Peer Re­view: Ru­bius re­cruits BD chief; Epizyme hires No­var­tis vet as CFO

Kris Elverum

Ru­bius Ther­a­peu­tics — clin­i­cal-stage bio­phar­ma­ceu­ti­cal com­pa­ny de­vel­op­ing a new class of med­i­cines called red cell ther­a­peu­tics — made the ad­di­tion of Kris Elverum to its se­nior lead­er­ship team as SVP of busi­ness de­vel­op­ment and strat­e­gy. Elverum joins the com­pa­ny from Turn­stone Bi­o­log­ics and has pre­vi­ous­ly served at SQZ Biotech, No­var­tis and McK­in­sey & Co

→ As Epizyme preps a tran­si­tion to the com­mer­cial stage — which could come as ear­ly as next Jan­u­ary if the FDA comes through — it’s in­stalling Pao­lo Tombe­si as CFO. A No­var­tis vet, Tombe­si has over­seen a sim­i­lar tran­si­tion for In­smed, help­ing launch a sub­sidiary in Japan and bring­ing in more than $1 bil­lion by Epizyme’s count. Aside for the sar­co­ma ap­pli­ca­tion, now un­der pri­or­i­ty pre­view, a sec­ond NDA for tazeme­to­stat is slat­ed for lat­er this year, he added.

Jim Wil­son and Steve Squin­to has en­list­ed two more ex­ecs to their lean team at Pas­sage Bio in pur­suit of AAV gene ther­a­pies to treat rare mono­genic cen­tral ner­vous sys­tem dis­eases. Jill Quigley, who’s cred­it­ed for ad­vice and ne­go­ti­a­tions in the Shire/NPS and Gilead/Phar­mas­set ac­qui­si­tions, has been tapped as COO and gen­er­al coun­sel, while Bio­gen vet Alex Fo­topou­los is com­ing on board as CTO. Hav­ing over­seen tech­ni­cal op­er­a­tions at Ul­tragenyx’s gene ther­a­py unit (ac­quired from Di­men­sion), Fo­topou­los will now lead the buildup of Pas­sage’s man­u­fac­tur­ing ca­pa­bil­i­ties as it ad­vances lead pro­grams in GM1 gan­gliosi­do­sis, fron­totem­po­ral de­men­tia and Krabbe dis­ease in­to the clin­ic in 2020.”

Alex Fo­topou­los

Cor­bus Phar­ma­ceu­ti­cals — a Phase III clin­i­cal-stage com­pa­ny fo­cused on the de­vel­op­ment and com­mer­cial­iza­tion of ther­a­peu­tics to treat in­flam­ma­to­ry and fi­brot­ic dis­eases — re­cent­ly hired Kaizar Lehri as head of glob­al sup­ply chain. Lehri joins the com­pa­ny as their lead prod­uct can­di­date, lenaba­sum — a syn­thet­ic, oral, se­lec­tive cannabi­noid re­cep­tor type 2 (CB2) ag­o­nist —  is cur­rent­ly be­ing eval­u­at­ed in sys­temic scle­ro­sis, cys­tic fi­bro­sis, der­mato­myosi­tis and sys­temic lu­pus ery­the­mato­sus. Lehri has had stints as as­so­ciate di­rec­tor, sup­ply chain process op­ti­miza­tion and ef­fec­tive­ness at Bio­gen and di­rec­tor, sup­ply chain op­er­a­tions at Re­gen­eron.

→ Since seal­ing a deal for Avi­ra­gen Ther­a­peu­tics to serve as Vaxart’s shell in a re­verse merg­er, Joseph Pat­ti has re­treat­ed to the back bench­es. But he’s jump­ing back to the front lines now as CEO of Ag­ilVax, tak­ing a stab at an­ti­body-based can­cer ther­a­pies. He suc­ceeds Fed­er­i­ca Per­i­cle, who is leav­ing the Al­bu­querque-based biotech for an­oth­er op­por­tu­ni­ty. Ag­ilVax prod­ucts go af­ter xCT, an amino-acid trans­porter over­ex­pressed in sev­er­al can­cers and sus­pect­ed to play a role in metas­ta­sis. Pat­ti — a sci­en­tif­ic co-founder of Bris­tol-My­ers Squibb ac­quired In­hib­i­tex — is tasked with steer­ing the two lead drugs in­to clin­i­cal tri­als, in com­bi­na­tion with chemo, check­point or KRAS in­hibitors. 

