Jonathan Sporn, Gilgamesh CEO

The Har­vard sci­en­tist act­ing as ATAI's trea­sure trove launch­es a new psy­che­delics firm fo­cused on drug 'ana­logues'

A for­mer Har­vard and NIH sci­en­tist is re­turn­ing to the psy­che­delics field with a new biotech af­ter sell­ing his last ef­fort to the buzzy ATAI Life Sci­ences.

Gil­gamesh Phar­ma­ceu­ti­cals com­plet­ed its $27 mil­lion Se­ries A on Thurs­day, the com­pa­ny an­nounced, with plans to use the cash to prep four pro­grams for INDs and con­tin­ue ex­pand­ing its lead­er­ship team. The biotech is led by CEO Jonathan Sporn, and it’s not his first rodeo in psy­che­delics.

Sporn pre­vi­ous­ly found­ed Per­cep­tion Neu­ro­science, fo­cus­ing on R-ke­t­a­mine for treat­ment-re­sis­tant de­pres­sion, and sold it to ATAI in ear­ly 2019. Per­cep­tion’s can­di­date is in ear­ly hu­man tests and is among the most ad­vanced in ATAI’s port­fo­lio.

Two oth­er mem­bers of his lead­er­ship team— his CSO and co-founder — al­so sold a com­pa­ny cen­tered around opi­oid use dis­or­der to ATAI last year in Kures. The col­lec­tive ex­pe­ri­ences among the group have cer­tain­ly helped Gil­gamesh get off the ground, Sporn told End­points News, but they want­ed to do things a lit­tle bit dif­fer­ent­ly this time around.

Sporn be­gan putting a team to­geth­er of what he called “un­usu­al” peo­ple for the space, main­ly med­i­c­i­nal chemists in­clud­ing the for­mer Kures lead­ers. These folks, Dal­i­bor Sames and An­drew Kruegel, had ex­ten­sive ex­pe­ri­ence in cre­at­ing and en­gi­neer­ing ana­logues to some of the more com­mon psy­che­del­ic drugs out there like ibo­gaine.

It’s the cre­ation of these ana­logues where Gil­gamesh will al­so spend its time and mon­ey, Sporn said, rather than try­ing to use things like syn­thet­ic psilo­cy­bin — the psy­choac­tive in­gre­di­ent in mag­ic mush­rooms that Com­pass Path­ways fo­cus­es on — or some­thing a bit more off­beat, like the drug col­lo­qui­al­ly known as ‘toad ven­om.’

“What we see with these oth­er com­pa­nies in the field, they seem to be fo­cus­ing more on things that al­ready ex­ist and where it’s a more com­plex process to try to pro­tect these things,” Sporn told End­points. “We’re more fo­cused on cre­at­ing the right group of peo­ple … we’re pulling to­geth­er the right peo­ple, it’s all very IP-cen­tric and very med­i­c­i­nal chem­istry-cen­tric.”

Gil­gamesh has al­so part­nered with NJ-based Psy­chogen­ics to use their AI plat­form, which he says was the first of its kind in psy­chi­a­try. Re­searchers ad­min­is­ter ex­per­i­men­tal drugs to mice and are ob­served by cam­eras that cat­a­logue their be­hav­ioral pat­terns, al­low­ing Gil­gamesh to mea­sure which dos­es are most ef­fec­tive and how long their ef­fects last af­ter leav­ing the body.

The com­pa­ny ex­pects to en­ter IND-en­abling stud­ies for two of its pro­grams over the next few months, the first of which is an oral ke­t­a­mine ana­logue like­ly to be stud­ied for treat­ment-re­sis­tant de­pres­sion and opi­ate use dis­or­der. This can­di­date’s ap­peal, Sporn says, is the oral for­mu­la­tion it­self: Gil­gamesh’s pill al­lows for few­er dis­so­cia­tive ef­fects and is much safer for home use or dur­ing psy­chother­a­py.

Sporn al­so high­light­ed an ana­logue of DMT Gil­gamesh is work­ing on, which is in­tend­ed to short­en the ther­a­peu­tic ef­fect from six hours to about one or two hours. That would ease the bur­den on the health­care sys­tem, as psy­chi­a­trists won’t have to spend all that time ob­serv­ing pa­tients af­ter tak­ing the drug. Gil­gamesh’s oth­er two pro­grams in­volve the sero­tonin re­cep­tor 5-HT2A.

With his ex­pe­ri­ence at Per­cep­tion and now at Gil­gamesh, Sporn says he’s been grate­ful to have a front row seat at this bur­geon­ing field. And he’s al­ready seen in­ter­est from mid-size phar­ma com­pa­nies in­ter­est­ed in ac­quir­ing Gil­gamesh. But for now, the fo­cus re­mains on build­ing out the team and en­sur­ing its pro­grams are full steam ahead.

“They’re start­ing to dip their toe in­to the wa­ter to look at ac­qui­si­tions in this space, or part­ner­ships in this space,” Sporn said. “It’s clear they’re in­ter­est­ed, and I think you’ll start to see more of that, more of those peo­ple be­gin­ning to cre­ate part­ner­ships around the space, and that will help, I think, a good deal.”

Susan Galbraith, AstraZeneca EVP, oncology R&D, at EUBIO22 (Rachel Kiki for Endpoints News)

Up­dat­ed: As­traZeneca jumps deep­er in­to cell ther­a­py 2.0 space with $320M biotech M&A

Right from the start, the execs at Neogene had some lofty goals in mind when they decided to try their hand at a cell therapy that could tackle solid tumors.

