Sean Park­er-backed cell ther­a­py start­up Ar­se­nal­Bio plucks Mer­ck VP as new CSO

Mer­ck’s im­muno-on­col­o­gy su­per­star Nicholas Hain­ing has been ap­point­ed CSO at Ar­se­nal­Bio, which is work­ing on an ap­proach to pro­gram­ma­ble cell ther­a­pies.

The ad­di­tion of a high-pro­file ap­point­ment like Hain­ing, who co-found­ed the com­pa­ny but has been serv­ing as VP of dis­cov­ery on­col­o­gy and im­munol­o­gy at Mer­ck Re­search Lab­o­ra­to­ries and al­so did work on pe­di­atric hema­tol­ogy/on­col­o­gy at the famed Dana-Far­ber Can­cer In­sti­tute, comes as Ar­se­nal­Bio may set its sights on an IPO in the near fu­ture.

Nicholas Hain­ing

Hain­ing re­places Genen­tech vet Jane Gro­gan, who in April moved over to be Graphite Bio’s CSO af­ter serv­ing as Ar­se­nal’s CSO since the biotech’s launch in Oc­to­ber 2019.

“Ar­se­nal­Bio has laid out a vi­sion and a roadmap for en­gi­neer­ing the fate and func­tion of T cells to help cure can­cer,” Hain­ing said in a state­ment. “It will be a priv­i­lege to be part of the mis­sion of trans­form­ing the best sci­ence in­to ef­fec­tive ther­a­pies for pa­tients who need them most.”

The new se­nior lead­er­ship fits right in with Ar­se­nal’s re­cent­ly an­nounced col­lab­o­ra­tion with Bris­tol My­ers Squibb. Back in Jan­u­ary, Ar­se­nal teamed up with BMS to find, de­vel­op and com­mer­cial­ize tar­get­ed T cell ther­a­pies for sol­id tu­mors. Ar­se­nal will han­dle the ear­ly dis­cov­ery work in the deal while Bris­tol will pay $70 mil­lion up­front with an op­tion to li­cense pre­clin­i­cal can­di­dates and bring them to mar­ket.

Ar­se­nal has sharp­ened its fo­cus in the near­ly two years since its in­cep­tion, with new work on us­ing a “stack” of bi­ol­o­gy com­po­si­tions to cre­ate de­sign­er T cells that can be ad­min­is­tered at low­er dos­es, bet­ter tar­get sol­id tu­mors and pre­vent the se­ri­ous side ef­fects com­mon in oth­er im­munother­a­pies. The biotech says its can­di­dates may be eas­i­er to man­u­fac­ture too, giv­en the fact they’re not ad­min­is­tered through in­ac­ti­vat­ed virus­es.

Ken Drazan

Led by Ken Drazan, a J&J vet and for­mer pres­i­dent of Grail, the South San Fran­cis­co-based biotech has a for­mi­da­ble group of in­vestors, in­clud­ing the bil­lion­aire and for­mer Nap­ster head Sean Park­er, who sits on Ar­se­nal’s board of di­rec­tors, and his Park­er In­sti­tute for Can­cer Im­munother­a­py, along with oth­ers like West­lake Vil­lage BioPart­ners, Klein­er Perkins, the Uni­ver­si­ty of Cal­i­for­nia, San Fran­cis­co Foun­da­tion In­vest­ment Com­pa­ny, Eu­clid­ean Cap­i­tal, and Os­age Uni­ver­si­ty Part­ners.

“Ar­se­nal­Bio al­lows us to rewrite vast stretch­es of code to give T cells dra­mat­ic new func­tions — that means they can be made to be more ef­fec­tive at killing can­cer and a broad spec­trum of oth­er dis­eases,” Park­er said in a state­ment. “It’s al­so very re­ward­ing to see Ar­se­nal­Bio born from the deep col­lab­o­ra­tion of PI­CI in­ves­ti­ga­tors — who worked to­geth­er across re­search cen­ters, hos­pi­tals and uni­ver­si­ties on the sci­ence be­hind these tech­nolo­gies.”

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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Laurent Fischer, Adverum CEO

Ad­verum faces murky fu­ture af­ter re­view turns up deep­er safe­ty is­sues for gene ther­a­py

Three months after revealing that a patient lost significant vision in one eye after receiving its experimental gene therapy, Adverum announced it found the safety issues were more widespread: Five of 12 patients who received a high dose of the therapy saw “similar clinically-relevant events.”

Three required surgery on their treated eye. And all 12 are being recommended “aggressive immunomodulatory treatments” to prevent further injury.

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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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