Biotech vet Paul Bren­nan takes helm at re­gen­er­a­tive med biotech; Ax­cel­la names CFO

Paul Bren­nan

→ Re­gen­er­a­tive med­i­cine com­pa­ny, Nerv­Gen Phar­ma — fo­cused on the treat­ment of nerve dam­age — has tapped Paul Bren­nan to head the helm of the com­pa­ny as CEO and pres­i­dent. Bren­nan is the suc­ces­sor to Ernest Wong, who will con­tin­ue to serve as a con­sul­tant to the com­pa­ny. In ad­di­tion, the com­pa­ny has en­list­ed Lloyd Macken­zie in the new­ly cre­at­ed po­si­tion of COO. Bren­nan’s pre­vi­ous stints in­clude roles at Eu­prax­ia Phar­ma­ceu­ti­cals, Aquinox Phar­ma­ceu­ti­cals, Ar­bu­tus Bio­phar­ma (for­mer­ly Tek­mi­ra Phar­ma­ceu­ti­cals) and AnorMED among oth­ers. Bren­nan played roles in han­dling the sale of As­pre­va to Vi­for Phar­ma for $915 mil­lion, the sale of AnorMED to Gen­zyme for $580 mil­lion and the merg­er of Tek­mi­ra and On­Core Bio­phar­ma to form Ar­bu­tus Bio­phar­ma, val­ued at over $1 bil­lion on the day of the trans­ac­tion. Macken­zie hails from his re­cent role as chief de­vel­op­ment of­fi­cer at No­table Labs and pri­or to that was the COO at Aquinox Phar­ma­ceu­ti­cals.

Lau­rent Chardon­net

Bill Hen­shaw-led Ax­cel­la Health — which closed its IPO ear­li­er in May, bag­ging $71.4 mil­lion — has ap­point­ed Lau­rent Chardon­net as CFO and pro­mot­ed VP of le­gal, Hei­dy King-Jones, to gen­er­al coun­sel. Chardon­net joins the com­pa­ny af­ter a 15-year stint at In­cyte, where he helped build the com­pa­ny from a $500 mil­lion de­vel­op­ment-stage or­ga­ni­za­tion in­to a com­mer­cial bio­phar­ma com­pa­ny. Pri­or to In­cyte, Chardon­net served as con­troller, VP of fi­nance and act­ing CFO at Dru­gAbuse Sci­ences. King-Jones joined Ax­cel­la in Jan­u­ary 2018 and pri­or to her time with the com­pa­ny, man­aged the cor­po­rate law de­part­ment and was lead com­mer­cial coun­sel at Sarep­ta Ther­a­peu­tics.

MiMedx — which yes­ter­day had the feds add fraud charges to the pil­ing ac­cu­sa­tions made against the com­pa­ny’s for­mer ex­ecshas wel­comed William Butch Hulse as its new gen­er­al coun­sel and sec­re­tary. Most re­cent­ly, Hulse served as a mem­ber of na­tion­al law firm Dyke­ma. Pri­or to that he served as chief com­pli­ance of­fi­cer and SVP of qual­i­ty, reg­u­la­to­ry and en­ter­prise risk man­age­ment at Aceli­ty LP.

Hei­dy King-Jones Ax­cel­la

In­ter­sect ENT — fo­cused on the treat­ment of ear, nose and throat con­di­tions — has ap­point­ed Richard (Randy) Meier as EVP and CFO. Meier pre­vi­ous­ly served in the same role as CFO, along with oth­er ex­ec po­si­tions, of Owens & Mi­nor. Pri­or to that, he was the EVP and CFO of Tele­flex and COO of Ad­vanced Med­ical Op­tics.

→ Acor­da Ther­a­peu­tics — where CEO Ron Co­hen re­struc­tured the com­pa­ny af­ter re­port­ing mea­ger sales from its new drug — has elect­ed for­mer Tenax Ther­a­peu­tics CEO John Kel­ley to serve as non-ex­ec­u­tive board chair. Kel­ley has been a mem­ber of the board since 2008.

→ IVER­IC bio —fo­cused on the treat­ment of reti­nal dis­eases — has wel­comed the cur­rent pres­i­dent of the Amer­i­can So­ci­ety of Gene and Cell Ther­a­py (AS­GCT), Guang­ping Gao — a pi­o­neer in AAV gene de­liv­ery tech­nol­o­gy — as chief strate­gist, gene ther­a­py. Gao will help shape the com­pa­ny’s strat­e­gy mov­ing for­ward in his new role. In ad­di­tion, Gao is the co-di­rec­tor, Li Wei­bo In­sti­tute for Rare Dis­eases Re­search and di­rec­tor, Ho­rae Gene Ther­a­py Cen­ter and Vi­ral Vec­tor Core.

