Tariq Kas­sum jumps from Ob­sid­i­an to Cel­sius helm; Quell Ther­a­peu­tics taps Iain McGill as new CEO

Tariq Kas­sum Linkedin

→ Cam­bridge, Mass­a­chu­setts-based Cel­sius Ther­a­peu­tics — which was launched in 2018 and backed by Third Rock Ven­tures and GV — has tapped Tariq Kas­sum to the helm. Kas­sum suc­ceed­ed Alex­is Borisy, who has been in­ter­im CEO and who stay as chair­man of the board of di­rec­tors.

Borisy re­cent­ly made an un­ex­pect­ed ex­it from Third Rock, be­fore their record $770 mil­lion fund for its next wave of in­vest­ments in the life sci­ence field.

Kas­sum was the COO at Ob­sid­i­an Ther­a­peu­tics, fol­low­ing stints at Mil­len­ni­um Phar­ma­ceu­ti­cals and Take­da.

Alex Sapir Re­Vi­ral

Alex Sapir has suc­ceed­ed Ed­dy Lit­tler as CEO of Re­Vi­ral — a stick­ler in the tough res­pi­ra­to­ry syn­cy­tial virus (RSV) field — and been elect­ed to the com­pa­ny’s board of di­rec­tors. Lit­tler will as­sume the po­si­tion of COO in­stead. Pri­or to join­ing Re­Vi­ral, Sapir was CEO and pres­i­dent at Do­va Phar­ma­ceu­ti­cals, help­ing raise $160 mil­lion in an IPO and fol­low-on of­fer­ings. In ad­di­tion, Sapir has had stints at Unit­ed Ther­a­peu­tics and GSK.

Iain McGill Linkedin

Weeks af­ter launch­ing out of Syn­cona’s crib, Quell Ther­a­peu­tics — which is spe­cial­iz­ing in the de­vel­op­ment of en­gi­neered Treg cell ther­a­pies — wel­comes Iain McGill as its CEO. Pri­or to join­ing Quell, McGill served as se­nior vice pres­i­dent in Eu­rope and the rest of the world for Jazz Phar­ma­ceu­ti­cals. Be­fore that, McGill had a stint at EU­SA Phar­ma and he al­so worked in var­i­ous po­si­tions in the field of trans­plan­ta­tion and im­munol­o­gy at Wyeth, No­var­tis and Roche Phar­ma­ceu­ti­cals.

James Ward-Lil­ley, CEO of res­pi­ra­to­ry drug de­vel­op­er Vec­tura Group, is step­ping down from both his po­si­tion and the board. Cur­rent CFO Paul Fry will step in as in­ter­im CEO, in ad­di­tion to his cur­rent re­spon­si­bil­i­ties. A search for a new suc­ces­sor will be­gin im­me­di­ate­ly.  

Jes­si­ca Mar­tins­son Sprint Bio­science

Sprint Bio­science CEO An­ders Åberg is step­ping down from his po­si­tion af­ter 10 years in the role, and cur­rent op­er­a­tional man­ag­er and co-founder Jes­si­ca Mar­tins­son will re­place him as the act­ing CEO. Åberg will re­tain his share­hold­ing and re­main as a se­nior ad­vi­sor to the com­pa­ny.

Louis Kay­i­talire Linkedin

→  Cam­bridge, Eng­land-based F-star has ap­point­ed Big Phar­ma vet Louis Kay­i­talire as its CMO. Kay­i­talire will over­see the de­vel­op­ment of F-star’s lead prod­uct can­di­date FS118 — a LAG-3/PD-L1-tar­get­ing tetrava­lent bis­pe­cif­ic an­ti­body cur­rent­ly in a Phase I clin­i­cal tri­al. He will al­so lead the clin­i­cal strat­e­gy and op­er­a­tions for F-star’s pipeline of bis­pecifics, in­clud­ing FS120 and FS222, which are on track for IND sub­mis­sions this year. Kay­i­talire has over 20 years of ex­pe­ri­ence in on­col­o­gy and im­muno-on­col­o­gy ac­cu­mu­lat­ed over the years at Bris­tol-My­ers Squibb, Cel­gene and Eli Lil­ly.

Thomas Schi­neck­er Roche

→ Swiss gi­ant Roche has un­veiled the new head of its $13 bil­lion di­ag­nos­tics unit — one day af­ter the FDA sanc­tioned the ac­cel­er­at­ed ap­proval of the com­pa­ny’s lat­est an­ti­body-drug con­ju­gate. Thomas Schi­neck­er — who has been with the com­pa­ny since 2003 — is be­ing pro­mot­ed to CEO of Roche Di­ag­nos­tics, and will be­gin his tenure from Au­gust 1, the com­pa­ny said. Schi­neck­er will re­place Roland Diggel­mann, who left his post last Au­gust.

In ad­di­tion, Roche board mem­ber Pe­ter Vos­er — who has been with the com­pa­ny since 2011 — has elect­ed to step down to fo­cus on his role as in­ter­im CEO of ABB. Fur­ther­more, Roche’s head of group com­mu­ni­ca­tions, Stephan Feld­haus, is al­so leav­ing and will be re­placed by Bar­bara Schaedler, who is cur­rent­ly head of pub­lic af­fairs at pri­vate en­er­gy com­pa­ny E.ON SE.

