Ox­ford spin­out Arg­onaut looks to hack can­cer cells and pro­gram them to die

Nick La Thangue, Uni­ver­si­ty of Ox­ford

A new Ox­ford on­col­o­gy spin­out is join­ing the biotech ranks in the UK’s Gold­en Tri­an­gle.

The brain­child of Nick La Thangue, chair of can­cer bi­ol­o­gy at the Uni­ver­si­ty of Ox­ford, Arg­onaut Ther­a­peu­tics is look­ing to hack can­cer cells and trig­ger their de­struc­tion.

The biotech is cur­rent­ly work­ing on some pre­clin­i­cal can­di­dates that tar­get PRMT5, an en­zyme that con­trols a “switch” or tran­scrip­tion fac­tor that binds to DNA and ei­ther turns on a sig­nal for the cell to pro­lif­er­ate or push­es it in­to apop­to­sis, or cell death mode. And the up­start is fo­cused on col­orec­tal can­cer and lym­phoma, for starters, as it looks to ad­vance a po­ten­tial match for some of the im­munother­a­pies com­ing in­to use.

La Thangue had this to say:

The beau­ty of this ap­proach is that we can al­so pre­dict whether tu­mors are like­ly to re­spond, as we can test whether the tran­scrip­tion fac­tor is methy­lat­ed or not. Our drug can­di­dates tar­get this tran­scrip­tion fac­tor, with the aim of re­in­stat­ing the body’s nat­ur­al cell death process­es, shrink­ing tu­mors nat­u­ral­ly rather than caus­ing gen­er­al cy­to­tox­i­c­i­ty, which is how many cur­rent can­cer drugs work. We be­lieve the com­bi­na­tion of our ap­proach and oth­er new im­munother­a­pies could mean physi­cians are able to tack­le can­cer in a dif­fer­ent and po­ten­tial­ly very pow­er­ful way.

The UK biotech hub an­chored by Lon­don, Ox­ford and Cam­bridge has seen a whole new gen­er­a­tion of com­pa­nies spring­ing up in re­cent years. Fi­nanc­ing con­tin­ues to be a prob­lem, but a sig­nif­i­cant num­ber of glob­al in­vestors have found their way here to back some of these star­tups, par­tic­u­lar­ly fo­cus­ing on on­col­o­gy.

Ox­ford Sci­ences In­no­va­tion is seed­ing Arg­onaut.

Hal Barron, GSK

Break­ing the death spi­ral: Hal Bar­ron talks about trans­form­ing the mori­bund R&D cul­ture at GSK in a crit­i­cal year for the late-stage pipeline

Just ahead of GlaxoSmithKline’s Q2 update on Wednesday, science chief Hal Barron is making the rounds to talk up the pharma giant’s late-stage strategy as the top execs continue to woo back a deeply skeptical investor group while pushing through a whole new R&D culture.

And that’s not easy, Barron is quick to note. He told the Financial Times:

I think that culture, to some extent, is as hard, in fact even harder, than doing the science.

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Aca­dia is mak­ing the best of it, but their lat­est PhI­II Nu­plazid study is a bust

Acadia’s late-stage program to widen the commercial prospects for Nuplazid has hit a wall. The biotech reported that their Phase III ENHANCE trial flat failed. And while they $ACAD did their best to cherry pick positive data wherever they can be found, this is a clear setback for the biotech.

With close to 400 patients enrolled, researchers said the drug flunked the primary endpoint as an adjunctive therapy for patients with an inadequate response to antipsychotic therapy. The p-value was an ugly 0.0940 on the Positive and Negative Syndrome Scale, which the company called out as a positive trend.

Their shares slid 12% on the news, good for a $426 million hit on a $3.7 billion market cap at close.

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Some Big Phar­mas stepped up their game on da­ta trans­paren­cy — but which flunked the test?

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Now in its third year, the nonprofit created a new set of standards with Yale School of Medicine and Stanford Law School to evaluate the track record on trial registration, results reporting, publication and data-sharing practice.

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Durect $DRRX got a badly needed shot in the arm Monday morning as Gilead’s busy BD team lined up access to its extended-release platform tech for HIV and hepatitis B.

Gilead, a leader in the HIV sector, is paying a modest $25 million in cash for the right to jump on the platform at Durect, which has been using its technology to come up with an extended-release version of bupivacaine. The FDA rejected that in 2014, but Durect has been working on a comeback.

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Whoever is taking Otezla off Bristol-Myers Squibb’s hands will have one more revenue stream to boast.

The drug — a rising star in Celgene’s pipeline that generated global sales of $1.6 billion last year — is now OK’d to treat oral ulcers associated with Behçet’s disease, a common symptom for a rare inflammatory disorder. This marks the third FDA approval for the PDE4 inhibitor since 2014, when it was greenlighted for plaque psoriasis and psoriatic arthritis.

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Francesco De Rubertis

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Francesco De Rubertis built Medicxi to be the kind of biotech venture player he would have liked to have known back when he was a full time scientist.

“When I was a scientist 20 years ago I would have loved Medicxi,’ the co-founder tells me. It’s the kind of place run by and for investigators, what the Medicxi partner calls “scientists with strange ideas — a platform for the drug hunter and scientific entrepreneur. That’s what I wanted when I was a scientist.”

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Af­ter a decade, Vi­iV CSO John Pot­tage says it's time to step down — and he's hand­ing the job to long­time col­league Kim Smith

ViiV Healthcare has always been something unique in the global drug industry.

Owned by GlaxoSmithKline and Pfizer — with GSK in the lead as majority owner — it was created 10 years ago in a time of deep turmoil for the field as something independent of the pharma giants, but with access to lots of infrastructural support on demand. While R&D at the mother ship inside GSK was souring, a razor-focused ViiV provided a rare bright spot, challenging Gilead on a lucrative front in delivering new combinations that require fewer therapies with a more easily tolerated regimen.

They kept a massive number of people alive who would otherwise have been facing a death sentence. And they made money.

And throughout, John Pottage has been the chief scientific and chief medical officer.

Until now.

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Vlad Coric (Biohaven)

In an­oth­er dis­ap­point­ment for in­vestors, FDA slaps down Bio­haven’s re­vised ver­sion of an old ALS drug

Biohaven is at risk of making a habit of disappointing its investors.

Late Friday the biotech $BHVN reported that the FDA had rejected its application for riluzole, an old drug that they had made over into a sublingual formulation that dissolves under the tongue. According to Biohaven, the FDA had a problem with the active ingredient used in a bioequivalence study back in 2017, which they got from the Canadian drugmaker Apotex.

Apotex, though, has been a disaster ground. The manufacturer voluntarily yanked the ANDAs on 31 drugs — in late 2017 — after the FDA came across serious manufacturing deficiencies at their plants in India. A few days ago, the FDA made it official.

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