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.”

A New Fron­tier: The In­ner Ear

What happens when a successful biotech venture capitalist is unexpectedly diagnosed with a chronic, life-disrupting vertigo disorder? Innovation in neurotology.

That venture capitalist was Jay Lichter, Ph.D., and after learning there was no FDA-approved drug treatment for his condition, Ménière’s disease, he decided to create a company to bring drug development to neurotology. Otonomy was founded in 2008 and is dedicated to finding new drug treatments for the hugely underserved community living with balance and hearing disorders. Helping patients like Jay has been the driving force behind Otonomy, a company heading into a transformative 2020 with three clinical trial readouts: Phase 3 in Ménière’s disease, Phase 2 in tinnitus, and Phase 1/2 in hearing loss. These catalysts, together with others in the field, highlight the emerging opportunity in neurotology.
Otonomy is leading the way in neurotology
Neurotology, or the treatment of inner ear neurological disorders, is a large and untapped market for drug developers: one in eight individuals in the U.S. have moderate-to-severe hearing loss, tinnitus or vertigo disorders such as Ménière’s disease.1 With no FDA-approved drug treatments available for these conditions, the burden on patients—including social anxiety, lower quality of life, reduced work productivity, and higher rates of depression—can be significant.2, 3, 4

Joe Jimenez, Getty

Ex-No­var­tis CEO Joe Jimenez is tak­ing an­oth­er crack at open­ing a new chap­ter in his ca­reer — and that in­cludes a new board seat and a $250M start­up

Joe Jimenez is back.

The ex-CEO of Novartis has taken a board seat on Century Therapeutics, the Versant and Bayer-backed startup focused on coming up with a brand new twist on cell therapies for cancer — a field where Jimenez made his mark backing the first personalized CAR-T approved for use.

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Can we make the an­tibi­ot­ic mar­ket great again?

The standard for-profit model in drug development is straightforward. Spend millions, even billions, to develop a medicine from scratch. The return on investment (and ideally a tidy profit) comes via volume and/or price, depending on the disease. But the string of big pharma exits and slew of biotech bankruptcies indicate that the model is sorely flawed when it comes to antibiotics.

The industry players contributing to the arsenal of antimicrobials are fast dwindling, and the pipeline for new antibiotics is embarrassingly sparse, the WHO has warned. Drugmakers are enticed by greener pastures, compared to the long, arduous and expensive path to antibiotic approval that offers little financial gain as treatments are typically priced cheaply, and often lose potency over time as microbes grow resistant to them.

Amber Saltzman (Ohana)

Flag­ship's first ven­ture of 2020 is out, and it's all about sperm

A couple years ago, Amber Salzman got a call as she was returning East full-time after a two-year stint running a gene therapy company in California.

It was from someone at Flagship Pioneering, the deep-pocketed biotech venture firm. They had a new company with a new way of thinking about sperm. It had been incubating for over a year, and now they wanted her to run it.

“It exactly fit,” Salzman told Endpoints News. “I just thought I had to do something.”

Pfiz­er ax­es 6 ear­ly to late-stage can­cer stud­ies from the pipeline — with one oth­er cut for sick­le cell dis­ease

Pfizer trimmed a group of 3 R&D programs using their PD-L1 Bavencio — partnered with Merck KGaA — in their latest pipeline cull.

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The FTC and New York state ac­cuse Mar­tin Shkre­li of run­ning a drug mo­nop­oly. They plan to squash it — and per­ma­nent­ly ex­ile him

Pharma bro Martin Shkreli was jailed, publicly pilloried and forced to confront some lawmakers in Washington riled by his move to take an old generic and move the price from $17.50 per pill to $750. But through 4 years of controversy and public revulsion, his company never backed away from the price — left uncontrolled by a laissez faire federal policy on a drug’s cost.

Now the FTC and the state of New York plan to pry his fingers off the drug once and for all and open it up to some cheap competition. And their lawsuit is asking that Shkreli — with several years left on his prison sentence — be banned permanently from the pharma industry.

UP­DAT­ED: Ac­celeron res­ur­rects block­buster hopes for so­tater­cept with pos­i­tive PhII — and shares rock­et up

Acceleron $XLRN says that its first major trial readout of 2020 is a success.

In a Phase II study of 106 patients with pulmonary arterial hypertension (PAH), Acceleron’s experimental drug sotatercept hit its primary endpoint: a significant reduction in pulmonary vascular resistance. The drug also met three different secondary endpoints, including the 6-minute walking test.

“We’re thrilled to report such positive topline results from the PULSAR trial,” Acceleron CEO Habib Dable said in a statement. The company said in a conference call they plan on discussing a Phase III trial design with regulators.

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UP­DAT­ED: In­cyte scores much need­ed PhI­II suc­cess — and of course it’s de­liv­ered by rux­oli­tinib

Incyte’s efforts to breathe a second life into ruxolitinib — its JAK inhibitor sold in pill form as Jakafi — has been greeted with clear, if preliminary and unsurprising, Phase III success.

Topline data from the TRuE-AD2 cements ruxolitinib’s foundational importance for Incyte, and gives analysts hope that there might yet be room for growth in a pipeline that’s suffered multiple R&D setbacks.

Stephen Hahn, AP

The FDA un­veils a new reg­u­la­to­ry frame­work to speed along gene ther­a­pies, re­ward­ing the lead­ing play­ers

Bioregnum Opinion Column by John Carroll

The emphasis at the FDA over the past 5 years or so has been on assisting drug developers as much as they can to speed up regulatory reviews and push more drugs into the market. And they are now crafting a final set of regulations aimed at flagging through a whole new generation of gene therapies in clinical testing at a rapid clip.

In a set of 6 prospective guidances posted on the FDA web site Tuesday morning, FDA commissioner Stephen Hahn committed the agency to staying flexible in handing out designations that are critical to gaining early approvals for drugs that claim to be once-and-done but don’t have anything close to the data needed to prove it.

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