Sun Bio­Phar­ma founder Michael Cullen steps up; Se­maThera set­tles on per­ma­nent CEO; On­coSec nabs Kel­lie Mal­loy Fo­ert­er from Sy­neos

Michael Cullen (LinkedIn)

David Kay­sen is step­ping down from Sun Bio­Phar­ma af­ter three years in the pres­i­dent and CEO of­fice, hand­ing the reins to ex­ec­u­tive chair­man and founder Michael Cullen. His de­par­ture is noth­ing against him, the com­pa­ny notes, but a re­sult of “the need for cost re­duc­tions to fo­cus fur­ther spend­ing on the cur­rent Phase 1a/1b clin­i­cal tri­al in the front-line com­bi­na­tion study of SBP-101 with gem­c­itabine and nab-pa­cli­tax­el for the treat­ment of metasta­t­ic pan­cre­at­ic can­cer.”

→ Mon­tre­al-based Se­maThera is ready to hire a per­ma­nent CEO, and it has tapped a vet­er­an Garth Cum­ber­lidge for the role. He is tasked with shep­herd­ing the com­pa­ny’s an­ti-SE­MA3A ther­a­pies in­to the clin­ic, start­ing with pro­grams in di­a­bet­ic mac­u­lar ede­ma and oth­er de­gen­er­a­tive retinopathies.

→ Hav­ing learned the ropes in the past few months, Chris Cargill is now the of­fi­cial ex­ec­u­tive vice pres­i­dent and CFO at So­sei, lead­ing the glob­al cor­po­rate fi­nance func­tions for the Tokyo-head­quar­tered com­pa­ny. Cargill first joined So­sei in 2017 af­ter a decade-long run as an in­vest­ment banker at JP Mor­gan.

Kel­lie Mal­loy Fo­ert­er (LinkedIn)

On­coSec has turned to the CRO world to hire its chief clin­i­cal de­vel­op­ment of­fi­cer, poach­ing In­Ven­tiv vet Kel­lie Mal­loy Fo­ert­er from Sy­neos Health. Brought in for her track record in clin­i­cal tri­al de­sign, ex­e­cu­tion and analy­sis, Mal­loy Fo­ert­er’s pri­or­i­ty will be to spear­head an on­go­ing Phase IIb study test­ing On­coSec’d IL-12 agent with Mer­ck’s Keytru­da in melanoma pa­tients who have failed pri­or an­ti-PD-1 treat­ment. She is al­so re­spon­si­ble for the rest of the pipeline, in­clud­ing a sec­ond com­bo tri­al in breast can­cer.

Glenn God­dard is the new CFO at gene edit­ing pi­o­neer In­tel­lia Ther­a­peu­tics $NT­LA. Still on the long ramp up to first-in-hu­man stud­ies of its CRISPR-Cas9-en­abled ther­a­peu­tics, In­tel­lia wants God­dard to flex some of the mus­cles he de­vel­oped in lead­ing Agios from an ear­ly-stage re­search com­pa­ny to a com­mer­cial-ready or­ga­ni­za­tion as the prin­ci­pal fi­nan­cial of­fi­cer. God­dard, who most re­cent­ly served as CFO of Gen­er­a­tion Bio, will al­so over­see IT and fa­cil­i­ties.

→ Just a month af­ter in­stalling Na­tal­ie Sacks as CMO, Har­poon Ther­a­peu­tics is adding two new ex­ecs to its C-suite. For­mer in­vest­ment banker Geor­gia Er­bez is tak­ing up the CFO post fol­low­ing sim­i­lar stints at Zosano Phar­ma, As­te­r­ias Bio­ther­a­peu­tics and Rap­tor Phar­ma­ceu­ti­cals. Mean­while, Hol­ger Wesche has been pro­mot­ed from SVP of re­search — a ti­tle he held for the past three years — to CSO.

→ San Ma­teo, CA-based start­up CuraSen has named Gabriel Var­gas as CMO, tasked with de­vel­op­ing a stealthy pipeline that’s de­signed to tack­le some tough neu­rode­gen­er­a­tive dis­eases like Alzheimer’s and Parkin­son’s. The biotech vets who run CuraSen like Var­gas’ work at Am­gen, where he man­aged the pre­clin­i­cal and ear­ly de­vel­op­ment por­tion of the neu­ro­science port­fo­lio.

