In­ovio adds two to the lead­er­ship team; Adri­an Woolf­son is out at Sang­amo

→ En­trenched in a le­gal bat­tle with their man­u­fac­tur­er that’s ev­i­dent­ly block­ing them from mak­ing their Covid-19 vac­cine can­di­date, In­ovio is mak­ing some lead­er­ship changes. Gene Kim will be pres­i­dent of In­ovio Asia, while Mam­men (An­za) Mam­men jumps aboard the biotech as SVP, clin­i­cal de­vel­op­ment, and is slat­ed over­see de­vel­op­ment of In­ovio’s DNA vac­cine can­di­date INO-4800.

An ex-CFO at VGX Phar­ma­ceu­ti­cals, Kim had pre­vi­ous­ly been the CFO of AfreecaTV and video game de­vel­op­er We­Made En­ter­tain­ment, both South Ko­re­an com­pa­nies. And Mam­men, who re­tired from the US Army with the rank of colonel, spent more than 6 years at Vi­cal, be­com­ing their SVP, clin­i­cal de­vel­op­ment, and pri­or to that role, was an in­fec­tious dis­ease con­sul­tant and found­ing chief of the DoD’s pan­dem­ic warn­ing team at Fort De­t­rick, MD.

→ Start­ing Ju­ly 13, Far­go, ND-based plas­mid DNA man­u­fac­tur­er Alde­vron will change CEOs. Kevin Ballinger, who was “on the verge of be­ing a lif­er” at Boston Sci­en­tif­ic, will take the helm. He’s re­plac­ing Michael Cham­bers, who was named ex­ec­u­tive chair­man of the board at Alde­vron, which was found­ed on the cam­pus of North Dako­ta State Uni­ver­si­ty in 1998 by Cham­bers and John Bal­lan­tyne. Ballinger was EVP and glob­al pres­i­dent of Boston Sci­en­tif­ic’s largest di­vi­sion, in­ter­ven­tion­al car­di­ol­o­gy, for the past 9 years.

Ja­son Fontenot

→ An R&D split is un­fold­ing at Sang­amo, where EVP of R&D Adri­an Woolf­son, who had on­ly been with the Cal­i­for­nia biotech since Jan­u­ary 2019, has been shown the door. With a search un­der­way for a new head of de­vel­op­ment, Bio­gen vet Ja­son Fontenot — who has been Sang­amo’s SVP of cell ther­a­py — steps up to the plate as in­ter­im head of re­search. Be­fore join­ing Sang­amo, Fontenot was CSO at Im­mu­soft Cor­po­ra­tion and, pri­or to that, found­ed Im­mune Au­toma­ta Con­sult­ing. He spent 8 years at Bio­gen, where he was a group leader in im­munol­o­gy dis­cov­ery.

→ Men­tal health and psy­che­delics biotech ATAI Life Sci­ences has launched In­tro­Spect Dig­i­tal Ther­a­peu­tics, nam­ing David Keene pres­i­dent and CEO of the new plat­form. ”By us­ing a va­ri­ety of dig­i­tal bio­mark­ers, we stand to make treat­ments in­creas­ing­ly re­fined, ef­fec­tive, and — most im­por­tant­ly for men­tal health­care — in­di­vid­u­al­ized,” Keene said in a state­ment. Keene found­ed Everys­to­ry, which was lat­er re­named Dthera Sci­ences in 2016, and was their chief tech­nol­o­gy of­fi­cer, lead­ing de­vel­op­ment of what has been de­scribed as an AI-en­abled de­vice for Alzheimer’s dubbed DTHR-ALZ.

Robert Radie

Neu­rap­tive Ther­a­peu­tics — fo­cused on the treat­ment of pe­riph­er­al nerve in­juries — has brought on Robert Radie to take over the helm of the com­pa­ny as CEO and chair­man of the board. Radie has ex­pe­ri­ence run­ning op­er­a­tions as CEO at Zy­la Life Sci­ences, Trans­mol­e­c­u­lar and Topaz Phar­ma­ceu­ti­cals (ac­quired by Sanofi Pas­teur). In ad­di­tion, he’s held posts at Prest­wick Phar­ma­ceu­ti­cals, Mor­photek and Vi­curon Phar­ma­ceu­ti­cals.

Samuel Tong

→ The Lab­o­ra­to­ry for Ad­vanced Med­i­cine has wooed Samuel Tong as CEO of the com­pa­ny’s Chi­nese op­er­a­tions. Tong hops aboard from NAM­SA, where he served as VP and gen­er­al man­ag­er of the Asia Pa­cif­ic Re­gion. Pre­vi­ous­ly, he served in roles at QI­A­GEN, Ab­bott Vas­cu­lar and GE Med­ical among oth­ers.

