Akre­via scoops ex-Ar­sa­nis chief René Rus­so as CEO; Scott Got­tlieb jumps back in­to in­dus­try; Seat­tle Ge­net­ics raids As­traZeneca for CCO

René Rus­so Akre­via Ther­a­peu­tics

→ Months af­ter re­sign­ing from Ar­sa­nis — now rel­e­gat­ed to biotech his­to­ry books af­ter a re­verse merg­er with X4 Phar­maRené Rus­so has land­ed her next CEO gig at Akre­via Ther­a­peu­tics. The new role will shift her at­ten­tion from an­ti-in­fec­tives to im­muno-on­col­o­gy, but she will lean on her ex­pe­ri­ence scal­ing up biotech op­er­a­tions from an ear­ly stage. Backed by F-Prime Cap­i­tal and At­las Ven­ture, Akre­via em­ploys plat­form tech that pack­ages a CT­LA4 in­hibitor in a way that the an­ti­body would be in­ac­tive un­til it reach­es the tu­mor mi­croen­vi­ron­ment.

Scott Got­tlieb Twit­ter

→ Just a lit­tle more than a month af­ter his sur­prise ex­it from the FDA — sug­gest­ing he want­ed to spend more time with his fam­i­ly in Con­necti­cut, Scott Got­tlieb is jump­ing back in­to the mon­ey side of the in­dus­try and re­join­ing Wash­ing­ton DC-based New En­ter­prise As­so­ci­ates as a full-time in­vest­ing part­ner, where he ex­pects to start back­ing biotech star­tups and sit­ting on boards again.


Robin Tay­lor Seat­tle Ge­net­ics

Seat­tle Ge­net­ics $SGEN has raid­ed the top ranks of As­traZeneca $AZN for its first chief com­mer­cial of­fi­cer, Robin Tay­lor. Tay­lor’s stint at As­traZeneca last­ed 7 months, and pri­or to jump­ing to the com­pa­ny, he led the can­cer im­munother­a­py fran­chise at Roche’s Genen­tech for close to 18 years.

“Robin will play a key role in ex­tend­ing our com­mer­cial ex­e­cu­tion across six Ad­cetris lym­phoma in­di­ca­tions, while prepar­ing for the po­ten­tial launch of en­for­tum­ab ve­dotin and lead­ing our glob­al com­mer­cial­iza­tion strat­e­gy for pos­si­ble fu­ture prod­ucts, such as tu­ca­tinib,” not­ed Seat­tle Ge­net­ics CEO Clay Sie­gall.

David Apelian Twit­ter

→ Cur­rent COO and ex­ec­u­tive med­ical of­fi­cer of late-stage Eiger Bio­Phar­ma­ceu­ti­cals, David Apelian, will be step­ping down ef­fec­tive June 14, 2019. Apelian will join a pri­vate biotech as its CEO. Apelian’s de­par­ture is hap­pen­ing while the com­pa­ny’s Phase III pro­gram for ion­a­farnib — a preny­la­tion in­hibitor for the treat­ment of He­pati­tis Delta Virus (HDV) in­fec­tion — is be­ing prepped for an NDA and MAA to treat Hutchin­son-Gil­ford Prog­e­ria Syn­drome (HG­PS or Prog­e­ria) and Progeroid Laminopathies, with plans to file in 2019. Apelian will con­tin­ue to serve on the com­pa­ny’s board of di­rec­tors.

Pamela Gar­zone Scripps Re­search

→ The drug de­vel­op­ment arm of Scripps Re­search, Cal­i­br, has named Pamela Gar­zone as its CMO. Gar­zone has pre­vi­ous­ly served as vice pres­i­dent with­in the ear­ly on­col­o­gy de­vel­op­ment at Pfiz­er $PFE as well as oth­er lead­er­ship roles. Cal­i­br is cur­rent­ly de­vel­op­ing mul­ti­ple drug can­di­dates, such as KA34 — a po­ten­tial os­teoarthri­tis ther­a­py that is cur­rent­ly in a Phase I hu­man clin­i­cal tri­al stage, and lat­er this year the com­pa­ny plans to sub­mit IND ap­pli­ca­tions for two can­cer ther­a­pies.

