Troy Wil­son re­cruits As­traZeneca vet to steer Ku­ra's late-stage piv­ot

Sev­en months af­ter Ku­ra On­col­o­gy bid farewell with co-founder and chief med­ical of­fi­cer An­to­nio Gual­ber­to, the biotech has found his suc­ces­sor from the ranks of Big Phar­ma alum­ni.

Troy Wil­son

With Phase II da­ta in hand for the lead drug, tip­i­farnib, and a sec­ond pro­gram al­most ready for the clin­ic, the biotech was look­ing for some­one well versed in tar­get­ed ther­a­py de­vel­op­ment and ex­pe­ri­enced with reg­u­la­tors, CEO Troy Wil­son told End­points News.

“I’m ba­si­cal­ly giv­ing you Stephen’s CV,” he said, re­fer­ring to new CMO Stephen Dale.

Dale, an As­traZeneca vet who just wrapped up a stint at Ky­owa Kirin, now holds Ku­ra’s one-man UK of­fice out of his house in Cheshire, UK.

Stephen Dale

In ad­di­tion to over­see­ing the on­go­ing Phase I/IIa study for KO-539, a menin-KMT2A(MLL) in­hibitor, he will al­so spear­head the ex­pect­ed launch next year of a com­bi­na­tion study of tip­i­farnib (a far­ne­syl­trans­ferase in­hibitor) with a PI3k in­hibitor.

A top pri­or­i­ty will be to en­sure that the tri­al will be, in his words, “de­signed in ser­vice of out­come.”

“Whilst lots of physi­cians in drug de­vel­op­ment, we love the aca­d­e­m­ic side of med­i­cine and de­vel­op­ment, but we’re here ac­tu­al­ly to get reg­u­la­to­ry ap­proval and ex­pe­dit­ed reg­u­la­to­ry ap­proval so we can get our med­i­cines to pa­tients as quick­ly as we can,” he said. “That takes ex­pe­ri­ence, it takes a cer­tain type of de­sign to do that.”

The idea be­hind tar­get­ed ther­a­py hasn’t changed much since his ear­ly days in the in­dus­try, he ob­served. As a clin­i­cal di­rec­tor and lat­er clin­i­cal head of on­col­o­gy, he led the clin­i­cal pro­gram for Ires­sa and Tagris­so — the lat­ter of which had nabbed ap­proval just 2.5 years af­ter dos­ing the first pa­tient. But a lot of the bio­mark­er and di­ag­nos­tics frame­work has ma­tured.

Dale ex­pects to spend much more time in Boston, where Ku­ra’s clin­i­cal op­er­a­tions and de­vel­op­ment team is lo­cat­ed, once he’s able to. He has yet to meet any­one on the 75-strong team; in fact, many of the com­pa­ny’s state­side staffers have al­so joined vir­tu­al­ly in re­cent months.

“You do what you have to do in these pan­dem­i­cal times,” Wil­son, who’s based in San Diego with the CMC and fi­nance groups, said.

Da­ta Lit­er­a­cy: The Foun­da­tion for Mod­ern Tri­al Ex­e­cu­tion

In 2016, the International Council for Harmonisation (ICH) updated their “Guidelines for Good Clinical Practice.” One key shift was a mandate to implement a risk-based quality management system throughout all stages of a clinical trial, and to take a systematic, prioritized, risk-based approach to clinical trial monitoring—on-site monitoring, remote monitoring, or any combination thereof.

Pfiz­er's big block­buster Xel­janz flunks its post-mar­ket­ing safe­ty study, re­new­ing harsh ques­tions for JAK class

When the FDA approved Pfizer’s JAK inhibitor Xeljanz for rheumatoid arthritis in 2012, they slapped on a black box warning for a laundry list of adverse events and required the New York drugmaker to run a long-term safety study.

That study has since become a consistent headache for Pfizer and their blockbuster molecule. Last year, Pfizer dropped the entire high dose cohort after an independent monitoring board found more patients died in that group than in the low dose arm or a control arm of patients who received one of two TNF inhibitors, Enbrel or Humira.

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Covid-19 roundup: EU and As­traZeneca trade blows over slow­downs; Un­usu­al unions pop up to test an­ti­bod­ies, vac­cines

After coming under fire for manufacturing delays last week, AstraZeneca’s feud with the European Union has spilled into the open.

