Jim Mellon [via YouTube]

Health­i­er, longer lifes­pans will be a re­al­i­ty soon­er than you think, Ju­ve­nes­cence promis­es as it clos­es $100M round

Ear­li­er this year, an ex­ec­u­tive from Ju­ve­nes­cence-backed AgeX pre­dict­ed the field of longevi­ty will even­tu­al­ly “dwarf the dot­com boom.” Greg Bai­ley, the UK-based an­ti-ag­ing biotech’s CEO, cer­tain­ly hopes so.

Gre­go­ry Bai­ley

On Mon­day, Ju­ve­nes­cence com­plet­ed its $100 mil­lion Se­ries B round of fi­nanc­ing. The com­pa­ny is backed by British bil­lion­aire Jim Mel­lon — who wrote his 400-page guide to in­vest­ing in the field of longevi­ty short­ly af­ter launch­ing the com­pa­ny in 2017. Bai­ley, who served as a board di­rec­tor for sev­en years at Medi­va­tion be­fore Pfiz­er swal­lowed the biotech for $14 bil­lion, is joined by De­clan Doogan, an in­dus­try vet­er­an with stints at Pfiz­er $PFE and Amarin $AM­RN.

The busi­ness of an­ti-ag­ing is gain­ing steam — Bank of Amer­i­ca has fore­cast the mar­ket will bal­loon to $610 bil­lion by 2025, from an es­ti­mat­ed $110 bil­lion cur­rent­ly — but in­vestors are cau­tious, Bai­ley not­ed in an in­ter­view with End­points News.

“I think there’s a huge amount of skep­ti­cism. There’s an enor­mous num­ber of char­la­tans…I un­der­stand why they would be think­ing you know, is this re­al?” he said. “(W)alk in­to your lo­cal drug­store, you’re go­ing to see about 50 prod­ucts that claim to be an­ti-ag­ing, and I can as­sure you that none of them are. So I think that there’s a healthy dose of skep­ti­cism.”

In­sti­tu­tions tend to move in lock­step when they’re in­vest­ing, he added.

“VCs are as­ton­ish­ing, you know, if one of them buys the yel­low hal­ter top, all of them have to buy a yel­low hal­ter top,” he said, quot­ing tech VC Tim Drap­er.

Bai­ley sug­gest­ed that in­vestors are not quite as en­thu­si­as­tic about plac­ing bets on an­ti-ag­ing, as they are in the tech world. “We’re dra­mat­i­cal­ly be­ing un­der­served…it’s not get­ting the ex­po­sure that tech gets, con­sid­er­ing the size of the mar­ket,” he said. “There is a dis­con­nect on what in­vestors — so­phis­ti­cat­ed in­vestors —  in­sti­tu­tions, how they’re view­ing this, I don’t think they quite grasp how fast this is go­ing to hap­pen, and how big it’s go­ing to be.”

Ju­ve­nes­cence has now raised $165 mil­lion in the last 18 months — in Jan­u­ary it un­veiled the first $46 mil­lion tranche of the Se­ries B — and the mon­ey is be­ing used to fund longevi­ty projects with the lofty goal of ex­tend­ing hu­man lifes­pans to 150 years.

It is a pop­u­lar vi­sion. In­spired by Mel­lon, ven­ture cap­i­tal­ist Sergey Young — who is in charge of all things longevi­ty at the non-prof­it XPRIZE and VC fund BOLD Cap­i­tal Part­ners — un­veiled a $100 mil­lion fund with the same goal in Feb­ru­ary. Google-owned stealthy biotech Cal­i­co is af­ter the same prize — and has part­nered with Ab­b­Vie $AB­BV.

Ju­ve­nes­cence has been busy, col­lab­o­rat­ing with dif­fer­ent groups and set­ting up JVs, such as Alex Zha­voronkov’s AI shop at In­sil­i­co Med­i­cine — and has in­vest­ed in firms in­clud­ing AgeX $AGE and Ly­Ge­n­e­sis. In Feb­ru­ary, Ju­ve­nes­cence de­buted an an­ti-ag­ing joint ven­ture with the Buck In­sti­tute ded­i­cat­ed to in­duc­ing ke­to­sis. In re­cent months, it spawned a new biotech called Sou­vien Ther­a­peu­tics, which is de­vel­op­ing med­i­cines to ad­dress the epi­ge­net­ic un­der­pin­nings of neu­rode­gen­er­a­tive dis­eases, and in­ject­ed $6.5 mil­lion in eq­ui­ty fi­nanc­ing in­to a pre­clin­i­cal meta­bol­ic dis­ease biotech dubbed BY­OMass.

