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.

 

Donald and Melania Trump watch the smoke of fireworks from the South Lawn of the White House on July 4, 2020 (via Getty)

Which drug de­vel­op­ers of­fer Trump a quick, game-chang­ing ‘so­lu­tion’ as the pan­dem­ic roars back? Eli Lil­ly and Ab­Cellera look to break out of the pack

We are unleashing our nation’s scientific brilliance and will likely have a therapeutic and/or vaccine solution long before the end of the year.

— Donald Trump, July 4

Next week administration officials plan to promote a new study they say shows promising results on therapeutics, the officials said. They wouldn’t describe the study in any further detail because, they said, its disclosure would be “market-moving.”

— NBC News, July 3

Something’s cooking. And it’s not just July 4 leftovers involving stale buns and uneaten hot dogs.

Over the long weekend observers picked up signs that the focus in the Trump administration may swiftly shift from the bright spotlight on vaccines being promised this fall, around the time of the election, to include drugs that could possibly keep patients out of the hospital and take the political sting out of the soaring Covid-19 numbers causing embarrassment in states that swiftly reopened — as Trump cheered along.

So far, Gilead has been the chief beneficiary of the drive on drugs, swiftly offering enough early data to get remdesivir an emergency authorization and into the hands of the US government. But their drug, while helpful in cutting stays, is known for a limited, modest effect. And that won’t tamp down on the hurricane of criticism that’s been tearing at the White House, and buffeting the president’s most stalwart core defenders as the economy suffers.

We’ve had positive early-stage vaccine data, most recently from Pfizer and BioNTech, playing catchup on an mRNA race led by Moderna — where every little sign of potential trouble is magnified into a lethal threat, just as every advance excites a frenzy of support. But that race still has months to play out, with more Phase I data due ahead of the mid-stage numbers looming ahead. A vaccine may not be available in large enough quantities until well into 2021, which is still wildly ambitious.

So what about a drug solution?

Trump’s initial support for a panacea focused on hydroxychloroquine. But that fizzled in the face of data underscoring its ineffectiveness — killing trials that aren’t likely to be restarted because of a recent population-based study offering some support. And there are a number of existing drugs being repurposed to see how they help hospitalized patients.

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George Yancopoulos (Regeneron)

UP­DAT­ED: Re­gen­eron co-founder George Yan­copou­los of­fers a com­bat­ive de­fense of the po­lice at a high school com­mence­ment. It didn’t go well

Typically, the commencement speech at Yorktown Central School District in Westchester — like most high schools — is an opportunity to encourage students to face the future with confidence and hope. Regeneron president and co-founder George Yancopoulos, though, went a different route.

In a fiery speech, the outspoken billionaire defended the police against the “prejudice and bias against law enforcement” that has erupted around the country in street protests from coast to coast. And for many who attended the commencement, Yancopoulos struck the wrong note at the wrong time, especially when he combatively challenged someone for interrupting his speech with a honk for “another act of cowardness.”

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Elias Zerhouni (Photo by Vincent Isore/IP3/Getty Images)

Elias Zer­houni dis­cuss­es ‘am­a­teur hour’ in DC, the de­struc­tion of in­fec­tious dis­ease R&D and how we need to prep for the next time

Elias Zerhouni favors blunt talk, and in a recent discussion with NPR, the ex-Sanofi R&D and ex-NIH chief had some tough points to make regarding the pandemic response.

Rather than interpret them, I thought it would be best to provide snippets straight from the interview.

On the Trump administration response:

It was basically amateur hour. There is no central concept of operations for preparedness, for pandemics, period. This administration doesn’t want to or has no concept of what it takes to protect the American people and the world because it is codependent. You can’t close your borders and say, “OK, we’re going to be safe.” You’re not going to be able to do that in this world. So it’s a lack of vision, basically just a lack of understanding, of what it takes to protect the American people.

