British bil­lion­aire Jim Mel­lon and high-pro­file part­ners roll the dice on an an­ti-ag­ing up­start

When British bil­lion­aire Jim Mel­lon wants to map out an in­vest­ment strat­e­gy, he likes to write a book first. Out of that process came his most re­cent work — Ju­ve­nes­cence: In­vest­ing in the Age of Longevi­ty. Now he and some close as­so­ciates with some of the best con­nec­tions in biotech are us­ing the book as in­spi­ra­tion to launch a new com­pa­ny — al­so named Ju­ve­nes­cence — with plans to make a big splash in an­ti-ag­ing re­search.

Jim Mel­lon

And they’re plant­i­ng the first seeds now with a new joint ven­ture that will start to lay the foun­da­tion for the pipeline with ar­ti­fi­cial in­tel­li­gence tech­nol­o­gy.

“We are at an in­flec­tion point for the treat­ment of ag­ing,” says Greg Bai­ley, who likes to high­light some of the new cel­lu­lar path­ways that are point­ing to new ther­a­pies that can counter the ef­fects of ag­ing.

“I think this is go­ing to be the biggest deal I’ve ever done,” Bai­ley tells me in a phone in­ter­view, as his plane was prepar­ing for a take­off.  “It will need repet­i­tive fi­nanc­ing.  Five to $600 mil­lion was raised for Medi­va­tion. As we hit in­flec­tion points, we will need to raise a dra­mat­ic amount of mon­ey.”

Gre­go­ry Bai­ley

Bai­ley, the CEO of Ju­ve­nes­cence, was one of the ear­ly back­ers of Medi­va­tion, where he was a board di­rec­tor for 7 years — be­fore Pfiz­er stepped in to buy the biotech for $14 bil­lion. More re­cent­ly, he helped po­si­tion Bio­haven for an IPO, as­sem­bling a pipeline that in­cludes a late-stage drug in-li­censed from Bris­tol-My­ers Squibb be­fore rais­ing $190 mil­lion a few months ago in their maid­en of­fer­ing. The chair­man at Bio­haven is his long­time col­league De­clan Doogan, a for­mer top Pfiz­er re­search ex­ec who is com­ing in as a prin­ci­pal to the new ven­ture along­side Mel­lon and Bai­ley.

The pri­ma­ry game plan at Ju­ve­nes­cence, ex­plains Bai­ley, is to come up with var­i­ous op­er­a­tions en­gaged in de­vel­op­ing new an­ti-ag­ing drugs. Ju­ve­nes­cence AI is a joint ven­ture they’ve just set up with Alex Zha­voronkov, who runs In­sil­i­co Med­i­cine, based in Bal­ti­more. Mel­lon met Zha­voronkov while he was re­search­ing his book, says Bai­ley, and be­lieves that the tech the sci­en­tist de­vel­oped can il­lu­mi­nate new pro­grams with a bet­ter chance of suc­cess.

“They are go­ing to take up to 5 mol­e­cules from us every year for de­vel­op­ment,” says Zha­voronkov, an en­thu­si­as­tic ad­vo­cate of AI in drug re­search who’s al­so been work­ing on some al­liances with Big Phar­ma play­ers. The group has in­vest­ed about $7 mil­lion in the tech­nol­o­gy so far, he says, get­ting the JV set up. More will fol­low.

Alex Zha­voronkov

“We can gen­er­ate mol­e­cules with spe­cif­ic mol­e­c­u­lar prop­er­ties,” adds Zha­voronkov, who al­so has a spe­cial fo­cus on an­ti-ag­ing re­search.

“The mas­sive lib­er­a­tion of new da­ta needs to trans­form in­to knowl­edge,” says Doogan. “AI is the buzz word; can we take in­cre­men­tal steps, in an it­er­a­tive learn­ing process, cap­ture all knowl­edge?”

Ju­ve­nes­cence Bio will be charged with build­ing the pipeline, says Bai­ley, in part with the mol­e­cules that will be iden­ti­fied through the AI ven­ture. And Doogan will play a lead role in or­ga­niz­ing the team now, much as he was cred­it­ed with at Bio­haven.

