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.

Biotech Half­time Re­port: Af­ter a bumpy year, is biotech ready to re­bound?

The biotech sector has come down firmly from the highs of February as negative sentiment takes hold. The sector had a major boost of optimism from the success of the COVID-19 vaccines, making investors keenly aware of the potential of biopharma R&D engines. But from early this year, clinical trial, regulatory and access setbacks have reminded investors of the sector’s inherent risks.

RBC Capital Markets recently surveyed investors to take the temperature of the market, a mix of specialists/generalists and long-only/ long-short investment strategies. Heading into the second half of the year, investors mostly see the sector as undervalued (49%), a large change from the first half of the year when only 20% rated it as undervalued. Around 41% of investors now believe that biotech will underperform the S&P500 in the second half of 2021. Despite that view, 54% plan to maintain their position in the market and 41% still plan to increase their holdings.

UP­DAT­ED: Boehringer nabs FDA's first in­ter­change­abil­i­ty des­ig­na­tion for its Hu­mi­ra com­peti­tor — but will it mat­ter?

The FDA late Friday awarded Boehringer Ingelheim the first interchangeability designation for its Humira biosimilar Cyltezo, meaning that when it launches in July 2023, pharmacists will be able to automatically substitute the Boehringer’s version for AbbVie’s mega-blockbuster without a doctor’s input.

The designation will likely give Boehringer, which first won approval for Cyltezo in 2017, the leg up on a crowded field of Humira competitors.

Bio­gen hit by ALS set­back with PhI­II fail­ure for tofersen — but fol­lows a fa­mil­iar strat­e­gy high­light­ing the pos­i­tive

Patients and analysts waiting to hear Sunday how Biogen’s SOD1-ALS drug tofersen fared in Phase III didn’t have to wait long for the top-line result they were all waiting for. The drug failed the primary endpoint on significantly improving the functional and neurologic decline of patients over 28 weeks as well as the extension period for continued observation.

In fact, there was very little difference in response.

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Scott Struthers, Crinetics CEO

Cri­net­ics spins out ra­dio­phar­ma ef­forts in­to a new com­pa­ny, high­light­ing the grow­ing field­'s al­lure

Largely known for its nonpeptide small molecule research, Crinetics has been keeping its radiopharma work comparatively under wraps. But that changed Monday afternoon as the California biotech spun out a new company focused solely on the burgeoning field.

Crinetics launched Radionetics after the closing bell Monday, the company announced, seeding the new entity with $30 million raised from 5AM Ventures and Frazier Healthcare Partners. Radionetics will start with its own radiopharma-centric platform and a pipeline of 10 programs aimed at solid tumors.

Amit Etkin, Alto Neuroscience CEO (Alto via Vimeo)

A star Stan­ford pro­fes­sor leaves his lab for a start­up out to re­make psy­chi­a­try

About five years ago, Amit Etkin had a breakthrough.

The Stanford neurologist, a soft-spoken demi-prodigy who became a professor while still a resident, had been obsessed for a decade with how to better define psychiatric disorders. Drugs for depression or bipolar disorder didn’t work for many patients with the conditions, and he suspected the reason was how traditional diagnoses didn’t actually get at the heart of what was going on in a patient’s brain.

Two drug­mak­ers hit with PDU­FA date de­lays from FDA amid back­log of in­spec­tions

As the FDA is weighed down with more and more pandemic responsibilities, the agency is beginning to miss PDUFA dates with more frequency too. Two different companies on Monday said they received notices that the FDA has not completed their drug reviews on time.

The review of an NDA for Avadel Pharmaceuticals’ candidate treatment for narcolepsy is not coming this month, the company said, and the review of UCB’s BLA for bimekizumab, used to treat moderate to severe plaque psoriasis, will miss its target date as well.

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Reshma Kewalramani, Vertex CEO (YouTube)

Ver­tex gets much-need­ed win with ‘ex­tra­or­di­nary’ first pa­tient re­sults on po­ten­tial di­a­betes cure

Vertex said Monday that the first patient dosed with its cell therapy for type 1 diabetes saw their need for insulin injections vanish almost entirely, a key early step in the decades-long effort to develop a curative treatment for the chronic disease.

The patient, who had suffered five potentially life-threatening hypoglycemic — or low blood sugar — episodes in the year before the therapy, was injected with synthetic insulin-producing cells. After 90 days, the patient’s new cells produced insulin steadily and ramped up their insulin production after a meal like normal cells do, as measured by a standard biomarker for insulin production.

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Covid-19 vac­cine boost­ers earn big thumbs up, but Mod­er­na draws ire over world sup­ply; What's next for Mer­ck’s Covid pill?; The C-suite view on biotech; and more

Welcome back to Endpoints Weekly, your review of the week’s top biopharma headlines. Want this in your inbox every Saturday morning? Current Endpoints readers can visit their reader profile to add Endpoints Weekly. New to Endpoints? Sign up here.

You may remember that at the beginning of this year, Endpoints News set a goal to go broader and deeper. We are still working towards that, and are excited to share that Beth Snyder Bulik will be joining us on Monday to cover all things pharma marketing. You can sign up for her weekly Endpoints MarketingRx newsletter in your reader profile.

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No­var­tis de­vel­op­ment chief John Tsai: 'We go deep in the new plat­form­s'

During our recent European Biopharma Summit, I talked with Novartis development chief John Tsai about his experiences over the 3-plus years he’s been at the pharma giant. You can read the transcript below or listen to the exchange in the link above.

John Carroll: I followed your career for quite some time. You’ve had more than 20 years in big pharma R&D and you’ve obviously seen quite a lot. I really was curious about what it was like for you three and a half years ago when you took over as R&D chief at Novartis. Obviously a big move, a lot of changes. You went to work for the former R&D chief of Novartis, Vas Narasimhan, who had his own track record there. So what was the biggest adjustment when you went into this position?

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