Am­gen bets on stem cell com­pa­ny For­tu­na Fix in $25M round

Am­gen’s ven­ture arm just made a bet on re­gen­er­a­tive med­i­cine for the first time. The phar­ma gi­ant pitched in to a new $25 mil­lion fi­nanc­ing round for Cana­di­an stem cell com­pa­ny For­tu­na Fix.

For­tu­na is work­ing on new ways to re­grow neur­al tis­sue dam­aged by de­gen­er­a­tion and trau­ma. With its tech­nol­o­gy, the com­pa­ny hopes to mim­ic the ca­pa­bil­i­ties of the Mex­i­can sala­man­der, known for its abil­i­ty to re­grow its own spinal cord, jaw, tail, skin and limbs — all with­out scar­ring.

Jan-Er­ic Ahlfors, For­tu­na Fix

The com­pa­ny says it’s re­pro­duced this phe­nom­e­na in test tubes by start­ing with reg­u­lar old mul­ti­po­tent stem cells, which can be tak­en from any tis­sue (hair, skin, bone mar­row, etc.) and re-en­gi­neered in­to neur­al stem cells. There’s a name for this kind of stem cell ther­a­py, but it’s a mouth­ful: au­tol­o­gous mul­ti­po­tent stem cells pro­duced by di­rect re­pro­gram­ming. The good thing about these stem cells is they don’t tend to spark tu­mor growth nor do they stim­u­late the im­mune sys­tem — ؅two of the biggest chal­lenges fac­ing stem cell ther­a­pies.

In the­o­ry, such re­pro­grammed cells can be in­ject­ed in­to a pa­tient mul­ti­ple times, al­low­ing for a treat­ment reg­i­men that could ful­ly re­gen­er­ate the tis­sue in mind. For­tu­na is hop­ing its neur­al stem cells will re­gen­er­ate the brains of Parkin­son’s dis­ease pa­tients.

Re­grow­ing brain tis­sue in PD

PD pa­tients lack the brain chem­i­cal dopamine, which helps con­trol mus­cle move­ment. Neur­al stem cells have the abil­i­ty to make and re­place the dead and dy­ing dopamine-pro­duc­ing cells in pa­tients, re­plac­ing the miss­ing neu­ro­trans­mit­ter and re­vers­ing the symp­toms.

For­tu­na, found­ed in 2015, will use cash from the new fi­nanc­ing round to do Phase I/IIa clin­i­cal tri­als in PD as well as spinal cord in­jury.

For­tu­na’s CEO and CSO Jan-Er­ic Ahlfors said the com­pa­ny’s tech­nol­o­gy might soon de­liv­er stem cells that can “read­i­ly re­place lost neu­rons, do not re­quire im­mune sup­pres­sion, are eth­i­cal­ly sourced, ef­fi­ca­cious and ad­dress some of the largest un­met med­ical needs.” And Am­gen is will­ing to put up some cash to see if it works.

Am­gen’s first for­ay in­to cel­lu­lar re­gen­er­a­tion

Philip Tagari, Am­gen

This is Am­gen’s first in­vest­ment in re­gen­er­a­tive med­i­cine, but the com­pa­ny’s long been in­ter­est­ed in treat­ing neu­rode­gen­er­a­tion. The com­pa­ny part­nered with No­var­tis back in 2015 to de­vel­op a BACE in­hibitor to treat Alzheimer’s dis­ease. The mol­e­cule is cur­rent­ly in Phase III test­ing.

Now, two Am­gen VPs are tied to the in­vest­ment deal with For­tu­na. John Dun­lop, VP of neu­ro­science dis­cov­ery re­search at Am­gen, will sit on For­tu­na’s sci­en­tif­ic ad­vi­so­ry board. Philip Tagari, VP of ther­a­peu­tic dis­cov­ery, will be a board ob­serv­er.

“This in­vest­ment in For­tu­na rep­re­sents Am­gen’s first for­ay in­to cel­lu­lar re­gen­er­a­tive re­search and un­der­scores our com­mit­ment to ad­vanc­ing nov­el neu­ro­science re­search for se­ri­ous brain dis­eases, such as Parkin­son’s,” Tagari said in a state­ment. “Re­gen­er­a­tive med­i­cine is one of the most ex­cit­ing fields of health care to­day, and we are de­light­ed to par­tic­i­pate in the ad­vance­ment of these in­no­v­a­tive so­lu­tions for pa­tients suf­fer­ing from se­vere neu­rode­gen­er­a­tive dis­eases and neu­ro­trau­ma.”

5AM Ven­tures: Fu­el­ing the Next Gen­er­a­tion of In­no­va­tors

By RBC Capital Markets
With Andy Schwab, Co-Founder and Managing Partner at 5AM Ventures

Key Points

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Hal Barron, GSK via YouTube

What does $29B buy you in Big Phar­ma? In Glax­o­SmithK­line’s case, a whole lot of un­com­fort­able ques­tions about the pipeline

Talk about your bad timing.

