Frank Zhang (AP Images)

CAR-T fil­ing in sight, Frank Zhang grabs full con­trol of J&J-part­nered Leg­end Biotech, steps down from Gen­Script

Two months af­ter Yuan Xu steered Leg­end Biotech to a $424 mil­lion pub­lic de­but on the Nas­daq, founder and chair­man Frank Zhang is grab­bing the reins as CEO.

In con­junc­tion with the move, Zhang is al­so step­ping down from the helm of Gen­Script — a po­si­tion he’s held for 18 years. Gen­Script, a Hong Kong-list­ed CRO, hatched Leg­end as a sub­sidiary in 2015 be­fore spin­ning it out, and re­mains a ma­jor­i­ty share­hold­er.

“This shows how much com­mit­ment I have for Leg­end,” he said in a con­fer­ence call. “Over the past years, Leg­end has al­ways been un­der my watch. And I’m very in­ter­est­ed in see­ing how it will grow in the next few years.”

Now is the nat­ur­al time for a tran­si­tion as Leg­end and its part­ners at J&J gear up to ini­ti­ate a BLA fil­ing of their BC­MA-tar­get­ed CAR-T ther­a­py by the end of the year, with an EMA fil­ing to fol­low in ear­ly 2021.

“I can as­sure you that this CEO tran­si­tion has noth­ing to do with any change in the planned ac­tiv­i­ties for the JNJ-4528 pro­gram, in­clud­ing clin­i­cal de­vel­op­ment and al­so reg­u­la­to­ry plans,” CFO Ying Huang said in the call.

Hav­ing built up a re­sume fea­tur­ing a who’s who in Big Phar­ma — span­ning Genen­tech, Glax­o­SmithK­line, No­var­tis, Am­gen, Gilead and Mer­ck — Xu took the helm in 2018 and has been run­ning Leg­end out of New York. She stepped down for “per­son­al rea­sons,” ac­cord­ing to a press re­lease.

Zhang promised that the dai­ly op­er­a­tions and re­la­tion­ship with J&J should re­main in­tact.

Jef­feries an­a­lyst Biren Amin was con­vinced. While the EMA time­line marks a slight de­lay from the orig­i­nal plan, he’s not both­ered ei­ther.

“We think Leg­end pur­pose­ly takes ex­tra time to pre­pare a strong CMC pack­age, to stay on the safe side,” he said.

The com­pa­ny might have tak­en a page from ri­vals’ re­cent trou­bles, he added:

Re­call that BMS and BLUE re­ceived Re­fusal-To-File (RTF) let­ter by FDA for the BLA sub­mis­sion of ide-cel/bb2121 in Mar ’20 and re­sub­mit­ted at the end of Ju­ly, which caused a 4-mos de­lay in reg­u­la­to­ry path. FDA re­quired a sup­ple­men­tal doc­u­men­ta­tion of CMC to pro­vide de­tails on val­i­da­tion con­trol process, and we think Leg­end takes ac­tions to min­i­mize any po­ten­tial reg­u­la­to­ry risks.

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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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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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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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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Ken Frazier, Merck CEO (Bess Adler/Bloomberg via Getty Images)

Ex-Mer­ck chief Ken Fra­zier takes a lead­ing role in a $600M 'Health As­sur­ance' ven­ture fund

Ken Frazier has opened up a new chapter in his storied career.

The ex-Merck CEO is joining a high-minded venture group with plans to carve a unique role for itself at the well-traveled juncture of tech and life sciences. And the new job comes through an old college buddy.

Officially, Frazier now becomes chairman of General Catalyst’s health assurance initiative. Their $600 million fund was unveiled back in early April, planning to invest in companies that could push the “evolution from a ‘sick care’ system to a resilient, proactive Health Assurance system designed to help people stay well, bend the cost curve, and make quality care more affordable and more accessible to all.”

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Mol­e­c­u­lar Di­ag­nos­tics Can Trans­form Can­cer Care. Let’s Make It Hap­pen.

Like so many people around the world, my life has been profoundly shaped by cancer. Those personal experiences, along with a deep love of clinical laboratory science and a passion to apply the power of genomics in medicine, motivated me to launch a company that would improve cancer care through better diagnostics. Thirteen years later, I am proud that we are delivering more accurate information at multiple points along the patient journey, with a focus on eight of the 10 cancers that are most commonly diagnosed in the United States.