its launch as SVP and glob­al head of oph­thal­mol­o­gy at Bay­er, and he was al­so glob­al head of oph­thal­mol­o­gy at No­var­tis.

Wei Li

Cy­tovia, an NK start­up that’s part­nered with the New York Stem Cell Foun­da­tion, has tapped Wei Li as CSO. Most re­cent­ly, Li served as chief de­vel­op­ment of­fi­cer at South Ko­re­an biotech OliX Phar­ma­ceu­ti­cals.  In ad­di­tion, she was EVP, prod­uct de­vel­op­ment at Boston Bio­med­ical and held a post at Ar­Qule.

Ali­gos Ther­a­peu­tics — fo­cused on the de­vel­op­ment of ther­a­pies in­clud­ing chron­ic he­pati­tis B, Covid-19 and NASH — has wooed Les­ley Ann Cal­houn as CFO. Cal­houn jumps aboard from Glob­al Blood Ther­a­peu­tics, where she served as SVP of fi­nance & ad­min­is­tra­tion and chief ac­count­ing of­fi­cer. Pri­or to that, she held posts at Hy­pe­r­i­on Ther­a­peu­tics and Ther­a­vance.

Af­ter snap­ping up X-Chem, GHO Cap­i­tal has in­stilled Matt Clark as the CEO of X-Chem. Pri­or to his new role, Clark was co-founder and SVP of chem­istry for X-Chem. He suc­ceeds Rick Wag­n­er. Pri­or to join­ing the com­pa­ny, Clark served as di­rec­tor of dis­cov­ery chem­istry at GSK.

Ra­jesh Mis­try

→ Us­ing CAR-T and im­munomod­u­la­tion ther­a­pies to treat sol­id tu­mors, Den­ver-based TriSalus Life Sci­ences has brought in Ra­jesh Mis­try as CFO. Mis­try was the se­nior di­rec­tor, head of cor­po­rate de­vel­op­ment & strat­e­gy (M&A) at Op­tion Care Health. Pri­or to that, Mis­try held the role of di­rec­tor of strate­gic fi­nance & in­vestor re­la­tions at Melin­ta Ther­a­peu­tics.

Jin­qiu Tang has tak­en over as CFO of ear­ly can­cer screen­ing and de­tec­tion-fo­cused biotech An­Pac Bio-Med­ical Sci­ence, re­plac­ing Yu Zhang, who re­signed for per­son­al rea­sons ef­fec­tive May 31. Tang had been the cor­po­rate con­troller since Oc­to­ber for An­Pac, which hit the Nas­daq ear­li­er this year, rais­ing $16 mil­lion for its IPO. Be­fore join­ing An­Pac, he was a glob­al in­ter­nal au­di­tor at Natuzzi S.p.A.

David Gilham

→ Along with Peg­gy Sotiropoulou’s pro­mo­tion to head of R&D last week, Bel­gian biotech Celyad al­so moved David Gilham up to the po­si­tion of CSO. Gilham was named VP of re­search & de­vel­op­ment for the off-the-shelf CAR-T play­er in 2016 and pre­vi­ous­ly served on the com­pa­ny’s im­muno-on­col­o­gy sci­en­tif­ic ad­vi­so­ry board.

→ Sanofi Ven­tures — which re­cent­ly helped lead $55 mil­lion in fund­ing for NodThera — has some new faces in its man­age­ment team. Ja­son Hafler has moved to the po­si­tion of man­ag­ing di­rec­tor, while Cris De Lu­ca and Jim Tren­kle join as glob­al head of dig­i­tal in­vest­ments and head of in­vest­ments re­spec­tive­ly. Hafler has been with the com­pa­ny since 2014 and joined from RaNA Ther­a­peu­tics. De Lu­ca pre­vi­ous­ly was a found­ing team mem­ber of J&J In­no­va­tion and Glob­al Head of Dig­i­tal In­no­va­tion, while Tren­kle pre­vi­ous­ly did a stint at Gilead Sci­ences.

