Ab­b­Vie antes up $225M in cash to buy in­to the Alzheimer's plat­form at Alec­tor

For well over a decade now, the ma­jor fo­cus in Alzheimer’s R&D has been con­cen­trat­ing heav­i­ly — though not ex­clu­sive­ly — on the tan­gles of tox­ic amy­loid be­ta and tau that are of­ten as­so­ci­at­ed with the dis­ease. Alec­tor set out to do things dif­fer­ent­ly, though, with a fo­cus on the in­nate im­mune re­sponse in the brain. Now as in­ves­ti­ga­tors for the lit­tle biotech aim for the clin­ic, Ab­b­Vie wants in, pay­ing a whop­ping $205 mil­lion in cash — with $20 mil­lion re­served for an up­com­ing round — and promis­ing an undis­closed mul­ti­ple in mile­stones to part­ner on the work.

Ab­b­Vie al­ready has an in-house pro­gram on tau. But look­ing a few years ahead to when the Hu­mi­ra fran­chise faces gener­ic com­pe­ti­tion, they’re dou­bling down on Alzheimer’s and a range of dis­eases that fall un­der the head­ing of neu­rode­gen­er­a­tion. A win here would be huge, and Ab­b­Vie is will­ing to bet big.

Robert Paul, Alec­tor

The way Alec­tor thinks of things, neu­rode­gen­er­a­tion and de­men­tia are caused by in­ac­tiv­i­ty of the im­mune sys­tem. And tak­ing a cue from im­muno-on­col­o­gy — where they have a sec­ondary, par­al­lel pro­gram in place — Alec­tor has been de­vel­op­ing a pre­clin­i­cal pipeline of an­ti­bod­ies that are de­signed to act to ei­ther ac­cel­er­ate the im­mune sys­tem or se­lec­tive­ly re­move the brakes that are in place.

If they’re right, the mi­croglia in the brain can go a long way to gob­bling up the tox­ic pro­teins that may be the cen­tral play­ers in dri­ving Alzheimer’s.

“We will go in­to the clin­ic a year from now, and we’re plan­ning to bring 5 drugs in­to the clin­ic in the next 18 months,” says Robert Paul, the chief med­ical of­fi­cer at Alec­tor.

Those drugs are com­ing di­rect­ly from Adimab, Till­man Gern­gross’s shop near Dart­mouth in New Hamp­shire. Gern­gross is the chair­man and co-founder at South San Fran­cis­co-based Alec­tor, which is run by Genen­tech vet­er­an Arnon Rosen­thal. And he’s had decades to per­fect new an­ti­bod­ies for the clients he works with, sell­ing turnkey an­ti­body de­vel­op­ment plat­forms to the ma­jor de­vel­op­ers in the in­dus­try or de­vis­ing pipelines for the biotechs he helps found.

In this new deal, Ab­b­Vie vaults from a ven­ture backer — help­ing to arrange the first $80 mil­lion in fund­ing — to a close col­lab­o­ra­tor. Ab­b­Vie will get an op­tion on two of Alec­tor’s ther­a­pies, which the biotech will take through proof-of-con­cept stud­ies. If Ab­b­Vie picks up its op­tions, they will then co-fund de­vel­op­ment in a dri­ve to com­mer­cial­ize the ther­a­pies — with a prof­it split for any­thing that gets ap­proved.

In ad­di­tion to the $205 mil­lion in cash, Ab­b­Vie is set­ting aside $20 mil­lion for an added eq­ui­ty stake in Alec­tor, which is con­cur­rent­ly rais­ing a big new round, with a syn­di­cate that in­cludes Mer­ck, Or­biMed, Po­laris, Mis­sion Bay Cap­i­tal and Top­spin Part­ners. The mile­stones are undis­closed, but in a pre­clin­i­cal deal that starts out with $225 mil­lion up front, they al­most cer­tain­ly run in­to 10 fig­ures.

Sabah Oney, Alec­tor

They’ll need the mon­ey. Neu­rode­gen­er­a­tion de­vel­op­ment does not come cheap, and Alec­tor wants to move a pipeline in­to the clin­ic, rather than just one or two can­di­dates.

Alec­tor and Ab­b­Vie al­so are acute­ly aware of the po­ten­tial here.

“If these drugs are suc­cess­ful, they are go­ing to be­come block­buster bi­o­log­ics,” says Sabah Oney, the head of busi­ness de­vel­op­ment at the biotech.

For the past 15 years, that block­buster bea­con has dri­ven a grow­ing slate of bit­ter Phase III fail­ures. The lat­est was at Ax­o­vant, a brash up­start that thought it could do what Glax­o­SmithK­line and ri­vals had tried by amp­ing up neu­ro­trans­mit­ters. Eli Lil­ly had three straight de­feats with solanezum­ab, and still hasn’t giv­en up on it. And now BACE and oth­er strate­gies are be­ing put to the test, with ear­ly fail­ures point­ing to the po­ten­tial for more dis­as­ter as well.

