Lars Christian Wilde, Compass co-founder and CBO (via YouTube)

Mush­room mag­ic draws $80M in­jec­tion for Lon­don-based men­tal health start­up

The coro­n­avirus out­break has in­ter­fered with a mid-stage de­pres­sion tri­al test­ing its psilo­cy­bin com­pound, but the mag­ic of the mush­room has scored Pe­ter Thiel-backed Com­pass Path­ways an $80 mil­lion in­jec­tion in fresh fund­ing.

Ex­as­per­at­ed with the of­ten-in­ef­fec­tive ex­ist­ing slate of an­ti­de­pres­sants, the com­pa­ny set up shop in Lon­don in 2016 and made a bee­line for psilo­cy­bin, the psy­choac­tive in­gre­di­ent in mag­ic mush­rooms. It re­ceived the FDA break­through ther­a­py sta­tus for the com­pound for treat­ment-re­sis­tant de­pres­sion in 2018.

The study, de­signed to re­cruit 216 pa­tients across sites in North Amer­i­ca and Eu­rope, had be­gun re­cruit­ing when the coro­n­avirus out­break un­fold­ed. “We de­cid­ed to — with the Covid cri­sis — pause the study for now, un­til there’s bet­ter vis­i­bil­i­ty on how the world will de­vel­op,” said co-founder and chief busi­ness of­fi­cer Lars Chris­t­ian Wilde in an in­ter­view. “The pos­i­tive news is that we have a huge num­ber of pa­tients that have com­plet­ed pre-screen­ing and we’re ready to start over again when the world nor­mal­izes.”

Psilo­cy­bin is a sub­stance that in most re­gions is clas­si­fied as hav­ing no med­i­c­i­nal val­ue, falling in the same cat­e­go­ry as chem­i­cals such as LSD. The com­pa­ny’s man-made ver­sion of the chem­i­cal — which is il­le­gal across ge­o­gra­phies in its nat­ur­al fun­gi form — had been well-tol­er­at­ed in an ear­ly-stage, place­bo-con­trolled tri­al in 89 healthy vol­un­teers in De­cem­ber.

“I think one thing that stands out not on­ly in our healthy vol­un­teer’s study but al­so in the ear­li­er tri­als, is that typ­i­cal­ly pa­tients re­port a deep sense of grate­ful­ness for the ex­pe­ri­ence, a re­con­tex­tu­al­iza­tion of their suf­fer­ing, and of­ten­times in­sight in­to how and what led them to be­come de­pressed, and al­so see­ing so­lu­tions on how to over­come their de­pres­sion,” said Wilde, who claimed that one ses­sion with mag­ic mush­rooms had cured his anx­i­ety dis­or­der and de­pres­sion, which led to the cre­ation of Com­pass along with his co-founders.

The new fund­ing round in­clud­ed the par­tic­i­pa­tion of ATAI Life Sci­ences (al­so co-found­ed by Wilde); as well as new in­vestors, in­clud­ing the Mc­Quade Cen­ter for Strate­gic Re­search and De­vel­op­ment (a mem­ber of the glob­al Ot­su­ka fam­i­ly of phar­ma­ceu­ti­cal com­pa­nies), Founders Fund, Able Part­ners, Cam­den Part­ners Nexus, Per­cep­tive Ad­vi­sors, Skyviews Life Sci­ence, and Soleus Cap­i­tal.

Giv­en glob­al spikes in al­co­hol con­sump­tion and symp­toms of lone­li­ness due to iso­la­tion mea­sures, in the coro­n­avirus era men­tal health treat­ments are need­ed now more than ever, Wilde said, not­ing that the plan was to orig­i­nal­ly raise $70 mil­lion.

