No­var­tis ties up with the vir­tu­al biotech Parvus to try a new ap­proach on Type 1 di­a­betes

Parvus CEO Jan­ice LeCocq

No­var­tis has turned to a small, vir­tu­al biotech in Cana­da for some fresh in­spi­ra­tion on how it might one day de­feat Type 1 di­a­betes.

The phar­ma gi­ant’s No­var­tis In­sti­tute of Bio­med­ical Re­search now has the ex­clu­sive li­cense to use Parvus Ther­a­peu­tics’ plat­form for di­a­betes, com­ing in with an un­spec­i­fied pack­age of mile­stones, an up­front, re­search sup­port and an eq­ui­ty stake to seal the deal.

That’s a very big deal for Parvus, which has been op­er­at­ing for the last few years on about $20 mil­lion in re­search grants and $5 mil­lion in an­gel in­vest­ments with a few full-time staffers to guide the work be­ing done in Pere San­ta­maria’s lab at the Uni­ver­si­ty of Cal­gary.

San­ta­maria, the CSO and founder at Parvus, was run­ning an imag­ing ex­per­i­ment us­ing nano-sized bits of iron ox­ide when he made a serendip­i­tous dis­cov­ery. As he went on to lat­er write in Na­ture:

(S)ys­temic de­liv­ery of nanopar­ti­cles coat­ed with au­toim­mune­ dis­ease ­rel­e­vant pep­tides bound to ma­jor his­to­com­pat­i­bil­i­ty com­plex class II (pMHCII) mol­e­cules trig­gers the gen­er­a­tion and ex­pan­sion of anti­gen­spe­cif­ic reg­u­la­to­ry CD4+ T cell type 1 (TR1)­like cells in dif­fer­ent mouse mod­els, in­clud­ing mice hu­man­ized with lym­pho­cytes from pa­tients, lead­ing to res­o­lu­tion of es­tab­lished au­toim­mune phe­nom­e­na.

Those re­pro­grammed reg­u­la­to­ry T cells were able to stop the au­toim­mune at­tack – in mice – with­out flat­ten­ing the im­mune sys­tem.

That’s what got No­var­tis’ in­ter­est.

Jay Brad­ner, NI­BR

“There had been in­for­mal con­tacts with No­var­tis fair­ly ear­ly on in the life of the com­pa­ny,” CEO Jan­ice LeCocq told me.

San­ta­maria’s first pa­per on this was pub­lished in 2010 with the sec­ond ap­pear­ing last year, and he’s been work­ing in the lab for years to com­plete the pre­clin­i­cal work need­ed to get an IND ready for the FDA, he says. A joint com­mit­tee with No­var­tis will now over­see that step, with the phar­ma gi­ant tak­ing charge of the clin­i­cal pro­gram.

LeCocq isn’t pro­vid­ing any time­lines on de­vel­op­ment right now.

Like a lot of vir­tu­al biotechs, Parvus de­pends on a net­work of con­sul­tants for much of the heavy lift­ing that needs to get done at the com­pa­ny. And now with No­var­tis’ sup­port the team will al­so get to start adding a de­vel­op­ment group, which can turn to one of the oth­er po­ten­tial au­toim­mune dis­ease tar­gets on the menu for their tai­lored Navacims.

Mul­ti­ple scle­ro­sis is the fur­thest along on that list, but LeCocq says they have made no fi­nal de­ci­sions on what Parvus will turn to next as NI­BR fo­cus­es on Type 1 di­a­betes.

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?

The nonprofit Bioethics International has come out with their latest scorecard on data transparency among the big biopharmas in the industry — flagging a few standouts while spotlighting some laggards who are continuing to underperform.

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.

Busy Gilead crew throws strug­gling biotech a life­line, with some cash up­front and hun­dreds of mil­lions in biobucks for HIV deal

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.

In­tec blitzed by PhI­II flop as lead pro­gram fails to beat Mer­ck­'s stan­dard com­bo for Parkin­son’s

Intec Pharma’s $NTEC lead drug slammed into a brick wall Monday morning. The small-cap Israeli biotech reported that its lead program — coming off a platform designed to produce a safer, more effective oral drug for Parkinson’s — failed the Phase III at the primary endpoint.

Researchers at Intec, which has already seen its share price collapse over the past few months, says that its Accordion Pill-Carbidopa/Levodopa failed to prove superior to Sinemet in reducing daily ‘off’ time. 

Cel­gene racks up third Ote­zla ap­proval, heat­ing up talks about who Bris­tol-My­ers will sell to

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

Medicxi is rolling out its biggest fund ever to back Eu­rope's top 'sci­en­tists with strange ideas'

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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