This quar­ter, Ju­ve­nes­cence plans to close three more projects, Bai­ley said. The com­pa­ny is work­ing on for­ti­fy­ing its ma­chine learn­ing ca­pa­bil­i­ty to make sense of huge swathes of da­ta that could help iso­late path­ways to de­vel­op dis­ease-mod­i­fy­ing ther­a­peu­tics, as well as adding prod­ucts to pad its port­fo­lio. The idea is to pur­sue prod­ucts that ad­dress in­flam­ma­tion and fi­bro­sis to slow ag­ing.

Mean­while, the com­pa­ny will main­tain a fo­cus on re­gen­er­a­tion. “I’m mind­ful that if you live to 150, you know, peo­ple don’t want to be all wrin­kled, and in a wheel­chair. So what we want to be able to do is re­gen­er­ate tis­sues,” Bai­ley said.

The plan for an IPO re­mains in place. Yet Bai­ley ac­knowl­edged the com­pa­ny is wary of leap­ing on­to a mar­ket pre­ma­ture­ly, draw­ing a com­par­i­son with plant-based meat sub­sti­tute mak­er Be­yond Meat.

“Clear­ly, we need to have a re­cep­tive mar­ket and…we’ve seen that with Be­yond Meat…so I think that in­vestors are go­ing to come to terms for this in the near fu­ture,” he said. “We’re talk­ing to banks…I think that we’re well-poised, go­ing in­to the next year to do that.”

In the com­ing five to sev­en years, Ju­ve­nes­cence has bold plans. It ex­pects to have at least four an­ti-ag­ing prod­ucts on the mar­ket, Bai­ley said. “I’m hope­ful that we have gone through proof-of-con­cept with three phar­ma­ceu­ti­cal agents and are li­cens­ing with big phar­ma, be­cause we’re not hir­ing 10,000 sales reps. So we’ll let them do that.”

Sci­ence fic­tion is now sci­ence, he un­der­scored. “I think the world is go­ing to be shocked.”

In a stun­ning set­back, Amarin los­es big patent fight over Vas­cepa IP. And its high-fly­ing stock crash­es to earth

Amarin’s shares $AMRN were blitzed Monday evening, losing billions in value as reports spread that the company had lost its high-profile effort to keep its Vascepa patents protected from generic drugmakers.

Amarin had been fighting to keep key patents under lock and key — and away from generic rivals — for another 10 years, but District Court Judge Miranda Du in Las Vegas ruled against the biotech. She ruled that:
(A)ll the Asserted Claims are invalid as obvious under 35 U.S.C.§ 103. Thus, the Court finds in favor of Defendants on Plaintiff’s remaining infringementclaim, and in their favor on their counterclaims asserting the invalidity of the AssertedClaims under 35 U.S.C. § 103.

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UP­DAT­ED: Have a new drug that promis­es to fight Covid-19? The FDA promis­es fast ac­tion but some de­vel­op­ers aren't hap­py

After providing an emergency approval to use malaria drugs against coronavirus with little actual evidence of their efficacy or safety in that setting, the FDA has already proven that it has set aside the gold standard when it comes to the pandemic. And now regulators have spelled out a new approach to speeding development that promises immediate responses in no uncertain terms — promising a program offering the ultimate high-speed pathway to Covid-19 drug approvals.

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Once fu­ri­ous over No­var­tis’ da­ta ma­nip­u­la­tion scan­dal, the FDA now says it’s noth­ing they need to take ac­tion on

Back in the BP era — Before Pandemic — the FDA ripped Novartis for its decision to keep the agency in the dark about manipulated data used in its application for Zolgensma while its marketing application for the gene therapy was under review.