Still, Bio­gen’s mixed suc­cess with ad­u­canum­ab has em­bold­ened many of the big play­ers, like Roche, to go back to the draw­ing board.

Alec­tor and Ab­b­Vie want to try some­thing dif­fer­ent now, and it will take years to see if it works.

Donald and Melania Trump watch the smoke of fireworks from the South Lawn of the White House on July 4, 2020 (via Getty)

Which drug de­vel­op­ers of­fer Trump a quick, game-chang­ing ‘so­lu­tion’ as the pan­dem­ic roars back? Eli Lil­ly and Ab­Cellera look to break out of the pack

We are unleashing our nation’s scientific brilliance and will likely have a therapeutic and/or vaccine solution long before the end of the year.

— Donald Trump, July 4

Next week administration officials plan to promote a new study they say shows promising results on therapeutics, the officials said. They wouldn’t describe the study in any further detail because, they said, its disclosure would be “market-moving.”

— NBC News, July 3

Something’s cooking. And it’s not just July 4 leftovers involving stale buns and uneaten hot dogs.

Over the long weekend observers picked up signs that the focus in the Trump administration may swiftly shift from the bright spotlight on vaccines being promised this fall, around the time of the election, to include drugs that could possibly keep patients out of the hospital and take the political sting out of the soaring Covid-19 numbers causing embarrassment in states that swiftly reopened — as Trump cheered along.

So far, Gilead has been the chief beneficiary of the drive on drugs, swiftly offering enough early data to get remdesivir an emergency authorization and into the hands of the US government. But their drug, while helpful in cutting stays, is known for a limited, modest effect. And that won’t tamp down on the hurricane of criticism that’s been tearing at the White House, and buffeting the president’s most stalwart core defenders as the economy suffers.

We’ve had positive early-stage vaccine data, most recently from Pfizer and BioNTech, playing catchup on an mRNA race led by Moderna — where every little sign of potential trouble is magnified into a lethal threat, just as every advance excites a frenzy of support. But that race still has months to play out, with more Phase I data due ahead of the mid-stage numbers looming ahead. A vaccine may not be available in large enough quantities until well into 2021, which is still wildly ambitious.

So what about a drug solution?

Trump’s initial support for a panacea focused on hydroxychloroquine. But that fizzled in the face of data underscoring its ineffectiveness — killing trials that aren’t likely to be restarted because of a recent population-based study offering some support. And there are a number of existing drugs being repurposed to see how they help hospitalized patients.

Endpoints Premium

Premium subscription required

Unlock this article along with other benefits by subscribing to one of our paid plans.

Regeneron CEO Leonard Schleifer speaks at a meeting with President Donald Trump, members of the Coronavirus Task Force, and pharmaceutical executives in the Cabinet Room of the White House (AP Photo/Andrew Harnik)

OWS shifts spot­light to drugs to fight Covid-19, hand­ing Re­gen­eron $450M to be­gin large scale man­u­fac­tur­ing in the US

The US government is on a spending spree. And after committing billions to vaccines defense operations are now doling out more of the big bucks through Operation Warp Speed to back a rapid flip of a drug into the market to stop Covid-19 from ravaging patients — possibly inside of 2 months.

The beneficiary this morning is Regeneron, the big biotech engaged in a frenzied race to develop an antibody cocktail called REGN-COV2 that just started a late-stage program to prove its worth in fighting the virus. BARDA and the Department of Defense are awarding Regeneron a $450 million contract to cover bulk delivery of the cocktail starting as early as late summer, with money added for fill/finish and storage activities.

Endpoints News

Keep reading Endpoints with a free subscription

Unlock this story instantly and join 84,800+ biopharma pros reading Endpoints daily — and it's free.

Noubar Afeyan, Flagship CEO and Tessera chairman (Victor Boyko/Getty Images)

Flag­ship ex­ecs take a les­son from na­ture to mas­ter ‘gene writ­ing,’ launch­ing a star-stud­ded biotech with big am­bi­tions to cure dis­ease

Flagship Pioneering has opened up its deep pockets to fund a biotech upstart out to revolutionize the whole gene therapy/gene editing field — before gene editing has even made it to the market. And they’ve surrounded themselves with some marquee scientists and execs who have crowded around to help shepherd the technology ahead.

The lead player here is Flagship general partner Geoff von Maltzahn, an MIT-trained synthetic biologist who set out in 2018 to do CRISPR — a widely used gene editing tool — and other rival technologies one or two better. Von Maltzahn has been working with Sana co-founder Jake Rubens, another synthetic biology player out of MIT who he describes as his “superstar,” who’s taken the CSO role.