→ Ef­fec­tive Ju­ly 30, Nicholas Green is suc­ceed­ing Rick Han­cock as pres­i­dent and CEO of Cal­i­for­nia-based CD­MO Avid Bioser­vices. Han­cock had been in­ter­im pres­i­dent and CEO for the past year. Green jumps to Avid af­ter 9 years as pres­i­dent and CEO of Ther­a­pure Bio­phar­ma, a com­pa­ny out of Mis­sis­sauga, On­tario that al­so in­cludes Ther­a­pure Man­u­fac­tur­ing. He was al­so pres­i­dent and CEO of Rho­dia Phar­ma So­lu­tions and was briefly the pres­i­dent of the phar­ma di­vi­sion at Codex­is.

Allen Melemed

Eli Lil­ly vet Allen Melemed has been named CMO of Chimerix, which six years ago found it­self at the cen­ter of a hur­ri­cane of pub­lic anger over its ini­tial re­fusal to pro­vide their lead ex­per­i­men­tal drug to a dy­ing child. Be­fore his move to the Durham, NC-based biotech, Melemed was a Dis­tin­guished Med­ical Fel­low and se­nior di­rec­tor of reg­u­la­to­ry af­fairs on­col­o­gy, North Amer­i­ca at Lil­ly. Among the on­col­o­gy med­i­cines he worked on in his 20-plus years at the phar­ma gi­ant is Verzenio, which just last week showed pos­i­tive re­sults in a Phase III tri­al for pa­tients with high risk hor­mone re­cep­tor/HER2 neg­a­tive breast can­cer.

→ An­oth­er Eli Lil­ly vet, Thane Wet­tig, is head­ed to San Fran­cis­co bio­phar­ma Fi­bro­Gen as their chief com­mer­cial of­fi­cer. Pri­or to Fi­bro­Gen, which just had its lead drug rox­idu­s­tat for ane­mia ac­cept­ed for re­view by the EMA, Wet­tig had been the chief com­mer­cial of­fi­cer and meta­bol­ic fran­chise leader at Intar­cia Ther­a­peu­tics. Be­fore then, Wet­tig was at Lil­ly for near­ly 28 years, leav­ing as VP of glob­al mar­ket­ing, strat­e­gy and al­liance man­age­ment for Lil­ly Di­a­betes.

Robert Jor­dan

→ Res­pi­ra­to­ry in­fec­tion-fo­cused Meis­sa Vac­cines has re­cruit­ed Robert Jor­dan as their VP of R&D af­ter a short tenure as Vir’s di­rec­tor of vi­rol­o­gy. Jor­dan al­so had a hand in the dis­cov­ery and de­vel­op­ment of an­tivi­ral ther­a­pies, most no­tably remde­sivir, when he was di­rec­tor of bi­ol­o­gy for Gilead. Be­fore his time at Gilead, he was di­rec­tor of vi­rol­o­gy at Siga Tech­nolo­gies.

Josefin-Beate Holz has been named CMO at RNA epi­ge­net­ics play­er Storm Ther­a­peu­tics. Holz makes her way to the Uni­ver­si­ty of Cam­bridge spin­out af­ter be­ing an in­de­pen­dent clin­i­cal ad­vi­sor since 2015. Her lead­er­ship ex­pe­ri­ence in­cludes tenures at Abl­ynx, GPC-Biotech, Gilead, Bris­tol My­ers Squibb, OSI Phar­ma­ceu­ti­cals (ac­quired by Astel­las) and LEO Phar­ma.

Com­pass Path­ways, the Lon­don men­tal health start­up backed by Pe­ter Thiel which grabbed $80 mil­lion in fund­ing back in April, has wel­comed Trevor Mill as chief de­vel­op­ment of­fi­cer. Mill joins Com­pass af­ter be­ing SVP, head of glob­al safe­ty and reg­u­la­to­ry sci­ences with Bio­gen. He was al­so Pfiz­er’s head of reg­u­la­to­ry strat­e­gy, phar­mather­a­peu­tics, and spent 12 years over­all at the phar­ma gi­ant.

Ter­ri Young

→ With its SER-109 pro­gram in Phase III de­vel­op­ment for re­cur­rent C. diff, and try­ing to work its way back in­to the mix af­ter 30% of its work­force was let go in ear­ly 2019, mi­cro­bio­me play­er Seres Ther­a­peu­tics has named Ter­ri Young EVP, chief com­mer­cial and strat­e­gy of­fi­cer, ef­fec­tive June 29. Young is leav­ing Sage Ther­a­peu­tics, where she was VP glob­al com­mer­cial strat­e­gy. The GSK vet al­so spent time in lead­er­ship at Bris­tol My­ers Squibb as VP and gen­er­al Man­ag­er, car­dio­vas­cu­lar.

Reina Ben­abou

→ Just a week af­ter plug­ging in Will Kane as chief com­mer­cial of­fi­cer, New Haven, CT phar­ma BioX­cel Ther­a­peu­tics has brought in Reina Ben­abou as SVP and chief de­vel­op­ment of­fi­cer. Ben­abou, who joins BioX­cel af­ter be­ing SVP & CMO at Cog­nivue, has a Big Phar­ma back­ground that in­cludes stints at No­var­tis (VP & world­wide med­ical head for the neu­ro­science fran­chise) and Pfiz­er (head of glob­al med­ical prod­uct eval­u­a­tion).