Civil and criminal sanctions were being discussed, the agency noted in a rare broadside at one of the world’s largest pharma companies. Notable lawmakers cheered the angry regulators on, urging the FDA to make an example of Novartis, which fielded Zolgensma at $2.1 million — the current record for a one-off therapy.

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Covid-19 roundup: GSK, Am­gen tai­lor R&D work to fit the coro­n­avirus age; Doud­na's ge­nomics crew launch­es di­ag­nos­tic lab

You can add Amgen and GSK to the list of deep-pocket drug R&D players who are tailoring their pipeline work to fit a new age of coronavirus.

Following in the footsteps of a lineup of big players like Eli Lilly — which has suspended patient recruitment for drug studies — Amgen and GSK have opted to take a more tailored approach. Amgen is intent on circling the wagons around key studies that are already fully enrolled, and GSK has the red light on new studies while the pandemic plays out.

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The race to de­vel­op Covid-19 drugs and vac­cines is on — here’s what’s hap­pen­ing in the UK

Weeks away from the results of ongoing US and China trials testing its experimental antiviral remdesivir, Gilead is going to trial the failed Ebola drug in a small group of coronavirus patients in England and Scotland. The United Kingdom is also home to a range of other therapeutic efforts, as the pandemic rages on across the globe.

On Tuesday, Southampton, UK-based startup Synairgen kicked off a mid-stage placebo-controlled study testing its experimental drug, SNG001 — an inhaled formulation of interferon-beta-1a — that has previously shown to be safe and effective in improving lung function in asthma patients with a respiratory viral infection in a pair of Phase II trials.

‘There was a grow­ing weari­ness’: Rush­ing against a pan­dem­ic clock, As­pen Neu­ro­sciences se­cures $70M Se­ries A

Just before Christmastime, Howard Federoff got a tip from Washington: There was a new virus in China. And this one could be bad.

News report of the virus had not yet appeared. Federoff, a neuroscientist, was briefed because years before, he was vetted as part of a group — he didn’t give a name for the group — to consult for the US government on emerging scientific issues. His day job, though, was CEO of Aspen Neurosciences, a Parkinson’s cell therapy startup that days before had come out of stealth mode and gave word to investors they were hoping to raise $70 million. That, Federoff realized, would be difficult if a pandemic shut down the global economy.

FDA puts pe­di­atric aGVHD drug on pri­or­i­ty re­view lane — will they go vir­tu­al with the ad­comm?

Despite worries about regulatory delays due to new work arrangements under Covid-19, the FDA appears intent to go full speed ahead with its everyday work, not only granting priority review to a stem cell therapy for acute graft versus host disease but also plotting an advisory committee meeting for it.

With a PDUFA date of September 30, the journey of the drug — remestemcel-L, or Ryoncil — could shed light on the agency’s capacity to facilitate drug development unrelated to Covid-19.

Covid-19 roundup: Trump push­es his new fa­vorite, untest­ed drug; CRISPR out­lines crip­pling im­pact of Covid-19

President Trump has a new favorite Covid-19 drug.

After a conversation with Japanese Prime Minister Shinzo Abe, Politico reports, the president is pressuring the FDA to issue emergency use authorization for favipiravir, a flu drug that showed glimpses of success in China but remains unproven and carries a list of worrying side effects. The push comes after a week-plus in which the White House touted a potentially effective but unproven malaria medication despite the concerns of scientific advisors such as NIAID director Anthony Fauci. And Trump ally Rudy Giuliani has been talking up unproven cell therapy efforts on Twitter.

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ITeos nabs $125M as they prep Keytru­da com­bi­na­tion tri­al — if Covid-19 will let them

For iTeos, it turned out, $75 million could only last so long.

Two years after announcing their eye-catching Series B raise, the Belgian biotech is back with an even larger Series B-2: $125 million.

The now $175 million financing – $25 million of the first B round is considered part of the second – illustrates the vast capital available for those with promising new immuno-oncology compounds, particularly those that might be used in combination with existing therapies. In December, iTeos announced a collaboration with Merck to test its lead compound with Keytruda this year. The proceeds will push forward that trial and help fund the ongoing Phase I/II trials for that compound, EOS-850, and a second one, EOS-448.

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