A little over a week ago, GSK R&D chief Hal Barron marked his third anniversary at the research helm by taking a turn at the virtual podium during JP Morgan to make the case that he and his team had built a valuable late-stage pipeline capable of churning out more than 10 blockbusters in the next 5 years.

And then, just days later, one of the cancer drugs he bet big on as a top prospect — bintrafusp, partnered with Merck KGaA — failed its first pivotal test in non-small cell lung cancer.

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Eli Lil­ly's an­ti­body cuts risk of Covid-19 by up to 80% among the most vul­ner­a­ble — but will it have a place next to vac­cines?

Eli Lilly says bamlanivimab lowered the risk of contracting symptomatic Covid-19 in a first-of-its-kind trial involving nursing home residents and staff, paving the way for a new option to protect against the virus.

But how big of an impact it might have, and what role it will play, at a time vaccines are being rolled out to the exact population it is targeting still remains unclear.

Among 965 participants in the study — all of whom tested negative for the coronavirus at baseline — the number of symptomatic cases reported in the bamlanivimab arm was 57% lower than that in the placebo arm (odds ratio 0.43, p=0.00021). In addition to that primary endpoint, all secondary endpoints reached statistical significance.

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Janet Woodcock (AP Images)

End­points poll: Janet Wood­cock takes the (in­ter­im) helm at the FDA. And a large ma­jor­i­ty of our read­ers want her to stay there

It’s official: Janet Woodcock is now the acting chief of the FDA.

And — according to an Endpoints poll — most industry readers would like her to stay there, although a significant minority is strongly opposed.

To recap: Joe Biden is reportedly choosing between Woodcock and former deputy FDA commissioner Joshua Sharfstein as his nominee for the permanent position. Given their respective track records, the decision is set to determine the agency’s lodestar for years to come.

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What’s next for End­points — and how to sup­port our in­de­pen­dent bio­phar­ma news mis­sion

The firehose of biopharma news is gushing these days.

That’s why broader and deeper is the theme for 2021 at Endpoints. You can expect new coverage outside our core R&D focus, with deeper reporting in some key areas. When John Carroll and I launched Endpoints nearly five years ago, we were wading in waist-high waters. Now we’re a team of 25 full-time staffers (and growing) with plans to cover the flood of biopharma news, Endpoints-style.

Charlie Fuchs, Roche and Genentech global head of product development for oncology and hematology (Yale Cancer Center)

Yale can­cer spe­cial­ist Char­lie Fuchs tapped as new glob­al de­vel­op­ment chief for Roche/Genen­tech

Roche and their big sub Genentech have just recruited a top cancer specialist at Yale to head up global product development in oncology and hematology.

I just got word that the pharma giant, which leads one of the most active cancer research operations in the world, recruited Charlie Fuchs, director of the Yale Cancer Center and physician-in-chief of Smilow Cancer Hospital. He’ll join the global operation March 1 and will be based in South San Francisco, where Genentech is based.

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Jonathan Weissman (MIT)

Can a new CRISPR tech­nique un­lock the se­crets of how can­cer spreads?

Jonathan Weissman’s team watched the cancer cells spread across the doomed mouse. Engineered with a bioluminescent enzyme, they appeared in scans first as a small navy blue diamond lodged near the heart; a week later, as a triangle splayed across the mouse’s upper body, with streaks of green and two distinct bright red hubs of activity. By day 54, the mouse resembled a lava lamp.

The images would have been familiar to any cancer biologist, but they didn’t actually tell you much about what was going on: why the cancer was metastasizing or which cells were responsible. For that, Weissman’s team had designed a new tool. Inside the original navy blue diamond, they had engineered the microbiological equivalent of an airplane’s black box — a “molecular recorder” that, after the mouse’s death, could allow them to extract the cells and wind back intimate footage of a single cancer’s ascent.

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Glax­o­SmithK­line scraps a LAG3 study, mark­ing an­oth­er fail­ure for the pipeline af­ter a crit­i­cal set­back

Another gap has appeared in GlaxoSmithKline’s pipeline.

Friday morning the Australian biotech Immutep put out word that Hal Barron’s R&D group at GSK had decided to scrap a Phase II proof-of-concept study in ulcerative colitis for their anti-LAG3 therapy GSK2831781. According to the biotech, the program didn’t survive an interim review.

The trial was stopped by GSK based on the assessment of clinical data as part of a planned interim analysis conducted in consultation with the trial’s Data Review Committee. GSK is conducting further reporting, assessment and analyses of the efficacy and safety data and evaluating the biology to determine next steps for the GSK2831781 development program.

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Janet Woodcock and Joshua Sharfstein (AP, Images)

Poll: Should Joshua Sharf­stein or Janet Wood­cock lead the FDA from here?

It’s time for a new FDA commissioner to come on board, a rite of passage for Joe Biden’s administration that should help seal the new president’s rep on seeking out the experts to lead the government over the next 4 years.

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