Leen Kawas, Athira CEO (Athira)

Can a small biotech suc­cess­ful­ly tack­le an Ever­est climb like Alzheimer’s? Athi­ra has $85M and some in­flu­en­tial back­ers ready to give it a shot

There haven’t been a lot of big ven­ture rounds for biotech com­pa­nies look­ing to run a Phase II study in Alzheimer’s.

The field has been a dis­as­ter over the past decade. Amy­loid didn’t pan out as a tar­get — go­ing down in a litany of Phase III fail­ures — and is now mak­ing its last stand at Bio­gen. Tau is a com­er, but when you look around and all you see is de­struc­tion, the idea of back­ing a start­up try­ing to find com­plex cock­tails to swing the course of this dev­il­ish­ly com­pli­cat­ed mem­o­ry-wast­ing dis­ease would daunt the pluck­i­est in­vestors.

Which brings me to Athi­ra, a lit­tle, Seat­tle-based biotech that caught my at­ten­tion with a heads-up that they’re an­nounc­ing an $85 mil­lion round to­day to fund their Phase II/III quest for Alzheimer’s. Athi­ra’s team has been on a long, 9-year jour­ney to get here, and they are acute­ly aware of the burned-out wreck­age and dis­as­ter head­lines cov­er­ing the route that they have been cruis­ing.

To get the mon­ey, they en­list­ed a long line of back­ers: Per­cep­tive Ad­vi­sors for the lead with par­tic­i­pa­tion from new in­vestors RTW In­vest­ments, Viking Glob­al In­vestors, Ven­rock Health­care Cap­i­tal Part­ners, Franklin Tem­ple­ton, Rock Springs Cap­i­tal, LifeSci Ven­ture Part­ners, Sur­vey­or Cap­i­tal (a Citadel com­pa­ny), High­side Cap­i­tal Man­age­ment, Lo­gos Cap­i­tal, funds man­aged by Janus Hen­der­son In­vestors, Sofinno­va In­vest­ments, Avid­i­ty Part­ners, and ex­ist­ing in­vestors in­clud­ing Rick and Suzanne Kayne and Sah­sen Ven­tures.

Joe Edel­man, who runs the well-con­nect­ed Per­cep­tive, is join­ing the board af­ter giv­ing the crew a thumbs up.

So far, Athi­ra’s back­ers have put up about $20 mil­lion to get to this point, so you can see how big a deal this is to the biotech team.

There are in­vestors out there who have nev­er been burned by Alzheimer’s and who are still ready to con­sid­er jump­ing in, says CEO Leen Kawas, who’s been mak­ing the rounds, and then there have been plen­ty which have.

“I’m proud we put to­geth­er a syn­di­cate that in­cludes both,” she tells me.

Edel­man and the rest are back­ing a drug — NDX-1017 — that by­pass­es the whole tox­ic plaque de­bate and fo­cus­es on an­oth­er fa­mil­iar strat­e­gy: the frayed synap­tic net­work in the brain that erodes with the dis­ease. Boost the net­work and you can stop, pos­si­bly re­verse, the dam­age that cor­rodes cog­ni­tion. For awhile.

Their small mol­e­cule is de­signed to tar­get he­pa­to­cyte growth fac­tor (HGF) and its re­cep­tor, MET, in an ef­fort to re­gen­er­ate af­flict­ed tis­sue. And that’s some­thing these in­vestors haven’t seen be­fore.

Athi­ra got this far by spot­light­ing da­ta they say back up the ef­fi­ca­cy pro­file they’re look­ing for. In a Phase Ib, Kawas says, re­searchers used a test to gauge pa­tients’ abil­i­ty to count odd tones pep­pered in a string of re­peat­ed tones. For pa­tients with de­men­tia, their nor­mal pat­tern of recog­ni­tion falls in a 400 to 450 mil­lisec­ond range, says the CEO. Their base­line in the study was 390. In the drug arm, just 7 pa­tients, that dropped to an av­er­age of 311. There was no change among 4 place­bo pa­tients, says Kawas.