→ Acute kid­ney in­jury-fo­cused An­gion Bio­med­ica has re­cruit­ed Jen­nifer Rhodes as SVP, gen­er­al coun­sel and cor­po­rate sec­re­tary. Rhodes joins from Adamas Phar­ma­ceu­ti­cals where she served in the same roles in ad­di­tion to chief com­pli­ance of­fi­cer and CBO. Pri­or to that, she held posts at Pfiz­er and Weil, Got­shal, & Manges. In ad­di­tion, the com­pa­ny wel­comed Jazz Phar­ma­ceu­ti­cals ex­ec Karen Wil­son, Gilbert Omenn, a for­mer di­rec­tor at Am­gen; and Allen Nis­senson, a pro­fes­sor of med­i­cine at UCLA, to its board of di­rec­tors.

Pao­lo Vici­ni

→ Sir­tex Med­ical — a man­u­fac­tur­er of tar­get­ed liv­er can­cer ther­a­pies — has ap­point­ed Mark Tur­co as glob­al CMO and EVP of re­search & de­vel­op­ment. Pri­or to his new role, Tur­co was chief in­no­va­tion and cor­po­rate out­reach of­fi­cer for the Uni­ver­si­ty of Penn­syl­va­nia’s Penn Cen­ter for In­no­va­tion (PCI). In ad­di­tion, he served in roles at Medtron­ic and Co­vi­di­en.

In a new­ly-cre­at­ed role, Bel­gian GPCR play­er Con­fo Ther­a­peu­tics has snagged Pao­lo Vici­ni as chief de­vel­op­ment of­fi­cer. Vici­ni has most re­cent­ly been VP, de­vel­op­ment sci­ences at Kymab, which just got a leg up in its on­go­ing court bat­tles with Re­gen­eron. Be­fore Kymab, he was Med­Im­mune’s se­nior di­rec­tor of trans­la­tion­al sci­ences, head­ing their clin­i­cal phar­ma­col­o­gy, phar­ma­co­met­rics and DMPK de­part­ment.

Ken­ton Stew­art

Vivek Ra­maswamy’s sick­le cell dis­ease and be­ta tha­lassemia-fo­cused Aru­vant has a new chief tech­nol­o­gy of­fi­cer in V. “Palani” Pala­niap­pan. He comes to Aru­vant from Sarep­ta, where he was SVP, head of glob­al tech­ni­cal op­er­a­tions and head of the bio­phar­ma’s An­dover and Burling­ton sites. Be­fore his time at Sarep­ta, he led teams at Take­da that cen­tered on CMC de­vel­op­ment and new modal­i­ty de­vel­op­ment.

→ An­oth­er Ra­maswamy com­pa­ny, Urovant Sci­ences, has new per­son­nel of its own. Walt John­ston has been se­lect­ed as SVP of com­mer­cial, while Ken­ton Stew­art is now the urol­o­gy-fo­cused bio­phar­ma’s SVP of mar­ket ac­cess. John­ston comes to Urovant af­ter 12 years at Astel­las, most re­cent­ly as SVP, urol­o­gy and hos­pi­tal busi­ness unit. The sea­soned vet was al­so at Pfiz­er for 18 years in a num­ber of roles. Like John­ston, Stew­art was al­so at Astel­las for 12 years, even­tu­al­ly be­com­ing SVP of health sys­tems. Be­fore join­ing Urovant, he held the same po­si­tion at Alk­er­mes.

Walt John­ston

Nim­bus Ther­a­peu­tics, which ex­pand­ed its col­lab­o­ra­tion last sum­mer with Cel­gene to in­clude Nim­bus’ HPK1 in­hibitor pro­gram, has pro­mot­ed Alan Col­lis to SVP, pre­clin­i­cal de­vel­op­ment. Col­lis start­ed at Nim­bus in 2018, lead­ing their Tyk2 pro­gram and be­com­ing VP, pre­clin­i­cal de­vel­op­ment ear­ly last year. Be­fore jump­ing on board at Nim­bus 2 years ago, Col­lis was ex­ec­u­tive di­rec­tor of DMPK at For­ma Ther­a­peu­tics. He’s al­so held po­si­tions at Pfiz­er and No­var­tis, and was se­nior di­rec­tor of US chem­istry at Aven­tis.

