Seer adds ex-FDA chief Mark Mc­Clel­lan to the board; Her­cules Cap­i­tal makes it of­fi­cial for new CEO Scott Bluestein

Mark Mc­Clel­lan

→ On the same day it an­nounced a $17.5 mil­lion Se­ries C, life sci­ences and health da­ta com­pa­ny Seer un­veiled that it had lured for­mer FDA com­mis­sion­er and ex-CMS ad­min­is­tra­tor Mark Mc­Clel­lan on to its board. “Mark’s deep un­der­stand­ing of the health care ecosys­tem and vi­sion­ary in­sights on pol­i­cy re­form will be cru­cial in in­form­ing our think­ing as we work to bring our liq­uid biop­sy and life sci­ences prod­ucts to mar­ket,” said Seer chief and founder Omid Farokhzad in a state­ment.

→ Re­mem­ber when Her­cules Cap­i­tal part­ed ways with Manuel Hen­riquez af­ter the CEO had been sin­gled out as a prin­ci­pal play­er in the big col­lege cheat­ing scan­dal known as Op­er­a­tion Var­si­ty Blues? Scott Bluestein, then chief in­vest­ment of­fi­cer, stepped up to as­sume the du­ties ad in­ter­im. Four months lat­er, the firm has de­cid­ed to make that ap­point­ment per­ma­nent, leav­ing him in charge of an in­vest­ment op­er­a­tion that’s been known for its in­volve­ment with um­brel­la-style biotech groups like Vivek Ra­maswamy’s My­ovant and Neil Ku­mar’s Bridge­Bio.

Scott Bluestein

→ Hav­ing built Pan­dion Ther­a­peu­tics up from a $58 mil­lion Se­ries A through an ear­ly R&D strat­e­gy to the cusp of clin­i­cal stud­ies, An­tho­ny Coyle is pass­ing the reins on. Rahul Kakkar, the new CEO, will work shoul­der-to-shoul­der with Jo Viney, who’s adding pres­i­dent to her cur­rent CSO ti­tle. Viney and Coyle are both founders of the Cam­bridge, MA-based biotech, which is work­ing on bis­pe­cif­ic an­ti­bod­ies de­signed to treat au­toim­mune dis­eases via tar­get­ed, lo­cal­ized mod­u­la­tion of the im­mune sys­tem. Bring­ing some fresh start­up ex­pe­ri­ence from Cor­vidia Ther­a­peu­tics, Kakkar will now lead the tran­si­tion in­to the next stage. SR One alum Vikas Goy­al is al­so join­ing as SVP of busi­ness de­vel­op­ment, hav­ing tak­en a deep look at the com­pa­ny on the in­vestor side of the ta­ble. 

→ For­mer Im­munomedics CEO Michael Pehl has emerged on the oth­er side of the At­lantic, tak­ing on an­oth­er can­cer chal­lenge as the new chief of GEMoaB. From the biotech’s head­quar­ters in Dres­den, Ger­many, Pehl will steer the de­vel­op­ment of its next-gen im­munother­a­pies de­signed to tone down tox­i­c­i­ties by fine-tun­ing the cells. Be­fore his ill-fat­ed stint at Im­munomedics — taint­ed by an FDA re­jec­tion and re­ports about a breach of da­ta in­tegri­ty — Pehl en­joyed a sol­id run as Cel­gene’s pres­i­dent of on­col­o­gy.

→ As Copen­hagen-based Or­p­hazyme gets se­ri­ous about fil­ing its Nie­mann-Pick dis­ease type C treat­ment for ap­proval, it’s looped in a new leader well versed in drug launch­es. Kim Strat­ton takes over from An­ders Hins­by, who’s been lead­ing the biotech as CEO since co-found­ing it a decade ago. A No­var­tis vet, Strat­ton was most re­cent­ly the in­ter­na­tion­al com­mer­cial head Shire’s spe­cial­ty and rare dis­ease port­fo­lio — giv­ing her in­sight in­to or­phan drug de­vel­op­ment across the UK, US, Eu­rope and emerg­ing mar­kets. The suc­ces­sion will of­fi­cial­ly take place in Oc­to­ber.

