Sesen's PhI­II blad­der can­cer da­ta send stock south as in­vestors fret over safe­ty

Fol­low­ing a brand­ing makeover just last week, Sesen Bio (which used to go by Eleven Bio­ther­a­peu­tics) has pub­lished three-month da­ta for its blad­der can­cer drug Vicini­um. The re­sults have some in­vestors cau­tious, as the com­pa­ny’s stock — trad­ing un­der the fresh­ly mint­ed tick­er sym­bol $SESN — is down 23% since the an­nounce­ment.

Stephen Hurly

Sesen was lit­tle more than a shell with a bank ac­count a cou­ple years ago af­ter its lead drug failed twice and it com­plet­ed a deal to li­cense out its re­main­ing pro­gram to Roche. But then the en­ti­ty ac­quired Toron­to-based Viven­tia, snag­ging its now lead drug can­di­date Vicini­um, a next-gen an­ti­body-drug con­ju­gate to treat high-grade non-mus­cle in­va­sive blad­der can­cer.

The new Vicini­um da­ta came from an on­go­ing Phase III tri­al called Vista, which en­rolled 133 pa­tients with high-grade NMIBC. These pa­tients had pre­vi­ous­ly been on BCG im­munother­a­py, a stan­dard treat­ment that doesn’t al­ways de­liv­er, said Ri­an Dick­stein, an in­ves­ti­ga­tor in the tri­al.

“For those pa­tients who re­lapse or who don’t re­spond at all, the stan­dard al­ter­na­tive is rad­i­cal cys­tec­to­my,” Dick­stein said in a state­ment. “In a cys­tec­to­my, the blad­der is re­moved along with sur­round­ing lymph nodes and oth­er or­gans that con­tain can­cer.”

Ri­an Dick­stein

Vicini­um is a hope­ful al­ter­na­tive to los­ing the blad­der. Vicini­um was de­vel­oped us­ing the com­pa­ny’s pro­pri­etary tar­get­ed pro­tein ther­a­peu­tics plat­form. The ther­a­py is com­prised of a re­com­bi­nant fu­sion pro­tein that tar­gets ep­ithe­lial cell ad­he­sion mol­e­cule (Ep­CAM) anti­gens on the sur­face of tu­mor cells to de­liv­er a po­tent pro­tein pay­load, Pseudomonas Ex­o­tox­in A.

The com­pa­ny said Ep­CAM is over­ex­pressed in NMIBC but not in healthy blad­der cells, so hom­ing in on it will hope­ful­ly de­crease tox­ic ef­fects in healthy tis­sues.

Sesen’s ef­fi­ca­cy da­ta, which came from 111 pa­tients with can­cer that had not spread from the blad­der in­to mus­cle or oth­er tis­sue, showed that Vicini­um had a com­plete re­sponse rate of 43%.

Four se­ri­ous ad­verse events re­lat­ed to the treat­ment were re­port­ed in the da­ta, in­clud­ing acute kid­ney in­jury or re­nal fail­ure and cholesta­t­ic he­pati­tis, the com­pa­ny said. But 72% of the ad­verse events were classed as grade 1 or 2.

Still, the se­ri­ous ad­verse events ap­pear to have some in­vestors wor­ried, with the com­pa­ny’s stock drop­ping from $3.00 per share to $2.30 by Mon­day’s close.

Stephen Hurly, the com­pa­ny’s pres­i­dent and CEO, said the da­ta are en­cour­ag­ing.

“The Vista tri­al three-month da­ta are en­cour­ag­ing for our com­pa­ny and the pa­tients with high-grade NMIBC who have been un­der­served for many years,” Hurly said. “We have made tremen­dous progress over the last sev­er­al years to get us to where we are to­day, and I am proud of what our team has ac­com­plished. Our new name is a re­flec­tion of the jour­ney we’ve tak­en to get to this point and rep­re­sents our mis­sion of im­prov­ing lives. With 12-month da­ta ex­pect­ed by mid-2019, we are con­tin­u­ing to ad­vance Vicini­um to as­sess its full po­ten­tial in treat­ing this dev­as­tat­ing can­cer.”

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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