Astel­las is shut­ter­ing Agen­sys, ax­ing 220 jobs and mov­ing away from ADC tech

Wataru Uchi­da, Astel­las

A decade ago Agen­sys’ an­ti­body work looked so ap­peal­ing that Astel­las hap­pi­ly paid $387 mil­lion in cash for it, re­serv­ing $150 mil­lion more in mile­stones. To­day, though, the Japan­ese phar­ma com­pa­ny says it is shut­ting down the op­er­a­tion in San­ta Mon­i­ca, CA and mov­ing on from an­ti­body-drug con­ju­ga­tions, lay­ing off all of the 220 staffers — un­less they can land an­oth­er job in the com­pa­ny.

Astel­las made it clear that while the com­pa­ny is con­tin­u­ing to use some of the ADC tech and test drugs tak­en from the ac­qui­si­tion, it’s look­ing to oth­er tech­nolo­gies for R&D.

In a state­ment to End­points News, the com­pa­ny said:

Astel­las is re­fin­ing its on­col­o­gy strat­e­gy by ex­pand­ing its in­vest­ment in the re­search of new tech­nolo­gies and modal­i­ties, such as im­muno-on­col­o­gy (I/O), and re­duc­ing its fo­cus on ADC re­search. The com­pa­ny be­lieves I/O is a ma­jor area for in­no­va­tion. Agen­sys op­er­a­tions, which have been pri­mar­i­ly fo­cused on re­search and dis­cov­ery of AD­Cs, are not aligned to this strate­gic shift in our fo­cus, thus we have de­cid­ed to wind-down re­search op­er­a­tion at the fa­cil­i­ty. The wind-down ac­tiv­i­ties be­gan on Ju­ly 26 and will be com­plet­ed in the first quar­ter of cal­en­dar year 2018.

There are ap­prox­i­mate­ly 220 em­ploy­ees at Agen­sys. We will be re­tain­ing no em­ploy­ees past Feb­ru­ary 2018 un­less they ap­ply for and re­ceive a po­si­tion in oth­er parts of the com­pa­ny. Cer­tain em­ploy­ees es­sen­tial to the wind-down process will be re­tained through first quar­ter 2018.

“Agen­sys has pos­i­tive­ly con­tributed to Astel­las’ ob­jec­tive of de­vel­op­ing in­no­v­a­tive treat­ments for pa­tients with can­cer,” said Wataru Uchi­da, se­nior vice pres­i­dent, Astel­las. “The team has pro­vid­ed post-Proof of Con­cept com­pounds and an­ti­body-re­lat­ed tech­nol­o­gy that have been in­cor­po­rat­ed in­to our promis­ing on­col­o­gy pipeline. Yet, the field of re­search has evolved and led to a new fron­tier of treat­ment op­tions. Ex­pand­ing our in­vest­ment in this new area of re­search and de­vel­op­ment will be crit­i­cal­ly im­por­tant and help us to bet­ter ad­dress high un­met med­ical needs, as well as de­liv­er in­no­v­a­tive ben­e­fits to pa­tients in the fight against many types of can­cers.”

No­var­tis reshuf­fles its wild cards; Tough sell for Bio­gen? Googling pro­teins; Ken Fra­zier's new gig; and more

Welcome back to Endpoints Weekly, your review of the week’s top biopharma headlines. Want this in your inbox every Saturday morning? Current Endpoints readers can visit their reader profile to add Endpoints Weekly. New to Endpoints? Sign up here.

If you enjoy the People section in this report, you may also want to check out Peer Review, my colleagues Alex Hoffman and Kathy Wong’s comprehensive compilation of comings and goings in biopharma.

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Demis Hassabis, DeepMind CEO (Qianlong/Imaginechina via AP Images)

Google's Deep­Mind opens its pro­tein data­base to sci­ence — po­ten­tial­ly crack­ing drug R&D wide open

Nearly a year ago, Google’s AI outfit DeepMind announced they had cracked one of the oldest problems in biology: predicting a protein’s structure from its sequence alone. Now they’ve turned that software on nearly every human protein and hundreds of thousands of additional proteins from organisms important to medical research, such as fruit flies, mice and malaria parasite.

The new database of roughly 350,000 protein sequences and structures represents a potentially monumental achievement for the life sciences, one that could hasten new biological insights and the development of new drugs. DeepMind said it will be free and accessible to all researchers and companies.