→ Ready to turn a new page af­ter a dra­mat­ic breakup with its ex-CEO, Rock­well Med­ical $RMTI is wrap­ping the year with the ap­point­ment of a new CFO. An­gus Smith joins from Pernix Ther­a­peu­tics, with busi­ness de­vel­op­ment as well as fi­nance ex­pe­ri­ence un­der his belt.   

In­scrip­ta, the start­up best known for dis­cov­er­ing an al­ter­na­tive CRISPR en­zyme to Cas9, has hired Ja­son Gam­mack from Qi­a­gen to mar­ket its re­search tools as its first chief com­mer­cial of­fi­cer.

Velox­is Phar­ma­ceu­ti­cals has giv­en a for­mal pro­mo­tion to Ira Duarte, who’s been fill­ing in as CFO af­ter Morten Marott de­part­ed fol­low­ing a 5-month stint.

→ An­tic­i­pat­ing late-stage re­sults for its lead bone cell ther­a­py, Bel­gium’s Bone Ther­a­peu­tics has tapped Lin­da Lebon — for­mer­ly of ar­genx and Quin­tiles, among oth­ers — as chief reg­u­la­to­ry of­fi­cer with a man­date to find the reg­u­la­to­ry path­way for this and oth­er pro­grams through to com­mer­cial­iza­tion.

→ Just a few days af­ter ad­mit­ting to a trou­bling fi­nan­cial sit­u­a­tion, Syn­er­gy Phar­ma­ceu­ti­cals $SYGP an­nounces that its long­time ex­ec­u­tive chair­man is out. Gary Ja­cob, who was cred­it­ed for co-in­vent­ing Syn­er­gy’s sole as­set Tru­lance, will be re­placed by Melvin Spigel­man.

Martin Shkreli [via Getty]

Pris­on­er #87850-053 does not get to add drug de­vel­op­er to his list of cred­its

Just days after Retrophin shed its last ties to founder Martin Shkreli, the biotech is reporting that the lead drug he co-invented flopped in a pivotal trial. Fosmetpantotenate flunked both the primary and key secondary endpoints in a placebo-controlled trial for a rare disease called pantothenate kinase-associated neurodegeneration, or PKAN.

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We­bi­nar: Re­al World End­points — the brave new world com­ing in build­ing fran­chise ther­a­pies

Several biopharma companies have been working on expanding drug labels through the use of real world endpoints, combing through the data to find evidence of a drug’s efficacy for particular indications. But we’ve just begun. Real World Evidence is becoming an important part of every clinical development plan, in the soup-through-nuts approach used in building franchises.

I’ve recruited a panel of 3 top experts in the field — the first in a series of premium webinars — to look at the practical realities governing what can be done today, and where this is headed over the next few years, at the prodding of the FDA.

ZHEN SU — Merck Serono’s Senior Vice President and Global Head of Oncology
ELLIOTT LEVY — Amgen’s Senior Vice President of Global Development
CHRIS BOSHOFF — Pfizer Oncology’s Chief Development Officer

A premium subscription to Endpoints News is required to attend this webinar. Please upgrade to either an Insider or Enterprise plan for access. Already have Endpoints Premium? Please sign-in below. You can contact our Subscriptions team at with any issues.

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Brian Kaspar. AveXis via Twitter

AveX­is sci­en­tif­ic founder fires back at No­var­tis CEO Vas Narasimhan, 'cat­e­gor­i­cal­ly de­nies any wrong­do­ing'

Brian Kaspar’s head was among the first to roll at Novartis after company execs became aware of the fact that manipulated data had been included in its application for Zolgensma, now the world’s most expensive therapy.

But in his first public response, the scientific founder at AveXis — acquired by Novartis for $8.7 billion — is firing back. And he says that not only was he not involved in any wrongdoing, he’s ready to defend his name as needed.