Aside from the cel­lu­lar path­ways that have at­tract­ed their at­ten­tion, the biotech will look to ef­fect change in the mi­to­chon­dria, the cell’s pow­er­house, as well as clean up senes­cent cells that ac­cu­mu­late as the body grows old­er. And Bai­ley ex­pects he’ll be work­ing some Bio­haven-like deals to de­vel­op an ad­vanced pipeline at a rapid pace.

The prin­ci­pals chipped in the seed mil­lions for the com­pa­ny and in­vest­ed in the JV with Zha­voronkov. Bai­ley says you can ex­pect to see $20 mil­lion to $50 mil­lion more from a friends-and-fam­i­ly raise be­fore the end of the year. And it’s ex­pect­ed to grow from there.

De­clan Doogan

Doogan plans to re­cruit var­i­ous team lead­ers, in­di­vid­u­als who will be in charge of spe­cif­ic projects with 10 or few­er peo­ple on the crew. Like any biotech, he notes, they plan to re­ly on a se­mi-vir­tu­al struc­ture, with a ma­jor amount of out­sourc­ing in place of staff.

The biotech won’t just be a biotech, says Doogan. It will cov­er “mul­ti­ple do­mains: di­ag­nos­tics, con­sumer, con­ven­tion­al drug de­vel­op­ment — broad ideas to en­gage the con­sumer.”

The key, he says, is fo­cus­ing on not just a longer life, but a bet­ter one.

“Not just longer, but bet­ter longer,” is the way Doogan puts it. “Healthy ag­ing is the ob­jec­tive here.”

That leaves a lot of room.

“There are 52 ways to drop blood pres­sure, but we’ve done noth­ing for os­teoarthri­tis,” says Doogan by way of ex­am­ple.

“We have to be re­al­ly clever,” says Bai­ley. Drugs like No­var­tis’ mTOR in­hibitor everolimus, which con­trols cell growth and pro­lif­er­a­tion, can be a mod­el. Os­teoarthri­tis, a dis­ease as­so­ci­at­ed with ag­ing, can be the kind of dis­ease fo­cus that can dri­ve ear­ly work.

It’s ear­ly days yet for an­ti-ag­ing drug re­search. A few stal­warts like Bob Nelsen at Arch have backed the first few star­tups in the field. But Mel­lon and his col­leagues say now’s the time.

The longevi­ty in­dus­try, Mel­lon said re­cent­ly, is des­tined to grow “in­to the world’s largest in­dus­try.”

And he wants in.

Paul Hudson, Getty Images

UP­DAT­ED: Sanofi CEO Hud­son lays out new R&D fo­cus — chop­ping di­a­betes, car­dio and slash­ing $2B-plus costs in sur­gi­cal dis­sec­tion

Earlier on Monday, new Sanofi CEO Paul Hudson baited the hook on his upcoming strategy presentation Tuesday with a tell-tale deal to buy Synthorx for $2.5 billion. That fits squarely with hints that he’s pointing the company to a bigger future in oncology, which also squares with a major industry tilt.

In a big reveal later in the day, though, Hudson offered a slate of stunners on his plans to surgically dissect and reassemble the portfoloio, saying that the company is dropping cardio and diabetes research — which covers two of its biggest franchise arenas. Sanofi missed the boat on developing new diabetes drugs, and now it’s pulling out entirely. As part of the pullback, it’s dropping efpeglenatide, their once-weekly GLP-1 injection for diabetes.

“To be out of cardiovascular and diabetes is not easy for a company like ours with an incredibly proud history,” Hudson said on a call with reporters, according to the Wall Street Journal. “As tough a choice as that is, we’re making that choice.”

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De­vel­op­ment of the Next Gen­er­a­tion NKG2D CAR T-cell Man­u­fac­tur­ing Process

Celyad’s view on developing and delivering a CAR T-cell therapy with multi-tumor specificity combined with cell manufacturing success
Overview
Transitioning potential therapeutic assets from academia into the commercial environment is an exercise that is largely underappreciated by stakeholders, except for drug developers themselves. The promise of preclinical or early clinical results drives enthusiasm, but the pragmatic delivery of a therapy outside of small, local testing is most often a major challenge for drug developers especially, including among other things, the manufacturing challenges that surround the production of just-in-time and personalized autologous cell therapy products.