Psy­choac­tive in­gre­di­ents, whether de­rived from cannabis, LSD or mag­ic mush­rooms, have long cap­ti­vat­ed men­tal health re­searchers. Nav­i­gat­ing the com­plex le­gal hur­dles to ac­cess these com­pounds has thawed the pace of re­search but with mo­ti­vat­ed sci­en­tists and a grow­ing bur­den of poor­ly treat­ed men­tal health con­di­tions, the ecosys­tem of psy­che­del­ic re­search has ex­plod­ed. In Sep­tem­ber, Johns Hop­kins un­veiled it had scored $17 mil­lion to open its very own cen­ter of psy­che­del­ic re­search to ex­plore the im­pact of psy­che­del­ic com­pounds on cre­ativ­i­ty and well-be­ing.

But the brim­ming en­thu­si­asm comes with a healthy dose of skep­ti­cism. Crit­ics wor­ry that the bur­geon­ing re­search could in­cen­tivize un­bri­dled use of non-phar­ma­ceu­ti­cal ver­sions of these drugs and that clin­i­cal tri­al da­ta could be cloud­ed by the fact that place­bo-con­trolled stud­ies are not nec­es­sar­i­ly dou­ble-blind­ed, be­cause it is far too easy to de­ter­mine which group of pa­tients have been giv­en a place­bo.

In a bid to com­bat some of these chal­lenges, the mid-stage tri­al has three arms — eval­u­at­ing a 1 mg, 10 mg and 25 mg dose of psilo­cy­bin.

“Based on ear­li­er clin­i­cal work at Johns Hop­kins, and we’re very con­fi­dent that the 1 mg dose doesn’t have any sub­jec­tive ef­fects and for the pa­tient, but the ben­e­fit of such a de­sign is that we can at least deal with ex­pectan­cy bias — every pa­tient will re­ceive no­tice that they will re­ceive psilo­cy­bin,” Wilde said, adding that the com­pa­ny is al­so us­ing blind­ed raters, who have not par­tak­en in the ther­a­py ses­sion.

Cell and Gene Con­tract Man­u­fac­tur­ers Must Em­brace Dig­i­ti­za­tion

The Cell and Gene Industry is growing at a staggering 30% CAGR and is estimated to reach $14B by 20251. A number of cell, gene and stem cell therapy sponsors currently have novel drug substances and products and many rely on Contract Development Manufacturing Organizations (CDMO) to produce them with adherence to stringent regulatory cGMP conditions. Cell and gene manufacturing for both autologous (one to one) and allogenic (one to many) treatments face difficult issues such as: a complex supply chain, variability on patient and cellular level, cell expansion count and a tight scheduling of lot disposition process. This complexity affects quality, compliance and accountability in the entire vein-to-vein process for critically ill patients.

Phase III read­outs spell dis­as­ter for Genen­tech’s lead IBD drug

Roche had big plans for etrolizumab. Eyeing a hyper-competitive IBD and Crohn’s market where they have not historically been a player, the company rolled out 8 different Phase III trials, testing the antibody for two different uses across a range of different patient groups.

On Monday, Roche released results for 4 of those studies, and they mark a decided setback for both the Swiss pharma and their biotech sub Genentech, potentially spelling an end to a drug they put over half-a-decade and millions of dollars behind.

DFC CEO Adam Boehler and Kodak CEO Jim Continenza (Kodak)

Covid-19 roundup: Cure­Vac beefs up its uni­corn IPO dreams as bil­lion­aire own­er takes this Covid-19 mR­NA play­er on a forced march to Nas­daq; Ko­dak's $765M deal is put on hold

When CureVac initially jotted down $100 million for its IPO raise a couple of weeks ago, it seemed small. The German mRNA player, after all, had jumped into a Covid-19 race that swelled the sails of Moderna and BioNTech by tens of billions. And after raising $640 million in a slate of deals, $100 million in a hot market like this seemed like a pittance in the bigger scheme of things.

Today, we got a look at a figure that probably comes closer to the game-changing number the top execs probably have in mind. Selling 15.3 million shares at the high end of their $14 to $16 range would net a $243 million bounty. Majority owner Dietmar Hopp is putting in another €100 million, bringing the total to around $350 million. And what are the chances they want to do even better than that?