Endpoints News

Keep reading Endpoints with a free subscription

Unlock this story instantly and join 84,800+ biopharma pros reading Endpoints daily — and it's free.

Shoshanna Shendelman, Applied Therapeutics CEO (Applied Therapeutics)

A lit­tle biotech slaps back at a 'crim­i­nal' short at­tack, vow­ing to pur­sue a pros­e­cu­tion of their case

As short attacks go, Biotech Research Partners’ assault on Applied Therapeutics’ “cherry picked” data and a variety of so-called red flags didn’t cause a whole lot of damage. Ahead of the July 4 holiday, its shares $APLT were dinged and showed signs of quick recovery.

But that didn’t stop an incendiary response, as the biotech swung into action bright and early Monday morning.

Applied Therapeutics accused the authors of the short report of manipulating graphs and figures, misrepresenting data and included factual misrepresentations — all of which added up, in their view, to fraud.

Endpoints News

Keep reading Endpoints with a free subscription

Unlock this story instantly and join 84,800+ biopharma pros reading Endpoints daily — and it's free.

Covid-19 roundup: Squab­bles with gov­ern­ment de­lay Mod­er­na’s PhI­II — re­ports; No­vavax se­cures largest Warp Speed deal yet: $1.6B

A much-anticipated Phase III trial for Moderna’s Covid-19 vaccine is being held up as the company delayed submitting trial protocols and sparred with government scientists on how to run the study and even what the benchmark for success should be, Reuters reported.

Moderna, the first US company to put their vaccine into human testing, was supposed to enter a 30,000-person study this month in partnership with the NIH to determine whether it can prevent infection. STAT reported last week that the trial was facing delays over the protocol, but that a July start was still possible. Neither the NIH nor Moderna ever disclosed a specific date the trial should start, but Reuters reported that the agency had hoped to begin on July 10.

Endpoints News

Keep reading Endpoints with a free subscription

Unlock this story instantly and join 84,800+ biopharma pros reading Endpoints daily — and it's free.

Boehringer In­gel­heim ties the knot with Num­ab on new an­ti­bod­ies; Ca­balet­ta inks pact with Ar­ti­san

→ Switzerland’s Numab Therapeutics has added Boehringer Ingelheim to its roster of collaborators. And they will start with two projects aiming at developing new drugs for difficult-to-treat lung and gastrointestinal cancers and patients with geographic atrophy. “Numab’s technology platform fits well with our internal antibody discovery and engineering capabilities and will enhance our efforts to deliver transformative antibody-based therapeutics to patients,” said Paige Mahaney, an SVP at Boehringer Ingelheim.

David Hallal

AlloVir tests how much an an­tivi­ral biotech can reap in a pan­dem­ic stock mar­ket

The pandemic stock market has proven fruitful for virtually any type of biotech. Now a 7-year-old cell therapy startup will see how much it can yield for a company that specializes in fighting viruses.

AlloVir, a company that until 2019 largely lived off grant money, has filed for a $100 million IPO to back its line of off-the-shelf, virus-fighting T cells. Although in normal circumstances, $100 million could be a solid return for a biotech that got its first major round of funding only last year, we’ll have to wait to see how much the company ultimately earns. As Covid-19 has sent investor money scurrying to almost anyone in drug development, every single biotech to go public this year has prized above their midpoint or upsized their offering, according to Renaissance Capital, sometimes dramatically so.

Take­da’s post-merg­er deals con­tin­ue as OTC sub­sidiary is pre­pared for sale

Takeda has been burdened under mountains of debt since acquiring Shire for $62 billion 18 months ago, but one of the company’s biggest moves yet to relieve the stress could be on the horizon.

The Japanese pharma is preparing a bidding war for its $3.7 billion over-the-counter subsidiary, a sale that would dwarf previous spinoffs. Any transaction would be the latest in what’s been a long string of sell-offs, as Takeda marches unflinchingly toward its ultimate goal of shedding $10 billion in assets.

Cel­lec­tis slammed af­ter pa­tient dies and FDA slaps a hold on their tri­al for an off-the-shelf CAR-T for mul­ti­ple myelo­ma

Cellectis was slammed after the market close on Monday as the biotech reported that the FDA demanded it hit the brakes on their MELANI-01 trial for their off-the-shelf cell therapy UCARTCS1A after one of the patients in the study died of treatment-related cardiac arrest.

The multiple myeloma patient had previously been treated unsuccessfully with various therapies, noted the biotech, and had been given dose level two (DL2) of their allogeneic CAR-T.

Endpoints News

Keep reading Endpoints with a free subscription

Unlock this story instantly and join 84,800+ biopharma pros reading Endpoints daily — and it's free.