Mar­tin Tred­er Af­fimed

Af­fimed $AFMD has part­ed ways with CSO Mar­tin Tred­er just as the Ger­man biotech ex­e­cutes a pipeline cleanup and nar­rows its fo­cus. Its AFM11 pro­gram got in­to trou­ble with the FDA last Oc­to­ber due to a pa­tient death and two life-threat­en­ing episodes, and reg­u­la­tors re­cent­ly in­formed them that the Phase I tri­al can­not re­sume with­out more da­ta. CEO Adi Hoess notes that he has a strong team and is in no rush, if ever, to re­place Tred­er — who re­mains as a con­sul­tant. In the mean­time, COO Wolf­gang Fis­ch­er will over­see the dis­cov­ery and pre­clin­i­cal ef­forts.

Di­nah Sah Voy­ager Ther­a­peu­tics

→ Cam­bridge, Mass­a­chu­setts-based clin­i­cal-stage gene com­pa­ny, Voy­ager Ther­a­peu­tics an­nounced the re­tire­ment of its CSO Di­nah Sah and the ex­pan­sion of Omar Khwa­ja’s cur­rent role as CMO to now in­clude head of R&D. Both changes will be ef­fec­tive on June 28, 2019. Sah will con­tin­ue to serve as a con­sul­tant to the com­pa­ny and will al­so join its sci­en­tif­ic ad­vi­so­ry board.  

Mor­gan Sheng Genen­tech

Mor­gan Sheng is re­turn­ing to acad­e­mia fol­low­ing a decade at Roche’s Genen­tech. As VP of neu­ro­science, he spear­head­ed re­search projects dig­ging in­to new treat­ments for neu­rode­gen­er­a­tive dis­eases and pain. He now takes that back to MIT, al­beit in some­what dif­fer­ent po­si­tions than when he left — core mem­ber at the Broad In­sti­tute, and co-di­rec­tor of the Stan­ley Cen­ter for Psy­chi­atric Re­search — with a clear aim to ad­vance new ways to study, di­ag­nose and treat men­tal ill­ness.

Kirk Christof­fersen Linkedin

→ Well on its way in the clin­ic, an­ti-CD47 play­er Arch On­col­o­gy is ready to look be­yond its lead as­set for op­por­tu­ni­ties to grow. Kirk Christof­fersen has been tapped for the new­ly-cre­at­ed chief busi­ness of­fi­cer role, re­spon­si­ble for cor­po­rate strat­e­gy. Jump­ing from Com­pu­gen (pre­ced­ed by a 10-year run at GlobeIm­mune) Christof­fersen joins Arch short­ly af­ter it banked $50 mil­lion in Se­ries B cash, al­low­ing it to ex­pand both the cor­po­rate/clin­i­cal de­vel­op­ment team in the Bay Area and the re­search group at St. Louis.

Greg Rys­lik Linkedin

→ Cam­bridge, Mass­a­chu­setts-based Cel­sius Ther­a­peu­tics — start­ed in 2018 and backed by Third Rock Ven­tures and GV (for­mer­ly Google Ven­tures) — an­nounced its first key lead­er­ship ap­point­ments. Greg Rys­lik has joined the com­pa­ny as its chief da­ta of­fi­cer, and Michael Boret­ti has joined as its CBO.

Michael Boret­ti Linkedin

“Over the past year, we have been build­ing our team and as­sem­bling an in­te­grat­ed, in­dus­tri­al-scale plat­form that com­bines sin­gle-cell ge­nomics, ma­chine learn­ing, deep bi­ol­o­gy and drug dis­cov­ery, which has en­abled Cel­sius to ad­vance its un­der­stand­ing of the spe­cif­ic cells and ge­net­ic dri­vers that could play a key role in au­toim­mune dis­eases and can­cer,” said Alex­is Borisy, chair­man of Cel­sius.

→ Af­ter an­nounc­ing that it had en­tered the bio­me­chan­ics mar­ket launch­ing op­er­a­tion in Min­neapo­lis, Min­neso­ta, Subio­Med has now made ad­di­tions to its man­age­ment team. Patrick Kull­mann joins the com­pa­ny as CEO and board mem­ber af­ter his re­cent stint as COO and pres­i­dent for Medovex Corp.

Patrick Kull­mann Linkedin

Kull­mann has al­so served lead­er­ship po­si­tion at J&J, Boston Sci­en­tif­ic and Medtron­ic and mul­ti­ple start-up med­ical tech­nol­o­gy com­pa­nies. Bri­an Bowen joins the com­pa­ny as ex­ec­u­tive VP and board mem­ber with 32 years of ex­pe­ri­ence in mar­ket­ing strat­e­gy and lead­er­ship. Ad­di­tion­al­ly, John Deedrick — co-founder and ex­ec­u­tive chair­man of Ac­tivOrtho, co-founder and di­rec­tor of DyaMX, co-Founder and di­rec­tor of CHIP II and Pres­i­dent of CHIP So­lu­tions — and Mar­tin Emer­son — pres­i­dent and CEO of Mon­teris Med­ical — have joined the com­pa­ny’s board.

