Kristin Fortney, BioAge Labs CEO

An­ti-ag­ing biotech up­start plucks a drug from Am­gen's dis­card pile, piv­ot­ing from heart fail­ure to mus­cle con­di­tions

Back in April 2019, Am­gen qui­et­ly shut down a Phase I tri­al for a drug named AMG 986. There was no safe­ty con­cern; the mol­e­cule just didn’t hit the mark on help­ing the small band of heart fail­ure pa­tients who re­ceived it.

A small biotech, though, be­lieves it would stand a chance in the bur­geon­ing an­ti-ag­ing field.

BioAge Labs has li­censed AMG 986 — now re­named BGE-105 — with plans to par­lay the ex­ist­ing IND in­to a quick Phase I tri­al teas­ing out the phar­ma­co­dy­nam­ic ef­fects and set the stage for mid-stage tests fo­cused on acute mus­cle in­di­ca­tions.

BGE-105 mim­ics the ef­fect of apelin, an en­doge­nous lig­and that boosts the pro­duc­tion of APJ, a re­cep­tor that tends to be down­reg­u­lat­ed as peo­ple grow old­er. By comb­ing through decades of health da­ta from thou­sands of healthy vol­un­teers tracked by their biobank part­ners, the biotech had ze­roed in on the apelin/APJ path­way as one key mol­e­c­u­lar dri­ver of ag­ing, CEO Kris­ten Fort­ney said.

“Our longevi­ty map iden­ti­fies prob­a­bly sev­er­al dozen path­ways that mat­ter for hu­man ag­ing, and we’re choos­ing strate­gi­cal­ly to fo­cus first on the ones that are the most well known,” she added, “where there is as­set avail­able to go im­me­di­ate­ly in­to the clin­ic.”

She imag­ines there are about 10 such pro­grams out there, rep­re­sent­ing a range of mech­a­nis­tic bets, that they can bring in be­fore turn­ing to dis­cov­ery ef­forts. The apelin/APJ one is the third, lin­ing up af­ter two oth­ers tar­get­ing the hy­pox­ia-in­ducible fac­tor and PGD2 DP1.

Along the search for as­sets BioAge con­nect­ed with Cedric Dray at France’s IN­SERM, who had found that in­ject­ing mice with apelin pep­tide en­hanced mus­cle func­tion con­sid­er­ably, but that nat­ur­al mol­e­cule has a short half-life of on­ly 5 min­utes. He helped test the Am­gen mol­e­cule in his mouse mod­els, ce­ment­ing the li­cens­ing deal.

Like most of the an­ti-ag­ing out­fits, Fort­ney ex­pects to start with acute in­di­ca­tions where BioAge can quick­ly gen­er­ate clin­i­cal da­ta and get reg­u­la­to­ry ap­provals — one ex­am­ple is pre­vent­ing mus­cle at­ro­phy for im­mo­bi­lized pa­tients in hos­pi­tals — be­fore mov­ing on to long-term chron­ic use in things like mus­cle re­gen­er­a­tion and frailty.

“Ide­al­ly our drugs would fol­low a de­vel­op­ment path like a statin, where they’re first ap­proved for a nar­row in­di­ca­tion and widen over time” un­til they’re pre­scribed to any­one over a cer­tain age with risk fac­tors, Fort­ney said.

There’s a lot to prove in the young an­ti-ag­ing space, with lofty goals that have been well-doc­u­ment­ed and well-sat­i­rized. Backed by high-pro­file in­vestors like An­dreessen Horowitz and se­r­i­al en­tre­pre­neur Elad Gil of Airbnb fame, BioAge Labs has re­cent­ly brought its to­tal fund­ing to $127 mil­lion and grown the team to 35.

“Frankly very few mech­a­nisms have even been tried in the clin­ic,” she said. “We’re sort of at the very be­gin­ning.”

Mov­ing Out of the Clin­ic with Dig­i­tal Tools: Mo­bile Spirom­e­try Dur­ing COVID-19 & Be­yond

An important technology in assessing lung function, spirometry offers crucial data for the diagnosis and monitoring of pulmonary system diseases, as well as the ongoing measurement of treatment efficacy. But trends in the healthcare industry and new challenges introduced by the COVID-19 pandemic are causing professionals in clinical practice and research to reevaluate spirometry’s deployment methods and best practices.

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Sanofi, Glax­o­SmithK­line jump back in­to the PhI­II race for a Covid vac­cine — as the win­ners con­gre­gate be­hind the fin­ish line

Sanofi got out early in the race to develop a vaccine using more of a traditional approach, then derailed late last year as their candidate failed to work in older people. Now, after likely missing the bus for the bulk of the world’s affluent nations, they’re back from that embarrassing collapse with a second attempt using GSK’s adjuvant that may get them back on track — with a potential Q4 launch that the rest of the world will be paying close attention to.

