Nick Haining, Arsenal Bio

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.

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.”

David Livingston (Credit: Michael Sazel for CeMM)

Renowned Dana-Far­ber sci­en­tist, men­tor and bio­phar­ma ad­vi­sor David Liv­ingston has died

David Livingston, the Dana-Farber/Harvard Med scientist who helped shine a light on some of the key molecular drivers of breast and ovarian cancer, died unexpectedly last Sunday.

One of the senior leaders at Dana-Farber during his nearly half century of work there, Livingston was credited with shedding light on the genes that regulate cell growth, with insights into inherited BRCA1 and BRCA2 mutations that helped lay the scientific foundation for targeted therapies and earlier detection that have transformed the field.

Biotech Half­time Re­port: Af­ter a bumpy year, is biotech ready to re­bound?

The biotech sector has come down firmly from the highs of February as negative sentiment takes hold. The sector had a major boost of optimism from the success of the COVID-19 vaccines, making investors keenly aware of the potential of biopharma R&D engines. But from early this year, clinical trial, regulatory and access setbacks have reminded investors of the sector’s inherent risks.

RBC Capital Markets recently surveyed investors to take the temperature of the market, a mix of specialists/generalists and long-only/ long-short investment strategies. Heading into the second half of the year, investors mostly see the sector as undervalued (49%), a large change from the first half of the year when only 20% rated it as undervalued. Around 41% of investors now believe that biotech will underperform the S&P500 in the second half of 2021. Despite that view, 54% plan to maintain their position in the market and 41% still plan to increase their holdings.

No­vo CEO Lars Fruer­gaard Jør­gensen on R&D risk, the deal strat­e­gy and tar­gets for gen­der di­ver­si­ty

 

I kicked off our European R&D summit last week with a conversation involving Novo Nordisk CEO Lars Fruergaard Jørgensen. Novo is aiming to launch a new era of obesity management with a new approval for semaglutide. And Jørgensen had a lot to say about what comes next in R&D, how they manage risk and gender diversity targets at the trendsetting European pharma giant.

John Carroll: I’m here with Lars Jørgensen, the CEO of Novo Nordisk. Lars, it’s been a really interesting year so far with Novo Nordisk, right? You’ve projected a new era of growing sales. You’ve been able to expand on the GLP-1 franchise that was already well established in diabetes now going into obesity. And I think a tremendous number of people are really interested in how that’s working out. You have forecast a growing amount of sales. We don’t know specifically how that might play out. I know a lot of the analysts have different ideas, how those numbers might play out, but that we are in fact embarking on a new era for Novo Nordisk in terms of what the company’s capable of doing and what it’s able to do and what it wants to do. And I wanted to start off by asking you about obesity in particular. Semaglutide has been approved in the United States for obesity. It’s an area of R&D that’s been very troubled for decades. There have been weight loss drugs that have come along. They’ve attracted a lot of attention, but they haven’t actually ever gained traction in the market. My first question is what’s different this time about obesity? What is different about this drug and why do you expect it to work now whereas previous drugs haven’t?

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Carl June (Brian Ach/Getty Images for TIME 100 Health Summit)

Carl June lends 'wings' to Chi­nese CAR-T start­up led by for­mer post­doc, pur­su­ing off-the-shelf ap­proach with CRISPR fla­vor

Carl June still has plenty of energy to bring forth new iterations of CAR-T technology — wherever they’re coming from.

Adding another role to his already lengthy list of titles, June is joining the scientific advisory board at Nanjing Bioheng Biotech, where he will serve as chairman.

The appointment, if slightly out of the ordinary, is both a testament to the fruitfulness of June’s lab at the University of Pennsylvania and China’s increasing appeal to biotech entrepreneurs educated overseas.

Man­u­fac­tur­ing woes for No­vavax’s Covid jab bad­ly dis­rupt plans for roll­out to the poor — re­port

Production problems at a Novavax facility in Maryland have led to delays in the Covax vaccine sharing program. Now, a shortage of 1 billion doses is expected, as the supplier tries to navigate producing a shot up to regulators’ standards, Politico reported Tuesday.

The company has run into trouble with the purity of the vaccine. Novavax has had trouble proving it can produce a shot consistently up to standards, and it has caused significant delays in the rollout to low- and middle-income countries. This follows several delays at Novavax that has put the executive crew on the defensive.

Sur­geons suc­cess­ful­ly at­tach pig kid­ney to a hu­man for the first time, us­ing tech from Unit­ed's Re­vivi­cor

In a first, researchers reportedly successfully transplanted a pig kidney into a human without triggering an immediate immune response this week. And the technology came from the biotech United Therapeutics.

Surgeons spent three days attaching the kidney to the patient’s blood vessels, but when all was said and done, the kidney appeared to be functioning normally in early testing, Reuters and the New York Times were among those to report. The kidney came from a genetically altered pig developed through United’s Revivicor unit.

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

Up­dat­ed: Bio­gen sells just $300K worth of Aduhelm in Q3, as ques­tions on long-term vi­a­bil­i­ty re­main

Barely anyone is accessing Biogen’s controversial Alzheimer’s treatment, with the company reporting just $0.3 million in Aduhelm sales in the third quarter. Although investors will be looking to the longer term, when CMS may decide to cover the drug and open the floodgates for more reimbursement, use of the drug is currently stalled.

Since June, when the FDA first signed off on the drug under its accelerated pathway, Biogen said Wednesday that it’s sold a total of $2 million worth of Aduhelm. That’s a far cry from the peak Wall Street sales estimate of about $9 billion in annual sales.

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With hun­dreds of mil­lions spent on failed ac­cel­er­at­ed ap­provals, re­searchers call for faster FDA with­drawals

Between 2017 and 2019, Medicare spent more than $220 million on cancer drugs for which the indications were either voluntarily pulled by their applicants or FDA’s oncology adcomm had recommended their withdrawal.

That kind of massive spending on cancer drugs lacking overall survival benefit is wasteful and risks harming people’s health, a research letter published in JAMA Internal Medicine on Monday said. The researchers from Harvard and the London School of Economics called on the FDA to move faster in both requiring timely postmarketing trials and accelerating the speed in pulling these dangling approvals when the confirmatory studies fail.

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Raymond Stevens, ShouTi Pharma CEO

A new Schrödinger-backed start­up emerges from the sci­en­tist who mapped the first hu­man GPCR

One of the most popular targets in drug development, representing about a third of existing drugs, are G-protein coupled receptors — the tiny but integral membrane proteins responsible for recognizing things like light, taste, smell, hormones and pain.

But due to challenges in mapping their structure, the protein family remains largely unexplored.

A slate of companies has emerged over the last few years to change that. If one can figure out the structure of these elusive membrane receptors, it might be possible to create small molecule drugs that overcome the limitations of, say, biologic and peptide therapies. That promise is what gets serial entrepreneur Raymond Stevens out of bed in the morning.