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.

Bob Nelsen (Photo by Michael Kovac/Getty Images)

With stars aligned and cash in re­serve, Bob Nelsen's Re­silience plans a makeover at 2 new fa­cil­i­ty ad­di­tions to its drug man­u­fac­tur­ing up­start

Bob Nelsen’s new, state-of-the-art drug manufacturing initiative is taking shape.

Just 3 months after gathering $800 million of launch money, a dream team board and a plan to shake up a field where he found too many bottlenecks and inefficiencies for the era of Covid-19, Resilience has snapped up a pair of facilities now in line for a retooling.

The company has acquired a 310,000-square-foot plant in Boston from Sanofi along with a 136,000-square-foot plant in Ontario to add to a network which CEO Rahul Singhvi says is just getting started on building his company’s operations up. The Sanofi deal comes with a contract to continue manufacturing one of its drugs.

Endpoints News

Keep reading Endpoints with a free subscription

Unlock this story instantly and join 102,300+ biopharma pros reading Endpoints daily — and it's free.

Amit Munshi, Arena

One of Are­na's top drugs flops in a PhI­Ib study for IBS pain. But re­searchers tease out a pos­si­ble path for­ward as CEO ex­plores 's­trate­gic op­tion­s'

Four years ago, when Arena CEO Amit Munshi cut its ties to a troubled weight drug and doubled down on the pipeline, a cannabinoid receptor 2 agonist figured prominently in the biotech’s future. On Tuesday evening, however, Munshi’s high hopes for the drug took a nasty hit after it failed a Phase IIb study for patients with irritable bowel syndrome pain.

Put through a randomized pace with 273 patients, researchers said it flat failed the primary endpoint among the large group with abdominal pain. But they quickly went on to highlight subgroup data, always a tricky and controversial ploy, where they spotlighted a positive p value for patients with moderate to severe pain who received the high dose of the drug — one of 3 provided in the study.

Ab­b­Vie tees up a biotech buy­out af­ter siz­ing up their Parkin­son's drug spun out of Ke­van Shokat's lab

AbbVie has teed up a small but intriguing biotech buyout after looking over the preclinical work it’s been doing in Parkinson’s disease.

The company is called Mitokinin, a Bay Area biotech spun out of the lab of UCSF’s Kevan Shokat, whose scientific explorations have formed the academic basis of a slew of startups in the biotech hub. One of Shokat’s PhD students in the lab, Nicholas Hertz, co-founded Mitokinin using their lab work on PINK1 suggesting that amping up its activity could play an important role in regulating the mitochondrial dysfunction contributing to Parkinson’s disease pathogenesis and progression.

Endpoints News

Keep reading Endpoints with a free subscription

Unlock this story instantly and join 102,300+ biopharma pros reading Endpoints daily — and it's free.

UP­DAT­ED: Mer­ck pulls Keytru­da in SCLC af­ter ac­cel­er­at­ed nod. Is the FDA get­ting tough on drug­mak­ers that don't hit their marks?

In what could be an early shot in the battle against drugmakers that whiff on confirmatory studies to support accelerated approvals, the FDA ordered Bristol Myers Squibb late last year to give up Opdivo’s approval in SCLC. Now, Merck is next on the firing line — are we seeing the FDA buckling down on post-marketing offenders?

Merck has withdrawn its marketing approval for PD-(L)1 inhibitor Keytruda in metastatic small cell lung cancer as part of what it describes as an “industry-wide evaluation” by the FDA of drugs that do not meet the post-marketing checkpoints on which their accelerated nods were based, the company said Monday.

Endpoints News

Keep reading Endpoints with a free subscription

Unlock this story instantly and join 102,300+ biopharma pros reading Endpoints daily — and it's free.

Pascal Soriot, AstraZeneca CEO (AP Images)

Pas­cal So­ri­ot cash­es in As­traZeneca’s chips on Mod­er­na for $1.2B cash in­jec­tion

While still working to prove its own Covid-19 vaccine, AstraZeneca has reportedly capitalized on the success of another.

The company has sold off its 7.7% stake in Moderna and turned it into $1.2 billion in cash, according to the Times, beefing up the reserves just as Pascal Soriot is wrapping up his $39 billion acquisition of Alexion and its rare disease pipeline.

AstraZeneca’s stock sale follows a similar move by Merck in December. But like its pharma brethren, the British giant is keeping its R&D collaborations with Moderna.

Endpoints News

Keep reading Endpoints with a free subscription

Unlock this story instantly and join 102,300+ biopharma pros reading Endpoints daily — and it's free.

Af­ter bail­ing on Covid-19 vac­cines, Mer­ck will team up with J&J to pro­duce its shot as part of un­usu­al Big Phar­ma pact

Merck took a big gamble when it opted to jump into the Covid-19 vaccine race late, and made an equally momentous decision to back out in late January. Now, looking to chip in on the effort, Merck reportedly agreed to team up with one of the companies that has already crossed the finish line.

President Joe Biden on Tuesday is expected to announce a partnership between drugmakers Merck and Johnson & Johnson to jointly produce J&J’s recombinant protein Covid-19 vaccine that received the FDA’s emergency use authorization Saturday, the Washington Post reported.

Paul Sekhri

The next big biotech su­per­star? Paul Sekhri has some thoughts on that

It occasionally occurs to Paul Sekhri that if they pull this off, his company will be on the front page of the New York Times and a lead story in just about every major news outlet on the planet. He tries not to dwell on it, though.

“I just want to be laser-focused on getting to that point,” Sekhri says, before acknowledging, “Yes, it absolutely crossed my mind.”

Sekhri, a longtime biopharma executive with tenures at Sanofi and Novartis, is now entering year three as CEO of eGenesis, the biotech that George Church protégé Luhan Yang founded to genetically alter pigs so that they can be used for organ transplants. He led them through one megaround and has just closed another, raising $125 million from 17 different investors to push the first-ever (humanized) pig to human transplants into the clinic.

Endpoints News

Keep reading Endpoints with a free subscription

Unlock this story instantly and join 102,300+ biopharma pros reading Endpoints daily — and it's free.

David Chang, WuXi AppTec

A 'love sto­ry': WuXi AppTec wraps UK-based CRO in­to its cell and gene ther­a­py unit

When WuXi AppTec, one of China’s largest contract research organizations, started working with UK-based Oxgene about a year ago, it was “love at first sight,” CEO David Chang jokes.

Oxgene, a roughly decade-old CRO focused on scalable gene therapy tech, began licensing some of their plasmid work to WuXi just over a year ago. And when that pilot went well, WuXi expressed interest in investing, Oxgene CEO Ryan Cawood said.

Fi­bro­Gen shares skid low­er as a sur­prise ad­comm rais­es risks on roxa OK

FibroGen will likely have to delay its US rollout for roxadustat once again.

In an unexpected move, the FDA is convening its Cardiovascular and Renal Drugs Advisory Committee to review the NDA in an advisory committee meeting. The date is yet to be confirmed.

Just a few weeks ago, SVB Leerink analyst Geoffrey Porges predicted that the roxa approval could come ahead of the PDUFA date on March 20 — effusive despite already being let down once by the FDA’s extension of its review back in December. AstraZeneca, which is partnered with FibroGen on the chronic kidney disease-related anemia drug, disclosed regulators had requested further clarifying analyses of clinical data.