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

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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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.

Dave Lennon, former president of Novartis Gene Therapies

Zol­gens­ma patent spat brews be­tween No­var­tis and Re­genxbio as top No­var­tis gene ther­a­py ex­ec de­parts

Regenxbio, a small licensor of gene therapy viral vectors spun out from the University of Pennsylvania, is now finding itself in the middle of some major league patent fights.

In addition to a patent suit with Sarepta Therapeutics from last September, Novartis, is now trying to push its smaller partner out of the way. The Swiss biopharma licensed Regenxbio’s AAV9 vector for its $2.1 million spinal muscular atrophy therapy Zolgensma.

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Den­mark's Gubra to col­lab­o­rate with Bay­er on pep­tides; Sam­sung and Bio­gen re­ceive FDA ap­proval for Lu­cen­tis biosim­i­lar

Danish biotech Gubra announced a research collaboration and license agreement with Bayer to develop peptide therapeutics to treat cardiorenal diseases. The collaboration will utilize Gubra’s peptide drug discovery platform to identify potential candidates.

This is not the first time Gubra has partnered with a company on peptide therapeutics — they partnered with Boehringer Ingelheim back in 2017 to create peptide therapeutics to treat obesity.

Volker Wagner (L) and Jeff Legos

As Bay­er, No­var­tis stack up their ra­dio­phar­ma­ceu­ti­cal da­ta at #ES­MO21, a key de­bate takes shape

Ten years ago, a small Norwegian biotech by the name of Algeta showed up at ESMO — then the European Multidisciplinary Cancer Conference 2011 — and declared that its Bayer-partnered targeted radionuclide therapy, radium-223 chloride, boosted the overall survival of castration-resistant prostate cancer patients with symptomatic bone metastases.

In a Phase III study dubbed ALSYMPCA, patients who were treated with radium-223 chloride lived a median of 14 months compared to 11.2 months. The FDA would stamp an approval on it based on those data two years later, after Bayer snapped up Algeta and christened the drug Xofigo.

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Rafaèle Tordjman (Jeito Capital)

Con­ti­nu­ity and di­ver­si­ty: Rafaèle Tord­j­man's women-led VC firm tops out first fund at $630M

For a first-time fund, Jeito Capital talks a lot about continuity.

Rafaèle Tordjman had spotlighted that concept ever since she started building the firm in 2018, promising to go the extra mile(s) with biotech entrepreneurs while pushing them to reach patients faster.

Coincidentally, the lack of continuity was one of the sore spots listed in a report about the European healthcare sector published that same year by the European Investment Bank — whose fund is one of the LPs, alongside the American pension fund Teacher Retirement System of Texas and Singapore’s Temasek, to help Jeito close its first fund at $630 million (€534 million). As previously reported, Sanofi had chimed in €50 million, marking its first investment in a French life sciences fund.

Mi­rati tri­umphs again in KRAS-mu­tat­ed lung can­cer with a close­ly watched FDA fil­ing now in the cards

After a busy weekend at #ESMO21, which included a big readout for its KRAS drug adagrasib in colon cancer, Mirati Therapeutics is ready to keep the pressure on competitor Amgen with lung cancer data that will undergird an upcoming filing.

In topline results from a Phase II cohort of its KRYSTAL-1 study, adagrasib posted a response rate of 43% in second-line-or-later patients with metastatic non-small cell lung cancer containing a KRAS-G12C mutation, Mirati said Monday.

Ex­elix­is pulls a sur­prise win in thy­roid can­cer just days ahead of fi­nal Cabome­tyx read­out

Exelixis added a thyroid cancer indication to its super-seller Cabometyx’s label on Friday — months before the FDA was expected to make a decision, and days before the company was set to unveil the final data at #ESMO21.

At a median follow-up of 10.1 months, differentiated thyroid cancer patients treated with Cabometyx (cabozantinib) lived a median of 11 months without their disease worsening, compared to just 1.9 months for patients given a placebo, Exelixis said on Monday.