Its founders have helped hone a new approach that would pack in multiple neoantigen targets to create a personalized TCR treatment that would not just make the leap from blood to solid tumors, but do it with durability. And they managed to make their way rapidly to the clinic, unveiling their first Phase I program for advanced tumors just last May.

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Tim Van Hauwermeiren, argenx CEO

Ar­genx pur­chas­es $100M+ FDA pri­or­i­ty re­view vouch­er from blue­bird bio

Argenx’s Vyvgart is due for a speedy review at the FDA, thanks to a $102 million priority review voucher (PRV).

The Netherland-based biotech picked up the PRV from bluebird bio, the companies announced on Wednesday. PRVs shorten a drug’s FDA review period from 10 months to 6 months, though they often sell on the open market for around $100 million each.

Argenx plans on using the express ticket on efgartigimod, its neonatal Fc receptor (FcRn) blocker marketed as Vyvgart for adults with generalized myasthenia gravis (gMG). While Vyvgart won its first approval last December for the chronic neuromuscular disease — which is characterized by difficulties with facial expression, speech, swallowing and breathing — CEO Tim Van Hauwermeiren said in a news release that he plans to “be active in fifteen disease targets by 2025.”

Ei­sai’s ex­pand­ed Alzheimer’s da­ta leave open ques­tions about safe­ty and clin­i­cal ben­e­fit

Researchers still have key questions about Eisai’s investigational Alzheimer’s drug lecanemab following the publication of more Phase III data in the New England Journal of Medicine Tuesday night.

In the paper, which was released in conjunction with presentations at an Alzheimer’s conference, trial investigators write that a definition of clinical meaningfulness “has not been established.” And the relative lack of new information, following topline data unveiled in September, left experts asking for more — setting up a potential showdown to precisely define how big a difference the drug makes in patients’ lives.

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Lil­ly's Covid-19 mAb no longer au­tho­rized due to Omi­cron sub­vari­ants, FDA says

The FDA on Wednesday announced that Eli Lilly’s Covid-19 drug bebtelovimab is no longer authorized to treat Covid-19 because of the rising numbers of two new subvariants that the drug does not work against.

The Centers for Disease Control and Prevention last week published new estimates that the combined proportion of Covid-19 cases caused by the Omicron subvariants BQ.1 and BQ.1.1 are greater than 57% nationally, and already above 50% in all individual regions but one.

Uğur Şahin, BioNTech CEO (ddp images/Sipa USA/Sipa via AP Images)

BioN­Tech bets on dif­fi­cult STING field via small mol­e­cule pact with a Pol­ish biotech

BioNTech is beefing up its relatively thin small molecule pipeline by adding weight to a clinically difficult corner of oncology R&D: STING agonists. To do so, BioNTech is teaming up with a 15-year-old Polish biotech and doling out €40 million, about $41.5 million, to start.

The deal is broken into two parts: First, BioNTech obtains an exclusive global license to develop and market Ryvu Therapeutics’ STING agonist portfolio as small molecules, whether alone or in combination with other agents.

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Paul Hudson, Sanofi CEO (Romuald Meigneux/Sipa via AP Images)

Sanofi and DN­Di aim to elim­i­nate sleep­ing sick­ness in Africa with promis­ing Ph II/III re­sults for new drug

The Drugs for Neglected Diseases initiative (DNDi) and Sanofi today said that their potential sleeping sickness treatment saw success rates of up to 95% from a Phase II/III study investigating the safety and efficacy of single-dose acoziborole.

The potentially transformative treatment for sleeping sickness would mainly be targeted at African countries, according to data published today in The Lancet Infectious Diseases medical journal. The clinical trial was led by DNDi and its partners in the Democratic Republic of the Congo (DRC) and Guinea, with the authors noting:

Illustration: Assistant Editor Kathy Wong for Endpoints News

Twit­ter dis­ar­ray con­tin­ues as phar­ma ad­ver­tis­ers ex­tend paus­es and look around for op­tions, but keep tweet­ing

Pharma advertisers on Twitter are done — at least for now. Ad spending among the previous top spenders flattened even further last week, according to the latest data from ad tracker Pathmatics, amid ongoing turmoil after billionaire boss Elon Musk’s takeover now one month ago.

Among 18 top advertisers tracked for Endpoints News, only two are spending: GSK and Bayer. GSK spending for the full week through Sunday was minimal at just under $1,900. Meanwhile, German drugmaker Bayer remains the industry outlier upping its spending to $499,000 last week from $480,000 the previous week. Bayer’s spending also marks a big increase from a month ago and before the Musk takeover, when it spent $16,000 per week.

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Vi­a­tris with­draws ac­cel­er­at­ed ap­proval for top­i­cal an­timi­cro­bial 24 years lat­er

After 24 years without confirming clinical benefit, the FDA announced Tuesday morning that Viatris (formed via Mylan and Pfizer’s Upjohn) has decided to withdraw a topical antimicrobial agent, Sulfamylon (mafenide acetate), after the company said conducting a confirmatory study was not feasible.

Sulfamylon first won FDA’s accelerated nod in 1998 as a topical burn treatment, with the FDA noting that last December, Mylan told the agency that it wasn’t running the trial.

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Lex­i­con slams FDA over hear­ing de­nial fol­low­ing a CRL for its SGLT2 in­hibitor can­di­date

Lexicon Pharmaceutical is not giving up on its Type I diabetes candidate, despite FDA’s repeated rejections. This week the company laid out is argument again for a hearing on sotagliflozin in response to the FDA’s most recent denial.

The issue goes back to March 2019 when the FDA made very clear to Lexicon and its now departed partner Sanofi that it would not approve their application for a potential Type I diabetes drug because it does not appear to be safe.