Lil­ly Asian Ven­tures backs Im­pact's PARP re­search again, chip­ping in for $30M Se­ries C led by Decheng Cap­i­tal

A Chi­nese biotech run­ning af­ter the “best-in-class” ti­tle in the PARP in­hibitor field has gath­ered $30 mil­lion to fu­el its still ear­ly-stage R&D work.

Min Cui

Decheng Cap­i­tal led the Se­ries C for Nan­jing-based Im­pact Ther­a­peu­tics, joined by ex­ist­ing in­vestor Lil­ly Asian Ven­tures. LAV first backed Im­pact in 2014 to­geth­er with Cen­o­va and WuXi Ven­tures and lat­er came back for a $10 mil­lion B round.

“Im­pact is an ex­cel­lent Chi­nese com­pa­ny with prod­ucts that can com­pete glob­al­ly,” said Xi­ang­min Cui, founder and man­ag­ing di­rec­tor of Decheng, in a state­ment.

Ye Ed­ward Tian

It will be a while be­fore we find out whether he’s right, as Im­pact’s lead drug has on­ly shown pre­lim­i­nary ef­fi­ca­cy in Phase I tri­als con­duct­ed in Aus­tralia and Chi­na. Mean­while, As­traZeneca has lined up a Chi­na NDA for its block­buster PARP drug Lyn­parza, with an ap­proval ex­pect­ed with­in the year.

Un­der the lead­er­ship of CEO Ye Ed­ward Tian, Im­pact has al­so be­gun search­ing for po­ten­tial com­bos with oth­er tar­get­ed can­cer ther­a­pies. Their plan, ac­cord­ing to their web­site, is to al­ways start ex­plor­ing col­lab­o­ra­tion and li­cens­ing deals as soon as their drugs en­ter clin­i­cal de­vel­op­ment.

Sui Xiong Cai

“Our da­ta in­di­cates that IMP4297 could be more ef­fi­ca­cious and/or less tox­ic than oth­er PARP in­hibitors cur­rent­ly in the mar­ket, mak­ing it a po­ten­tial best-in-class drug,” said Sui Xiong Cai, Im­pact’s SVP and CTO. “With this se­ries C fi­nanc­ing, we are well-po­si­tioned to achieve key da­ta mile­stones as we ac­cel­er­ate the clin­i­cal de­vel­op­ment of IMP4297, in the hope of bring­ing it to mar­ket and pa­tients soon.”

Pro­ceeds from the round will al­so bankroll Im­pact’s pre­clin­i­cal pro­grams tar­get­ing can­cer cells’ DNA dam­age re­sponse (DDR) — a mech­a­nism that they be­lieve can achieve se­lec­tive killing of can­cer cells.

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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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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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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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.