→ While gun­ning to­wards a vagi­nal yeast in­fec­tion drug ap­proval, an­ti­fun­gal drug de­vel­op­er Scynex­is has en­list­ed Jim Maf­fez­zoli as VP of mar­ket­ing and sales. In his new role, Maf­fez­zoli will lead mar­ket­ing and com­mer­cial­iza­tion of the com­pa­ny’s clin­i­cal as­set, ibrex­a­fungerp. Maf­fez­zoli brings ex­pe­ri­ence from his times at Viveve Med­ical, Al­ler­gan and Pfiz­er.

Mert Sahin

Glob­al de­vel­op­er and man­u­fac­tur­er of lab­o­ra­to­ry tools H.E.L Group has wel­comed Mert Sahin as gen­er­al man­ag­er and SVP of North Amer­i­can op­er­a­tions. Sahin hails from GE Health­care, where he most re­cent­ly served as chief mar­ket­ing of­fi­cer for GE’s med­ical imag­ing busi­ness.

New York AAV biotech Pre­vail Ther­a­peu­tics has brought on Ki­ra Schwartz as gen­er­al coun­sel. Schwartz was pre­vi­ous­ly SVP, as­so­ciate gen­er­al coun­sel and as­sis­tant sec­re­tary at Al­ler­gan, lead­ing Ac­tavis’ ac­qui­si­tion of Al­ler­gan in 2015.

Life sci­ence ex­ec Dami­an Mar­ron is now the chair­man of Bris­tol, UK-based vac­cine start­up Imophoron as the com­pa­ny works on pre­clin­i­cal Covid-19 can­di­dates. The cur­rent chair­man of Tar­go­v­ax, Mar­ron is al­so a non-ex­ec­u­tive di­rec­tor at Bone Ther­a­peu­tics and Resolys Bio.

Ver­tex has made a new ad­di­tion to its board of di­rec­tors with the ap­point­ment of for­mer Am­gen ex­ec Di­ana McKen­zie as an in­de­pen­dent di­rec­tor. Dur­ing her time at Am­gen, McKen­zie served as SVP and chief in­for­ma­tion of­fi­cer.

Vick­ie Capps

Sil­ver­back Ther­a­peu­tics, where Lau­ra Shawver just signed on as CEO in April, has turned to Vick­ie Capps to be a mem­ber of their board of di­rec­tors and au­dit com­mit­tee chair. The for­mer CFO of DJO Glob­al from 2002-13, Capps was pre­vi­ous­ly a board mem­ber at Syn­thorx, where Shawver used to be CEO un­til Sanofi bought it for $2.5 bil­lion.

Biond Bi­o­log­ics has snagged for­mer Cel­gene CMO Jerome Zeld­is to its board of di­rec­tors. In ad­di­tion to his 20-year stint at Cel­gene, Zeld­is al­so served as CMO and pres­i­dent of clin­i­cal re­search, med­ical af­fairs, drug safe­ty, qual­i­ty and reg­u­la­to­ry at Sor­ren­to Ther­a­peu­tics.

Ann Rhoads

Ann Rhoads, most re­cent­ly the CFO at Forty Sev­en, has been ap­point­ed to the board of di­rec­tors at iTeos Ther­a­peu­tics, which grabbed $125 mil­lion in Se­ries B fi­nanc­ing in April. Rhoads was al­so the EVP and CFO at Zo­genix from 2010-17.

With their eyes set on a $100 mil­lion IPO, Vax­cyte — a vac­cine play­er that just changed its name — has ap­point­ed Hal­ley Gilbert to the com­pa­ny’s board of di­rec­tors. Gilbert’s ap­point­ment comes a lit­tle over a month af­ter she hopped on­to the board of di­rec­tors at Arc­turis Ther­a­peu­tics. Most re­cent­ly, Gilbert was SVP for cor­po­rate de­vel­op­ment and chief ad­min­is­tra­tive of­fi­cer at Iron­wood Phar­ma­ceu­ti­cals.