→ Five months af­ter leav­ing Vivek Ra­maswamy’s rare dis­ease off­shoot En­zy­vant, Alvin Shih has land­ed his next CEO job at Dis­arm Ther­a­peu­tics. In­cu­bat­ed out of At­las Ven­ture’s Cam­bridge, MA hatch­ing grounds, the biotech is ze­ro­ing in on SARM1 in hopes of dis­rupt­ing the process of ax­on­al de­gen­er­a­tion. Shih’s ex­pe­ri­ence with rare neu­ro­log­i­cal dis­eases preps him for the chal­lenge of ap­ply­ing this tech­nol­o­gy to a broad range of dis­eases in­clud­ing mul­ti­ple scle­ro­sis and ALS to pe­riph­er­al neu­ropathies, Dis­arm said.

Alvin Shih

→ France’s Im­Check Ther­a­peu­tics has put Re­cep­tos alum Paul Frohna in charge of its im­mune mod­u­la­tor pro­grams across can­cer and au­toim­mune dis­eases. As the com­pa­ny’s first CMO, Frohna will lead an an­tic­i­pat­ed en­try in­to the clin­ic by ear­ly 2020. He brings some fresh ex­pe­ri­ence from the same role at Bion­iz, a biotech in Irvine, Cal­i­for­nia he’d helped cre­ate. In­stead of cy­tokines, though, his new niche will be g9d2 T cells and a nov­el fam­i­ly of im­munomod­u­la­tors dubbed bu­ty­rophilins. 

→ With a num­ber of pro­grams for eye and neu­rode­gen­er­a­tive dis­eases in mid-stage stud­ies, Alka­h­est is ap­par­ent­ly con­fi­dent enough about its an­ti-ag­ing plat­form to be­gin scout­ing part­ner­ships. Robert Klein will be head­ing up that ef­fort as its new­ly-mint­ed CBO, lever­ag­ing his back­ground in neu­ro­science drug de­vel­op­ment as well as re­cent ex­po­sure to busi­ness de­vel­op­ment. Re­cent stints in­clude CEO at iKaryos Di­ag­nos­tics and CSO at Amnestix. Alka­h­est al­ready has an al­liance with Spain’s Gri­fols, an ear­ly be­liev­er in its pro­tein prod­ucts de­rived from blood plas­ma.

NeuBase Ther­a­peu­tics wel­comed Danith Ly aboard as their CSO. Ly is cred­it­ed as the pri­ma­ry in­ven­tor of the com­pa­ny’s pep­tide nu­cle­ic acid (PNA) an­ti­sense oligonu­cleotide (PA­TrOL) plat­form tech­nol­o­gy. Pri­or to join­ing the com­pa­ny, Ly co-found­ed PNA In­no­va­tions (now Tru­code Gene Re­pair) and held stints as a sci­en­tif­ic ad­vi­so­ry board mem­ber at He­lixBind and a mem­ber of the board of di­rec­tors of Karuna Com­mune En­ter­prise. He is a found­ing di­rec­tor of the Bio­mol­e­c­u­lar De­sign and Dis­cov­ery In­sti­tute (BDI) at Carnegie Mel­lon Uni­ver­si­ty. In ad­di­tion to his role at NeuBase, Dr. Ly will main­tain his fac­ul­ty ap­point­ment as pro­fes­sor of chem­istry at Carnegie Mel­lon Uni­ver­si­ty’s Mel­lon Col­lege of Sci­ence.

Verb Sur­gi­cal — the ro­bot­ic surgery joint ven­ture from Ver­i­ly and J&J —  tapped Kurt Azarbarzin as its pres­i­dent and CEO. Azarbarzin joins the com­pa­ny from his la­paro­scop­ic surgery start­up, SurgiQuest — known for its FDA-ap­proved AirSeal de­vice. Azarbarzin was CEO of SurgiQuest un­til its ac­qui­si­tion in 2015 by Con­med, where he then be­came Con­med’s chief tech­nol­o­gy of­fi­cer.

Joseph Pa­pan­drea

Joseph Pa­pan­drea hopped to Zynex — a com­pa­ny that sells elec­trother­a­py med­ical de­vices used for pain man­age­ment, such as Neu­ro­Move — as their COO. Pri­or to jump­ing aboard Zynex, Pa­pan­drea was the vice pres­i­dent of op­er­a­tions at Ar­row Elec­tron­ics — a glob­al provider of elec­tron­ic com­po­nents and en­ter­prise com­put­ing so­lu­tions. Pa­pan­drea has al­so held var­i­ous stints in Aus­tralia, Sin­ga­pore, Ger­many, the UK, Chile and the US in a va­ri­ety of se­nior lead­er­ship roles. 

KE­PRO ap­points John Malanows­ki as chief peo­ple of­fi­cer. In this new role, Malanows­ki will be in charge of tal­ent man­age­ment, lead­er­ship de­vel­op­ment and com­pen­sa­tion and ben­e­fits. Malanows­ki re­cent­ly served as the in­ter­im chief hu­man re­source of­fi­cer for Virence Health Tech­nolo­gies and Uni­ver­si­ty of Texas, South­west­ern Med­ical Cen­ter. 