Guang­ping Gao Gao Lab

No­vo Seeds, the ear­ly-stage in­vest­ment arm of No­vo Hold­ings, has an­nounced that sev­er­al en­tre­pre­neurs will be join­ing its ad­vi­so­ry unit, BiO­ri­gin. For­mer ex­ecs Mar­tin Bonde of Vac­ci­body, John Hau­rum of F-star and An­ders Hins­by of Or­p­hazyme have all hopped aboard as en­tre­pre­neurs-in-res­i­dence. In ad­di­tion, the com­pa­ny has en­list­ed co-founder and for­mer CEO of Plexxikon Pe­ter Hirth and for­mer Lund­beck ex­ec An­ders Gersel Ped­er­sen as ad­vi­sors.

→ As Re­zo­lute gears up to start Phase IIb tri­als for its an­ti­body, RZ358, for the ul­tra-or­phan in­di­ca­tion of con­gen­i­tal hy­per­in­sulin­ism, the com­pa­ny has wel­comed Nek­tar Ther­a­peu­tics COO and CFO Gil Labrucherie to its board of di­rec­tors as chair­man of the au­dit com­mit­tee.

George Tid­marsh

La Jol­la Phar­ma­ceu­ti­cal has to re­con­sid­er its fu­ture with­out CEO George Tid­marsh. He hit the ex­it af­ter a 7-year stint at the com­pa­ny to pur­sue oth­er op­por­tu­ni­ties, fol­low­ing a key tri­al fail­ure. The com­pa­ny’s board di­rec­tors Kevin Tang and Craig John­son will step in to over­see the man­age­ment team, along with be­ing tasked with max­i­miz­ing sales of Gi­apreza — a vaso­con­stric­tor ap­proved to in­crease blood pres­sure in adults with sep­tic or oth­er dis­trib­u­tive shock in the US, and to treat re­frac­to­ry hy­poten­sion for the same pop­u­la­tion in Eu­rope — and seek an FDA green light for the malar­ia ther­a­py LJPC-0118. La Jol­la has re­cent­ly filed an NDA for the drug.

BiTE® Plat­form and the Evo­lu­tion To­ward Off-The-Shelf Im­muno-On­col­o­gy Ap­proach­es

Despite rapid advances in the field of immuno-oncology that have transformed the cancer treatment landscape, many cancer patients are still left behind.1,2 Not every person has access to innovative therapies designed specifically to treat his or her disease. Many currently available immuno-oncology-based approaches and chemotherapies have brought long-term benefits to some patients — but many patients still need other therapeutic options.3

President Donald Trump (left) and Moncef Slaoui, head of Operation Warp Speed (Alex Brandon, AP Images)

UP­DAT­ED: White House names fi­nal­ists for Op­er­a­tion Warp Speed — with 5 ex­pect­ed names and one no­table omis­sion

A month after word first broke of the Trump Administration’s plan to rapidly accelerate the development and production of a Covid-19 vaccine, the White House has selected the five vaccine candidates they consider most likely to succeed, The New York Times reported.

Most of the names in the plan, known as Operation Warp Speed, will come as little surprise to those who have watched the last four months of vaccine developments: Moderna, which was the first vaccine to reach humans and is now the furthest along of any US effort; J&J, which has not gone into trials but received around $500 million in funding from BARDA earlier this year; the joint AstraZeneca-Oxford venture which was granted $1.2 billion from BARDA two weeks ago; Pfizer, which has been working with the mRNA biotech BioNTech; and Merck, which just entered the race and expects to put their two vaccine candidates into humans later this year.

Is a pow­er­house Mer­ck team prepar­ing to leap past Roche — and leave Gilead and Bris­tol My­ers be­hind — in the race to TIG­IT dom­i­na­tion?

Roche caused quite a stir at ASCO with its first look at some positive — but not so impressive — data for their combination of Tecentriq with their anti-TIGIT drug tiragolumab. But some analysts believe that Merck is positioned to make a bid — soon — for the lead in the race to a second-wave combo immuno-oncology approach with its own ambitious early-stage program tied to a dominant Keytruda.

