Toad ven­om to treat de­pres­sion? RA Cap­i­tal wa­gers $125M on lat­est psy­che­del­ic biotech

Can an in­haled ver­sion of the psy­che­del­ic known as ‘toad ven­om’ be used to treat tough-to-crack de­pres­sion? For GH Re­search, that’s the $125 mil­lion ques­tion.

The Dublin-based biotech an­nounced Mon­day it closed a Se­ries B round to help ad­vance its lead pro­gram, an in­halant called GH001, for psy­chi­atric and neu­ro­log­i­cal dis­or­ders. GH is be­gin­ning with treat­ment-re­sis­tant de­pres­sion and has two as-yet-undis­closed in­di­ca­tions on tap.

Mon­day’s round was co-led RA Cap­i­tal and RTW In­vest­ments, along with ex­ist­ing in­vestor BVF Part­ners. GH de­clined to com­ment be­yond its press re­lease.

The drug in ques­tion is a sci­en­tif­ic mouth­ful — 5-Methoxy-N, N-di­methyl­trypt­a­mine is the of­fi­cial name — but is more com­mon­ly re­ferred to as 5-MeO-DMT or slangi­ly as toad ven­om, due to its pres­ence in a cer­tain toad species na­tive to the south­west­ern US and north­west­ern Mex­i­co. It can al­so be de­rived from plants or made syn­thet­i­cal­ly, with the plant ver­sion used as an en­theogen in some parts of Cen­tral and South Amer­i­ca.

Per a 2018 VICE News re­port, the psy­che­del­ic saw a rapid rise in pop­u­lar­i­ty in the mid-2010s among those try­ing to achieve the ‘ego death’ phe­nom­e­non, in which re­searchers be­lieve the part of the brain re­spon­si­ble for one’s sense of self shuts down tem­porar­i­ly. The drug saw heavy in­ter­est from users on Red­dit and YouTube, VICE re­port­ed, who en­gaged in an “arms race” to boast about their ex­pe­ri­ences get­ting high.

Psy­che­delics-fo­cused biotechs have seen a surge in in­vestor in­ter­est in re­cent years, most no­tably sur­round­ing the Pe­ter Thiel-backed ATAI Life Sci­ences. That com­pa­ny us­es a unique busi­ness mod­el for de­vel­op­ing ther­a­peu­tics cov­er­ing a range of men­tal health dis­or­ders by bring­ing port­fo­lio com­pa­nies un­der one um­brel­la.

Though ATAI has more than 13 pro­grams de­vel­op­ing drugs, GH is much more nar­row­ly fo­cused on its 5-MeO-DMT work. So far, GH001 has com­plet­ed a Phase I study in healthy vol­un­teers, the com­pa­ny said. Re­sults showed GH001 was well-tol­er­at­ed, and it’s now in a Phase I/II tri­al in pa­tients with treat­ment-re­sis­tant de­pres­sion.

The biotech is al­so work­ing on an in­jectable for­mu­la­tion of 5-MeO-DMT, which they are call­ing GH002 and for which they’re al­so keep­ing po­ten­tial in­di­ca­tions close to the vest.

Treat­ment-re­sis­tant de­pres­sion oc­curs in pa­tients who see lit­tle to no suc­cess with an­ti­de­pres­sants or psy­chother­a­py, ac­cord­ing to the Mayo Clin­ic. Symp­toms can range from mild to se­vere and there’s gen­er­al­ly not a sin­gle ap­proach that works for every pa­tient.

In ad­di­tion to RA Cap­i­tal and RTW In­vest­ments, oth­er new in­vestors in­clud­ed Acu­ta Cap­i­tal Part­ners, Box­er Cap­i­tal, Cor­morant As­set Man­age­ment, Deer­field Man­age­ment Com­pa­ny, Lo­gos Cap­i­tal, Sur­vey­or Cap­i­tal, Ven­rock Health­care Cap­i­tal Part­ners and Veri­tion Fund Man­age­ment.

At the In­flec­tion Point for the Next Gen­er­a­tion of Can­cer Im­munother­a­py

While oncology researchers have long pursued the potential of cellular immunotherapies for the treatment of cancer, it was unclear whether these therapies would ever reach patients due to the complexity of manufacturing and costs of development. Fortunately, the recent successful development and regulatory approval of chimeric antigen receptor-engineered T (CAR-T) cells have demonstrated the significant benefit of these therapies to patients.

