Pe­ter Thiel-backed ATAI launch­es new Salvia-fo­cused biotech; Pur­due bank­rupt­cy tri­al ex­pect­ed to be­gin to­day — re­port

ATAI Life Sci­ences, the Pe­ter Thiel-backed um­brel­la de­vel­op­er of psy­che­delics and oth­er drugs for men­tal health con­di­tions, launched a new port­fo­lio com­pa­ny Thurs­day.

The new out­fit is called Re­vix­ia Life Sci­ences, and its mis­sion is to bring the main ac­tive in­gre­di­ent in Salvia to the clin­ic for treat­ment-re­sis­tant de­pres­sion, sub­stance use dis­or­der and pain, ATAI an­nounced Thurs­day morn­ing. The in­gre­di­ent in ques­tion is called Salvi­norin A, and Re­vix­ia says it’s a non-ni­troge­nous ag­o­nist of the kap­pa-opi­oid re­cep­tor.

“Due to SalA’s short psy­che­del­ic ef­fect, it will be an at­trac­tive op­tion for those who would like psy­che­del­ic treat­ment but are un­will­ing or un­able to par­tic­i­pate in longer ses­sions,” said Re­vix­ia CEO Glenn Short in a state­ment. “The short­er ex­pe­ri­ence will al­low for more prac­ti­cal ad­min­is­tra­tion and mon­i­tor­ing, which may even make it pos­si­ble to at­tend psy­chother­a­py ses­sions on the same day.”

Salvia has his­tor­i­cal­ly seen use by the Maza­tec peo­ple in Oax­a­ca, Mex­i­co to treat a va­ri­ety of ill­ness­es like di­ar­rhea and headaches, Re­vix­ia said in its re­lease. The com­pa­ny’s the­o­ry is that Salvi­norin A can in­di­rect­ly in­flu­ence the cannabi­noid sys­tem with­out in­ter­act­ing with the 5-HT2A sero­tonin re­cep­tor — the main tar­get for hal­lu­cino­gens such as DMT and psilo­cy­bin.

Re­vix­ia plans to pair the drug with a dig­i­tal ther­a­peu­tic be­ing de­vel­oped by an­oth­er ATAI com­pa­ny, and clin­i­cal tri­als are ex­pect­ed to be­gin in the sec­ond half of 2022. — Max Gel­man

Pur­due bank­rupt­cy tri­al ex­pect­ed to be­gin Thurs­day — re­port

The Sack­ler fam­i­ly, who found­ed Oxy­con­tin pro­duc­er Pur­due Phar­ma decades ago, are re­port­ed­ly near­ing the end of their own­er­ship tenure.

A bank­rupt­cy tri­al is ex­pect­ed to be­gin for the fam­i­ly Thurs­day, Bloomberg re­port­ed, in which the Sack­lers are ex­pect­ed to ask to pay $4.5 bil­lion over nine to 10 years in ex­change for life­time im­mu­ni­ty from a range of opi­oid-re­lat­ed law­suits. Their pro­pos­al, which val­ues Pur­due at $10 bil­lion, would al­so in­volve hand­ing over the busi­ness.

The tri­al is ex­pect­ed to last 11 days.

Pur­due filed for bank­rupt­cy in 2019 af­ter fac­ing the law­suits, and signed a guilty plea back in Oc­to­ber 2020. Their bank­rupt­cy plan has been round­ly crit­i­cized as too lit­tle resti­tu­tion for Pur­due’s role in the opi­oid epi­dem­ic that has plagued the US for years. — Max Gel­man

Jun­shi, Co­herus nab BTD sta­tus for the lat­est PD-1 to near an FDA OK

Shang­hai-based Jun­shi is be­ing re­ward­ed for tak­ing on front­line cas­es of na­sopha­ryn­geal car­ci­no­ma with its PD-1 drug tori­pal­imab. The Chi­nese biotech and its US part­ner Co­herus have nabbed break­through ther­a­py des­ig­na­tion for the drug, which would put it on a path to be­ing the lat­est in a grow­ing swarm of PD-(L)1 play­ers on the mar­ket.