Now, they’ll need to see if they can repli­cate a cog­ni­tive im­prove­ment in a much larg­er Phase II. And then they can move on to a piv­otal Phase III. The FDA re­quires pos­i­tive da­ta from 2 con­trolled stud­ies, and that might be it. But Kawas knows that if they can’t con­vince reg­u­la­tors — bal­anc­ing the da­ta against the moun­tain­ous un­met need — they’d need to go on to a sec­ond Phase III.

The odds against suc­cess here are sig­nif­i­cant. Every­thing fails in Alzheimer’s. Or has. But win­ning over a syn­di­cate of in­vestors able to pro­vide that kind of cash is al­so val­i­dat­ing — and no mean achieve­ment in this en­vi­ron­ment.

Right now, the Athi­ra team has spent a good chunk of their lives de­vot­ed to see­ing if this drug can work. “We’re be­liev­ers that this can be done,” says the CEO.

It’s a daunt­ing up­hill climb, but they in­tend to make be­liev­ers out of every­one else as well. As some­where down the trail, the plan is to float an IPO down Wall Street to see if they can win over an even big­ger group of be­liev­ers.

Biotech in­vestors and CEOs see two paths to growth, but are they equal­ly vi­able?

The dynamic in the biotech market has been highly volatile in the last few years, from the high peaks immediately after the COVID vaccine in 2021, to the lowest downturns of the last 20 years in 2022. This uncertainty makes calling the exact timing of the market’s turn something of a fool’s errand, according to Dr. Chen Yu, Founder and Managing Partner of TCG Crossover (TCG X). He speaks with RBC’s Noël Brown, Head of US Biotechnology Investment Banking, about the market’s road ahead and two possible paths for growth.

Vlad Coric, Biohaven CEO

Vlad Coric charts course for 'New Bio­haven' with neu­ro­science push and Big Phar­ma vets on board

What’s Biohaven without its CGRP portfolio? That’s what CEO Vlad Coric is tasked with deciding as he maps out the “New Biohaven” post-Pfizer takeover.

Pfizer officially scooped up Biohaven’s CGRP assets on Monday, including blockbuster migraine drug Nurtec and the investigational zavegepant, for $11.6 billion. As a result, Coric spun the broader pipeline into an independent company on Tuesday — with the same R&D team behind Nurtec but about 1,000 fewer staffers and a renewed focus on neuroscience and rare disease.

In AstraZeneca's latest campaign, wild eosinophils called Phils personify the acting up often seen in uncontrolled asthma

As­traZeneca de­buts an­noy­ing pur­ple ‘Phil’ crea­tures, per­son­i­fied asth­ma eosinophils ‘be­hav­ing bad­ly’

There are some odd-looking purple creatures lurking around the halls of AstraZenca lately. The “Phil” character cutouts are purple, personified eosinophils with big buggy eyes and wide mouths, and they’re a part of AZ’s newest awareness effort to help people understand eosinophilic asthma.

The “Asthma Behaving Badly” characters aren’t only on the walls at AZ to show the new campaign to employees, however. The “Phils” are also showing up online on the campaign website, and in digital and social ads and posts on Facebook and Instagram.

Casey McPherson shows his daughters Rose (left) and Weston around Everlum Bio, a lab that he co-founded to spark a treatment for Rose and others with ultra-rare conditions. (Ilana Panich-Linsman)

Fa­ther starts lab af­ter in­tel­lec­tu­al prop­er­ty is­sues stymie rare dis­ease drug de­vel­op­ment

Under bright lab lights, Casey McPherson holds his 6-year-old daughter, Rose. His free hand directs Rose’s gaze toward a computer screen with potential clues in treating her one-of-a kind genetic condition.

