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.”

The Big Phar­ma dis­card pile; Lay­offs all around while some biotechs bid farewell; New Roche CEO as­sem­bles top team; 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.

With earnings seasons in full swing, we’ve listened in on all the calls so you don’t have to. But news is popping up from all corners, so make sure you check out our other updates, too.

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Sen. Ron Wyden (D-OR) (Francis Chung/E&E News/Politico via AP Images)

In­fla­tion re­bates in­com­ing: Wyden calls on CMS to move quick­ly as No­var­tis CEO pledges re­ver­sal

Senate Finance Chair Ron Wyden (D-OR) this week sent a letter to the head of the Centers for Medicare & Medicaid Services seeking an update on how and when new inflation-linked rebates will take effect for drugs that see major price spikes.

The newly signed Inflation Reduction Act requires manufacturers to pay a rebate to Medicare when they increase drug prices faster than the rate of inflation.

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Trodelvy notch­es a win in most com­mon form of breast can­cer

Following a promise last year to go “big and fast in breast cancer,” Gilead has secured a win for Trodelvy in the most common form.

The drug was approved to treat HR-positive, HER2-negative breast cancer patients who’ve already received endocrine-based therapy and at least two other systemic therapies for metastatic cancer, Gilead announced on Friday.

Trodelvy won its first indication in metastatic triple-negative breast cancer back in 2020, and has since added urothelial cancer to the list. HR-positive HER2-negative breast cancer accounts for roughly 70% of new breast cancer cases worldwide per year, according to senior VP of oncology clinical development Bill Grossman, and many patients develop resistance to endocrine-based therapies or worsen on chemotherapy.

Raymond Stevens, Structure Therapeutics CEO

Be­hind Fri­day's $161M IPO: A star sci­en­tist, GPCR drug dis­cov­ery and a plan to chal­lenge phar­ma in di­a­betes

What does it take to pull off a $161 million biotech IPO these days?

In Structure Therapeutics’ case, it means having a star scientist co-founder paired with the computational drug discovery company Schrödinger, $198 million in private funding from blue-chip investors, almost six years of research work on G protein-coupled receptors and a slate of oral, small-molecule drugs, with an eye on the huge and growing diabetes and weight-loss market.

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Af­ter 13 years, Ramy Mah­moud steps in­to CEO seat at Opti­nose; Ru­pert Vessey set to ex­it Bris­tol My­ers in Ju­ly

After 13 years as president and COO at Optinose, Ramy Mahmoud has stepped into a new role as its CEO. He is taking the place of Peter Miller, who stepped down earlier this week, though Miller is still staying with the company as a consultant.

In 2010, the two business partners joined Optinose to take it in a new direction, transforming it from a delivery platform to product company. They previously worked together at Johnson & Johnson, when Miller was president at Janssen and Mahmoud headed medical affairs. Miller said after he learned about Optinose, “I did what I always do, which is find people smarter than me to talk with about the idea. And the first person I called was Ramy … and I said, ‘Hey, Ramy, what do you think of this technology?’”

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Goldfinch Bio CEO Tony Johnson (L) and Karuna Therapeutics CEO Bill Meury

Karuna li­cens­es Goldfinch as­sets to com­pete with Boehringer In­gel­heim in neu­ro­science

Karuna Therapeutics is looking to compete with Boehringer Ingelheim on depression and anxiety with a new license to Goldfinch Bio’s assets, starting with $15 million to the shuttered biotech.

Karuna steps into an arena already being tested by Boehringer in multiple Phase II studies — the two are targeting transient receptor potential canonical 4 and 5, or TRPC4/5, which is thought to have a role in neuroscience indications. Goldfinch’s asset went through a Phase II in kidney diseases, but Karuna’s sights are set on mood and anxiety disorders for now.

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Te­va drops out of in­dus­try trade group PhRMA

Following in AbbVie’s footsteps, Teva confirmed on Friday that it’s dropping out of the industry trade group Pharmaceutical Research and Manufacturers of America (PhRMA).

Teva didn’t give a reason for its decision to leave, saying only in a statement to Endpoints News that it annually reviews “effectiveness and value of engagements, consultants and memberships to ensure our investments are properly seated.”

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Sanofi CFO Jean-Baptiste de Chatillon (L) and CEO Paul Hudson (Romuald Meigneux/Sipa via AP Images)

Sanofi sees downtick in flu sales as it preps for launch of RSV an­ti­body

Sanofi expects its RSV antibody jointly developed with AstraZeneca will be available next season, executive VP of vaccines Thomas Triomphe announced on the company’s quarterly call.

Beyfortus, also known as nirsevimab, was approved in the EU back in November and is currently under FDA review with an expected decision coming in the third quarter of this year. The news comes as the FDA plans to hold advisory committee meetings over the next couple months to review RSV vaccines from Pfizer and GSK.

Christophe Weber, Takeda CEO (Photographer: Shoko Takayasu/Bloomberg via Getty Images)

Take­da fo­cus­es on ‘di­verse’ pipeline prospects on heels of two ac­qui­si­tions

After a whopping $4 billion asset buy from Nimbus Therapeutics, along with a $400 million deal with Hutchmed for a colorectal cancer drug, Takeda executives touted pipeline optimism on its latest earnings call this week.

That’s because the TYK2 inhibitor for psoriasis Takeda is getting from Nimbus, along with the Hutchmed fruquintinib commercialization outside of China, are just two of what it reports are 10 late-stage development programs of promising candidates.