Regeneron CEO Leonard Schleifer speaks at a meeting with President Donald Trump, members of the Coronavirus Task Force, and pharmaceutical executives in the Cabinet Room of the White House (AP Photo/Andrew Harnik)

OWS shifts spot­light to drugs to fight Covid-19, hand­ing Re­gen­eron $450M to be­gin large scale man­u­fac­tur­ing in the US

The US government is on a spending spree. And after committing billions to vaccines defense operations are now doling out more of the big bucks through Operation Warp Speed to back a rapid flip of a drug into the market to stop Covid-19 from ravaging patients — possibly inside of 2 months.

The beneficiary this morning is Regeneron, the big biotech engaged in a frenzied race to develop an antibody cocktail called REGN-COV2 that just started a late-stage program to prove its worth in fighting the virus. BARDA and the Department of Defense are awarding Regeneron a $450 million contract to cover bulk delivery of the cocktail starting as early as late summer, with money added for fill/finish and storage activities.

Endpoints News

Keep reading Endpoints with a free subscription

Unlock this story instantly and join 84,800+ biopharma pros reading Endpoints daily — and it's free.

UP­DAT­ED: Bio­gen shares spike as ex­ecs com­plete a de­layed pitch for their con­tro­ver­sial Alzheimer's drug — the next move be­longs to the FDA

Biogen is stepping out onto the high wire today, reporting that the team working on the controversial Alzheimer’s drug aducanumab has now completed their submission to the FDA. And they want the agency to bless it with a priority review that would cut the agency’s decision-making time to a mere 6 months.

The news drove a 10% spike in Biogen’s stock $BIIB ahead of the bell.

Part of that spike can be attributed to a relief rally. Biogen execs rattled backers and a host of analysts earlier in the year when they unexpectedly delayed their filing to the third quarter. That delay provoked all manner of speculation after CEO Michel Vounatsos and R&D chief Al Sandrock failed to persuade influential observers that the pandemic and other factors had slowed the timeline for filing. Actually making the pitch at least satisfies skeptics that the FDA was not likely pushing back as Biogen was pushing in. From the start, Biogen execs claimed that they were doing everything in cooperation with the FDA, saying that regulators had signaled their interest in reviewing the submission.

Endpoints News

Keep reading Endpoints with a free subscription

Unlock this story instantly and join 84,800+ biopharma pros reading Endpoints daily — and it's free.

FDA bars the door — for now — against Mer­ck’s star can­cer drug af­ter Roche beat them to the punch

Merck has been handed a rare setback at the FDA.

After filing for the accelerated approval of a combination of their star PD-1 drug Keytruda with Eisai’s Lenvima as a first-line treatment for unresectable hepatocellular carcinoma, the FDA nixed the move, handing out a CRL because Roche beat them to the punch on the same indication by a matter of weeks.

According to Merck:

Ahead of the Prescription Drug User Fee Act action dates of Merck’s and Eisai’s applications, another combination therapy was approved based on a randomized, controlled trial that demonstrated overall survival. Consequently, the CRL stated that Merck’s and Eisai’s applications do not provide evidence that Keytruda in combination with Lenvima represents a meaningful advantage over available therapies for the treatment of unresectable or metastatic HCC with no prior systemic therapy for advanced disease. Since the applications for KEYNOTE-524/Study 116 no longer meet the criteria for accelerated approval, both companies plan to work with the FDA to take appropriate next steps, which include conducting a well-controlled clinical trial that demonstrates substantial evidence of effectiveness and the clinical benefit of the combination.

Endpoints News

Keep reading Endpoints with a free subscription

Unlock this story instantly and join 84,800+ biopharma pros reading Endpoints daily — and it's free.