I reached out to Brian Kaspar after Novartis put out word that he and his brother Allen had been axed in mid-May, two months after the company became aware of the allegations related to manipulated data. His response came back through his attorneys.

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Hal Barron. GSK

GSK's Hal Bar­ron her­alds their sec­ond pos­i­tive piv­otal for cru­cial an­ti-BC­MA ther­a­py, point­ing to a push for quick OKs in a crowd­ed field

Hal Barron has his second positive round of Phase III data in hand for his anti-BCMA antibody drug conjugate belantamab mafodotin (GSK2857916). And GSK’s research chief says the data paves the way for their drive in search of an FDA approval for treating multiple myeloma.

It’s hard to overestimate the importance of this drug for GSK, a cornerstone of Barron’s campaign to make a dramatic impact on the oncology market and provide some long-lost excitement for the pharma giant’s pipeline. They’re putting this BCMA program at the front of that charge — looking to lead a host of rivals all aimed at the same target.

We don’t know what the data are yet, but DREAMM-2 falls on the heels of a promising set of data delivered 5 months ago for DREAMM-1. There investigators noted that complete responses among treatment-resistant patients rose to 15% in the extra year’s worth of data to look over, with a median progression-free survival rate of 12 months, up from 7.9 months reported earlier. The median duration of response was 14.3 months.

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UP­DAT­ED: An em­bold­ened As­traZeneca splurges $95M on a pri­or­i­ty re­view vouch­er. Where do they need the FDA to hus­tle up?

AstraZeneca is in a hurry.

We learned this morning that the pharma giant — not known as a big spender, until recently — forked over $95 million to get its hands on a priority review voucher from Sobi, otherwise known as Swedish Orphan Biovitrum.

That marks another step down on price for a PRV, which allows the holder to slash 4 months off of any FDA review time.

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Bob Smith, Pfizer

Pfiz­er is mak­ing a $500M state­ment to­day: Here’s how you be­come a lead play­er in the boom­ing gene ther­a­py sec­tor

Three years ago, Pfizer anted up $150 million in cash to buy Bamboo Therapeutics in Chapel Hill, NC as it cautiously stuck a toe in the small gene therapy pool of research and development.

Company execs followed up a year later with a $100 million expansion of the manufacturing operations they picked up in that deal for the UNC spinout, which came with $495 million in milestones.

And now they’re really going for it.

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Video: Putting the AI in R&D — with Badhri Srini­vasan, Tony Wood, Rosana Kapeller, Hugo Ceule­mans, Saurabh Sa­ha and Shoibal Dat­ta

During BIO this year, I had a chance to moderate a panel among some of the top tech experts in biopharma on their real-world use of artificial intelligence in R&D. There’s been a lot said about the potential of AI, but I wanted to explore more about what some of the larger players are actually doing with this technology today, and how they see it advancing in the future. It was a fascinating exchange, which you can see here. The transcript has been edited for brevity and clarity. — John Carroll

As­traZeneca’s Imfinzi/treme com­bo strikes out — again — in lung can­cer. Is it time for last rites?

AstraZeneca bet big on the future of their PD-L1 Imfinzi combined with the experimental CTLA-4 drug tremelimumab. But once again it’s gone down to defeat in a major Phase III study — while adding damage to the theory involving targeting cancer with a high tumor mutational burden.

Early Wednesday the pharma giant announced that their NEPTUNE study had failed, with the combination unable to beat standard chemo at overall survival in high TMB cases of advanced non-small cell lung cancer. We won’t get hard data until later in the year, but the drumbeat of failures will call into question what — if any — future this combination can have left.

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Why would Am­gen want to buy Alex­ion? An­a­lysts call hot­ly ru­mored takeover un­like­ly, but seize the mo­ment

A rumor that Amgen is closing in on buyout deal for Alexion has sparked a guessing game on just what kind of M&A strategy Amgen is pursuing and how much Alexion is worth.

Mizuho analyst Salim Syed first lent credence to the report out of the Spanish news outlet Intereconomía, which said Amgen is bidding as much as $200 per share. While the source may be questionable, “the concept of this happening doesn’t sound too crazy to me,” he wrote.