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SCO­TUS de­clines to re­view En­brel biosim­i­lar case, tee­ing up 30+ years of ex­clu­siv­i­ty and $20B more for Am­gen’s block­buster

As the House Oversight Committee is set to grill AbbVie CEO Richard Gonzalez on Tuesday over tactics to block competition for its best-selling drug of all time, another decision on Capitol Hill on Monday opened the door for billions more in Amgen profits over the next eight years.

The Supreme Court on Monday denied Novartis subsidiary Sandoz’s petition to review a Federal Circuit’s July 2020 decision concerning its biosimilar Erelzi (etanercept-szzs), which FDA approved in 2016 as a biosimilar to Amgen’s Enbrel (etanercept). Samsung’s Enbrel biosimilar Eticovo also won approval in 2019 and remains sidelined.

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Charles Riv­er keeps adding on to its CD­MO arm, snatch­ing up a vi­ral vec­tor play­er for a tidy $350M

Contract researcher Charles River Laboratories has been on a roll recently to flesh out its manufacturing arm with a specific focus on its capabilities in gene therapy. Now, the firm is putting its name to a big check for a Maryland-based viral vector firm it thinks will add to its growing expertise in the field.

Charles River will dole out $292.5 million for gene therapy CDMO Vigene Biosciences with the possibility for an additional $57.5 million in performance-based payments, the companies said Monday. The deal will close at the start of Q3, a Charles River spokesman said.

How to man­u­fac­ture Covid-19 vac­cines with­out the help of J&J, Pfiz­er or Mod­er­na? Bi­ol­yse sees the dif­fi­cul­ties up close

When Biolyse, an Ontario-based manufacturer of sterile injectables, forged a deal with Bolivia last week to manufacture up to 50 million J&J Covid-19 vaccine doses, the agreement kicked off what will prove to be a test case for how difficult the system of compulsory licenses is to navigate.

The first problem: When Biolyse asked J&J, via a March letter, to license its Covid-19 vaccine, manufacture it in Canada and pay 5% royalties on shipments to needy, low-income countries, J&J rejected the offer, refusing to negotiate. J&J also did not respond to a request for comment.

Tim Mayleben (L) and Sheldon Koenig (Esperion)

On the heels of a sting­ing Q1 set­back, Es­pe­ri­on's long­time cham­pi­on is ex­it­ing the helm and turn­ing the wheel over to a mar­ket­ing pro

Just days after getting stung by criticism from a badly disappointed group of analysts, there’s a big change happening today at the helm of Esperion $ESPR.

Longtime CEO Tim Mayleben, who championed the company for 9 years from early clinical through a lengthy late-stage drive to successfully get their cholesterol drug approved for a significant niche of patients in the US, is out of the C suite, effective immediately. Sheldon Koenig — hired at the end of 2020 with a resume replete with Big Pharma CV sales experience —  is stepping into his place, promising to right a badly listing commercial ship that’s been battered by market forces.

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No­var­tis' En­tresto takes its 2nd fail­ure of the week­end at ACC, show­ing no ben­e­fit in most dire heart fail­ure pa­tients

Novartis’ Entresto started the ACC weekend off rough with a trial flop in heart attack patients, slowing the drug’s push into earlier patients. Now, an NIH-sponsored study is casting doubt on Entresto’s use in the most severe heart failure patients, another black mark on the increasingly controversial drug’s record.

Entresto, a combination of sacubitril and valsartan, could not beat out valsartan alone in an outcomes head-to-head for severe heart failure patients with a reduced ejection fraction (HFrEF), according to data presented Monday at the virtual American College of Cardiology meeting.

Matt Gline (L) and Vivek Ramaswamy

In­sid­er ac­count of Roivan­t's SPAC deal — and that $7.3B val­u­a­tion — re­veals a few se­crets as Matt Gline po­si­tions the com­pa­ny as the new ‘Big Phar­ma’

It was Oct. 7, 2020, and Matt Gline wasn’t wasting any time.

The CEO of Roivant had word that KKR vet Jim Momtazee’s SPAC had priced late the night before, triggering a green light for anyone interested in pursuing a big check for future operations and riding the financial instrument to Nasdaq. So he wrote a quick email congratulating Momtazee, whom he knew, for the launch.

Oh, and maybe Momtazee would like to schedule something with Gline and his executive chairman, Roivant founder Vivek Ramaswamy, to chat about Roivant and its business?

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Josep Bassaganya-Riera, Landos Biopharma CEO (Landos)

Per­cep­tive's Chi­na up­start Lian­Bio con­tin­ues swing­ing deals, team­ing up with lead Xon­toge­ny biotech Lan­dos in IBD

One of China’s biggest up-and-comers has a brand new partner, and it’s one whose backers are likely familiar with the other’s.

Perceptive’s LianBio has secured a collaboration with Landos Biopharma, the lead company in Chris Garabedian’s Xontogeny fund, to develop and market two programs in Greater China and other countries in the region, the biotechs announced Monday morning. In exchange, Landos is getting an upfront payment of $18 million, up to $200 million in milestones and royalties on sales in the licensed territories.