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.

Tar­get­ing a Po­ten­tial Vul­ner­a­bil­i­ty of Cer­tain Can­cers with DNA Dam­age Re­sponse

Every individual’s DNA is unique, and because of this, every patient responds differently to disease and treatment. It is astonishing how four tiny building blocks of our DNA – A, T, C, G – dictate our health, disease, and how we age.

The tricky thing about DNA is that it is constantly exposed to damage by sources such as ultraviolet light, certain chemicals, toxins, and even natural biochemical processes inside our cells.¹ If ignored, DNA damage will accumulate in replicating cells, giving rise to mutations that can lead to premature aging, cancer, and other diseases.

Steve Cutler, Icon CEO (Icon)

In the biggest CRO takeover in years, Icon doles out $12B for PRA Health Sci­ences to fo­cus on de­cen­tral­ized clin­i­cal work

Contract research M&A had a healthy run in recent years before recently petering out. But with the market ripe for a big buyout and the Covid-19 pandemic emphasizing the importance of decentralized trials, Wednesday saw a tectonic shift in the CRO world.

Icon, the Dublin-based CRO, will acquire PRA Health Sciences for $12 billion in a move that will shake up the highest rungs of a fragmented market. The merger would combine the 5th- and 6th-largest CROs by 2020 revenue, according to Icon, and the merger will set the newco up to be the second-largest global CRO behind only IQVIA.

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Fol­low biotechs go­ing pub­lic with the End­points News IPO Track­er

The Endpoints News team is continuing to track IPO filings for 2021, and we’ve designed a new tracker page for the effort.

Check it out here: Biopharma IPOs 2021 from Endpoints News

You’ll be able to find all the biotechs that have filed and priced so far this year, sortable by quarter and listed by newest first. As of the time of publishing on Feb. 25, there have already been 16 biotechs debuting on Nasdaq so far this year, with an additional four having filed their S-1 paperwork.

Tom Barnes (Orna)

The mR­NA era is here. MPM be­lieves the fu­ture be­longs to oR­NA — and Big Phar­ma wants a seat at the ta­ble

If the ultra-fast clinical development of Covid-19 vaccines opened the world’s eyes to the promises of messenger RNA, the subsequent delays in supply offered a crash course on the ultra-complex process of producing them. Even before the formulation and fill-finish steps, mRNA is the precious end product from an arduous journey involving enzyme-aided transcription, modification and purification.

For Bristol Myers Squibb, Novartis Institutes for Biomedical Research, Gilead’s Kite and Astellas, it’s time to rethink the way therapeutic RNA is engineered.

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Ken Frazier, Merck CEO (Bess Adler/Bloomberg via Getty Images)

UP­DAT­ED: Mer­ck takes a swing at the IL-2 puz­zle­box with a $1.85B play for buzzy Pan­dion and its au­toim­mune hope­fuls

When Roger Perlmutter bid farewell to Merck late last year, the drugmaker perhaps best known now for sales giant Keytruda signaled its intent to take a swing at early-stage novelty with the appointment of discovery head Dean Li. Now, Merck is signing a decent-sized check to bring an IL-2 moonshot into the fold.

Merck will shell out roughly $1.85 billion for Pandion Pharmaceuticals, a biotech hoping to gin up regulatory T cells (Tregs) to treat a range of autoimmune disorders, the drugmaker said Thursday.

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S&P ex­pects steady ero­sion in Big Phar­ma's cred­it pro­file in 2021 as new M&A deals roll in — but don't un­der­es­ti­mate their un­der­ly­ing strength

S&P Global has taken a look at the dominant forces shaping the pharma market and come to the conclusion that there will be more downgrades than upgrades in 2021 — the 8th straight year of steady decline.

But it’s not all bad news. Some things are looking up, and there’s still plenty of money to be made in an industry that enjoys a 30% to 40% profit margin, once you factor in steep R&D expenses.

Tal Zaks, Moderna CMO (AP Photo/Rodrique Ngowi, via still image from video)

CMO Tal Zaks bids Mod­er­na a sur­prise adieu as biotech projects $18.4B in rev­enue, plots post-Covid ex­pan­sion

How do you exit a company after six years in style? Developing one of the most lucrative and life-saving products in pharma history is probably not the worst way to go.

Tal Zaks, Moderna’s CMO since 2015, will leave the mRNA biotech in September, the biotech disclosed in their annual report this morning. The company has already retained the recruitment firm Russell Reynolds to find a replacement.

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Glax­o­SmithK­line re­thinks strat­e­gy for Covid-19 an­ti­body — not the Vir ones — af­ter tri­al flop. Is there hope in high-risk pa­tients?

In the search for a better Covid-19 therapeutic, GlaxoSmithKline and Vir have partnered up on two antibodies they hope have a chance. GSK is also testing its own in-house antibody, and early results may have shut the door on its widespread use.

A combination of GSK’s monoclonal antibody otilimab plus standard of care couldn’t best standard of care alone in preventing death and respiratory failure in hospitalized Covid-19 patients after 28 days, according to data from the Phase IIa OSCAR study unveiled Thursday.

Photo: Shutterstock

Bio­phar­ma's suc­cess rate in bring­ing drugs to mar­ket has long been abysmal. Can new tools help rewrite that trou­bled past?

In 2011, a team of researchers at British drugmaker AstraZeneca had a problem they were looking to solve.

For years, drug discovery and development were a wasteland for innovation. Novel drugs largely fell into one of two categories — monoclonal antibodies and small molecules — and new therapeutic modalities were hard to come by. After a rush of promising approvals in the late 1990s — including then-Biogen’s CD20 targeting antibody breakthrough Rituxan — the field stagnated and attrition rates stayed sky-high. What exactly is the industry doing wrong? AstraZeneca asked itself.

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