RA backs Mede­or’s $57M round as re­searchers fast for­ward to PhI­II

The Bay Area’s fast-grow­ing biotech Mede­or Ther­a­peu­tics has raised $57 mil­lion in a B round to ad­vance its late-stage tech, which might pre­vent the body’s re­jec­tion of or­gan trans­plants.

Pe­ter Kolchin­sky

The round was led by RA Cap­i­tal Man­age­ment, a well-known crossover in­vestor, sig­nal­ing Mede­or Ther­a­peu­tics may be prep­ping for an IPO in the near fu­ture.

The Cal­i­for­nia biotech, found­ed in 2012, is de­vel­op­ing per­son­al­ized cell-based im­munother­a­py that’s de­signed to switch off the body’s im­mune re­sponse to do­nat­ed and trans­plant­ed or­gans.

Al­most 29,000 or­gan trans­plants have been per­formed in the US this year, with most of those pro­ce­dures in­volv­ing the kid­neys. Af­ter these trans­plants are done, pa­tients of­ten take drugs like cy­closporine and tacrolimus to sup­press the body’s im­mune sys­tem and help pre­vent re­jec­tion of the new or­gan. But these drugs must be tak­en for life, and can cause some pret­ty se­ri­ous side ef­fects.

Mede­or’s ap­proach to im­prov­ing or­gan trans­plant suc­cess is quite dif­fer­ent. The com­pa­ny’s lead pro­gram, called MDR-101, in­volves in­ject­ing blood stem cells and T cells from the or­gan’s donor in­to the re­ceiv­ing pa­tient. In ef­fect, this would “trick” the im­mune sys­tem of the pa­tient to ac­cept the do­nat­ed or­gan as if it was their own.

The com­pa­ny al­ready has this pro­gram in Phase III clin­i­cal tri­als in HLA-matched kid­ney trans­plant pa­tients. The tri­al is be­ing con­duct­ed un­der a Spe­cial Pro­to­col Agree­ment with the FDA, which should speed the process along to­wards ap­proval. Mede­or is al­so do­ing Phase IIb tri­als in HLA-mis­matched kid­ney trans­plants, and plans to start two ad­di­tion­al pro­grams with the new funds.

Oth­er new in­vestors in the round in­clud­ed Sofinno­va Ven­tures and 6 Di­men­sions Cap­i­tal. Ex­ist­ing in­vestors Vi­vo Cap­i­tal and WuXi Health­care Ven­tures al­so joined.

As part of the fi­nanc­ing, Mede­or is get­ting two new board mem­bers: Pe­ter Kolchin­sky, port­fo­lio man­ag­er and man­ag­ing di­rec­tor at RA Cap­i­tal; and Anand Mehra, gen­er­al part­ner at Sofinno­va.

“Or­gan trans­plan­ta­tion is one of the most re­mark­able life-giv­ing feats of mod­ern med­i­cine, though pa­tients must deal with in­tense and some­times in­tol­er­a­ble chron­ic im­mune sup­pres­sion,” Kolchin­sky said in a state­ment. “Based on bril­liant in­sights in­to hu­man im­munol­o­gy, we be­lieve Mede­or may have el­e­gant­ly trans­formed this pro­ce­dure to mean­ing­ful­ly re­duce the need for long-term im­muno­sup­pres­sion, al­low­ing pa­tients not on­ly to sur­vive thanks to the gen­eros­i­ty of a donor but al­so to en­joy a high­er qual­i­ty of life.”

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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