Nel­lo Main­olfi

Nel­lo Main­olfi is step­ping up his lead­er­ship role at Kymera Ther­a­peu­tics, as Lau­rent Au­doly pur­sues an­oth­er ven­ture idea. With the pro­mo­tion to pres­i­dent, Main­olfi — a co-founder and the cur­rent CSO — is on­ly as­sum­ing half of Au­doly’s job. The com­pa­ny is search­ing for a new CEO while al­so wel­com­ing West­field man­ag­ing part­ner Bruce Ja­cobs as CFO. The shake­up comes weeks af­ter Au­doly and Main­olfi inked a $70 mil­lion deal with Ver­tex to de­ploy the small­er play­er’s pro­tein degra­da­tion tech for vague but de­cid­ed­ly next-gen us­es. The duo had found­ed the start­up to­geth­er with the bless­ing of At­las Ven­ture, where Au­doly was en­tre­pre­neur-in-res­i­dence.

Nav­i­tor is ready to send its mTORC path­way ac­ti­va­tors in­to the clin­ic, and James “Randy” Owen will be their man for the task. As the biotech’s first CMO, Owen is first tasked with clin­i­cal and reg­u­la­to­ry de­vel­op­ment NV-5138 for treat­ment-re­sis­tant de­pres­sion. In the same role at Aca­dia Phar­ma, he’d helped ad­vance the Parkin­son’s psy­chosis drug known as Nu­plazid, or pi­ma­vanserin — an ex­pe­ri­ence he’s ex­pect­ed to lever­age in his new gig.

David Chang

Ca­balet­ta Bio — fo­cused on the dis­cov­ery and de­vel­op­ment of cell ther­a­pies for B cell-me­di­at­ed au­toim­mune dis­eases — wel­comes au­toim­mune clin­i­cal drug de­vel­op­ment ex­pert, David Chang, in­to its ranks as the com­pa­ny’s CMO. Chang hops on board af­ter a stint as SVP and head of in­flam­ma­tion, au­toim­mu­ni­ty and neu­ro­science, glob­al med­i­cines de­vel­op­ment at As­traZeneca. He was the vice pres­i­dent and head of im­muno-in­flam­ma­tion, clin­i­cal de­vel­op­ment at GSK and has served at Mer­ck and Wyeth ear­li­er in his ca­reer. 

Vac­citech brings Mariem Charafed­dine on board as its CMO to over­see the de­vel­op­ment of its grow­ing clin­i­cal pipeline of T Cell-in­duc­ing vi­ral vec­tor vac­cines. Charafed­dine joins the com­pa­ny af­ter a six-year stint at Ab­b­vie as their med­ical di­rec­tor for phar­ma­covig­i­lance and pa­tient safe­ty sci­ences, in­fec­tious dis­eases and neu­ro­sciences. Pri­or to her time at Ab­b­vie, Charafed­dine served at Hoff­mann-La Roche/Genen­tech.

Mariem Charafed­dine

Parvus Ther­a­peu­tics — fo­cused on the de­vel­op­ment and com­mer­cial­iza­tion of Navacim ther­a­peu­tics tar­get­ing au­toim­mune and oth­er in­flam­ma­to­ry dis­eases — added some new faces to its board of di­rec­tors and lead­er­ship team. Hugh Young Rien­hoff joined as the com­pa­ny’s chair­man of the board, Charles John­son was ap­point­ed to the board and Alain Del­cayre hopped on as se­nior vice pres­i­dent of re­search. 

Rien­hoff is the CEO of Ima­go Bio­sciences, his fourth start-up. Pri­or to his po­si­tion at Ima­go, Rien­hoff was the CEO of Fer­roKin Bio­sciences (lat­er ac­quired by Shire in 2012). He has al­so served as the di­rec­tor at Abing­worth Man­age­ment in Lon­don and as a part­ner at New En­ter­prise As­so­ci­ates. John­son, most re­cent­ly, served as the CMO of Neu­rotech and pri­or to that was the vice pres­i­dent of glob­al med­ical af­fairs at Ver­tex. He’s al­so had stints at In­spire Phar­ma­ceu­ti­cals, APT Phar­ma­ceu­ti­cals and Genen­tech. Del­cayre is cred­it­ed as VP of re­search and de­vel­op­ment at Anosys with the co-dis­cov­ery of Ex­o­some Dis­play — a tech­nique to ma­nip­u­late ex­o­some pro­tein con­tent — with his team.

→ Cell ther­a­py com­pa­ny Im­mu­soft has man­aged to snag Am­gen’s $AMGN for­mer head of bi­o­log­ics Robert Hayes as its chief sci­en­tif­ic of­fi­cer. The Seat­tle-based firm has de­vel­oped a tech­nol­o­gy en­gi­neered to in­sert func­tion­al genes in­to im­mune cells us­ing a non-vi­ral vec­tor. Its lead ther­a­py is de­signed to help pa­tients with a rare, lethal child­hood ge­net­ic dis­ease that af­fects the body’s abil­i­ty to pro­duce an es­sen­tial en­zyme that helps to break down long-chain sug­ars in­side cells. 