Co­herus came up with a $1.1 bil­lion pack­age to in-li­cense the drug ear­li­er this year. Now the two part­ners can ex­pect ex­pe­dit­ed treat­ment at the FDA, which has be­come an ex­pert at re­view­ing these check­point treat­ments.

This is Jun­shi’s sec­ond BTD. The FDA had ear­li­er laid out the red car­pet for tori­pal­imab monother­a­py for pa­tients with re­cur­rent or metasta­t­ic NPC with dis­ease pro­gres­sion on or af­ter plat­inum-con­tain­ing chemother­a­py.

“We are pleased to have re­ceived break­through ther­a­py des­ig­na­tion for our nov­el PD-1 block­ing an­ti­body, tori­pal­imab, for na­sopha­ryn­geal car­ci­no­ma, which is an ag­gres­sive can­cer with no im­muno-on­col­o­gy treat­ment op­tions ap­proved in the Unit­ed States,” said Pa­tri­cia Kee­gan, the CMO of Jun­shi Bio­sciences. — John Car­roll

Au­to­lus re­port­ed­ly plan­ning new $90M head­quar­ters

The British biotech Au­to­lus Ther­a­peu­tics could soon find it­self a new head­quar­ters.

Lo­cal of­fi­cials in Steve­nage, Eng­land, are re­port­ed­ly ex­pect­ed to meet next week to dis­cuss plans for al­low­ing Au­to­lus to build a new cen­tral of­fice for about $90 mil­lion. The space would be built on an old car park and have near­ly 7,000 square feet of lab­o­ra­to­ry and oth­er of­fice ar­eas, per a Hert­ford­shire Mer­cury re­port.

Plans for the space were sub­mit­ted in June with the hopes of cre­at­ing a new life sci­ences cen­ter in the area.

The news of the head­quar­ter up­grade comes about 10 days af­ter Au­to­lus signed on to a new part­ner­ship with Mod­er­na, giv­ing the Covid-19 vac­cine mak­er ex­clu­sive rights to four mR­NA-based im­muno-on­col­o­gy can­di­dates us­ing pro­pri­etary bind­ing tech from Au­to­lus. — Max Gel­man

Biotech Half­time Re­port: Af­ter a bumpy year, is biotech ready to re­bound?

The biotech sector has come down firmly from the highs of February as negative sentiment takes hold. The sector had a major boost of optimism from the success of the COVID-19 vaccines, making investors keenly aware of the potential of biopharma R&D engines. But from early this year, clinical trial, regulatory and access setbacks have reminded investors of the sector’s inherent risks.

RBC Capital Markets recently surveyed investors to take the temperature of the market, a mix of specialists/generalists and long-only/ long-short investment strategies. Heading into the second half of the year, investors mostly see the sector as undervalued (49%), a large change from the first half of the year when only 20% rated it as undervalued. Around 41% of investors now believe that biotech will underperform the S&P500 in the second half of 2021. Despite that view, 54% plan to maintain their position in the market and 41% still plan to increase their holdings.

Covid-19 vac­cine boost­ers earn big thumbs up, but Mod­er­na draws ire over world sup­ply; What's next for Mer­ck’s Covid pill?; The C-suite view on biotech; 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.

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No­var­tis de­vel­op­ment chief John Tsai: 'We go deep in the new plat­form­s'

During our recent European Biopharma Summit, I talked with Novartis development chief John Tsai about his experiences over the 3-plus years he’s been at the pharma giant. You can read the transcript below or listen to the exchange in the link above.