Ar­cis Biotech­nol­o­gy — a nu­cle­ic acid sam­ple prepa­ra­tion provider — has tapped pro­fes­sor Steve How­ell as non-ex­ec­u­tive chair­man to suc­ceed Paul Foul­ger, who was serv­ing as the in­ter­im chair­man on be­half of the board. How­ell joins the com­pa­ny af­ter their re­cent an­nounce­ments of strate­gic dis­tri­b­u­tion and li­cens­ing agree­ments with Open­trons and Mir­nax Biosens re­spec­tive­ly. How­ell found­ed In­no­va Part­ner­ships in 2006, where he helped cre­ate over a dozen life sci­ence start-ups and raised in ex­cess £100M in fi­nanc­ing. How­ell has al­so held po­si­tions at Unilever, Alere and Uni­path. In 2015, he was made vis­it­ing pro­fes­sor of com­mer­cial in­no­va­tion at King’s Col­lege, Lon­don.

IM­brave150: Roche’s reg­u­la­to­ry crew plans a glob­al roll­out of Tecen­triq com­bo for liv­er can­cer as PhI­II scores a hit

Just weeks after Bristol-Myers Squibb defended its failed pivotal study pitting Opdivo against Nexavar in liver cancer, Roche says it’s beat the frontline challenge with a combination of their PD-L1 Tecentriq with Avastin. And now they’re rolling their regulatory teams in the US, Europe and China in search of a new approval — badly needed to boost a trailing franchise effort.
Given their breakthrough and Big Pharma status as well as the use of two approved drugs, FDA approval may well prove to be something of a formality. And the Chinese have been clear that they want new drugs for liver cancer, where lethal disease rates are particularly high.
Researchers at their big biotech sub, Genentech, say that the combo beat Bayer’s Nexavar on both progression-free survival as well as overall survival — the first advance in this field in more than a decade. We won’t get the breakdown in months of life gained, but it’s a big win for Roche, which has lagged far, far behind Keytruda and Opdivo, the dominant PD-1s that have captured the bulk of the checkpoint market so far.
Researchers recruited hepatocellular carcinoma — the most common form of liver cancer — patients for the IMbrave150 study who weren’t eligible for surgery ahead of any systemic treatment of the disease.
Roche has a fairly low bar to beat, with modest survival benefit for Nexavar, approved for this indication 12 years ago. But they also plan to offer a combo therapy that could have significantly less toxicity, offering patients a much easier treatment regimen.
Cowen’s Steven Scala recently sized up the importance of IMbrave150, noting:

Endpoints News

Keep reading Endpoints with a free subscription

Unlock this story instantly and join 62,500+ biopharma pros reading Endpoints daily — and it's free.

UP­DAT­ED: Clay Sie­gall’s $614M wa­ger on tu­ca­tinib pays off with solid­ly pos­i­tive piv­otal da­ta and a date with the FDA

Back at the beginning of 2018, Clay Siegall snagged a cancer drug called tucatinib with a $614 million cash deal to buy Cascadian. It paid off today with a solid set of mid-stage data for HER2 positive breast cancer that will in turn serve as the pivotal win Siegall needs to seek an accelerated approval in the push for a new triplet therapy.

And if all the cards keep falling in its favor, they’ll move from 1 drug on the market to 3 in 2020, which is shaping up as a landmark year as Seattle Genetics prepares for its 23rd anniversary on July 15.

Endpoints News

Keep reading Endpoints with a free subscription

Unlock this story instantly and join 62,500+ biopharma pros reading Endpoints daily — and it's free.

Med­ical an­i­ma­tion: Mak­ing it eas­i­er for the site and the pa­tient to un­der­stand

Medical animation has in recent years become an increasingly important tool for conveying niche information to a varied audience, particularly to those audiences without expertise in the specialist area. Science programmes today, for example, have moved from the piece-to-camera of the university professor explaining how a complex disease mechanism works, to actually showing the viewer first-hand what it might look like to shrink ourselves down to the size of an ant’s foot, and travel inside the human body to witness these processes in action. Effectively communicating a complex disease pathophysiology, or the novel mechanism of action of a new drug, can be complex. This is especially difficult when the audience domain knowledge is limited or non-existent. Medical animation can help with this communication challenge in several ways.
Improved accessibility to visualisation
Visualisation is a core component of our ability to understand a concept. Ask 10 people to visualise an apple, and each will come up with a slightly different image, some apples smaller than others, some more round, some with bites taken. Acceptable, you say, we can move on to the next part of the story. Now ask 10 people to visualise how HIV’s capsid protein gets arranged into the hexamers and pentamers that form the viral capsid that holds HIV’s genetic material. This request may pose a challenge even to someone with some virology knowledge, and it is that inability to effectively visualise what is going on that holds us back from fully understanding the rest of the story. So how does medical animation help us to overcome this visualisation challenge?