Leslie Dan steps down from the board of di­rec­tors of Sesen Bio — fo­cused on the de­vel­op­ment of tar­get­ed fu­sion pro­tein ther­a­peu­tics for the treat­ment of pa­tients with can­cer — and in­to re­tire­ment. With his re­tire­ment the board will now con­sist of five di­rec­tors, four of whom are in­de­pen­dent. Dan start­ed his ca­reer in the phar­ma­ceu­ti­cal in­dus­try in 1964 as the founder of Novopharm, one of Cana­da’s largest gener­ic phar­ma­ceu­ti­cal com­pa­nies with about $750 mil­lion in rev­enue and over 3,000 em­ploy­ees (lat­er be­com­ing a part of Te­va Phar­ma­ceu­ti­cal in 2000). Af­ter Novopharm, Dan found­ed Viven­tia Bio, which was lat­er sold to Sesen in 2016. 

San­jay Pa­tel is step­ping up to suc­ceed Tama­ra Sey­mour, who has served as the in­ter­im CFO, as CFO at Im­mu­nic — a com­pa­ny fo­cused on the de­vel­op­ment of oral ther­a­pies for the treat­ment of chron­ic in­flam­ma­to­ry and au­toim­mune dis­eases. Pa­tel comes from the same po­si­tion at Pernix Ther­a­peu­tics, where he helped in sourc­ing and ex­e­cut­ing ac­qui­si­tions in ex­cess of $600 mil­lion and rais­ing more that $460 mil­lion in var­i­ous fi­nanc­ing trans­ac­tions. Pa­tel has had stints at Can­tor Fitzger­ald, the William J Clin­ton Foun­da­tion, and at Cowen and Com­pa­ny

Max Don­ley

Au­rinia — cur­rent­ly de­vel­op­ing its in­ves­ti­ga­tion­al drug, vo­closporin for the treat­ment of Lu­pus Nephri­tis, Fo­cal Seg­men­tal Glomeru­loscle­ro­sis and Dry Eye Syn­drome — strength­ened its se­nior man­age­ment team with the ad­di­tion of Max Don­ley as ex­ec­u­tive vice pres­i­dent of in­ter­nal op­er­a­tions and Glenn Schul­man as SVP of cor­po­rate com­mu­ni­ca­tions and in­vestor re­la­tions. Most re­cent­ly, Don­ley led hu­man re­sources, in­for­ma­tion tech­nol­o­gy and fa­cil­i­ties at Senseon­ics. Pri­or to that, he served at Su­cam­po Phar­ma­ceu­ti­cals and Med­Im­mune. Schul­man jumps on board af­ter a stint as cor­po­rate com­mu­ni­ca­tions and in­vestor re­la­tions at Achillion Phar­ma­ceu­ti­cals and pre­vi­ous­ly, has served at Cura­Gen. 

→ Mary­land-based biotech­nol­o­gy com­pa­ny, Im­mu­nom­ic Ther­a­peu­tics, has ap­point­ed An­drew Eisen as VP, Clin­i­cal De­vel­op­ment. Eisen joined the com­pa­ny with ex­pe­ri­ence from roles at Rex­ahn Phar­ma­ceu­ti­cals, Acor­da Ther­a­peu­tics, Ei­sai On­col­o­gy Prod­uct Cre­ation Sys­tems, Dai­ichi-Sankyo Phar­ma De­vel­op­ment and Cura­Gen

Daniel Wal­lace has joined the board of di­rec­tors of Lu­pus Ther­a­peu­tics. Wal­lace is the med­ical di­rec­tor of the Wal­lace Rheumat­ic Study Cen­ter and as­so­ciate di­rec­tor of the Rheuma­tol­ogy Fel­low­ship Pro­gram at Cedars-Sinai in Los An­ge­les. Wal­lace has over 40 years of ex­pe­ri­ence and has been in­volved in more than 50 clin­i­cal tri­als and is cur­rent­ly con­duct­ing six tri­als.

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?

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. 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.

“Macrophages are interesting because we were all educated probably 20 years ago that they are the big eaters in the immune system, but they’re really the orchestrators of the immune system,” CEO Christine Bunt said.

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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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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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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The FDA will hus­tle up an ex­pe­dit­ed re­view for As­traZeneca’s next shot at a block­buster can­cer drug fran­chise

AstraZeneca paid a hefty price to partner with Daiichi Sankyo on their experimental antibody drug conjugate for HER2 positive breast cancer. And they’ve been rewarded with a fast ride through the FDA, with a straight shot at creating another blockbuster oncology franchise.

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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.

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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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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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