Kim Smith, ViiV CEO, at GlaxoSmithKline's Investor Day

Bank­ing on in­te­grase in­hibitors as HIV cor­ner­stone, Vi­iV bags 3rd-gen­er­a­tion com­pound from Sh­iono­gi

As a 12% share­hold­er of Vi­iV Health­care, Japan’s Sh­iono­gi has com­mand­ed a much low­er pro­file than its fel­low own­ers, Glax­o­SmithK­line and Pfiz­er. But be­hind the scenes, it’s played an out­sized role in the de­vel­op­ment of Vi­iV’s HIV drugs, com­ing up with the two top pro­grams — the in­te­grase in­hibitors do­lute­gravir and cabote­gravir — cur­rent­ly in Vi­iV’s port­fo­lio.

And it’s time for round three.

Vi­iV is pay­ing Sh­iono­gi £20 mil­lion ($27 mil­lion) in cash to li­cense S-365598, which it’s call­ing a third-gen­er­a­tion in­te­grase in­hibitor. On the hook for an ad­di­tion­al £15 mil­lion mile­stone pay­ment and roy­al­ties on par with its pre­vi­ous deals, Sh­iono­gi will chip in on de­vel­op­ment costs up to an an­nu­al max­i­mum. First-in-hu­man tri­als are slat­ed for 2023.

Both do­lute­gravir and cabote­gravir are be­ing de­ployed as part of ap­proved HIV treat­ment reg­i­mens: Dova­to, a pill con­sist­ing of do­lute­gravir and lamivu­dine, is tak­en by an es­ti­mat­ed 17 mil­lion around the world, while cabote­gravir plus rilpivirine was ap­proved ear­li­er this year as Cabe­nu­va.

The com­pa­ny added Tues­day that cabote­gravir has scored a pri­or­i­ty re­view as pre-ex­po­sure pro­phy­lax­is, com­mon­ly re­ferred to as PrEP.

“Our be­lief is that in­te­grase in­hibitors should an­chor reg­i­mens of the present and the fu­ture,” Kim Smith, R&D chief at Vi­iV, told End­points News. “We will add in med­i­cines that have nov­el mech­a­nisms of ac­tion, like our mat­u­ra­tion in­hibitor, like cap­sid in­hibitors, like our broad­ly neu­tral­iz­ing an­ti­bod­ies that we’ll look to com­bine with the in­te­grase in­hibitors, but we like the foun­da­tion of an in­te­grase in­hibitor.”

On top of a “unique re­sis­tance pro­file” seen in pre­clin­i­cal ex­per­i­ments that point to high po­ten­cy, Smith said S-365598 ap­pears to have a half life longer than cabote­gravir, which has shown to last two months max­i­mum.

“The fu­ture is all long-act­ing,” she said.

Her team has been hard at work striv­ing to­ward that fu­ture, most re­cent­ly team­ing up with Halozyme to ex­plore sub­cu­ta­neous ad­min­is­tra­tions that could be dosed at longer in­ter­vals.

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.

Covid-19 vac­cine boost­ers earn big thumbs up, but Mod­er­na draws ire over world sup­ply; What's next for Mer­ck’s Covid pill?; The C-suite view on biotech; 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.

You may remember that at the beginning of this year, Endpoints News set a goal to go broader and deeper. We are still working towards that, and are excited to share that Beth Snyder Bulik will be joining us on Monday to cover all things pharma marketing. You can sign up for her weekly Endpoints MarketingRx newsletter in your reader profile.

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No­var­tis de­vel­op­ment chief John Tsai: 'We go deep in the new plat­form­s'

During our recent European Biopharma Summit, I talked with Novartis development chief John Tsai about his experiences over the 3-plus years he’s been at the pharma giant. You can read the transcript below or listen to the exchange in the link above.

John Carroll: I followed your career for quite some time. You’ve had more than 20 years in big pharma R&D and you’ve obviously seen quite a lot. I really was curious about what it was like for you three and a half years ago when you took over as R&D chief at Novartis. Obviously a big move, a lot of changes. You went to work for the former R&D chief of Novartis, Vas Narasimhan, who had his own track record there. So what was the biggest adjustment when you went into this position?

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Amit Etkin, Alto Neuroscience CEO (Alto via Vimeo)

A star Stan­ford pro­fes­sor leaves his lab for a start­up out to re­make psy­chi­a­try

About five years ago, Amit Etkin had a breakthrough.

The Stanford neurologist, a soft-spoken demi-prodigy who became a professor while still a resident, had been obsessed for a decade with how to better define psychiatric disorders. Drugs for depression or bipolar disorder didn’t work for many patients with the conditions, and he suspected the reason was how traditional diagnoses didn’t actually get at the heart of what was going on in a patient’s brain.

Susan Galbraith, Executive VP, Oncology R&D, AstraZeneca

As­traZeneca on­col­o­gy R&D chief Su­san Gal­braith: 'Y­ou're go­ing to need or­thog­o­nal com­bi­na­tion­s'


Earlier in the week we broadcast our 4th annual European Biopharma Summit with a great lineup of top execs. One of the one-on-one conversations I set up was with Susan Galbraith, the oncology research chief at AstraZeneca. In a wide-ranging discussion, Galbraith reviewed the cancer drug pipeline and key trends influencing development work at the pharma giant. You can watch the video, above, or stick with the script below. — JC

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Roche's Tecen­triq cross­es the fin­ish line first in ad­ju­vant lung can­cer, po­ten­tial­ly kick­ing off gold rush

While falling behind the biggest PD-(L)1 drugs in terms of sales, Roche has looked to carve out a space for its Tecentriq with a growing expertise in lung cancer. The drug will now take an early lead in the sought-after adjuvant setting — but competitors are on the way.

The FDA on Friday approved Tecentriq as an adjuvant therapy for patients with Stage II-IIIA non small cell lung cancer with PD-(L)1 scores greater than or equal to 1, making it the first drug of its kind approved in an early setting that covers around 40% of all NSCLC patients.

Rahul Singhvi, Resilience CEO

A Bob Nelsen start­up turns to Har­vard to help sharp­en its tech, in­spir­ing first spin­out

One of Bob Nelsen’s latest projects is headed to Harvard.

Resilience, a company started with the goal of establishing itself as a “one-stop-shop” for companies looking to scale manufacturing, including for hard-to-develop cell and gene therapies, is less than a year old. Friday, it announced a five-year R&D deal with Harvard University that includes $30 million to develop biologics, including vaccines, nucleic acids and cell and gene therapies.

John Oyler, BeiGene CEO (Paul Yeung/Bloomberg via Getty Images)

Bris­tol My­ers wants to pull out of its Abrax­ane deal in Chi­na. BeiGene says no way

A year and a half after Chinese officials ordered BeiGene to stop selling Bristol Myers Squibb’s Abraxane in the wake of an alarming inspection of a US facility, the manufacturing issues at the root of the import suspension still appear unresolved.

And Bristol Myers wants to axe the Abraxane supply deal altogether.

But BeiGene, which is currently in arbitration proceedings against its Big Pharma partner, won’t let it off the hook so easily.

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FDA ad­comm votes unan­i­mous­ly in sup­port of a J&J Covid-19 boost­er two months af­ter one-dose shot

The FDA’s Vaccines and Related Biological Products Advisory Committee (VRBPAC) on Friday voted 19-0 in favor of authorizing a second shot of J&J’s Covid-19 vaccine to follow at least two months after the initial dose.

Regulators don’t have to follow VRBPAC’s recommendation, but they almost always do. Considering that the CDC’s advisory committee has already been set to review the expanded EUA, VRBPAC’s recommendation is likely to be adopted.