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.

2023 Spot­light on the Fu­ture of Drug De­vel­op­ment for Small and Mid-Sized Biotechs

In the context of today’s global economic environment, there is an increasing need to work smarter, faster and leaner across all facets of the life sciences industry.  This is particularly true for small and mid-sized biotech companies, many of which are facing declining valuations and competing for increasingly limited funding to propel their science forward.  It is important to recognize that within this framework, many of these smaller companies already find themselves resource-challenged to design and manage clinical studies themselves because they don’t have large teams or in-house experts in navigating the various aspects of the drug development journey. This can be particularly challenging for the most complex and difficult to treat diseases where no previous pathway exists and patients are urgently awaiting breakthroughs.

Kristen Hege, Bristol Myers Squibb SVP, early clinical development, oncology/hematology and cell therapy (Illustration: Assistant Editor Kathy Wong for Endpoints News)

Q&A: Bris­tol My­er­s' Kris­ten Hege on cell ther­a­py, can­cer pa­tients and men­tor­ing the next gen­er­a­tion

Kristen Hege leads Bristol Myers Squibb’s early oncology discovery program carrying on from the same work at Celgene, which was acquired by BMS in 2019. She’s known for her early work in CAR-T, having pioneered the first CAR-T cell trial for solid tumors more than 25 years ago.

However, the eminent physician-scientist is more than just a drug developer mastermind. She’s also a practicing physician, mother to two young women, an avid backpacker and intersecting all those interests — a champion of young women and people of color in STEM and life sciences.

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Eisai and METAvivor plan to debut the latest 'This is MBC' campaign at the San Antonio Breast Cancer Symposium (SABCS).

Ei­sai re-ups metasta­t­ic breast can­cer aware­ness cam­paign with strik­ing pa­tient pho­tographs

Eisai is debuting the newest ads in its long-running “This is MBC” campaign this week. In what’s become an annual tradition, Eisai and metastatic breast cancer advocacy partner METAvivor will show the striking photographs of people living with metastatic breast cancer first at the San Antonio Breast Cancer Symposium (SABCS).

The new “Imagine” campaign features 12 patients photographed around waterfalls to symbolize that same kind of sudden drop into a pool that MBC causes in a person’s life, said Beth Fairchild, co-founder of #CancerCulture who was the president of METAvivor six years ago when the campaign began. Fairchild, who is living with MBC, has helped create all of the annual “This is MBC” campaigns.

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Pfiz­er and BioN­Tech look to toss Mod­er­na patent suit, call­ing claims 'unen­force­able'

Pfizer and BioNTech took a swing at Moderna’s Covid-19 patent claims in Massachusetts federal court on Monday, calling them “invalid,” “overbroad” and “unenforceable.”

The defendants also filed counterclaims against the Cambridge, MA-based biotech, seeking a dismissal of the case, recovery of court fees and an official judgment invalidating Moderna’s claims.

Moderna sued Pfizer and BioNTech back in August, alleging that the partners’ Covid-19 vaccine Comirnaty copied parts of Moderna’s vaccine technology patented before the pandemic, when it was developing an mRNA vaccine for MERS, another respiratory illness.

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Gossamer Bio CEO Faheem Hasnain at Endpoints' #BIO22 panel (J.T. MacMillan Photography for Endpoints News)

Gos­samer’s Fa­heem Has­nain de­fends a round of pos­i­tive PAH da­ta as a clear win. But can these PhII re­sults stand up to scruti­ny?

Gossamer Bio $GOSS posted a statistically significant improvement for its primary endpoint in the key Phase II TORREY trial for lead drug seralutinib on Tuesday morning. But CEO Faheem Hasnain has some explaining to do on the important secondary of the crucial six-minute walk distance test — which will be the primary endpoint in Phase III — as the data on both endpoints fell short of expectations, missing one analyst’s bar on even modest success.

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Rick Modi, Affinia Therapeutics CEO

Ver­tex-part­nered gene ther­a­py biotech Affinia scraps IPO plans

Affinia Therapeutics has ditched its plans to go public in a relatively closed-door market that has not favored Nasdaq debuts for the drug development industry most of this year. A pandemic surge in 2020 and 2021 opened the doors for many preclinical startups, which caught Affinia’s attention and gave the gene therapy biotech confidence in the beginning days of 2022 to send in its S-1.

But on Friday, Affinia threw in the S-1 towel and concluded now is not the time to step onto Wall Street. The biotech has put out few public announcements since the spring of this year. Endpoints News picked the startup as one of its 11 biotechs to watch last year.

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Bob Duggan, Summit Therapeutics co-CEO

Bounc­ing from ma­jor set­back, Sum­mit hands out $500M cash for can­cer drug — thanks to a loan from bil­lion­aire CEO

After hitting a dead end with Summit Therapeutics’ lead program, Bob Duggan has found the drug that he believes will usher into a compelling second act. So compelling, in fact, that it involves $500 million cash — and he’s taking money out of his own pocket to fund the deal.

Striking a partnership with Akeso Therapeutics out of China, Summit is bringing in a bispecific antibody that blocks both PD-1 and VEGF called ivonescimab. Akeso, which has a PD-1/CTLA-4 bispecific approved in China, has already taken ivonescimab into multiple clinical trials, including a Phase III in lung cancer.

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Glen­mark hit with warn­ing let­ter over pro­ce­dures, qual­i­ty con­trol is­sues at In­dia man­u­fac­tur­ing plant

The generics producer Glenmark Pharmaceuticals has been handed a warning letter by US regulators.

The letter, which was sent to the manufacturer on Nov. 22, noted issues from an inspection over the summer at Glenmark’s facility in the town of Colvale, India, in the state of Goa.

According to the letter, the FDA found that Glenmark’s investigation of rejected batches of drugs “failed to extend to other batches, dosage strengths, and drug products.” The warning letter also noted that the site had failed to establish “adequate written procedures” for production and process control to ensure drugs have the correct strength, quality and purity.

Klick Health is lighting the way, literally, this holiday season to encourage connection for lonely seniors in long-term care facilities.

Klick Health an­nu­al hol­i­day spot­light se­nior lone­li­ness and the pow­er of con­nec­tion

Every year Klick Health leans into a cause for the holidays, and this year it’s highlighting the sometimes lonely season for seniors. So Klicksters, as employees call themselves, decided to brighten one nursing home community in hopes of inspiring others to do the same.

Klick literally lit up the Tony Stacey Centre for Veterans Care, a long-term care home in Toronto where 75% of residents receive no visitors during the holiday season. The agency brought staff and family along with lighting crews and musicians for a “Light the Way” event, creating a video of the experience debuting on Tuesday.

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