Peter Thiel, Getty (Photographer: Kiyoshi Ota/Bloomberg)

Pe­ter Thiel's psy­che­delics-fo­cused ATAI ac­quires ma­jor­i­ty stake in Recog­ni­fy and its lead schiz­o­phre­nia can­di­date

Bil­lion­aire Pe­ter Thiel has made sig­nif­i­cant and some­times con­tro­ver­sial push­es in­to life sci­ences over the past few years, and one of his star­tups out of Berlin has made a new ac­qui­si­tion less than two months af­ter achiev­ing uni­corn sta­tus.

ATAI Life Sci­ences pur­chased a ma­jor­i­ty stake Tues­day in Recog­ni­fy Life Sci­ences, a com­pa­ny fo­cused on de­vel­op­ing treat­ments for cog­ni­tive im­pair­ment as­so­ci­at­ed with schiz­o­phre­nia. The fi­nan­cial terms of the deal weren’t dis­closed, but the ac­qui­si­tion fol­lows up a $125 mil­lion Se­ries C in No­vem­ber co-led by Thiel, lead­ing to a post-mon­ey val­u­a­tion of about $1 bil­lion for ATAI.

Recog­ni­fy adds to ATAI’s port­fo­lio of com­pa­nies with psy­che­del­ic and non-psy­che­del­ic ap­proach­es to men­tal health dis­or­ders, in­clud­ing de­pres­sion, anx­i­ety and ad­dic­tion. Tues­day’s deal cen­ters around Recog­ni­fy’s lead pro­gram, RL-007, a small mol­e­cule that the com­pa­ny says can mod­u­late three mech­a­nisms cen­tral to learn­ing and mem­o­ry: the cholin­er­gic, NM­DA and GA­BA type B re­cep­tor sys­tems.

“We’re fo­cused on CNS and with­in CNS men­tal health in­di­ca­tions, and we’re not lim­it­ed to ad­dic­tion, de­pres­sion, anx­i­ety, but will holis­ti­cal­ly ex­plore any­thing cat­e­go­rized in the DSM-5,” ATAI CEO Flo­ri­an Brand told End­points News. “[Schiz­o­phre­nia] is very much in our wheel­house.”

Srini­vas Rao

ATAI has com­plet­ed sev­en Phase I and two Phase II stud­ies for RL-007, but the ma­jor­i­ty of these were re­lat­ed to pain in di­a­bet­ic neu­ropa­thy, CSO Srini­vas Rao told End­points News. Three of those stud­ies demon­strat­ed im­prove­ments in ver­bal learn­ing and mem­o­ry, ATAI said, in­clud­ing in a large Phase II study of sub­jects with pe­riph­er­al neu­ro­path­ic pain.

The plan go­ing for­ward, Rao said, is to try to ex­tend the re­sults seen in these ear­li­er stud­ies and see if the com­pound’s mech­a­nism can be fur­ther es­tab­lished. Recog­ni­fy had in­clud­ed sec­ondary end­points in cog­ni­tive per­for­mance in their neu­ro­path­ic pain stud­ies, in­clud­ing a chal­lenge study in healthy vol­un­teers with the mo­tion-sick­ness drug scopo­lamine, and ATAI’s goal is to pur­sue those sig­nals in an open-la­bel tri­al ex­pect­ed to launch ear­ly this year.

“We have a bio­mark­er we can use, which are these EEG pa­ra­me­ters,” Rao said. “There were par­tic­u­lar phe­nom­e­na not­ed in the scopo­lamine chal­lenge, ba­si­cal­ly that slows down the fre­quen­cies in your EEG; that’s some­thing seen in folks with schiz­o­phre­nia. So that’s one of the first things we want to see, can you ac­tu­al­ly in­crease the fre­quen­cy … which would be con­sis­tent with pro-cog­ni­tive ef­fects.”

ATAI got start­ed back in 2018 as R&D in­ter­est — and in­vestor fund­ing — in psy­che­delics picked back up to see if the field could prove fruit­ful in men­tal-health con­di­tions. The area had been large­ly aban­doned since the des­ig­na­tion of psy­che­del­ic mol­e­cules as con­trolled sub­stances in the 1970s and sub­se­quent crack­down, but a group of re­searchers has been dip­ping their toes to try to en­gi­neer new ver­sions of those com­pounds.

Tues­day’s ac­qui­si­tion comes about five months af­ter ATAI picked up Em­path­Bio, which is ad­vanc­ing a new MD­MA treat­ment for PTSD. Though that out­fit is far from the clin­ic, ATAI hopes its can­di­dates have bet­ter pro­files than those in ear­li­er re­search where sci­en­tists had to ad­min­is­ter vari­a­tions of the par­ty drug over mul­ti­ple days, in fa­cil­i­ties where pa­tients had to be su­per­vised by trained pro­fes­sion­als for hours.

Thiel, who made his for­tune from co-found­ing Pay­Pal and mak­ing the first out­side in­vest­ment in Face­book, has been busy as well. He joined a $35.4 mil­lion Se­ries B for Pep­ti­log­ics, a pep­tide drug de­sign and de­vel­op­ment biotech, in De­cem­ber, and hopped on­to the board of Eli Lil­ly part­ner Ab­Cellera one month ear­li­er.

Health­care Dis­par­i­ties and Sick­le Cell Dis­ease

In the complicated U.S. healthcare system, navigating a serious illness such as cancer or heart disease can be remarkably challenging for patients and caregivers. When that illness is classified as a rare disease, those challenges can become even more acute. And when that rare disease occurs in a population that experiences health disparities, such as people with sickle cell disease (SCD) who are primarily Black and Latino, challenges can become almost insurmountable.

