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.

Mi­no­ryx and Sper­o­genix ink an ex­clu­sive li­cense agree­ment to de­vel­op and com­mer­cial­ize lerigli­ta­zone in Chi­na

September 23, 2020 – Hong Kong, Beijing, Shanghai (China) and Mataró, Barcelona (Spain)  

Minoryx will receive an upfront and milestone payments of up to $78 million, as well as double digit royalties on annual net sales 

Sperogenix will receive exclusive rights to develop and commercialize leriglitazone for the treatment of X-linked adrenoleukodystrophy (X-ALD), a rare life-threatening neurological condition

President Trump walks past HHS secretary Alex Azar (Getty Images)

Azar falls in line un­der Trump again. Ex­perts say he's re­in­forc­ing a dark sig­nal sent to the FDA

In the latest incident where Alex Azar has steadfastly taken the side of President Donald Trump over that of the FDA, the HHS secretary was noncommittal this morning when asked if he supports the attempt by his subordinates at the FDA to strengthen guidelines for a vaccine EUA.

Appearing on NBC’s Today Show, the HHS secretary muddied the waters, stating that the guidance that matters is the one that is “actually already out there.”

CDC’s Robert Redfield, NIAID’s Anthony Fauci, Admiral Brett Giroir at HHS, and FDA’s Stephen Hahn prepare to testify at a House hearing on June 23 (Getty)

'Ex­treme­ly po­lit­i­cal' — Trump neuters FDA's at­tempt to strength­en vac­cine EUA

Stephen Hahn went before a Senate committee Wednesday and declared he’s fighting. “Every one of the decisions we have reached has been made by career FDA scientists based on science and data, not politics,” he exclaimed, adding that “FDA will not permit any pressure from anyone to change that. I will fight for science.”

A few hours later, he was undermined by President Donald Trump when a reporter asked if he was okay with stricter vaccine guidelines that the FDA was said to be cooking up. “That has to be approved by the White House. We may or may not approve it. That sounds like a political move,” he decided.

New York governor Andrew Cuomo (AP Images)

An­drew Cuo­mo says New York will un­der­take its own vac­cine re­view process, and wouldn’t rec­om­mend trust­ing the fed­er­al gov­ern­ment

The concerns keep mounting over President Donald Trump’s politicization of the FDA and other federal agencies guiding the development of a safe and effective vaccine. And today, the telegenic New York governor Andrew Cuomo appeared to introduce even more politics into the matter — latest in an ongoing series of incidents that have cast the proudly independent FDA in starkly political terms.

During his daily press conference Cuomo said that the state will review any coronavirus vaccines approved by the federal government, citing a lack of trust of the Trump administration. The announcement comes one day after Trump accused the FDA of making an “extremely political” move in proposing stricter vaccine guidance.

Covid-19 roundup: Op­er­a­tion Warp Speed's 7th vac­cine is live at­ten­u­at­ed; Small biotech touts big suc­cess where gi­ants have failed

Operation Warp Speed is stacking its vaccine portfolio with a “TBD” new candidate: a live attenuated vaccine that can be administered in a single dose, potentially as an oral formulation rather than an injection.

Sound familiar?

That could be because the unannounced candidate appears to match the profile of an inoculation being developed by Merck, according to Bloomberg, which first reported the development based on a presentation by Moncef Slaoui.

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On­ly five months af­ter a Se­ries A launch, Taysha goes pub­lic with $157M IPO

As has been the trend in 2020, Taysha Gene Therapies has become the latest biotech to make a quick ascent from a small, privately-funded company to enjoying its very own Nasdaq ticker.

The Dallas-based biotech raised $157 million for its IPO after pricing shares at $20 apiece Thursday, the high-point of its expected range. Initially pegging $100 million in financing, Taysha offered a little less than 8 million shares and will trade under the $TSHA symbol.

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David Berry (Flagship)

Flag­ship's next big tech­no­log­i­cal bet? The cloud

Earlier this month, Flagship announced their big bet on the software half the industry is talking about, launching the AI and machine learning startup. Now, they and a couple other investors are gambling $100 million on a software that much of the public generally thinks of as a cool, IT afterthought: cloud computing.

The idea, says founder and Flagship partner David Berry, is one of scale: The sheer magnitude of biological data that you can store on cloud technology is unprecedented. And that size, when leveraged properly, can allow you to ask questions and form insights that are similarly unprecedented.

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PhII Alzheimer's fail­ure deals new blow to Roche, AC Im­mune — but the tau hy­poth­e­sis is far from dead

The leading anti-tau antibody has failed its first Phase II testing, casting a shadow on a popular target (just trailing amyloid beta) for Alzheimer’s disease.

Roche and AC Immune are quick to acknowledge disappointment in the topline readout, which suggested that semorinemab did not reduce cognitive decline among patients with early Alzheimer’s disease, who are either just starting to have symptoms or have mild manifestations.

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Covid-19 roundup: J&J be­gins piv­otal Phase III tri­al for vac­cine; Con­tro­ver­sial hu­man chal­lenge tri­als to be­gin in Lon­don — re­port

Johnson & Johnson announced it’s beginning a pivotal Phase III trial for its Covid-19 candidate, JNJ-78436735 — the first single-dose vaccine in this stage.

The Phase III trial, dubbed ENSEMBLE, will enroll 60,000 patients worldwide, making it the largest Phase III study of a Covid-19 vaccine to date. J&J said the candidate achieved positive interim results in a Phase I/IIa study, which will be published “imminently.” There’s a possibility that the first batches will be ready for potential emergency use in early 2021, according to the company.

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