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.”

Scoop: Boehringer qui­et­ly shut­ters a PhII for one of its top drugs — now un­der re­view

Boehringer Ingelheim has quietly shut down a small Phase II study for one of its lead drugs.

The private pharma player confirmed to Endpoints News that it had shuttered a study testing spesolimab as a therapy for Crohn’s patients suffering from bowel obstructions.

A spokesperson for the company tells Endpoints:

Taking into consideration the current therapeutic landscape and ongoing clinical development programs, Boehringer Ingelheim decided to discontinue our program in Crohn’s disease. It is important to note that this decision is not based on any safety findings in the clinical trials.

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A Mer­ck part­ner is sucked in­to the fi­nan­cial quag­mire as key lender calls in a note

Another biotech standing on shaky financial legs has fallen victim to the bears.

Merck partner 4D Pharma has reported that a key lender, Oxford Finance, shoved the UK company into administration after calling in a $14 million loan they couldn’t immediately make good on. Trading in their stock was halted with a market cap that had fallen to a mere £30 million.

“Despite the very difficult prevailing market conditions,” 4D reported on Friday, the biotech had been making progress on finding some new financing and turned to Oxford with an alternative late on Thursday and then again Friday morning.

David Loew (Ipsen)

Ipsen snags an ap­proved can­cer drug in $247M M&A deal as an­oth­er bat­tered biotech sells cheap

You can add Paris-based Ipsen to the list of discount buyers patrolling the penny stock pack for a cheap M&A deal.

The French biotech, which has had plenty of its own problems to grapple with, has swooped in to buy Epizyme $EPZM for $247 million in cash and a CVR with milestones attached to it. Epizyme shareholders, who had to suffer through a painfully soft launch of their EZH2a inhibitor cancer drug Tazverik, will get $1.45 per share along with a $1 CVR tied to achieving $250 million in sales from the drug over four consecutive quarters as well as an OK for second-line follicular lymphoma by Jan. 1, 2028.

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Alex­ion puts €65M for­ward to strength­en its po­si­tion on the Emer­ald Isle

Ireland has been on a roll in 2022, with several large pharma companies announcing multimillion-euro projects. Now AstraZeneca’s rare disease outfit Alexion is looking to get in on the action.

Alexion on Friday announced a €65 million ($68.8 million) investment in new and enhanced capabilities across two sites in the country, including at College Park in the Dublin suburb of Blanchardstown and the Monksland Industrial Park in the central Irish town of Athlone, according to the Industrial Development Agency of Ireland.

State bat­tles over mifepri­s­tone ac­cess could tie the FDA to any post-Roe cross­roads

As more than a dozen states are now readying so-called “trigger” laws to kick into effect immediate abortion bans following the overturning of Roe v. Wade on Friday, these laws, in the works for more than a decade in some states, will likely kick off even more legal battles as states seek to restrict the use of prescription drug-based abortions.

Since Friday’s SCOTUS opinion to overturn Americans’ constitutional right to an abortion after almost 50 years, reproductive rights lawyers at Planned Parenthood and other organizations have already challenged these trigger laws in Utah and Louisiana. According to the Guttmacher Institute, other states with trigger laws that could take effect include Arkansas, Idaho, Kentucky, Mississippi, Missouri, North Dakota, Oklahoma, South Dakota, Tennessee, Texas, and Wyoming.

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Deborah Dunsire, Lundbeck CEO

Af­ter a 5-year re­peat PhI­II so­journ, Lund­beck and Ot­su­ka say they're fi­nal­ly ready to pur­sue OK to use Rex­ul­ti against Alzheimer's ag­i­ta­tion

Five years after Lundbeck and their longtime collaborators at Otsuka turned up a mixed set of Phase III data for Rexulti as a treatment for Alzheimer’s dementia-related agitation, they’ve come through with a new pivotal trial success they believe will finally put them on the road to an approval at the FDA. And if they’re right, some analysts believe they’re a short step away from adding more than $500 million in annual sales for the drug, already approved in depression and schizophrenia.

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Members of the G7 from left to right: Prime Minister of Italy Mario Draghi, European Commission President Ursula von der Leyen, President Joe Biden, German Chancellor Olaf Scholz, British Prime Minister Boris Johnson, Canadian Prime Minister Justin Trudeau, Prime Minister of Japan Fumio Kishida, French President Emmanuel Macron and European Council President Charles Michel (AP Photo/Susan Walsh)

Biden and G7 na­tions of­fer funds for vac­cine and med­ical prod­uct man­u­fac­tur­ing project in Sene­gal

Amidst recently broader vaccine manufacturing initiatives from the EU and European companies, the G7 summit in the mountains of Bavaria has brought about some positive news for closing vaccine and medical product manufacturing gaps around the globe.

According to a statement from the White House, the G7 leaders have formally launched the partnership for global infrastructure, PGII. The effort will aim to mobilize hundreds of billions of dollars to deliver infrastructure projects in several sectors including the medical and pharmaceutical manufacturing space.

Fed­er­al judge de­nies Bris­tol My­er­s' at­tempt to avoid Cel­gene share­hold­er law­suit

Some Celgene shareholders aren’t happy with how Bristol Myers Squibb’s takeover went down.

On Friday, a New York federal judge ruled that they have a case against the pharma giant, denying a request to dismiss allegations that it purposely slow-rolled Breyanzi’s approval to avoid paying out $6.4 billion in contingent value rights (CVR).

When Bristol Myers put down $74 billion to scoop up Celgene back in 2019, liso-cel — the CAR-T lymphoma treatment now marketed as Breyanzi — was supposedly one of the centerpieces of the deal. After going back and forth on negotiations for about six months, BMS put $6.4 billion into a CVR agreement that required an FDA approval for Zeposia, Breyanzi and Abecma, each by an established date.

Chris Anzalone, Arrowhead CEO

Take­da, Ar­row­head spot­light da­ta from small tri­al show­ing RNAi works in a rare liv­er con­di­tion

Almost two years after Takeda wagered $300 million cash to partner with Arrowhead on an RNAi therapy for a rare disease, the companies are spelling out Phase II data that they believe put them one step closer to their big dreams.

In a small, open label study involving only 16 patients who had liver disease associated with alpha-1 antitrypsin deficiency (AATD), Arrowhead’s candidate — fazirsiran, previously ARO-AAT — spurred substantial reductions in accumulated mutant AAT protein in the liver, a hallmark of the condition. Investigators also tracked improvements in symptoms, with seven out of 12 who received the high, 200 mg dose seeing regression of liver fibrosis.

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