Karin Schmitt Linkedin

→ UK- based com­pa­ny Mo­gri­fy has re­lo­cat­ed to the Bio-In­no­va­tion Cen­tre at the Cam­bridge Sci­ence Park, af­ter adding 15 new staff mem­bers to its sci­en­tif­ic and man­age­ment teams, in­clud­ing Karin Schmitt as CBO and Joe Fos­ter as COO. The com­pa­ny says that “these new hires and fa­cil­i­ties will aid Mo­gri­fy in build­ing a scal­able in­fra­struc­ture to gen­er­ate IP around nov­el cell con­ver­sion to pow­er the de­vel­op­ment and man­u­fac­ture of new cell ther­a­pies across mul­ti­ple ther­a­peu­tic ar­eas.”

Rob Jack­son Linkedin

→ Ramp­ing up prepa­ra­tions for the po­ten­tial launch of RHB-105 — or Tal­i­cia as it’s al­ready call­ing the an­ti-in­fec­tive com­bat­ting H. Py­loriRed­Hill Bio­phar­ma has added three sea­soned ex­ec to its com­mer­cial team. Rob Jack­son, VP of mar­ket­ing, joins from Bioven­tus; Syn­er­gy Phar­ma’s for­mer VP of mar­ket ac­cess, Robert Gilkin, as­sumes the same role at Red­Hill; Steven Thomasian brings ex­pe­ri­ence from Kala and Cem­pra to his role as VP of sup­ply chain.

Je­re­my Grun­stein Linkedin

Am­gen $AMGN vet Je­re­my Grun­stein is the new VP of busi­ness de­vel­op­ment at Xen­cor $XN­CR, tasked with scout­ing new col­lab­o­ra­tions and deals for its an­ti­body tech, with sev­er­al po­ten­tial ap­pli­ca­tions in­clud­ing in bis­pe­cif­ic — re­cent­ly en­tic­ing Genen­tech to sign up for an al­liance.

Sean Parker, AP

Sean Park­er helps cre­ate a CRISPRed cell ther­a­py 2.0 play — and he’s got a high-pro­file set of lead­ers on the team

You can rack up one more high-profile debut effort in the wave of activity forming around cell therapy 2.0. It’s another appealing Bay Area group that’s attracted some of the top hands in the business to a multi-year effort to create a breakthrough. And they have $85 million in hand to make that first big step to the clinic.

Today it’s Ken Drazan and the team at South San Francisco-based ArsenalBio that are coming from behind the curtain for a public bow, backed by billionaire Sean Parker and a collection of investors that includes Beth Seidenberg’s new venture investment operation based in LA.
Drazan — a J&J Innovation vet with a long record of entrepreneurial endeavors — exited the stage in 2018 when his last mission ended as he stepped aside as president of Grail. It wasn’t long, though, before he was helping out with a business plan for ArsenalBio that revolved around the work of a large group of interconnected scientists supported by the Parker Institute for Cancer Immunology.
The biotech started by putting together an “arsenal” of technologies aimed at making cell therapies for cancer much, much better than the rather crude first-generation drugs that hit the market from Novartis and Kite.
Their drugs have become the baseline against which all others are being measured.
“The technology set we’re developing is independent of the chassis,” Drazan tells me. “It doesn’t have to be autologous (extracted from the patient) or allogeneic (off the shelf). It doesn’t have to be a T cell, it could be a B cell.” But they are starting out on the autologous side, where they have the most knowledge and insight into manufacturing techniques.
It also doesn’t have to be close to the clinic.
Drazan expects the biotech will be working its way through preclinical operations for “a few years,” with enough money from the $85 million launch round to get into humans.
By today’s superheated fundraising standards, that’s not a huge amount of cash. Lyell, another cell therapy 2.0 startup we featured last week, raised $600 million in a year, including a big chunk of cash from GlaxoSmithKline. Drazan is interested in dealmaking as well, but he also knows he has the cash necessary to support the company for a good run — a key part of what it takes to bring together a stellar team of top players.