Alex­ion clinch­es aHUS ap­proval for Ul­tomiris as the clock ticks on Soliris con­ver­sion

Alexion has racked up a second approval for Ultomiris, the successor therapy to Soliris, as its mainstay blockbuster therapy faces a patent review process that could drastically shorten its patent exclusivity.

The FDA OK for atypical hemolytic uremic syndrome (aHUS) on Friday was widely expected after Alexion posted a full slate of positive Phase III data in January. But regulators also flagged concerns about serious meningococcal infections, slapping a black box warning on the label and mandating a REMS.

FDA ap­proval lets Foamix set its maid­en ac­ne ther­a­py on course for US mar­ket launch

Months ago, Foamix leaned on its biggest shareholders — Perceptive Advisors and OrbiMed — to financially grease its wheels, ahead of the FDA decision date for its acne therapy. On Friday, that approval came in — and the topical formulation of the antibiotic minocycline is set for a January launch.

The therapy, Amzeeq (formerly known as FMX101), was approved to treat inflammatory lesions of non-nodular moderate-to-severe acne vulgaris in patients aged 9 and older.

Alice Shaw, Lung Cancer Foundation of America

Top ALK ex­pert and can­cer drug re­searcher Al­ice Shaw bids adieu to acad­e­mia, hel­lo to No­var­tis

Jay Bradner has recruited a marquee oncology drug researcher into the ranks of the Novartis Institutes for BioMedical Research. Alice Shaw is jumping from prestigious posts intertwined through Mass General, Harvard and Dana-Farber to take the lead of NIBR’s translational clinical oncology group.

Endpoints News

Keep reading Endpoints with a free subscription

Unlock this story instantly and join 62,500+ biopharma pros reading Endpoints daily — and it's free.

Hal Barron, GSK's president of R&D and CSO, speaks to Endpoints News founder and editor John Carroll in London at Endpoints' #UKBIO19 summit on October 8, 2019

[Video] Cel­e­brat­ing tri­al fail­ures, chang­ing the cul­ture and al­ly­ing with Cal­i­for­nia dream­ers: R&D chief Hal Bar­ron talks about a new era at GSK

Last week I had a chance to sit down with Hal Barron at Endpoints’ #UKBIO19 summit to discuss his views on R&D at GSK, a topic that has been central to his life since he took the top research post close to 2 years ago. During the conversation, Barron talked about changing the culture at GSK, a move that involves several new approaches — one of which involves celebrating their setbacks as they shift resources to the most promising programs in the pipeline. Barron also discussed his new alliances in the Bay Area — including his collaboration pact with Lyell, which we covered here — frankly assesses the pluses and minuses of the UK drug development scene, and talks about his plans for making GSK a much more effective drug developer.

This is one discussion you won’t want to miss. Insider and Enterprise subscribers can log-in to watch the video.

Endpoints Premium

Premium subscription required

Unlock this article along with other benefits by subscribing to one of our paid plans.

Christine Bunt, Robert Langer. Verseau

Armed with Langer tech and $50M, Verseau hails new check­point drugs un­leash­ing macrophages against can­cer

The rising popularity of CD47 has propelled the “don’t-eat-me” signal to household name status in the immuno-oncology world: By blocking that protein, the theory goes, one can stop cancer cells from fooling macrophages. But just as PD-(L)1 merely represents the most fruitful of all checkpoints regulating T cells, Verseau Therapeutics is convinced that CD47 is one of many regulators one can modulate to stir up or tame the immune system.

Mi­rati preps its first look at their KRAS G12C con­tender, and they have to clear a high bar for suc­cess

If you’re a big KRAS G12C fan, mark your calendars for October 28 at 4:20 pm EDT.

That’s when Mirati $MRTX will unveil its first peek at the early clinical data available on MRTX849 in presentations at the AACR-NCI-EORTC International Conference on Molecular Targets and Cancer Therapeutics in Boston.

Mirati has been experiencing the full effect of a rival’s initial success at targeting the G12C pocket found on KRAS, offering the biotech some support on the concept they’re after — and biotech fans a race to the top. Amgen made a big splash with its first positive snapshot on lung cancer, but deflated sky-high expectations as it proved harder to find similar benefits in other types of cancers.

Endpoints News

Keep reading Endpoints with a free subscription

Unlock this story instantly and join 62,500+ biopharma pros reading Endpoints daily — and it's free.