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Gilead bol­sters its case for block­buster hope­ful fil­go­tinib as FDA pon­ders its de­ci­sion

Before remdesivir soaked up the spotlight amid the coronavirus crisis, Gilead’s filgotinib was the star experimental drug tapped to rake in billions competing with other JAK inhibitors made by rivals including AbbVie and Eli Lilly.

Now, long term data on the drug — discovered by Gilead’s partners at Galapagos and posted as part of a virtual medical conference — have solidified the durability and safety of filgotinib in patients with rheumatoid arthritis, spanning data from three late-stage trials. An FDA decision on the drug is expected this year.

Leen Kawas, Athira CEO (Athira)

Can a small biotech suc­cess­ful­ly tack­le an Ever­est climb like Alzheimer’s? Athi­ra has $85M and some in­flu­en­tial back­ers ready to give it a shot

There haven’t been a lot of big venture rounds for biotech companies looking to run a Phase II study in Alzheimer’s.

The field has been a disaster over the past decade. Amyloid didn’t pan out as a target — going down in a litany of Phase III failures — and is now making its last stand at Biogen. Tau is a comer, but when you look around and all you see is destruction, the idea of backing a startup trying to find complex cocktails to swing the course of this devilishly complicated memory-wasting disease would daunt the pluckiest investors.

GSK presents case to ex­pand use of its lu­pus drug in pa­tients with kid­ney dis­ease, but the field is evolv­ing. How long will the mo­nop­oly last?

In 2011, GlaxoSmithKline’s Benlysta became the first biologic to win approval for lupus patients. Nine years on, the British drugmaker has unveiled detailed positive results from a study testing the drug in lupus patients with associated kidney disease — a post-marketing requirement from the initial FDA approval.

Lupus is a drug developer’s nightmare. In the last six decades, there has been just one FDA approval (Benlysta), with the field resembling a graveyard in recent years with a string of failures including UCB and Biogen’s late-stage flop, as well as defeats in Xencor and Sanofi’s programs. One of the main reasons the success has eluded researchers is because lupus, akin to cancer, is not just one disease — it really is a disease of many diseases, noted Al Roy, executive director of Lupus Clinical Investigators Network, an initiative of New York-based Lupus Research Alliance that claims it is the world’s leading private funder of lupus research, in an interview.

Covid-19 roundup: Mod­er­na read­ies to en­ter PhI­II in Ju­ly, As­traZeneca not far be­hind; EU ready to ne­go­ti­ate vac­cine ac­cess with $2.7B fund

Moderna may soon add another first to the Covid-19 vaccine race.

In March, the mRNA biotech was the first company to put a Covid-19 vaccine into humans. Next month, they may become the first company to put their vaccine into the large, late-stage trials that are needed to prove whether the vaccine is effective.

In an interview with JAMA editor Howard Bauchner, NIAID chief Anthony Fauci said that a 30,000-person, Phase III trial for Moderna’s vaccine could start in July. The news comes a week after Moderna began a Phase II study that will enroll several hundred people.

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José Basel­ga finds promise in new class of RNA-mod­i­fy­ing can­cer tar­gets, lock­ing in 3 pre­clin­i­cal pro­grams with $55M

Having dived early into some of the RNA breakthroughs of the last decades — betting on Moderna’s mRNA tech and teaming up with Silence on the siRNA front — AstraZeneca is jumping into a new arena: going after proteins that modify RNA.

Their partner of choice is Accent Therapeutics, which is receiving $55 million in upfront payment to steer a selected preclinical program through to the end of Phase I. After AstraZeneca takes over, the Lexington, MA-based startup has the option to co-develop and co-commercialize in the US — and collect up to $1.1 billion in milestones in the long run. The deal also covers two other potential drug candidates.

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David Meline, incoming Moderna CFO

Am­gen vet David Meline finds a new CFO roost at Mod­er­na, tak­ing a ride on the Covid-19 tiger as de­part­ing ex­ec cash­es out with $12M

We found out a few weeks ago that Moderna CFO Lorence Kim isn’t waiting around to see how the biotech wunderkind makes out in its frantic race to field a messenger RNA vaccine that can quell Covid-19. And now we know who’s stepping on board to take his place in the latest move in the executive suite.

David Meline, who forged his rep during a 6-year run at Amgen, slipped out the exit right after his Q2 “retirement” party in California — presumably virtual — and started the next chapter of his career at a biotech company betting big on revolutionizing the vaccine R&D space.

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