Jim Robin­son takes over the reins at Urovant; Car­los Cam­poy moves to Cy­tomX

Jim Robin­son

→ Af­ter near­ly a year as pres­i­dent and COO at Paragon Bio­sciences, Jim Robin­son has jumped to Urovant Sci­ences, where he will be pres­i­dent and CEO of the urol­o­gy-fo­cused biotech, suc­ceed­ing found­ing CEO Kei­th Katkin. Robin­son will con­tin­ue as a mem­ber of Urovant’s board of di­rec­tors. His pre­vi­ous stops in­clude Alk­er­mes as pres­i­dent and COO and a num­ber of po­si­tions at Astel­las and Scher­ing-Plough Phar­ma­ceu­ti­cals.

Car­los Cam­poy

→ At the same time as an $80 mil­lion part­ner­ship with Astel­las, Cy­tomX has re­cruit­ed Eli Lil­ly vet Car­los Cam­poy as SVP and CFO. Most re­cent­ly, Cam­poy served as CFO of Alder Bio­Phar­ma­ceu­ti­cals, help­ing com­plete its $2 bil­lion sale to Lund­beck. Pri­or to that, Cam­poy was VP of fi­nance, in­ter­na­tion­al at Al­ler­gan.

Bris­tol My­ers‘ for­mer top deal­mak­er Paul Bion­di — who’s cur­rent­ly serv­ing as an ex­ec­u­tive part­ner at Flag­ship Pi­o­neer­inghas joined the board of di­rec­tors at Seres Ther­a­peu­tics, suc­ceed­ing Flag­ship CEO Noubar Afeyan who’s step­ping down.

→ UK-based Im­mune Reg­u­la­tion has wooed the for­mer CEO of SteadyMed Ther­a­peu­tics (ac­quired by Unit­ed Ther­a­peu­tics) Jonathan Rig­by to the helm of their com­pa­ny as CEO. Rig­by co­found­ed Zo­genix and ear­li­er in his ca­reer served at Mer­ck and Bris­tol My­ers Squibb.

→ Shang­hai-based EpimAb Bio­ther­a­peu­tics has en­list­ed Xinyi “David” Gu as CFO. Gu makes the hop over from Mil­len­ni­um Man­age­ment, and pri­or to that served at Jef­feries as VP and glob­al phar­ma­ceu­ti­cal eq­ui­ty re­search an­a­lyst. In ad­di­tion, Gu has held a post at McK­in­sey & Com­pa­ny.

David Gu EpimAb

→ Af­ter bag­ging $26 mil­lion in fund­ing and earn­ing fast track des­ig­na­tion for its lead drug can­di­date, gene ther­a­py com­pa­ny Gen­prex has re­cruit­ed Michael Red­man as EVP and COO and Cather­ine Vaczy as EVP and chief strat­e­gy of­fi­cer. Red­man was the for­mer CEO and pres­i­dent of On­col­ix for more than a decade. Pri­or to On­col­ix he served in posts at Bone Med­ical, Opexa Phar­ma­ceu­ti­cals and Zon­a­gen, among oth­ers. Vaczy was a co-founder of NeoStem (now Cal­adrius Bio­sciences) and served at Im­Clone Sys­tems (ac­quired by Eli Lil­ly).

Men­lo Ther­a­peu­tics has tapped An­drew Saik as CFO and trea­sur­er. Saik will be based at the com­pa­ny’s head­quar­ters at Bridge­wa­ter, New Jer­sey. Most re­cent­ly, Saik served as CFO of PDS Biotech­nol­o­gy. Pri­or to that, he was CFO at Ver­tice Phar­ma and Aux­il­i­um Phar­ma­ceu­ti­cals — help­ing in the $2.6 bil­lion sale of the com­pa­ny. His pre­vi­ous ex­pe­ri­ence in­cludes stints at En­do Health So­lu­tions and Valeant Phar­ma­ceu­ti­cals.

Lisa Ro­jk­jaer has joined Virac­ta Ther­a­peu­tics as CMO, ef­fec­tive May 1. Pri­or to her ap­point­ment at the pre­ci­sion on­col­o­gy com­pa­ny, Ro­jk­jaer was CMO at Oslo-based Nordic Nanovec­tor and glob­al clin­i­cal pro­gram head, on­col­o­gy glob­al de­vel­op­ment at No­var­tis. Among her re­spon­si­bil­i­ties will be steer­ing Virac­ta’s lead pro­gram to­ward reg­u­la­to­ry ap­provals for Ep­stein-Barr virus (EBV) pos­i­tive lym­phomas.