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Vi­da Ven­tures co-leads Dyne's $115M megaround for next-gen oli­go ther­a­pies aimed square­ly at mus­cles

Dyne Therapeutics started out last April with a modest $50 million to mine targeted muscle disease therapies from its in-house conjugate technology. The biotech has now convinced more investors that it’s got gems on its hands, closing $115 million in fresh financing to push its next-gen oligonucleotide drugs into the clinic.

Vida Ventures and Surveyor Capital led the round, joined by a group of other new backers including Wellington Management Company, Logos Capital and Franklin Templeton.

Eric Shaff (Seres)

UP­DAT­ED: Af­ter a 4-year so­journ, strug­gling mi­cro­bio­me pi­o­neer Seres claims a break­out PhI­II come­back. And shares re­spond in fren­zied spike

Almost exactly 4 years ago, Seres Therapeutics $MCRB experienced one of those soul-crunching failures that can raise big questions about a biotech’s future. Out front in their pursuit of a gut punch to C. difficile infection (CDI), the Phase II test was a flat failure, and investors wiped out a billion dollars of equity value that never returned in the years that followed.

Seres, though, pressed ahead, changing out CEOs a year ago — bidding Merck vet Roger Pomerantz farewell from the C suite — and pushing through a Phase III, hoping that amping up the dosage would make the key difference. And this morning, they unveiled a claim that they had aced the Phase III and positioned themselves for a run at a landmark FDA OK.

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Eli Lil­ly teams with Pieris on HER2+ tu­mors; Op­di­vo + Yer­voy best chemo in mesothe­lioma

Despite the FDA putting a partial clinical hold on its lead program only a few weeks ago, Boston-based Pieris Pharmaceuticals is plowing forward with a new collaboration.

Pieris will work with Eli Lilly to further advance studies on PRS-343, a 4-1BB/HER2 bispecific for HER2-positive tumors, in combination with the latter’s ramucirumab and paclitaxel for the second-line treatment of patients with HER2-positive gastric cancer in a single-arm, Phase II study.

In­novent and Eli Lil­ly chal­lenge Mer­ck­'s mega-block­buster Keytru­da in non-small cell lung can­cer field

China-based Innovent Biologics and its multinational ally Eli Lilly shared Phase III evidence that their PD-1 inhibitor combo can delay the progression of nonsquamous non-small cell lung cancer.

But the drugmakers will face stiff competition in China from Merck’s Keytruda, the ruling PD-1 which is already approved to treat both squamous and nonsquamous NSCLC and boasts positive overall survival rates.

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Anap­tys­Bio's etokimab pro­vides more dis­ap­point­ing re­sults, rais­ing ques­tions about com­pound's fu­ture

The lead program for AnaptysBio’s in-house pipeline has hit another setback.

Etokimab, an IL-33 inhibitor, did not achieve statistically significant improvement in a Phase II trial for patients suffering from chronic rhinosinusitis with nasal polyps. Researchers measured the individuals’ bilateral nasal polyps score and sino-nasal outcome test, finding that neither improved upon a placebo after both four- and eight-week time markers, though they did demonstrate improvement over baseline levels of the examinations.

Gallia Levy, Spark CMO (Roche)

Spark Ther­a­peu­tics nabs new CMO from Genen­tech, fill­ing a ma­jor post-merg­er de­par­ture

Spark Therapeutics is getting a new CMO from their new owners.

The gene therapy company-turned-subsidiary has named Gallia Levy, who had been running rare blood disorders — including clinical development for their blockbuster-potential hemophilia antibody Hemlibra for Roche’s big biotech sub Genentech — to run medical affairs.

The appointment is a fitting one. Roche spent $4.8 billion to acquire Spark last year in large part to get their hands on their hemophilia gene therapy, SPK-8011, and expand the toe-hold Hemlibra gave them in an crowded hemophilia space.  It’s also a somewhat ironic appointment: The FTC held up the Spark acquistions for nearly a year, reportedly over concerns about the anti-trust implications of Roche owning both a top chronic treatment in Hemlibra and a top one-time treatment in Spark’s gene therapy.

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