Zai Lab inks Chi­na deal with Turn­ing Point with $25M up­front; Xen­cor, Atre­ca team up on bis­pecifics

Zai Lab is paying out a $25 million upfront for the rights to sell Turning Point Therapeutics’ lead drug repotrectinib in Greater China. The San Diego-based biotech is also in line for up to $151 million in milestones, along with mid-to-high teen royalties. Zai plans to add sites to the Phase II trial of the drug, which is designed to treat ROS1-positive advanced NSCLC in patients who were not previously treated with a TKI.

Sin­gu­lar fo­cus on ROR1 earns Velos­Bio $137M to fund PhI ADC and oth­er pro­grams

Years after selling Acerta to AstraZeneca for $7 billion, largely on the promise of its BTK inhibitor, Dave Johnson has once again gathered hefty financial support behind a new cancer target.

Matrix Capital Management and Surveyor Capital are leading a $137 million round for VelosBio, which has recently begun a Phase I study for its lead antibody-drug conjugate targeted against ROR1. Johnson took up the CEO post in October 2018.

Roger Tung, Concert Pharmaceuticals CEO (Concert)

Con­cert gets BTD for alope­cia drug, set­ting up a late-stage show­down with gi­ant ri­val Pfiz­er

Concert Pharmaceuticals’ path to developing a drug that treats alopecia areata has been bumpy, but the pharma company scored a win Wednesday.

The FDA granted Concert a Breakthrough Therapy Designation (BTD) for its oral Janus kinase inhibitor, named CTP-543, paving the way for a Phase III study of the drug to begin in the fourth quarter of 2020. The news follows positive Phase II results from last September, which saw the drug meet its primary endpoint in both 8 mg and 12 mg twice-daily doses.

Alexander Vos, VarmX CEO

'Fun­da­men­tal­ly dif­fer­en­t' from Por­to­la, Dutch biotech lands €32M to steer an­ti-an­ti­co­ag­u­lant through the clin­ic

Portola may not have had much success proving the commercial value of an anti-anticoagulant, but that’s not stopping European investors from pouring $36.2 million (€32 million) into what they see as a superior approach put forth by a Dutch biotech.

VarmX’s blood thinner reversal agent stems from research done by founder and CSO Pieter Reitsma at Leiden University Medical Center. A modified recombinant form of factor X, VMX-C001 “has an insertion of 16 amino acids that replaces a stretch of 7 amino acids in the so-called serine protease domain” compared to the native coagulation factor, CEO Alexander Vos told Endpoints News.

Covid-19 roundup: Mod­er­na sticks to Ju­ly for its Phase III as ru­mors swirl; Fol­low­ing US lead, EU buys up Covid-19 treat­ments

The Phase III might be delayed from its original early July goal, but Moderna says it will still kick off the pivotal study for what could ultimately be the first Covid-19 vaccine before the end of the month.

A day after Reuters reported that squabbling between the Cambridge biotech and government regulators had held up the trial by about two weeks, Moderna released a statement saying that they had completed enrollment of their 650-person Phase II trial and were on track to begin Phase III by the end of the month. The protocol for that study, which is meant to prove whether or not the vaccine can prevent people from becoming sick, has been finalized, they said.

Stephen Hahn, AP

Trump and Navar­ro press again for hy­drox­y­chloro­quine. Can the FDA stay in­de­pen­dent?

Tuesday morning, economist and Trump advisor Peter Navarro walked onto the White House driveway and promptly brought a political cloud back onto the FDA.

Speaking to a White House pool reporter, Navarro said that four Detroit doctors were, based on a single disputed study, filing for the FDA to again issue an emergency authorization for hydroxychloroquine, the anti-malarial pill that President Trump hyped for months as a Covid-19 treatment over the objections of his own scientists. Then, while avoiding directly calling for the FDA to OK the drug, blasted the agency. He said its decision to pull an earlier authorization “was based on bad science” and “had a tremendously negative effect” on doctors and patients.

Endpoints News

Keep reading Endpoints with a free subscription

Unlock this story instantly and join 84,800+ biopharma pros reading Endpoints daily — and it's free.