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.”

ZS Per­spec­tive: 3 Pre­dic­tions on the Fu­ture of Cell & Gene Ther­a­pies

The field of cell and gene therapies (C&GTs) has seen a renaissance, with first generation commercial therapies such as Kymriah, Yescarta, and Luxturna laying the groundwork for an incoming wave of potentially transformative C&GTs that aim to address diverse disease areas. With this renaissance comes several potential opportunities, of which we discuss three predictions below.

Allogenic Natural Killer (NK) Cells have the potential to displace current Cell Therapies in oncology if proven durable.

Despite being early in development, Allogenic NKs are proving to be an attractive new treatment paradigm in oncology. The question of durability of response with allogenic therapies is still an unknown. Fate Therapeutics’ recent phase 1 data for FT516 showed relatively quicker relapses vs already approved autologous CAR-Ts. However, other manufacturers, like Allogene for their allogenic CAR-T therapy ALLO-501A, are exploring novel lymphodepletion approaches to improve persistence of allogenic cells. Nevertheless, allogenic NKs demonstrate a strong value proposition relative to their T cell counterparts due to comparable response rates (so far) combined with the added advantage of a significantly safer AE profile. Specifically, little to no risk of graft versus host disease (GvHD), cytotoxic release syndrome (CRS), and neurotoxicity (NT) have been seen so far with allogenic NK cells (Fig. 1). In addition, being able to harness an allogenic cell source gives way to operational advantages as “off-the-shelf” products provide improved turnaround time (TAT), scalability, and potentially reduced cost. NKs are currently in development for a variety of overlapping hematological indications with chimeric antigen receptor T cells (CAR-Ts) today, and the question remains to what extent they will disrupt the current cell therapy landscape. Click for more details.

Lat­est news on Pfiz­er's $3B+ JAK1 win; Pacts over M&A at #JPM22; 2021 by the num­bers; Bio­gen's Aduhelm reck­on­ing; The sto­ry of sotro­vimab; 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.

For those of you who attended #JPM22 in any shape or form, we hope you had a fruitful time. Regardless of how you spent the past hectic week, may your weekend be just what you need it to be.

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A $3B+ peak sales win? Pfiz­er thinks so, as FDA of­fers a tardy green light to its JAK1 drug abroc­i­tinib

Back in the fall of 2020, newly crowned Pfizer chief Albert Bourla confidently put their JAK1 inhibitor abrocitinib at the top of the list of blockbuster drugs in the late-stage pipeline with a $3 billion-plus peak sales estimate.

Since then it’s been subjected to serious criticism for the safety warnings associated with the class, held back by a cautious FDA and questioned when researchers rolled out a top-line boast that their heavyweight contender had beaten the champ in the field of atopic dermatitis — Dupixent — in a head-to-head study.

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Robert Califf, FDA commissioner nominee (Graeme Sloan/Sipa USA/Sipa via AP Images)

Rob Califf ad­vances as Biden's FDA nom­i­nee, with a close com­mit­tee vote

Rob Califf’s second confirmation process as FDA commissioner is already much more difficult than his near unanimous confirmation under the Obama administration.

The Senate Health Committee on Thursday voted 13-8 in favor of advancing Califf’s nomination to a full Senate vote. Several Democrats voted against Califf, including Sen. Bernie Sanders and Sen. Maggie Hassan. Several other Democrats who aren’t on the committee, like West Virginia’s Joe Manchin and Ed Markey of Massachusetts, also said Thursday that they would not vote for Califf. Markey, Hassan and Manchin all previously expressed reservations about the prospect of Janet Woodcock as an FDA commissioner nominee too.

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Michel Vounatsos, Biogen CEO (World Economic Forum/Ciaran McCrickard)

Bio­gen vows to fight CM­S' draft cov­er­age de­ci­sion for Aduhelm be­fore April fi­nal­iza­tion

Biogen executives made clear in an investor call Thursday they are not preparing to run a new CMS-approved clinical trial for their controversial Alzheimer’s drug anytime soon.

As requested in a draft national coverage decision from CMS earlier this week, Biogen and other anti-amyloid drugs will need to show “a meaningful improvement in health outcomes” for Alzheimer’s patients in a randomized, placebo-controlled trial to get paid for their drugs, rather than just the reduction in amyloid plaques that won Aduhelm its accelerated approval in June.

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CRO own­er pleads guilty to ob­struct­ing FDA in­ves­ti­ga­tion in­to fal­si­fied clin­i­cal tri­al da­ta

The co-owner of a Florida-based clinical research site pleaded guilty to lying to an FDA investigator during a 2017 inspection, revealing that she falsely portrayed part of a GlaxoSmithKline pediatric asthma study as legitimate, when in fact she knew that certain data had been falsified, the Department of Justice said Wednesday.

Three other employees — Yvelice Villaman Bencosme, Lisett Raventos and Maytee Lledo — previously pleaded guilty and were sentenced in connection with falsifying data associated with the trial at the CRO Unlimited Medical Research.

Susan Galbraith, AstraZeneca EVP, Oncology R&D

Can­cer pow­er­house As­traZeneca rolls the dice on a $75M cash bet on a buzzy up­start in the on­col­o­gy field

After establishing itself in the front ranks of cancer drug developers and marketers, AstraZeneca is putting its scientific shoulder — and a significant amount of cash — behind the wheel of a brash new upstart in the biotech world.

The pharma giant trumpeted news this morning that it is handing over $75 million upfront to ally itself with Scorpion Therapeutics, one of those biotechs that was newly birthed by some top scientific, venture and executive talent and bequeathed with a fortune by way of a bankroll to advance an only hazily explained drug platform. And they are still very much in the discovery and preclinical phase.

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‘Skin­ny la­bels’ on gener­ics can save pa­tients mon­ey, re­search shows, but re­cent court de­ci­sions cloud fu­ture

New research shows how generic drug companies can successfully market a limited number of approved indications for a brand name drug, prior to coming to market for all of the indications. But several recent court decisions have created a layer of uncertainty around these so-called “skinny” labels.

While courts have generally allowed generic manufacturers to use their statutorily permitted skinny-label approvals, last summer, a federal circuit court found that Teva Pharmaceuticals was liable for inducing prescribers and patients to infringe GlaxoSmithKline’s patents through advertising and marketing practices that suggested Teva’s generic, with its skinny label, could be employed for the patented uses.

A patient in Alaska receiving an antibody infusion to prevent Covid hospitalizations in September. All but one of these treatments has been rendered useless by Omicron (Rick Bowmer/AP Images)

How a tiny Swiss lab and two old blood sam­ples cre­at­ed one of the on­ly ef­fec­tive drugs against Omi­cron (and why we have so lit­tle of it)

Exactly a decade before a novel coronavirus broke out in Wuhan, Davide Corti — a newly-minted immunologist with frameless glasses and a quick laugh — walked into a cramped lab on the top floor of an office building two hours outside Zurich. He had only enough money for two technicians and the ceiling was so low in parts that short stature was a job requirement, but Corti believed it’d be enough to test an idea he thought could change medicine.

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