All about Omi­cron; We need more Covid an­tivi­rals; GSK snags Pfiz­er’s vac­cine ex­ec; Janet Wood­cock’s fu­ture at FDA; and more

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Lisa Deschamps, AviadoBio CEO

Ex-No­var­tis busi­ness head hops over to a gene ther­a­py start­up — and she's reeled in $80M for a dash to the clin­ic

Neurologist and King’s College London professor Christopher Shaw has been researching neurodegenerative diseases like ALS and collaborating with drugmakers for the last 25 years in the hopes of pushing new therapies forward. But unfortunately, none of those efforts have come anywhere close to fruition.

“So, you know, after 20 years in the game, I said, ‘Let’s try and do it ourselves,’” he told Endpoints News. 

Merck's new antiviral molnupiravir (Quality Stock Arts / Shutterstock)

As Omi­cron spread looms, oral an­tivi­rals ap­pear to be one of the best de­fens­es — now we just need more

After South African scientists reported a new Covid-19 variant — dubbed Omicron by the WHO — scientists became concerned about how effective vaccines and monoclonal antibodies might be against it, which has more than 30 mutations in the spike protein.

“I think it is super worrisome,” Dartmouth professor and Adagio co-founder and CEO Tillman Gerngross told Endpoints News this weekend. Moderna CEO Stéphane Bancel echoed similar concerns, telling the Financial Times that experts warned him, “This is not going to be good.”

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Radek Spisek, Sotio CEO (Cellestia)

A qui­et Czech biotech bags $315M to dri­ve its blos­som­ing can­cer pipeline through the clin­ic

In the rather insular world of biotech, most innovation inevitably comes from a cluster of R&D hubs — Cambridge, San Francisco, etc. But sometimes success stories sprout from rocky soil, which is most certainly the case with Prague-based Sotio Biotech and its suddenly jam-packed pipeline of cancer drugs.

After years in quiet development, Sotio now has $315 million in new funds to play with from parent company PPF Group, an investment group founded in the Czech Republic, as the biotech looks to advance its growing pipeline through early- and mid-stage trials.

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In­cor­po­rat­ing Ex­ter­nal Da­ta in­to Clin­i­cal Tri­als: Com­par­ing Dig­i­tal Twins to Ex­ter­nal Con­trol Arms

Most drug development professionals are familiar with the nerve-racking wait for the read-out of a large trial. If it’s negative, is the investigational therapy ineffective? Or could the failure result from an unforeseen flaw in the design or execution of the protocol, rather than a lack of efficacy? The team could spend weeks analyzing data, but a definitive answer may be elusive due to insufficient power for such analyses in the already completed trial. These problems are only made worse if the trial had lower enrollment, or higher dropout than expected due to an unanticipated event like COVID-19. And if a trial is negative, the next one is likely to be larger and more costly — if it happens at all.

Ab­b­Vie tacks on a new warn­ing to Rin­voq la­bel as safe­ty frets crimp JAK class

The safety problems that continue to plague the JAK class as new data highlight some severe side effects are casting a large shadow over AbbVie’s Rinvoq.

As a result of a recent readout highlighting major adverse cardiac events (MACE), malignancy, mortality and thrombosis with Xeljanz a couple of months ago, AbbVie put out a notice late Friday afternoon that it is adding the new class risks to its label for their rival drug.

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Biospec­i­men M&A: Dis­cov­ery ac­quires Al­bert Li's he­pa­to­cyte project; PhI­II tri­al on Bay­er's Nube­qa reached pri­ma­ry end­point

Discovery Life Sciences has acquired what claims to be the Maryland-based host of the world’s largest hepatocyte inventory, known as IVAL, to help researchers select more effective and safer drug candidates in the future.

The combined companies will now serve a wider range of drug research and development scientists, according to Albert Li, who founded IVAL in 2004 and is set to join the Discovery leadership team as the CSO of pharmacology and toxicology.

Pfiz­er, Am­gen and Janssen seek fur­ther clar­i­ty on FDA's new ben­e­fit-risk guid­ance

Three top biopharma companies are seeking more details from the FDA on how the agency conducts its benefit-risk assessments for new drugs and biologics.

While Pfizer, Amgen and Janssen praised the agency for further spelling out its thinking on the subject in a new draft guidance, including a discussion of patient experience data as part of the assessment, the companies said the FDA could’ve included more specifics in the 20-page draft document.

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