John Carroll: I followed your career for quite some time. You’ve had more than 20 years in big pharma R&D and you’ve obviously seen quite a lot. I really was curious about what it was like for you three and a half years ago when you took over as R&D chief at Novartis. Obviously a big move, a lot of changes. You went to work for the former R&D chief of Novartis, Vas Narasimhan, who had his own track record there. So what was the biggest adjustment when you went into this position?

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Amit Etkin, Alto Neuroscience CEO (Alto via Vimeo)

A star Stan­ford pro­fes­sor leaves his lab for a start­up out to re­make psy­chi­a­try

About five years ago, Amit Etkin had a breakthrough.

The Stanford neurologist, a soft-spoken demi-prodigy who became a professor while still a resident, had been obsessed for a decade with how to better define psychiatric disorders. Drugs for depression or bipolar disorder didn’t work for many patients with the conditions, and he suspected the reason was how traditional diagnoses didn’t actually get at the heart of what was going on in a patient’s brain.

Susan Galbraith, Executive VP, Oncology R&D, AstraZeneca

As­traZeneca on­col­o­gy R&D chief Su­san Gal­braith: 'Y­ou're go­ing to need or­thog­o­nal com­bi­na­tion­s'


Earlier in the week we broadcast our 4th annual European Biopharma Summit with a great lineup of top execs. One of the one-on-one conversations I set up was with Susan Galbraith, the oncology research chief at AstraZeneca. In a wide-ranging discussion, Galbraith reviewed the cancer drug pipeline and key trends influencing development work at the pharma giant. You can watch the video, above, or stick with the script below. — JC

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Roche's Tecen­triq cross­es the fin­ish line first in ad­ju­vant lung can­cer, po­ten­tial­ly kick­ing off gold rush

While falling behind the biggest PD-(L)1 drugs in terms of sales, Roche has looked to carve out a space for its Tecentriq with a growing expertise in lung cancer. The drug will now take an early lead in the sought-after adjuvant setting — but competitors are on the way.

The FDA on Friday approved Tecentriq as an adjuvant therapy for patients with Stage II-IIIA non small cell lung cancer with PD-(L)1 scores greater than or equal to 1, making it the first drug of its kind approved in an early setting that covers around 40% of all NSCLC patients.

FDA ad­comm to de­cide on mol­nupi­ravir EUA; Can­cer at­las un­veils new po­ten­tial drug tar­get

The FDA has another adcomm coming down the pipeline — this time on Covid-19 oral antiviral molnupiravir.

The federal agency’s advisory committee will meet on November 30th to go over Merck and Ridgeback’s EUA request for their investigational antiviral drug, and discuss the available data supporting its use in Covid-19 patients.

This comes two weeks after Merck claimed that their antiviral pill reduced the chance that newly diagnosed Covid-19 patients would be hospitalized or die by 50%. The pharma made the announcement after interim data on 775 patients in their clinical trial showed the antiviral’s potential.

FDA ad­comm votes unan­i­mous­ly in sup­port of a J&J Covid-19 boost­er two months af­ter one-dose shot

The FDA’s Vaccines and Related Biological Products Advisory Committee (VRBPAC) on Friday voted 19-0 in favor of authorizing a second shot of J&J’s Covid-19 vaccine to follow at least two months after the initial dose.

Regulators don’t have to follow VRBPAC’s recommendation, but they almost always do. Considering that the CDC’s advisory committee has already been set to review the expanded EUA, VRBPAC’s recommendation is likely to be adopted.

Rahul Singhvi, Resilience CEO

A Bob Nelsen start­up turns to Har­vard to help sharp­en its tech, in­spir­ing first spin­out

One of Bob Nelsen’s latest projects is headed to Harvard.

Resilience, a company started with the goal of establishing itself as a “one-stop-shop” for companies looking to scale manufacturing, including for hard-to-develop cell and gene therapies, is less than a year old. Friday, it announced a five-year R&D deal with Harvard University that includes $30 million to develop biologics, including vaccines, nucleic acids and cell and gene therapies.