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.

Scoop: Boehringer qui­et­ly shut­ters a PhII for one of its top drugs — now un­der re­view

Boehringer Ingelheim has quietly shut down a small Phase II study for one of its lead drugs.

The private pharma player confirmed to Endpoints News that it had shuttered a study testing spesolimab as a therapy for Crohn’s patients suffering from bowel obstructions.

A spokesperson for the company tells Endpoints:

Taking into consideration the current therapeutic landscape and ongoing clinical development programs, Boehringer Ingelheim decided to discontinue our program in Crohn’s disease. It is important to note that this decision is not based on any safety findings in the clinical trials.

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Alex­ion puts €65M for­ward to strength­en its po­si­tion on the Emer­ald Isle

Ireland has been on a roll in 2022, with several large pharma companies announcing multimillion-euro projects. Now AstraZeneca’s rare disease outfit Alexion is looking to get in on the action.

Alexion on Friday announced a €65 million ($68.8 million) investment in new and enhanced capabilities across two sites in the country, including at College Park in the Dublin suburb of Blanchardstown and the Monksland Industrial Park in the central Irish town of Athlone, according to the Industrial Development Agency of Ireland.

State bat­tles over mifepri­s­tone ac­cess could tie the FDA to any post-Roe cross­roads

As more than a dozen states are now readying so-called “trigger” laws to kick into effect immediate abortion bans following the overturning of Roe v. Wade on Friday, these laws, in the works for more than a decade in some states, will likely kick off even more legal battles as states seek to restrict the use of prescription drug-based abortions.

Since Friday’s SCOTUS opinion to overturn Americans’ constitutional right to an abortion after almost 50 years, reproductive rights lawyers at Planned Parenthood and other organizations have already challenged these trigger laws in Utah and Louisiana. According to the Guttmacher Institute, other states with trigger laws that could take effect include Arkansas, Idaho, Kentucky, Mississippi, Missouri, North Dakota, Oklahoma, South Dakota, Tennessee, Texas, and Wyoming.

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Deborah Dunsire, Lundbeck CEO

Af­ter a 5-year re­peat PhI­II so­journ, Lund­beck and Ot­su­ka say they're fi­nal­ly ready to pur­sue OK to use Rex­ul­ti against Alzheimer's ag­i­ta­tion

Five years after Lundbeck and their longtime collaborators at Otsuka turned up a mixed set of Phase III data for Rexulti as a treatment for Alzheimer’s dementia-related agitation, they’ve come through with a new pivotal trial success they believe will finally put them on the road to an approval at the FDA. And if they’re right, some analysts believe they’re a short step away from adding more than $500 million in annual sales for the drug, already approved in depression and schizophrenia.

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A Mer­ck part­ner is sucked in­to the fi­nan­cial quag­mire as key lender calls in a note

Another biotech standing on shaky financial legs has fallen victim to the bears.

Merck partner 4D Pharma has reported that a key lender, Oxford Finance, shoved the UK company into administration after calling in a $14 million loan they couldn’t immediately make good on. Trading in their stock was halted with a market cap that had fallen to a mere £30 million.

“Despite the very difficult prevailing market conditions,” 4D reported on Friday, the biotech had been making progress on finding some new financing and turned to Oxford with an alternative late on Thursday and then again Friday morning.

Members of the G7 from left to right: Prime Minister of Italy Mario Draghi, European Commission President Ursula von der Leyen, President Joe Biden, German Chancellor Olaf Scholz, British Prime Minister Boris Johnson, Canadian Prime Minister Justin Trudeau, Prime Minister of Japan Fumio Kishida, French President Emmanuel Macron and European Council President Charles Michel (AP Photo/Susan Walsh)

Biden and G7 na­tions of­fer funds for vac­cine and med­ical prod­uct man­u­fac­tur­ing project in Sene­gal

Amidst recently broader vaccine manufacturing initiatives from the EU and European companies, the G7 summit in the mountains of Bavaria has brought about some positive news for closing vaccine and medical product manufacturing gaps around the globe.

According to a statement from the White House, the G7 leaders have formally launched the partnership for global infrastructure, PGII. The effort will aim to mobilize hundreds of billions of dollars to deliver infrastructure projects in several sectors including the medical and pharmaceutical manufacturing space.

Fed­er­al judge de­nies Bris­tol My­er­s' at­tempt to avoid Cel­gene share­hold­er law­suit

Some Celgene shareholders aren’t happy with how Bristol Myers Squibb’s takeover went down.

On Friday, a New York federal judge ruled that they have a case against the pharma giant, denying a request to dismiss allegations that it purposely slow-rolled Breyanzi’s approval to avoid paying out $6.4 billion in contingent value rights (CVR).

When Bristol Myers put down $74 billion to scoop up Celgene back in 2019, liso-cel — the CAR-T lymphoma treatment now marketed as Breyanzi — was supposedly one of the centerpieces of the deal. After going back and forth on negotiations for about six months, BMS put $6.4 billion into a CVR agreement that required an FDA approval for Zeposia, Breyanzi and Abecma, each by an established date.

Chris Anzalone, Arrowhead CEO

Take­da, Ar­row­head spot­light da­ta from small tri­al show­ing RNAi works in a rare liv­er con­di­tion

Almost two years after Takeda wagered $300 million cash to partner with Arrowhead on an RNAi therapy for a rare disease, the companies are spelling out Phase II data that they believe put them one step closer to their big dreams.

In a small, open label study involving only 16 patients who had liver disease associated with alpha-1 antitrypsin deficiency (AATD), Arrowhead’s candidate — fazirsiran, previously ARO-AAT — spurred substantial reductions in accumulated mutant AAT protein in the liver, a hallmark of the condition. Investigators also tracked improvements in symptoms, with seven out of 12 who received the high, 200 mg dose seeing regression of liver fibrosis.

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No stranger to gene ther­a­py woes, Astel­las runs in­to an­oth­er safe­ty-re­lat­ed clin­i­cal hold

Astellas Pharma, which has been at the forefront of uncovering the risks associated with gene therapies delivered by adeno-associated viruses, must take another safety alarm head-on.

The FDA has slapped a clinical hold on Astellas’ Phase I/II trial of a gene therapy candidate for late-onset Pompe disease, after investigators flagged a serious case of peripheral sensory neuropathy.

It marks the latest in a streak of setbacks Astellas has encountered since making a splashy entry into the gene therapy space with its $3 billion buyout of Audentes. But the lead program, AT132 for the treatment of X-linked myotubular myopathy (XLMTM), had to be halted more than once after a total of four patients died in the trial — and the scientific community still doesn’t have all the answers of what caused the deaths.

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