Large advertisements for the drug Vivitrol decorate the walls of Grand Central Station on June 15, 2017 in New York City. (Photo: Andrew Lichtenstein via Getty)

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The ads piqued interest as soon as they started appearing in 2016: at Grand Central Station, on the Red Line in Cambridge, and on a billboard off the New Jersey Turnpike. All showed a young person, generally with his or her arms crossed, and the question, “what is Vivitrol?”

Vivitrol’s maker, Alkermes, was in the midst of a marketing and lobbying campaign to promote the anti-opioid addiction drug — a campaign that would face significant backlash for tarnishing competitors despite little evidence for Vivitrol’s superiority.

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The pharma giant this morning played their ace in the hole, showing off why they were willing to commit to a $6.9 billion deal — with $1.35 billion in a cash upfront — to partner on the drug.

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FDA in-house re­view spot­lights an is­sue with one of Hori­zon's end­points but notes ef­fi­ca­cy for lead drug

The FDA in-house review highlights a disagreement of investigators’ use of a key endpoint by Horizon Pharma in the late-stage trial for the top drug in its pipeline, but largely agreed that the antibody was effective.

Horizon submitted a BLA for thyroid eye disease (TED) drug teprotumumab in March, less than two years after they bought the drug (and the rest of a division) from Narrow River for $145 million upfront. With breakthrough status, priority review, orphan designation and in-house sales projections of up to $750 million, the one-time Roche reject became the marquee pipeline asset for a company that’s developed some of the world’s most expensive drugs.

Seat­tle Ge­net­ics de­tails pos­i­tive OS and PFS da­ta for tu­ca­tinib in breast can­cer

Seattle Genetics $SGEN is showing off more positive data around tucatinib, its pivotal-stage drug for HER2 positive breast cancer.

A month after hearing about solidly upbeat hazard ratios, we learned today that the estimated progression-free survival rate at one year was 33% in the tucatinib arm compared to 12% for patients taking trastuzumab and capecitabine alone.

Median PFS was 7.8 months (95% CI: 7.5, 9.6) in the tucatinib arm, compared to 5.6 months (95% CI: 4.2, 7.1) in the control arm.

Bat­tered, cash hun­gry In­tec feels the burn of No­var­tis re­jec­tion

It’s a case of some bad timing for Intec.

Just when a key trial testing the company’s Accordion drug delivery tech imploded in Parkinson’s disease, they handed Novartis data from a successful PK study of a custom Accordion pill engineered to deliver a Novartis compound to entice the Swiss drugmaker into signing a licensing agreement.

Novartis said thanks, but no thanks.

For the cash-strapped Israeli drug developer, the failure to clinch the deal marks a big blow. As of the third quarter, the company has $15.7 million in cash and equivalents, which HC Wainwright analysts estimate will keep the lights on into mid-2020.

Bris­tol-My­ers shows off a low-pro­file AML con­tender it gained from Cel­gene buy­out — and they’re tak­ing it straight to the FDA

Bristol-Myers Squibb reaped an enormous pipeline with its much-criticized $64 billion megadeal to buy Celgene. And it got a few hidden gems in the deal.

One of those gems was brought out for display on Tuesday, with a late-breaker at ASH on CC-486, which is now being prepped for regulatory filings at the FDA and elsewhere.

Celgene top-lined the positive results in a maintenance setting for acute myeloid leukemia a few months ago, but at ASH investigators pulled back the curtains on the all-important data they believe will give them an advantage in the commercial wars to come.

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De­sert­ed by Astel­las and Mer­ck, lit­tle Cor­re­vio still can't win over FDA pan­el con­cerned with its AFib drug's safe­ty

When the FDA spurned Astellas’ pitch for atrial fibrillation drug vernakalant in 2008, regulators made it abundantly clear that it wasn’t the efficacy they had a problem with — two Phase III trials had shown the drug successfully restored 52% of patients’ heartbeat from irregular to normal — but the cardio safety issues for a drug that was to compete with well established, low-risk options. One licensing deal, one clinical hold and several studies later, the chances of approval aren’t looking any better.