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.

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While oncology researchers have long pursued the potential of cellular immunotherapies for the treatment of cancer, it was unclear whether these therapies would ever reach patients due to the complexity of manufacturing and costs of development. Fortunately, the recent successful development and regulatory approval of chimeric antigen receptor-engineered T (CAR-T) cells have demonstrated the significant benefit of these therapies to patients.

Stéphane Bancel, Moderna CEO

'This is not go­ing to be good': Mod­er­na CEO Ban­cel warns of a 'ma­te­r­i­al drop' in vac­cine ef­fi­ca­cy as Omi­cron spreads

Even as public health officials remain guarded about their comments on the likelihood Omicron will escape the reach of the currently approved Covid-19 vaccines, there’s growing scientific consensus that we’re facing a variant that threatens to overwhelm the vaccine barricades that have been erected.

Stéphane Bancel, the CEO of Moderna, one of the leading mRNA players whose quick vault into the markets with a highly effective vaccine created an instant multibillion-dollar market, added his voice to the rising chorus early Tuesday. According to Bancel, there will be a significant drop in efficacy when the average immune system is confronted by Omicron. The only question now is: How much?

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Philip Dormitzer, new GSK global head of vaccines R&D

Glax­o­SmithK­line poach­es Pfiz­er's vi­ral vac­cines lead in rush to cap­i­tal­ize on fu­ture of mR­NA

GlaxoSmithKline has appointed Philip Dormitzer, formerly chief scientific officer of Pfizer’s viral vaccines unit, as its newest global head of vaccines R&D, looking to leverage one of the leading minds behind Pfizer and BioNTech’s RNA collaboration that led to Covid-19 jab Comirnaty, the British drug giant said Tuesday.

Dormitzer had been with Pfizer for a little more than six years, joining up after a seven-year stint with Novartis, where he reached the role of US head of research and head of global virology for the company’s vaccines and diagnostics unit.

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In­tro­duc­ing End­points Stu­dio, a new way to ad­ver­tise with End­points-craft­ed brand­ing cam­paigns

Since our start in 2016, Endpoints has grown fast while executing our mission to cover biopharma’s most critical developments for industry pros worldwide. As readership has grown, our advertising business has too. Endpoints advertising partners support the mission and engage their desired audiences through announcements on our email and web platforms, brand recognition in our event coverage and sponsorships of Endpoints daily and weekly reports.

Tillman Gerngross (Adagio)

Till­man Gern­gross on Omi­cron: 'It is a grim sit­u­a­tion...we’re go­ing to see a sig­nif­i­cant drop in vac­cine ef­fi­ca­cy'

Tillman Gerngross, the rarely shy Dartmouth professor, biotech entrepreneur and antibody expert, has been warning for over a year that the virus behind Covid-19 would likely continue to mutate, potentially in ways that avoid immunity from infection and the best defenses scientists developed. He spun out a company, Adagio, to build a universal antibody, one that could snuff out any potential mutation.

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In­cor­po­rat­ing Ex­ter­nal Da­ta in­to Clin­i­cal Tri­als: Com­par­ing Dig­i­tal Twins to Ex­ter­nal Con­trol Arms

Most drug development professionals are familiar with the nerve-racking wait for the read-out of a large trial. If it’s negative, is the investigational therapy ineffective? Or could the failure result from an unforeseen flaw in the design or execution of the protocol, rather than a lack of efficacy? The team could spend weeks analyzing data, but a definitive answer may be elusive due to insufficient power for such analyses in the already completed trial. These problems are only made worse if the trial had lower enrollment, or higher dropout than expected due to an unanticipated event like COVID-19. And if a trial is negative, the next one is likely to be larger and more costly — if it happens at all.

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After years as the top spending pharma TV advertiser, AbbVie’s Humira brand finally downshifted earlier this year, ceding much of its marketing budget to up-and-coming sibling meds Skyrizi and Rinvoq. However, now Humira is back on TV with ads for another condition — Hidradenitis suppurativa (HS).

The chronic and painful skin condition results in lumps and abscesses caused by inflammation or infection of sweat glands, most often in the armpits or groin. Humira was first approved to treat HS in 2015 and remains the only FDA-approved drug for the condition. Two TV ads both note more than 30,000 people with HS have been prescribed Humira.

As lead drug runs in­to a wall, De­ci­phera slims down its pipeline, puts 140 jobs on the chop­ping block

Barely a month after disappointing data shattered hopes for a major label expansion for the GI tumor drug Qinlock, Deciphera is making a major pivot — scrapping development plans for that drug and discarding another while it hunkers down and focuses on two remaining drugs in the pipeline.

As a result, 140 of its staffers will be laid off.

The restructuring, which claims the equivalent of 35% of its total workforce, will take place across all departments including commercial, R&D as well as general and administrative support functions, Deciphera said, as it looks to streamline Qinlock-related commercial operations in the US while concentrating only on a “select number of key European markets.”

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FDA can­cels ODAC meet­ing this week to re­view two more dan­gling ac­cel­er­at­ed ap­provals — but won't ex­plain why

The FDA’s Oncologic Drugs Advisory Committee has decided to cancel a planned meeting on Thursday to discuss two cancer drugs that previously won accelerated approvals but failed to confirm clinical benefit in required follow-up trials or have taken a long time to finish those trials.

The FDA said in a statement that the meeting “is no longer needed” but did not offer further detail on why exactly it was canceled, telling Endpoints News to contact the companies. Attempts to contact both Secura Bio and Acrotech went unreturned. The companies may have decided to pull these treatments from the market, or they’ve come to new agreements with the agency on their confirmatory trials.