Gray specks on the screen show her cells that scientists reprogrammed with the goal of zeroing in on a custom medicine. McPherson co-founded the lab, Everlum Bio, to spark a treatment for Rose — and others like her. A regarded singer-songwriter, McPherson never imagined going into drug development.

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Dave Marek, Myovant CEO

My­ovant board balks as ma­jor­i­ty own­er Sum­it­o­mo swoops in with a $2.5B deal to buy them out

Three years after Sumitomo scooped up Roivant’s 46% stake in the publicly traded Myovant $MYOV as part of a 5-company, $3 billion deal, they’re coming back for the whole thing.

But these other investors at Myovant want more than what the Japanese pharma company is currently offering to pay at this stage.

Sumitomo is bidding $22.75 a share for the outstanding stock, which now represents 48% of the company after Sumitomo bumped its ownership since the original deal with Roivant. Myovant, however, created a special committee on the board, and they’re shaking their heads over the offer.

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Ying Huang, Legend CEO

Lentivi­ral vec­tor ramp-up: J&J and Leg­end to in­vest $500M in New Jer­sey man­u­fac­tur­ing to sup­port Carvyk­ti

In response to a question on manufacturing scale at Legend Biotech’s R&D day yesterday, the company’s top exec said its partnership with Johnson & Johnson will be doubling its investment in its New Jersey manufacturing center and will be investing a total of $500 million.

With an eye on their BCMA-directed CAR-T therapy Carvykti (cilta-cel), approved in February as a fifth-line treatment for multiple myeloma, Legend CEO Ying Huang said that the ramp-up in production and the decision to manufacture its own lentiviral vectors — currently in shortage worldwide — means they won’t have to deal with that shortage.

Kite Phar­ma gets FDA to sign off on new Cal­i­for­nia-based vec­tor man­u­fac­tur­ing fa­cil­i­ty

Kite Pharma just got FDA approval to kick off operations at a new manufacturing campus.

The cancer-focused, CAR-T cell therapy player made the announcement Monday, saying that the federal regulatory agency gave the green light to Kite’s 100,000 square-foot, retroviral vector manufacturing facility in Oceanside, CA.

Kite’s global head of technical operations Chris McDonald tells Endpoints News that the facility has been in the works for about four years, after Kite teamed up with its parent company Gilead. Gilead acquired Kite Pharma for just shy of $12 billion in 2017.

Mar­ket­ingRx roundup: No­var­tis re­cruits NFL coach for Leqvio cam­paign; Pfiz­er pro­motes ‘Sci­ence’ merch on so­cial me­dia

Novartis is turning to a winning coach to talk about Leqvio and the struggles of high cholesterol — including his own. Bruce Arians, the retired NFL head coach of the Arizona Cardinals and Super Bowl-winning Tampa Bay Buccaneers, is partnering with the pharma for its “Coaching Cholesterol” digital, social and public relations effort.

In the campaign, Arians talks about the potential for “great comebacks” in football and heart health. Once nicknamed a “quarterback whisperer,” he is now retired from fulltime coaching (although still a front-office consultant for Tampa Bay), and did a round of media interviews for Novartis, including one with People and Forbes.

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Amy West, Novo Nordisk head of US digital innovation and transformation (Illustration: Assistant Editor Kathy Wong for Endpoints News)

Q&A: No­vo Nordisk dig­i­tal in­no­va­tion chief Amy West dis­cuss­es phar­ma pain points and a health­care 'easy but­ton’

Amy West joined Novo Nordisk more than a decade ago to oversee marketing strategies and campaigns for its US diabetes portfolio. However, her career path shifted into digital, and she hasn’t looked back. West went from leading Novo’s first digital health strategy in the US to now heading up digital innovation and transformation.

She’s currently leading the charge at Novo Nordisk to not only go beyond the pill with digital marketing and health tech, but also test, pilot and develop groundbreaking new strategies needed in today’s consumerized healthcare world.

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