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.”

Secretary of health and human services Alex Azar speaking in the Rose Garden at the White House (Photo: AFP)

Trump’s HHS claims ab­solute au­thor­i­ty over the FDA, clear­ing path to a vac­cine EUA

The top career staff at the FDA has vowed not to let politics overrule science when looking at vaccine data this fall. But Alex Azar, who happens to be their boss’s boss, apparently won’t even give them a chance to stand in the way.

In a new memorandum issued Tuesday last week, the HHS chief stripped the FDA and other health agencies under his purview of their rule making ability, asserting all such power “is reserved to the Secretary.” Sheila Kaplan of the New York Times first obtained and reported the details of the September 15 bulletin.

President Donald Trump (via AP Images)

Signs of an 'Oc­to­ber Vac­cine Sur­prise' alarm ca­reer sci­en­tists. HHS con­tin­ues to claim Azar “will de­fer com­plete­ly to the FDA"

President Donald Trump, who seems intent on announcing a Covid-19 vaccine before Election Day, could legally authorize a vaccine over the objections of experts, officials at the FDA and even vaccine manufacturers, who have pledged not to release any vaccine unless it’s proved safe and effective.

In podcasts, public forums, social media and medical journals, a growing number of prominent health leaders say they fear that Trump — who has repeatedly signaled his desire for the swift approval of a vaccine and his displeasure with perceived delays at the FDA — will take matters into his own hands, running roughshod over the usual regulatory process.

#ES­MO20: Push­ing in­to front­line, Mer­ck and Bris­tol My­ers duke it out with new slate of GI can­cer da­ta

Having worked in parallel for years to move their respective PD-1 inhibitors up to the first-line treatment of gastrointestinal cancers, Merck and Bristol Myers Squibb finally have the data at ESMO for a showdown.

Comparing KEYNOTE-590 and CheckMate-649, of course, comes with the usual caveats. But a side-by-side look at the overall survival numbers also offer some perspective on a new frontier for the reigning checkpoint rivals, both of whom are claiming to have achieved a first.

Is­raeli biotech rais­es $57M to go where cur­rent BRAF in­hibitors can't, with back­ing from No­var­tis, SR One

For the blockbuster potential of Novartis’ Tafinlar and Pfizer’s Braftovi, all the BRAF inhibitors on the market so far only target V600 mutations — which accounts for roughly 50% of patients.

Israeli biotech Novellus now has $57 million to develop a drug that they say can help the other 50% who have everything else.

The Series C will fund a Phase II trial for PLX-8394, a “paradox breaker” that could block RAF without activating MAPK signaling. In a Phase I trial, a patient with a BRAF fusion saw their tumor go away after taking the drug, allowing Novellus to hit the ground running.

Jonathan Rigby, Immune Regulation group CEO

Im­mune Reg­u­la­tion, tak­ing two clin­i­cal pro­grams to 're­set' the im­mune sys­tem, nets $53M+ Se­ries B

A little under two years after a company rebranding, Immune Regulation is taking an even bigger step toward advancing its goals.

Formerly known as Peptinnovate, the British biotech announced a $53.4 million Series B early Monday morning, helping to further advance two clinical programs in rheumatoid arthritis and asthma. Though those are the two initial indications the company is focusing on, CEO Jonathan Rigby told Endpoints News he hopes the candidates can be applied to a broad swath of autoimmune disorders.

UP­DAT­ED: Two wild weeks for Grail end in $8B Il­lu­mi­na buy­out

Grail’s whirlwind two weeks have ended in the wealthy arms of its former founder and benefactors.

Illumina has shelled out $8 billion to reacquire the closely-watched liquid biopsy startup they spun out just 5 years ago and sold off much of its shares just 3 years ago. The deal comes nearly two weeks after the well-heeled startup filed for a potentially massive IPO — one that was disrupted just a week later when Bloomberg reported that Illumina was in talks to buy their former spinout for up to $8 billion.

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Roche vaults to the front of the NL­RP3 clin­i­cal race, pay­ing $448M up­front to bag In­fla­zome

Roche is going all in on NLRP3.

The pharma giant is putting down $448 million (€380 million) upfront to snatch Novartis-backed Inflazome, which makes it a clinical player in the space overnight.

Dublin and Cambridge, UK-based Inflazome is the second NLRP3-focused biotech Roche has acquired in less than two years, and although no numbers were disclosed in the Jecure buyout, this is almost certainly a much larger deal.

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Eli Lilly CSO Dan Skovronsky (file photo)

UP­DAT­ED: #ES­MO20: Eli Lil­ly shows off the da­ta for its Verzenio suc­cess. Was it worth $18 bil­lion?

The press release alone, devoid of any number except for the size of the trial, added nearly $20 billion to Eli Lilly’s market cap back in June. Now investors and oncologists will get to see if the data live up to the hype.

On Sunday at ESMO, Eli Lilly announced the full results for its Phase III MonarchE trial of Verzenio, showing that across over 5,000 women who had had HR+, HER2- breast cancer, the drug reduced the odds of recurrence by 25%. That meant 7.8% of the patients on the drug arm saw their cancers return within 2 years, compared with 11.3% on the placebo arm.

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Greg Friberg (File photo)

#ES­MO20: Am­gen team nails down sol­id ear­ly ev­i­dence of AMG 510’s po­ten­tial for NSCLC, un­lock­ing the door to a wave of KRAS pro­grams

The first time I sat down with Amgen’s Greg Friberg to talk about the pharma giant’s KRAS G12C program for sotorasib (AMG 510) at ASCO a little more than a year ago, there was high excitement about the first glimpse of efficacy from their Phase I study, with 5 of 10 evaluable non-small cell lung cancer patients demonstrating a response to the drug.

After decades of failure targeting KRAS, sotorasib offered the first positive look at a new approach that promised to open a door to a whole new approach by targeting a particular mutation to a big target that had remained “undruggable” for decades.

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