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.

Con­quer­ing a silent killer: HDV and Eiger Bio­Phar­ma­ceu­ti­cals

Hepatitis delta, also known as hepatitis D, is a liver infection caused by the hepatitis delta virus (HDV) that results in the most severe form of human viral hepatitis for which there is no approved therapy.

HDV is a single-stranded, circular RNA virus that requires the envelope protein (HBsAg) of the hepatitis B virus (HBV) for its own assembly. As a result, hepatitis delta virus (HDV) infection occurs only as a co-infection in individuals infected with HBV. However, HDV/HBV co-infections lead to more serious liver disease than HBV infection alone. HDV is associated with faster progression to liver fibrosis (progressing to cirrhosis in about 80% of individuals in 5-10 years), increased risk of liver cancer, and early decompensated cirrhosis and liver failure.
HDV is the most severe form of viral hepatitis with no approved treatment.
Approved nucleos(t)ide treatments for HBV only suppress HBV DNA, do not appreciably impact HBsAg and have no impact on HDV. Investigational agents in development for HBV target multiple new mechanisms. Aspirations are high, but a functional cure for HBV has not been achieved nor is one anticipated in the forseeable future. Without clearance of HBsAg, anti-HBV investigational treatments are not expected to impact the deadly course of HDV infection anytime soon.

Am­gen chops 172 more staffers in R&D, op­er­a­tions and sales amid neu­ro­science ex­it, rev­enue down­turn

Neuroscience wasn’t the only unit that’s being hit by a reorganization underway at Amgen. As well as axing 149 employees in its Cambridge office, the company has disclosed that 172 others nationwide, including some from its Thousand Oaks, CA headquarters, are being let go.

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Ahead of strate­gic up­date, new Sanofi CEO mulls op­tions for con­sumer health­care arm — re­ports

Big pharma has made moves to sharpen its focus on developing new medicines, while slow-growing consumer health divisions fall by the wayside. Looks like another large drugmaker is considering a similar move. On Thursday, reports citing sources indicated that Sanofi is reportedly mulling a joint venture, sale, or a public listing of its consumer health arm.

The French group is in discussions for options that could value the division at $30 billion, Bloomberg and Reuters reported, citing sources familiar with the matter.

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The triple crown in biotech: An all-or-noth­ing bet on an FDA ap­proval of 3 drugs over 16 months starts to­day

Bristol-Myers Squibb’s $74 billion Celgene deal closed as expected Wednesday evening. And now a new clock has begun to tick down for Celgene shareholders who came away from the deal with CVRs — contingent value rights — worth $9 or nothing. Those CVRs start trading today as $BMYRT.

The new deadline they have is the end of March 2021, a little more than 16 months from now, when Bristol-Myers will need to gain approvals on 3 late-stage drugs it’s picking up in the buyout: Ozanimod and liso-cel (JCAR017) are due up at the end of 2020, with bb2121 deadlined at the end of Q1 in 2021.

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Genap­sys fi­nal­ly un­veils vaunt­ed se­quencer, but can it dent Il­lu­mi­na?

Hesaam Esfandyarpour holds what looks like a mini-cooler up to the computer screen in his California office.

Esfandyarpour is in his late-30s, with crows feet creeping up against a youthful face. He wears a gray polo and the device in his hand — with its hard plastic-looking shell, blue-and-white pattern, and a white plastic paddle resembling a handle jutting out the front — might contain diced strawberries and peanut-butter sandwiches to meet mom and the kids at a SoCal park. Instead, Esfandyarpour tells me it’s going to change medicine and biopharma research.

Brii Bio backs in­fec­tious dis­ease start­up while ink­ing deal for its lead TB drug, dou­bling down on an­tibi­otics

Almost two years after leaving GSK to launch Brii Bio with a whopping $260 million in funding, Zhi Hong is seeing the trans-Pacific infectious disease specialist he set out to build take shape.

“Our pipeline is coming together,” he told Endpoints News, with 12 partnered assets plus some internal programs.

As its latest partner, AN2 Therapeutics, comes into the limelight for the first time with a $12 million seed round, so is Brii’s plans in the antibiotics space. Brii has obtained China rights to AN2’s antibacterial targeting mycobacterium tuberculosis for multi-drug resistant TB, which it says is in the clinical stage.

UP­DAT­ED: Make that 2 ap­proved RNAi drugs at Al­ny­lam af­ter the FDA of­fers a speedy OK on ul­tra-rare dis­ease drug

Seventeen years into the game, Alnylam’s pivot into commercial operations is picking up speed.
The bellwether biotech $ALNY has nabbed their second FDA OK for an RNAi drug, this time for givosiran, the only therapy now approved for acute hepatic porphyria. This second approval came months ahead of the February deadline — even after winning priority review following their ‘breakthrough’ title earlier.
AHP is an extremely rare disease, with some 3,000 patients in Europe and the US, not all diagnosed, and analysts have projected peak revenue of $600 million to $700 million a year. The drug will be sold as Givlaari.

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David Ricks. Eli Lilly

Eli Lil­ly touts $400M man­u­fac­tur­ing ex­pan­sion, 100 new jobs to much fan­fare in In­di­anapo­lis — even though it's been chop­ping staff

Eli Lilly is pouring in $400 million to beef up manufacturing facilities at its home base of Indianapolis. The investment, which was lauded by the city’s mayor, is expected to create 100 new jobs.

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No­var­tis, Bay­er, Long­wood back ge­nomics start­up to speed search for im­munother­a­py tar­gets

Nearly a century passed between the first proto-immunotherapy attempts in cancer — crude and obscure but nonetheless with some scientific basis — and Jim Allison’s first T cell paper. Thirty-plus years flipped between the discovery of CTLA-4 as an off-switch and the approval of Yervoy. Twenty-two rolled between PD-1’s isolation and Opdiva and Keytruda. 

Longwood co-founder Lea Hachigian is betting she can hasten that. It’s a bet on newly established single-cell genomic analysis tech and the ability to crunch endless troves of data at a rate few others can, and investors including Leaps by Bayer and Novartis Venture Fund just put $39 million behind it. They call it Immunitas.