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Eli Lil­ly’s first PhI­II show­down for their $1.6B can­cer drug just flopped — what now?

When Eli Lilly plunked down $1.6 billion in cash to acquire Armo Biosciences a little more than a year ago, the stars seemed aligned in its favor. The jewel in the crown they were buying was pegilodecakin, which had cleared the proof-of-concept stage and was already in a Phase III trial for pancreatic cancer.

And that study just failed.

Lilly reported this morning that their cancer drug flopped on overall survival when added to FOLFOX (folinic acid, 5-FU, oxaliplatin), compared to FOLFOX alone among patients suffering from advanced pancreatic cancer.

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Swamy Vijayan. Plexium

San Diego up­start de­buts dis­cov­ery en­gine that puts a twist to pro­tein degra­da­tion

For years, the idea of protein degradation — utilizing the cell’s natural garbage disposal system to mark problematic proteins for destruction — remained an elegant but technically difficult concept. But now established as a promising clinical strategy, with major biopharma players such as Bayer, Gilead and Vertex trying to grab a foothold via partnership deals, a San Diego startup is looking to exploit it and push its limits.

CSL ac­cus­es ri­val Pharm­ing of par­tic­i­pat­ing in a scheme to rip off IP on HAE while re­cruit­ing se­nior R&D staffer

Pharming has landed in the middle of a legal donnybrook after recruiting a senior executive from a rival R&D team at CSL. The Australian pharma giant slapped Pharming with a lawsuit alleging that the Dutch biotech’s new employee, Joseph Chiao, looted a large cache of proprietary documents as he hit the exit. And they want it all back.
Federal Judge Juan Sanchez in the Eastern District Pennsylvania court issued an injunction on Tuesday prohibiting Chiao from doing any work on HAE or primary immune deficiency in his new job and demanding that he return any material from CSL that he may have in his possession. And he wants Pharming to tell its employees not to ask for any information on the forbidden topics.
For its part, Pharming fired off an indignant response this morning denying any involvement in extracting any kind of IP from CSL, adding that it’s cooperating in the internal probe that CSL has underway.

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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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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?

UP­DAT­ED: Alex­ion pays $930M to buy out Achillion and its promis­ing com­pan­ion drug to Soliris

After a series of stock-crunching setbacks over the years, Achillion enjoyed a turn in the sun a few weeks ago as the FDA blessed their lead drug danicopan (ACH-4471) — a complementary therapy for PNH patients taking Alexion’s Soliris — with a breakthrough drug designation after taking a look at some solid supporting Phase II data.

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The $102B club: The top 15 R&D spenders in the glob­al bio­phar­ma busi­ness — 2019 edi­tion

Over the past few years, the deluge of capital into biotech has helped lead to a dramatic shift in focus on new drug approvals, as startups are now able to raise enough cash to get through a pivotal and onto the market. But the top 15 players still account for $102 billion in spending, and their successes and failures continue to determine just how productive the industry is.

Recently we’ve seen a number of new R&D chiefs take their places at the Big 15, either setting the stage for a more focused R&D strategy — often playing more heavily in oncology. That’s true for AstraZeneca, which has had some landmark successes, and GSK, which is in search of its own turnaround in pharma R&D. HIV and vaccines are separate from that group, now led by Hal Barron.

I’ve made a point of watching their track record every year for more than a decade now. What follows is intended as a broad gauge of their activity. You don’t have to have a lot of major successes to score a winning record here, but it’s virtually impossible without a blockbuster or three in the pipeline.

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Andrew Dickinson, Gilead

Gilead­'s chief strat­e­gy ex­ec gets a big pro­mo­tion af­ter or­ches­trat­ing multi­bil­lion-dol­lar deals

After gaining credit as the architect of Gilead’s $12 billion Kite buyout as well as the recent $5 billion partnership with Galapagos, chief strategy officer Andrew Dickinson is being promoted to the prestigious CFO post at the big biotech. And new CEO Daniel O’Day says the latest move completes his makeover of the top team.
Dickinson will remain in charge of strategy in his new post.
A 3-year veteran at Gilead, Dickinson joined the bellwether biotech after a lengthy stint at Lazard Frères & Co, where he was global co-head of healthcare investing. Before that, ironically enough, he had been at Myogen, which was bought out by Gilead in 2006. Now he’ll be primarily responsible for building confidence in the numbers at a company that has a strong foundation in HIV, a disappearing franchise in hep C and a CAR-T subsidiary in Kite that has a long way to go in establishing a new business.