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Tesla and SpaceX founder Elon Musk gestures to the audience after being recognized by President Trump following the successful launch of a Falcon 9 rocket at the Kennedy Space Center. (via Getty Images)

Tes­la chief Elon Musk teams up with Covid-19 play­er Cure­Vac to build 'R­NA mi­cro­fac­to­ries'

Elon Musk has joined the global tech crusade now underway to revolutionize vaccine manufacturing — now aimed at delivering billions of doses of a new mRNA vaccine to fight Covid-19. And he’s cutting right to the front.

In a late-night tweet Wednesday, the Tesla chief announced:

Tesla, as a side project, is building RNA microfactories for CureVac & possibly others.

That’s not a lot to go on. But the tweet comes a year after Tesla’s German division in Grohmann and CureVac filed a patent on a “bioreactor for RNA in vitro transcription, a method for RNA in vitro transcription, a module for transcribing DNA into RNA and an automated apparatus for RNA manufacturing.” CureVac, in the meantime, has discussed a variety of plans to build microfactories that can speed up the whole process for a global supply chain.

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Sec­ond death trig­gers hold on Astel­las' $3B gene ther­a­py biotech's lead pro­gram, rais­ing fresh con­cerns about AAV

Seven months after Astellas shelled out $3 billion to acquire the gene therapy player Audentes, the biotech company’s lead program has been put on hold following the death of 2 patients taking a high dose of their treatment. And there was another serious adverse event recorded in the study as well, with a total of 3 “older” patients in the study affected.

The incidents are derailing plans to file for a near-term approval, which had been expected right about now.

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No­vavax snags Ben Machielse for CMC and pro­motes a trio of staffers; Mar­ty Du­vall lands an­oth­er CEO post at On­copep­tides

Novavax has been making waves recently by securing a $384 million commitment from CEPI to cover R&D and manufacturing for its Covid-19 vaccine while also spending $167 million on a 150,000 square-foot facility. The Maryland biotech continues to shore up its leadership team as well, bringing in Ben Machielse as their EVP of CMC just a couple weeks after nabbing AstraZeneca vet Filip Dubrovsky as their new CMO. Machielse was president and CEO of Vtesse from 2014-17, and before that, he also spent more than 11 years at MedImmune and was EVP of operations for the back half of his tenure.

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Pfiz­er shares surge on pos­i­tive im­pact of their mR­NA Covid-19 vac­cine — part­nered with BioN­Tech — in an ear­ly-stage study

Pfizer and their partners at the mRNA specialist BioNTech have published the first glimpse of biomarker data from an early-stage study spotlighting the “robust immunogenicity” triggered by their Covid-19 vaccine, which is one of the leaders in the race to vanquish the global pandemic.

Researchers selected 45 healthy volunteers 18-55 years of age for the study. They were randomized to receive 2 doses, separated by 21 days, of 10 µg, 30 µg, or 100 µg of BNT162b1, “a lipid nanoparticle-formulated, nucleoside-modified, mRNA vaccine that encodes trimerized SARS-CoV-2 spike glycoprotein RBD.” Their responses were compared against the effect of a natural, presumably protective defense offered by a regular infection.

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An ex­pe­ri­enced biotech is stitched to­geth­er from transpa­cif­ic parts, with 265 staffers and a fo­cus on ‘new bi­ol­o­gy’

Over the past few years, different teams at a pair of US-based biotechs and in labs in Japan have labored to piece together a group of cancer drug programs, sharing a single corporate umbrella with research colleagues in Japan. But now their far-flung operations have been knit together into a single unit, creating a pipeline with 10 cancer drug development programs — going from early-stage right into Phase III — and a host of discovery projects managed by a collective staff of some 265 people.

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New stan­dard of care? FDA hands Pfiz­er, Mer­ck KGaA an OK for Baven­cio in blad­der can­cer

The breakthrough therapy designation Pfizer and Merck KGaA notched for Bavencio in bladder cancer has quickly paved way for a full approval.

The PD-L1 drug is now sanctioned as a first-line maintenance treatment for patients with locally advanced or metastatic urothelial carcinoma, applicable in cases where cancer hasn’t progressed after platinum-containing chemotherapy.

Petros Grivas, the principal investigator of the supporting Phase III JAVELIN Bladder 100, called the approval “one of the most significant advances in the treatment paradigm in this setting in 30 years.”