The next check­points? Im­muno-on­col­o­gy up­start looks to find new ways to un­leash T cells

With much of the re­search com­mu­ni­ty in on­col­o­gy fo­cused on T cell reg­u­la­tors like LAG-3 to fol­low up on CT­LA4 and PD-L1 in the hunt for new tar­gets to quell can­cer, a pair of in­ves­ti­ga­tors in Ger­many asked them­selves a sim­ple ques­tion.

If tu­mor cells ex­press PD-L1 to in­hib­it T cells, what else can be found on the sur­face of these cells that block T cells?

CEO Se­bas­t­ian Meier-Ew­ert

The ques­tion spurred them to be­gin an am­bi­tious tu­mor screen­ing pro­gram for new tar­gets. And their work has now in­spired a start­up, iOmx Ther­a­peu­tics, which has put to­geth­er a $44 mil­lion A round to back the first few years of pre­clin­i­cal work and at least one proof-of-con­cept study for a lead pro­gram.

MPM Cap­i­tal and Sofinno­va Part­ners co-led the A round, joined by Welling­ton Part­ners and Mer­ck Ven­tures.

At this stage, i/o has clear­ly emerged as the hottest field in drug re­search, in­spir­ing an ex­plo­sion of re­search projects and a long chain of deals that play out on a day-to-day ba­sis. So how do you po­si­tion a start­up as a po­ten­tial ground­break­er on next-gen check­point pro­grams amid all the ac­tion?

“The key is the re­al in­no­va­tion on the sci­ence side and the in­no­v­a­tive­ness of the tar­gets,” says CEO Se­bas­t­ian Meier-Ew­ert. In a num­ber of cas­es, there’s noth­ing in the lit­er­a­ture to sug­gest that some of their tar­gets be­ing test­ed in tis­sue sam­ples and mice are on the radar.

“Some of these tar­gets,” he adds, “we know that no one is work­ing on them, full stop.”

He should know. Meier-Ew­ert gave up his job as a man­ag­ing part­ner at MPM Cap­i­tal to take the lead as a full time CEO. And he chose iOmx af­ter get­ting a look at a lot of po­ten­tial projects. Now the small three-mem­ber staff in the Mar­tin­sried biotech hub in Mu­nich will be beefed up to 10 by the end of the year, on its way to 15-20 in the next few years.

Just don’t ask yet what his first new tar­gets are. This is a hot­ly com­pet­i­tive field, and iOmx wants to main­tain si­lence on its first pro­grams as the CEO sorts through the first round of part­ner­ing in­ter­est.

Co-founder Philipp Beck­hove did much of the foun­da­tion re­search while work­ing at the Ger­man Can­cer Re­search Cen­ter in Hei­del­berg, and is now at the RCI Re­gens­burg Cen­ter for In­ter­ven­tion­al Im­munol­o­gy. The com­pa­ny’s screen­ing plat­form was de­vel­oped by co-founder Nisit Khan­del­w­al, SVP of Re­search.

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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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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Chas­ing Roche's ag­ing block­buster fran­chise, Am­gen/Al­ler­gan roll out Avastin, Her­ceptin knock­offs at dis­count

Let the long battle for biosimilars in the cancer space begin.

Amgen has launched its Avastin and Herceptin copycats — licensed from the predecessors of Allergan — almost two years after the FDA had stamped its approval on Mvasi (bevacizumab-awwb) and three months after the Kanjinti OK (trastuzumab-anns). While the biotech had been fielding biosimilars in Europe, this marks their first foray in the US — and the first oncology biosimilars in the country.