Unum Ther­a­peu­tics has en­list­ed sev­er­al C-suite mem­bers on its on­go­ing quest for a new kind of T cell ther­a­py. Matthew Os­borne, a for­mer VP of cor­po­rate af­fairs, com­mu­ni­ca­tions and in­vestors re­la­tions at Voy­ager Ther­a­peu­tics, is the new CFO. Take­da vet Jes­si­ca Sachs has been pro­mot­ed to CMO, re­plac­ing Michael Vas­con­celles. In ad­di­tion, Mert Ak­tar has been ap­point­ed to the new­ly cre­at­ed role of head of busi­ness and cor­po­rate de­vel­op­ment af­ter 8 years at Shire.

Michael Vas­con­celles has been re­cruit­ed by Flat­iron Health to serve as its CMO. Vas­con­celles just left the same po­si­tion at Unum Ther­a­peu­tics. Vas­con­celles’ pre­vi­ous stints in­clude serv­ing at Take­da/Mil­len­ni­um, Gen­zyme and Sanofi On­col­o­gy. Cur­rent­ly, he is as a clin­i­cal in­struc­tor in med­i­cine at Har­vard Med­ical School and is a prac­tic­ing on­col­o­gist and as­so­ciate physi­cian at the Dana-Far­ber Can­cer In­sti­tute and Brigham & Women’s Hos­pi­tal in Boston.

→ Af­ter a re­cent stint as vice pres­i­dent of glob­al reg­u­la­to­ry af­fairs and qual­i­ty as­sur­ance at Charleston Lab­o­ra­to­ries, Mark Man­nebach is join­ing Eiger Bio­Phar­ma­ceu­ti­cals as its vice pres­i­dent of glob­al reg­u­la­to­ry af­fairs.

Mark Man­nebach Linkedin

“Eiger’s pipeline is now late-stage with planned glob­al reg­u­la­to­ry ac­tiv­i­ties in­clud­ing an NDA and MAA for Prog­e­ria and Progeroid Laminopathies, en­roll­ment of a glob­al Phase III study for Lon­a­farnib in HDV, and End of Phase 2 meet­ings for Pegin­ter­fer­on Lamb­da in HDV and Avex­i­tide in Post-Bariatric Hy­po­glycemia,” said David Cory, pres­i­dent and CEO of Eiger. “Mark’s glob­al reg­u­la­to­ry ex­per­tise and ex­pe­ri­ence will strength­en our lead­er­ship team and ex­e­cu­tion.”

Some of Man­nebach’s pre­vi­ous stints in­clude roles at Sanofi, Pfiz­er, Co­vi­di­en and Mallinck­rodt Phar­ma­ceu­ti­cals.

Zy­la Life Sci­ences re­cruit­ed Jef­frey Wilkins as its CMO and se­nior vice pres­i­dent. Wilkins joins the com­pa­ny from the same po­si­tion at Lyc­era. Pri­or to his time at Lyc­era, Wilkins had stints at Nex­ep­tion Ther­a­peu­tics, Cep­taris Ther­a­peu­tics, Acte­lion and GSK.

Deepi­ka Jalota Linkedin

PMV Phar­ma­ceu­ti­cals — a biotech fo­cused on p53-tar­get­ed small mol­e­cule drugs for can­cer — an­nounced the ap­point­ment of Deepi­ka Jalota as its se­nior vice pres­i­dent and head of reg­u­la­to­ry af­fairs.

Pri­or to join­ing the com­pa­ny, Jalota served as vice pres­i­dent glob­al-reg­u­la­to­ry strat­e­gy head, on­col­o­gy at Bay­er Health­care. Be­fore that, Jalota had stints at Sanofi-Aven­tis, For­est Lab­o­ra­to­ries and Proc­tor and Gam­ble.

Chelsea Place John­son Linkedin

Chelsea Place John­son has joined the ear­ly-stage VC At­las Ven­ture as its se­nior as­so­ciate, fo­cus­ing on new com­pa­ny for­ma­tion across ar­eas of un­met med­ical need. John­son, who most re­cent­ly man­aged busi­ness de­vel­op­ment for Tan­go Ther­a­peu­tics, had pre­vi­ous­ly worked at Third Rock Ven­tures.

→ As Ac­celeron Phar­ma ap­proach­es the fin­ish line with lus­pa­ter­cept, co-founder Tom Ma­ni­atis is re­tir­ing from the board while con­tin­u­ing to ad­vise the com­pa­ny’s de­vel­op­ment of TGF-be­ta su­per­fam­i­ly ther­a­peu­tics. Ma­ni­atis co-found­ed the com­pa­ny in 2003 and has since tak­en up a CEO role at New York Genome Cen­ter, which he al­so helped start.

Do­main Ther­a­peu­tics — a bio­phar­ma­ceu­ti­cal com­pa­ny spe­cial­ized in the dis­cov­ery and de­vel­op­ment of new drug can­di­dates tar­get­ing trans­mem­brane re­cep­tors, in par­tic­u­lar, G pro­tein-cou­pled re­cep­tors (GPCRs) — an­nounced the ap­point­ment of Sylvie Rycke­busch to its board of di­rec­tors.

Rycke­busch was most re­cent­ly the CBO the non­prof­it Es­peR­are Foun­da­tion. In ad­di­tion, her ex­pe­ri­ence spans to roles at Mer­ck Serono and as the founder of Oc­tave Biotech Con­sult­ing.

 

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.

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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:

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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.

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.

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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.

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.

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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.

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