BioReg­num: The mir­a­cle drug sto­ry that just won’t die

Bioreg­num
The view from End­points

Eight years ago resver­a­trol was the mir­a­cle drug of the hour. Linked to pre­clin­i­cal ev­i­dence that it could ex­pand the life spans of mice, Glax­o­SmithK­line paid a whop­ping $720 mil­lion in cold, hard cash to get its hands on Sir­tris, the biotech start­up that promised to de­liv­er an an­ti-ag­ing mir­a­cle by turn­ing an in­gre­di­ent in red wine in­to a med­ical re­al­i­ty.

Queue the jokes about drink­ing more red wine for bet­ter health. This is the stuff head­lines are made of, and I was hap­py to par­tic­i­pate.

GSK, which just demon­strat­ed its ap­petite for dis­cov­ery and ear­ly-stage de­vel­op­ment with its elec­tro­ceu­ti­cal part­ner­ship with Ver­i­ly, didn’t do very well with its new sub­sidiary. Progress was slow. Telling­ly, aca­d­e­mics be­gan to de­bate over whether the an­i­mal stud­ies GSK bought in­to could ever be repli­cat­ed. And the phar­ma gi­ant even­tu­al­ly de­cid­ed to dis­band the Sir­tris team in Cam­bridge, MA and ab­sorb the work in its Philly op­er­a­tions.

That’s the last I heard about it from GSK.

Resver­a­trol, though, is mak­ing a come­back as a mir­a­cle drug.

I read in the au­gust pages of the Wall Street Jour­nal Mon­day that sci­en­tists the world over “ap­pear to be get­ting clos­er to har­ness­ing one of red wine’s most elu­sive health-giv­ing in­gre­di­ents and putting it in­to a pill.”

Shaz­am.

To back that up, the Jour­nal cites a tiny hu­man study last fall that tracked a bio­mark­er for Alzheimer’s, an aw­ful dis­ease that is still poor­ly un­der­stood and re­mains as one of the sin­gle great­est chal­lenges in bio­phar­ma re­search to­day, along with new aca­d­e­m­ic re­search at Uni­ver­si­ty of New South Wales and a project at a small biotech com­pa­ny in Flori­da called Jupiter Or­phan Ther­a­peu­tics.

Out of such small serv­ings a great feast is made.

One of the chal­lenges at resver­a­trol, aside from ever prov­ing that it could do what some sci­en­tists be­lieved it could, was find­ing a safe con­cen­tra­tion of the drug. As an in­gre­di­ent in wine, you’d have to drink an ocean of it in or­der to get any kind of ther­a­peu­tic ef­fect.

Per­haps one day sci­en­tists will fig­ure out how to make resver­a­trol in­to a drug. It’s al­ways en­ter­tain­ing to track these dis­cov­ery projects. But it’s al­so im­por­tant to dis­tin­guish the kind of ex­tra­or­di­nary risks and epic time­lines that are in­volved — es­pe­cial­ly when a mir­a­cle drug re­turns to main­stream me­dia, dressed up once again as a pipeline con­tender to be reck­oned with. — John Car­roll.

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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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

Prescription Digital Therapeutics, cell therapy technologies, and in silico medicines will be a vital part of future treatment modalities.
Unlocking the potential of the microbiome could be the missing link to better disease diagnosis.
Growing links between academia, industry, and venture capital are spinning out more innovative biotech companies.
Biotech is now seen by investors as a growth space as well as a safe haven, fuelling the recent IPO boom.

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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Fast on Glax­o­SmithK­line's heels, Au­rinia wins OK to steer a sec­ond lu­pus nephri­tis drug straight to the mar­ket

GlaxoSmithKline’s Benlysta isn’t alone in the small circle of approved lupus nephritis drugs anymore.

Little Aurinia Pharmaceuticals has gotten the green light from the FDA to start marketing its first and only program, voclosporin, under the brand name Lupkynis — something CEO Peter Greenleaf says it’s been ready to do since December.

Regulators went right down to the wire on the decision, keeping the company and the entire salesforce it’s already assembled on its toes.

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.

As of now, the competition for the top job appears to have narrowed down to 2 people: The longtime CDER chief Janet Woodcock and Joshua Sharfstein, the former principal deputy at the FDA under Peggy Hamburg. Both were appointed by Barack Obama.

Kimberly Smith, ViiV R&D chief (ViiV Healthcare)

Af­ter sting­ing FDA set­back, Glax­o­SmithK­line's Vi­iV fi­nal­ly notch­es US ap­proval for long-act­ing HIV in­jec­tion

GlaxoSmithKline’s HIV unit ViiV was dealt a stinging loss back in late 2019 when the FDA slammed the brakes on its application for a once-monthly injection based on manufacturing issues. Now, with that roadblock in the rearview, ViiV has finally made good on its promise to change the HIV game.

The FDA on Thursday approved ViiV’s Cabenuva (cabotegravir and rilpivirine) as a long acting, once-monthly therapy for HIV-positive adults who are virologically suppressed and on a stable antiviral regimen.