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.”

Ugur Sahin, BioNTech CEO (Bernd von Jutrczenka/dpa via AP Images)

BioN­Tech is spear­head­ing an mR­NA vac­cine de­vel­op­ment pro­gram for malar­ia, with a tech trans­fer planned for Africa

Flush with the success of its mRNA Covid-19 vaccine, BioNTech is now gearing up for one of the biggest challenges in vaccine development — which comes without potential profit.

The German mRNA pioneer says it plans to work on a jab for malaria, then transfer the tech to the African continent, where it will work with partners on developing the manufacturing ops needed to make this and other vaccines.

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How one start­up fore­told the neu­ro­science re­nais­sance af­ter '50 years of shit­show'

In the past couple of years, something curious has happened: Pharma and VC dollars started gushing into neuroscience research.

Biogen’s controversial new Alzheimer’s drug Aduhelm has been approved on the basis of removing amyloid plaque from the brain, but the new neuro-focused pharma and biotechs have much loftier aims. Significantly curbing or even curing the most notorious disorders would prove the Holy Grail for a complex system that has tied the world’s best drug developers in knots for decades.

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Bob Bradway, Amgen CEO (Scott Eisen/Bloomberg via Getty Images)

Am­gen bel­lies back up to the M&A ta­ble for an­oth­er biotech buy­out, this time with a $2.5B deal for an an­ti­body play­er fo­cused on PS­MA

Five months after Amgen CEO Bob Bradway stepped up to the M&A table and acquired Five Prime for $1.9 billion, following up with the smaller Rodeo acquisition, he’s gone back in for another biotech buyout.

This time around, Amgen is paying $900 million cash while committing up to $1.6 billion in milestones to bag the privately held Teneobio, an antibody drug developer that has expertise in developing new bispecifics and multispecifics. In addition, Amgen cited Teneobio’s “T-cell engager platform, which expands on Amgen’s existing leadership position in bispecific T-cell engagers by providing a differentiated, but complementary, approach to Amgen’s current BiTE platform.”

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Why is On­col­o­gy Drug De­vel­op­ment Re­search Late to the Dig­i­tal Bio­mark­ers Game?

During the recent Annual ASCO Meeting, thousands of cancer researchers and clinicians from across the globe joined together virtually to present and discuss the latest findings and breakthroughs in cancer research and care. There were more than 5000+ scientific abstracts presented during this event, yet only a handful involved the use of motion-tracking wearables to collect digital measures relating to activity, sleep, mobility, functional status, and/or quality of life. Although these results were a bit disappointing, they should come as no surprise to those of us in the wearable technology field.

Art Levinson (Calico)

Google-backed Cal­i­co dou­bles down on an­ti-ag­ing R&D pact with Ab­b­Vie as part­ners ante up $1B, start to de­tail drug tar­gets

Seven years after striking up a major R&D alliance, AbbVie and Google-backed anti-aging specialist Calico are doubling down on their work with a joint, $1 billion commitment to continuing their work together. And they’re also beginning to offer some details on where this project is taking them in the clinic.

According to their statement, each of the two players is putting up $500 million more to keep the labs humming.

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Andrea Pfeifer, AC Immune CEO (AC Immune)

Look­ing to repli­cate Covid-19 suc­cess in neu­ro, BioN­Tech back­ers bet on AC Im­mune and its new­ly-ac­quired Parkin­son's vac­cine

The German billionaires behind BioNTech have found a new vaccine project to back.

Through their family office Athos Service, twin brothers Thomas and Andreas Strüngmann are leading a $25 million private placement into Switzerland’s AC Immune — which concurrently announced that it’s shelling out $58.7 million worth of stock to acquire Affiris’ portfolio of therapies targeting alpha-synuclein, including a vaccine candidate, for Parkinson’s disease.

Christophe Weber, Takeda CEO (Kyodo via AP Images)

Take­da flesh­es out CNS pact with pep­tide drug­mak­er, set­ting aside $3.5B in fu­ture mile­stones

One of a suite of drugmakers looking to reinvest in the neuroscience space, Takeda has been aggressive in signing on new partners to help build up its pipeline in that space. But sometimes the best partner is the one you already have.

Takeda will set aside $3.5 billion in future milestones and an undisclosed upfront payment to build out its drug discovery deal with Japanese peptide conjugate maker PeptiDream, adding neurodegeneration to the partnership’s list of CNS targets, the companies said Tuesday.

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Michael Henderson, BridgeBio CBO

Bris­tol My­ers Squibb catch­es the SHP2 wave in a new col­lab­o­ra­tion deal with Bridge­Bio

Once considered “undruggable,” the phosphatase enzyme SHP2 has seen recent interest from a suite of Big Pharmas, including AstraZeneca, Amgen, Novartis and Merck. Now Bristol Myers Squibb is getting in on the action, with a deal to pair its PD-1 superstar Opdivo with BridgeBio’s SHP2 inhibitor for difficult-to-treat cancers.

BMS and BridgeBio took the wraps off the non-exclusive, co-funded collaboration early Tuesday morning. The “catalyst,” BridgeBio CBO Michael Henderson said, was last year’s virtual JP Morgan conference, where the companies met to discuss early preclinical results they were seeing between SHP2 and immuno-oncology therapies.

Busi­ness­es and schools can man­date the use of Covid-19 vac­cines un­der EUAs, DOJ says

As public and private companies stare down the reality of the Delta variant, many are now requiring that their employees or students be vaccinated against Covid-19 prior to attending school or to returning or starting a new job. Claims that such mandates are illegal or cannot be used for vaccines under emergency use authorizations have now been dismissed.

Setting the record straight, the Department of Justice on Monday called the mandates legal in a new memo, even when used for people with vaccines that remain subject to EUAs.