Jacob Van Naarden (Eli Lilly)

Ex­clu­sives: Eli Lil­ly out to crash the megablock­buster PD-(L)1 par­ty with 'dis­rup­tive' pric­ing; re­veals can­cer biotech buy­out

It’s taken 7 years, but Eli Lilly is promising to finally start hammering the small and affluent PD-(L)1 club with a “disruptive” pricing strategy for their checkpoint therapy allied with China’s Innovent.

Lilly in-licensed global rights to sintilimab a year ago, building on the China alliance they have with Innovent. That cost the pharma giant $200 million in cash upfront, which they plan to capitalize on now with a long-awaited plan to bust up the high-price market in lung cancer and other cancers that have created a market worth tens of billions of dollars.

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So what hap­pened with No­var­tis' gene ther­a­py group? Here's your an­swer

Over the last couple of days it’s become clear that the gene therapy division at Novartis has quietly undergone a major reorganization. We learned on Monday that Dave Lennon, who had pursued a high-profile role as president of the unit with 1,500 people, had left the pharma giant to take over as CEO of a startup.

Like a lot of the majors, Novartis is an open highway for head hunters, or anyone looking to staff a startup. So that was news but not completely unexpected.

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Who are the women su­per­charg­ing bio­phar­ma R&D? Nom­i­nate them for this year's spe­cial re­port

The biotech industry has faced repeated calls to diversify its workforce — and in the last year, those calls got a lot louder. Though women account for just under half of all biotech employees around the world, they occupy very few places in C-suites, and even fewer make it to the helm.

Some companies are listening, according to a recent BIO survey which showed that this year’s companies were 2.5 times more likely to have a diversity and inclusion program compared to last year’s sample. But we still have a long way to go. Women represent just 31% of biotech executives, BIO reported. And those numbers are even more stark for women of color.

David Meek, new Mirati CEO (Marlene Awaad/Bloomberg via Getty Images)

Fresh off Fer­Gene's melt­down, David Meek takes over at Mi­rati with lead KRAS drug rac­ing to an ap­proval

In the insular world of biotech, a spectacular failure can sometimes stay on any executive’s record for a long time. But for David Meek, the man at the helm of FerGene’s recent implosion, two questionable exits made way for what could be an excellent rebound.

Meek, most recently FerGene’s CEO and a past head at Ipsen, has become CEO at Mirati Therapeutics, taking the reins from founding CEO Charles Baum, who will step over into the role of president and head of R&D, according to a release.

Jay Bradner (Jeff Rumans for Endpoints News)

Div­ing deep­er in­to in­her­it­ed reti­nal dis­or­ders, No­var­tis gob­bles up an­oth­er bite-sized op­to­ge­net­ics biotech

Right about a year ago, a Novartis team led by Jay Bradner and Cynthia Grosskreutz at NIBR swooped in to scoop up a Cambridge, MA-based opthalmology gene therapy company called Vedere. Their focus was on a specific market niche: inherited retinal dystrophies that include a wide range of genetic retinal disorders marked by the loss of photoreceptor cells and progressive vision loss.

But that was just the first deal that whet their appetite.

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When ef­fi­ca­cy is bor­der­line: FDA needs to get more con­sis­tent on close-call drug ap­provals, agency-fund­ed re­search finds

In the exceedingly rare instances in which clinical efficacy is the only barrier to a new drug’s approval, new FDA-funded research from FDA and Stanford found that the agency does not have a consistent standard for defining “substantial evidence” when flexible criteria are used for an approval.

The research comes as the FDA is at a crossroads with its expedited-review pathways. The accelerated approval pathway is under fire as the agency recently signed off on a controversial new Alzheimer’s drug, with little precedent to explain its decision. Meanwhile, top officials like Rick Pazdur have called for a major push to simplify and clarify all of the various expedited pathways, which have grown to be must-haves for sponsors of nearly every newly approved drug.

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Lat­est news: It’s a no on uni­ver­sal boost­ers; Pa­tient death stuns gene ther­a­py field; In­side Tril­li­um’s $2.3B turn­around; and more

Welcome back to Endpoints Weekly, your review of the week’s top biopharma headlines. Want this in your inbox every Saturday morning? Current Endpoints readers can visit their reader profile to add Endpoints Weekly. New to Endpoints? Sign up here.

Next week is shaping up to be a busy one, as our editor-in-chief John Carroll and managing editor Kyle Blankenship lead back-to-back discussions with a great group of experts to discuss the weekend news and trends. John will be spending 30 minutes with Jake Van Naarden, the CEO of Lilly Oncology, and Kyle has a brilliant panel lined up: Harvard’s Cigall Kadoch, Susan Galbraith, the new head of cancer R&D at AstraZeneca, Roy Baynes at Merck, and James Christensen at Mirati. Don’t miss out on the action — sign up here.

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FDA hands ac­cel­er­at­ed nod to Seagen, Gen­mab's so­lo ADC in cer­vi­cal can­cer, but com­bo stud­ies look even more promis­ing

Biopharma’s resident antibody-drug conjugate expert Seagen has scored a clutch of oncology approvals in recent years, finding gold in what are known as “third-gen” ADCs. Now, another of their partnered conjugates is ready for prime time.

The FDA on Monday handed an accelerated approval to Seagen and Genmab’s Tivdak (tisotumab vedotin-tftv, or “TV”) in second-line patients with recurrent or metastatic cervical cancer who previously progressed after chemotherapy rather than PD-(L)1 systemic therapy, the companies said in a release.