→ There are pro­mo­tions ga­lore at Coral Gables, FL-based Cat­a­lyst Phar­ma­ceu­ti­cals, the mak­er of Fir­dapse to treat adults with Lam­bert-Eaton myas­thenic syn­drome. Jef­frey Del Car­men gets the bump to chief com­mer­cial of­fi­cer af­ter ar­riv­ing at Cat­a­lyst in Au­gust 2018 as SVP of sales and mar­ket­ing. Del Car­men had pre­vi­ous­ly been VP of busi­ness de­vel­op­ment for Paragon Bio­sciences. Mean­while, Pe­te Cur­ry moves to VP of sales, and Maria Pan­dol­fo has been pro­mot­ed to VP of pa­tient ser­vices.

→ Af­ter re­cent­ly post­ing pos­i­tive in­ter­im da­ta for their Phase I tri­al, Cal­i­for­nia-based biotech Ad­verum Biotech­nolo­gies has added a new face to the team with the ap­point­ment of Heik­ki Jout­ti­järvi as VP, man­u­fac­tur­ing. Jout­ti­järvi hops aboard from Men­lo Ther­a­peu­tics, where he served as VP, tech­ni­cal op­er­a­tions. Pre­vi­ous­ly, Jout­ti­järvi served in roles at San­ten Phar­ma­ceu­ti­cal Com­pa­ny.

Syg­na­ture Dis­cov­ery, a Not­ting­ham-based provider of drug dis­cov­ery and pre­clin­i­cal ser­vices, has made a new ad­di­tion to its lead­er­ship team with the ap­point­ment of Paul Over­ton as SVP of busi­ness de­vel­op­ment. Over­ton joins the com­pa­ny from Eu­rofins, where he served as head of Eu­ro­pean sales, mar­ket­ing and key ac­count man­age­ment.

Tere­sa Bair

→ Can­cer-fo­cused Buf­fa­lo, NY bio­phar­ma Athenex has pro­mot­ed Tere­sa Bair to gen­er­al coun­sel and SVP, ad­min­is­tra­tion from her pre­vi­ous po­si­tion of SVP, le­gal af­fairs and ad­min­is­tra­tion. Be­fore mak­ing it to Athenex in 2015, Bair was a part­ner at Har­ris Beach.

→ Over at a dif­fer­ent Cat­a­lyst, Charles De­mocko has moved to Cat­a­lyst Bio­sciences to be­come SVP, reg­u­la­to­ry af­fairs. De­mocko had led Cy­tomX’s reg­u­la­to­ry af­fairs and qual­i­ty, and be­fore that, he was VP of reg­u­la­to­ry af­fairs at an ar­ray of com­pa­nies such as As­cendis, Kalo­Bios, No­vacea, Phar­ma­co­Fore, and Con­net­ics.

Nascent Biotech out of San Diego has as­signed Nav­paul Singh to the role of chief med­ical con­sul­tant for Covid-19 re­search, par­tic­u­lar­ly as it per­tains to their lead prod­uct, Pri­tu­mum­ab. “This op­por­tu­ni­ty with Nascent Biotech al­lows me to con­tin­ue my med­ical work in vi­ral in­fec­tions that are with us to­day and pos­si­bly in the fu­ture,” Singh said in a state­ment.

→ Cana­di­an CRO Al­ta­sciences — which pre­vi­ous­ly inked a deal with fel­low CRO WuXi last May — has en­list­ed Joseph Fran­cis­co as chief tox­i­col­o­gist. Fran­cis­co joins with ex­pe­ri­ence from his time at Charles Riv­er Lab­o­ra­to­ries, Seat­tle Ge­net­ics and Bris­tol My­ers Squibb.

Part­ner­ing with Roche’s Genen­tech on an im­muno-on­col­o­gy col­lab­o­ra­tion, Bi­cy­cle Ther­a­peu­tics has ap­point­ed Sir Kei­th Pe­ters chair­man of their sci­en­tif­ic ad­vi­so­ry board. Pe­ters, the emer­i­tus regius pro­fes­sor of physic at the Uni­ver­si­ty of Cam­bridge, was al­so on the board of med­ical ad­vis­ers to Mer­ck Re­search Lab­o­ra­to­ries and se­nior con­sul­tant in R&D for GSK.

Jane Was­man

→ Nat­ur­al killer im­munother­a­py play­er Cy­tovia Ther­a­peu­tics has added Leila Al­land and Jane Was­man to their board of di­rec­tors. Al­land, the cur­rent CMO at PMV Phar­ma, was pre­vi­ous­ly the CEO at Af­fimed and has held po­si­tions at such Big Phar­mas as As­traZeneca, Bris­tol My­ers Squibb and No­var­tis. Was­man, the chair of the board at Sel­l­as Life Sci­ences, al­so spent 15 years at Acor­da Ther­a­peu­tics.

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.

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.

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.