Lisa Ro­jk­jaer

→ Af­ter wel­com­ing Shafique Vi­rani last week as chief cor­po­rate de­vel­op­ment of­fi­cer, AI biotech Re­cur­sion has added Michael Sec­o­ra as CFO. Sec­o­ra joins the com­pa­ny af­ter a decade of ser­vice at Lau­ri­on Cap­i­tal, where he served as man­ag­ing di­rec­tor and head of cap­i­tal mar­kets and ven­ture. Near the same time as Vi­rani’s ap­point­ment last week, for­mer Cel­gene ex­ec Robert Her­sh­berg was ap­point­ed to the com­pa­ny’s board of di­rec­tors. Her­sh­berg served as Cel­gene’s CSO and EVP and head of busi­ness de­vel­op­ment and glob­al al­liance.

→ Bel­gian or­tho­pe­dics-fo­cused biotech Bone Ther­a­peu­tics has a new CBO, nam­ing Ste­fanos Theo­haris to the post. With ex­pe­ri­ence in the cell and gene ther­a­py are­na, Theo­haris was for­mer­ly SVP at Cell Med­ica and CBO at apceth GmbH.

Pravin Dugel has been ap­point­ed EVP and chief strat­e­gy and busi­ness of­fi­cer of IVER­IC bio, which con­cen­trates on treat­ment for reti­nal dis­eases. Dugel brings more than 25 years of ex­pe­ri­ence in the field to the New York bio­phar­ma and has al­so been man­ag­ing part­ner at Reti­nal Con­sul­tants of Ari­zona and the Reti­nal Re­search In­sti­tute.

I-Mab has se­lect­ed Gi­gi Feng to be its VP, glob­al head of cor­po­rate com­mu­ni­ca­tions start­ing on April 20. She will over­see all com­mu­ni­ca­tions at the Chi­na-based bio­phar­ma, which cen­ters on nov­el or high­ly dif­fer­en­ti­at­ed bi­o­log­ics to treat dis­eases with sig­nif­i­cant un­met med­ical needs. Feng pre­vi­ous­ly had com­mu­ni­ca­tions roles at Am­gen and Sanofi.

Meenu Chhabra, the CEO and pres­i­dent of Pro­teosta­sis Ther­a­peu­tics, has hopped aboard the board of di­rec­tors at Va­som­mune Ther­a­peu­tics — a com­pa­ny work­ing on a treat­ment for Covid-19/pathogen-in­duced ARDS.

→ NASH biotech 89bio has wel­comed Steven Altschuler as chair­man to its board of di­rec­tors. Altschuler serves as man­ag­ing di­rec­tor of health­care ven­tures at Ziff Cap­i­tal Part­ners.

→ Im­muneer­ing — whose cur­rent pipeline fo­cus­es on dis­eases such as can­cer cachex­ia and metas­ta­sis — has brought on three new ad­di­tions to its sci­en­tif­ic ad­vi­so­ry board. Daniel Ahn, di­rec­tor of the GI On­col­o­gy Trans­la­tion­al Re­search Work­ing Group; Mitesh Bo­rad, di­rec­tor of the can­cer cell, gene and virus ther­a­py lab at the Mayo Clin­ic Cen­ter for In­di­vid­u­al­ized Med­i­cine; and Bi­jan Ne­jad­nik, the CMO and head of re­search at San­Bio.

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

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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FDA de­lays de­ci­sion on No­var­tis’ po­ten­tial block­buster MS drug, wip­ing away pri­or­i­ty re­view

So much for a speedy review.

In February, Novartis announced that an application for their much-touted multiple sclerosis drug ofatumumab had been accepted and, with the drug company cashing in on one of their priority review vouchers, the agency was due for a decision by June.

But with June less than 48 hours old, Novartis announced the agency has extended their review, pushing back the timeline for approval or rejection to September. The Swiss pharma filed the application in December, meaning their new schedule will be nearly in line with the standard 10-month window period had they not used the priority voucher.

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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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Pfiz­er’s Doug Gior­dano has $500M — and some ad­vice — to of­fer a cer­tain breed of 'break­through' biotech

So let’s say you’re running a cutting-edge, clinical-stage biotech, probably public, but not necessarily so, which could see some big advantages teaming up with some marquee researchers, picking up say $50 million to $75 million dollars in a non-threatening minority equity investment that could take you to the next level.

Doug Giordano might have some thoughts on how that could work out.

The SVP of business development at the pharma giant has helped forge a new fund called the Pfizer Breakthrough Growth Initiative. And he has $500 million of Pfizer’s money to put behind 7 to 10 — or so — biotech stocks that fit that general description.

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Joseph Kim, Inovio CEO (Andrew Harnik, AP Images)

Caught in a stand­off with its con­tract man­u­fac­tur­er over Covid-19 vac­cine, In­ovio files suit in an at­tempt to break free while ri­vals race ahead

Inovio was one of the first vaccine developers to snag attention for a jab that their execs said promised to end the Covid-19 pandemic. Using their own unique DNA tech, CEO Joseph Kim said it took just 3 hours to work it out.

But while rivals are racing to the finish line with ambitious plans to make vast quantities of their vaccines with billions of dollars of deals, Inovio is still stuck at the starting line on manufacturing.