The bloc accused the pharma giant on Wednesday of pulling out of a meeting to discuss cuts to its vaccine supplies, the AP reported. AstraZeneca denied the reports, saying it still planned on attending the discussion.

Early Wednesday, an EU Commission spokeswoman said that “the representative of AstraZeneca had announced this morning, had informed us this morning that their participation is not confirmed, is not happening.” But an AstraZeneca spokesperson later called the reports “not accurate.”

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Adeno-associated virus-1 illustration; the use of AAVs resurrected the gene therapy field, but companies are now testing the limits of a 20-year-old technology (File photo, Shutterstock)

Af­ter 3 deaths rock the field, gene ther­a­py re­searchers con­tem­plate AAV's fu­ture

Nicole Paulk was scrolling through her phone in bed early one morning in June when an email from a colleague jolted her awake. It was an article: Two patients in an Audentes gene therapy trial had died, grinding the study to a halt.

Paulk, who runs a gene therapy lab at the University of California, San Francisco, had planned to spend the day listening to talks at the American Association for Cancer Research annual meeting, which was taking place that week. Instead, she skipped the conference, canceled every work call on her calendar and began phoning colleagues across academia and industry, trying to figure out what happened and why. All the while, a single name hung in the back of her head.

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Pascal Soriot, AP

As­traZeneca CEO Pas­cal So­ri­ot sev­ers an un­usu­al board con­nec­tion, steer­ing clear of con­flicts while re­tain­ing im­por­tant al­liances

CSL Behring chief Paul Perreault scored an unusual coup last summer when he added AstraZeneca CEO Pascal Soriot to the board, via Zoom. It’s rare, to say the least, to see a Big Pharma CEO take any board post in an industry where interests can simultaneously connect and collide on multiple levels of operations.

The tie set the stage for an important manufacturing connection. The Australian pharma giant agreed to supply the country with 10s of millions of AstraZeneca’s Covid-19 vaccine, once it passes regulatory muster.

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Mer­ck scraps Covid-19 vac­cine pro­grams af­ter they fail to mea­sure up on ef­fi­ca­cy in an­oth­er ma­jor set­back in the glob­al fight

After turning up late to the vaccine development game in the global fight against Covid-19, Merck is now making a quick exit.

The pharma giant is reporting this morning that it’s decided to drop development of 2 vaccines — V590 and V591 — after taking a look at Phase I data that simply don’t measure up to either the natural immune response seen in people exposed to the virus or the vaccines already on or near the market.

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Anthony Fauci, NIAID director (AP Images)

As new Covid-19 task force gets un­der­way, threat looms of vac­cine, mon­o­clon­al an­ti­body-re­sis­tant vari­ants

Hours before President Biden’s Covid-19 team gave their first virtual press conference, the famed AIDS researcher David Ho delivered concerning news in a new pre-print: SARS-CoV-2 B.1.351, the variant that emerged in South Africa, is “markedly more resistant” to antibodies from convalescent plasma and vaccinated individuals.

The news for several monoclonal antibodies, including Eli Lilly’s bamlanivimab, was even worse: Their ability to neutralize was “completely or markedly abolished,” Ho wrote. Lilly’s antibody cocktail, which was just shown to dramatically reduce the risk of hospitalizations or death, also became far less potent.

Florian Brand (L) and Srinivas Rao (ATAI)

Psy­che­del­ic biotech ATAI hopes to ex­pand port­fo­lio through re­search part­ner­ship with Mass Gen­er­al

Psychedelics have made a comeback for mental health research, with companies like startup biotech ATAI Life Sciences raising millions and earning the backing of prominent investors like Peter Thiel, but there’s a hole at the heart of the resurgence: Researchers still don’t fully understand how they work.

A new partnership between ATAI and world-renowned Mass General Hospital hopes to change that.

Jackie Fouse, Agios CEO

Agios scores its sec­ond pos­i­tive round of da­ta for its lead pipeline drug — but that won't an­swer the stub­born ques­tions that sur­round this pro­gram

Agios $AGIO bet the farm on its PKR activator drug mitapivat when it recently decided to sell off its pioneering cancer drug Tibsovo and go back to being a development-stage company — for what CEO Jackie Fouse hoped would be a short stretch before they got back into commercialization.

On Tuesday evening, the bellwether biotech flashed more positive topline data — this time from a small group of patients in a single-arm study. And the executive team plans to package this with its earlier positive results from a controlled study to make its case for a quick OK.

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