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In­side Bio­gen's scram­ble to sell Aduhelm: Pro­ject 'Javelin' and pres­sure to ID as many pa­tients as pos­si­ble

In anticipation of Aduhelm’s approval for Alzheimer’s in June, Biogen employees were directed to identify and guarantee treatment centers would administer the drug through a program called “Javelin,” a senior Biogen employee told Endpoints News.

The program identified about 800 centers for use, he said, and Biogen now pays for the use of bioassays to identify beta amyloid in potential patients having undergone a lumbar puncture procedure, the employee said — and one center preparing to administer the drug confirmed its participation in the bioassay program.

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EMA re­jects FDA-ap­proved Parkin­son's drug, signs off on Mod­er­na vac­cine use in ado­les­cents ahead of FDA

The European Medicines Agency on Friday rejected Kyowa Kirin’s Parkinson’s disease drug Nouryant (istradefylline), which the US FDA approved in 2019 under the brand name Nourianz.

EMA said it considered that the results of the clinical studies used to support the application “were inconsistent and did not satisfactorily show that Nouryant was effective at reducing the ‘off’ time. Only four out of the eight studies showed a reduction in ‘off’ time, and the effect did not increase with an increased dose of Nouryant.”

6 top drug­mak­ers of­fer per­spec­tives on FDA's new co­vari­ates in RCTs guid­ance

Back in May, the FDA revised and expanded a 2019 draft guidance that spells out how to adjust for covariates in the statistical analysis of randomized controlled trials.

Building on the ICH’s E9 guideline on the statistical principles for clinical trials, the 3-page draft was transformed into an 8-page draft, with more detailed recommendations on linear and nonlinear models to analyze the efficacy endpoints in RCTs.

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Vas Narasimhan, Novartis CEO (Jason Alden/Bloomberg via Getty Images)

No­var­tis dis­cards one of its ‘wild card’ drugs af­ter it flops in key study. But it takes one more for the hand

Always remember just how risky it is to gamble big on small studies.

A little more than 4 years ago, Novartis reportedly put up a package worth up to $1 billion for the dry eye drug ECF843 after a small biotech called Lubris put it through its paces in a tiny study of 40 moderate to severe patients, tracking some statistically significant markers of efficacy.

By last fall, the program had risen up to become one of CEO Vas Narasimhan’s top “wild card” programs in line for a potential breakthrough year in 2021. These drugs were all considered high-risk, high-reward efforts. And in this case, risk won.

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No­var­tis to pay near­ly $178M in law­suit over BRAF drug — and will be on the hook for roy­al­ty

After a four-year battle over a cancer drug patent, Novartis has been ordered by a California judge to pay a Daiichi Sankyo subsidiary $177.8 million.

Plexxikon filed a lawsuit against the pharma giant in 2017, alledging that Tafinlar, a rival to its melanoma drug Zelboraf that was brought to market in collaboration with Roche, has stepped on its intellectual property. The jury ruled in its favor, adding that the infringement is in fact willful.

Al Sandrock, Biogen R&D chief (Biogen via YouTube)

Bio­gen has a shaky end to H1 with a $542M write-off adding to its woes — but an­a­lysts see big rev­enue ahead for Aduhelm

All eyes at Biogen’s Q2 earnings call Thursday were on Aduhelm, but investors also got a glimpse of what Biogen would have faced had the FDA not opted to approve their controversial Alzheimer’s drug.

That glimpse, revealing a combination of declining sales, growing competition and failed medicines, underscores the stakes of the big biotech’s Aduhelm efforts, as execs punch back at the criticism they’ve engendered in the political and medical world and vigorously pushes its sales staff to roll out the drug as fast as possible.

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Michel Vounatsos, Biogen CEO (Credit: World Economic Forum/Valeriano Di Domenico)

Bio­gen de­fends slow roll­out of new Alzheimer's drug, crit­i­cizes neg­a­tive me­dia at­ten­tion

As Biogen execs bemoaned the negative media coverage around Aduhelm’s approval a month ago, the biotech isn’t gaining much traction yet in using its new drug, largely due to a lack of insurance coverage, according to an earnings call Thursday.

Management indicated that of the nearly 900 sites that were prepped and ready following Aduhelm’s approval, 325 of those, or about 35%, have completed a positive pharmacy and therapeutics (P&T) review or won’t require one. The review is a step some hospitals or health systems take prior to using a new drug. Some major sites, however, have said they won’t participate.