Mark Rus, Delix CEO

A new psy­che­delics play­er emerges to treat men­tal health dis­or­ders — mi­nus the hal­lu­cino­genic ef­fects

One line in an aca­d­e­m­ic pa­per changed every­thing for David Ol­son.

It was 2018 when Ol­son’s lab at the Uni­ver­si­ty of Cal­i­for­nia, Davis pub­lished a pa­per demon­strat­ing psy­che­delics’ abil­i­ty to pro­mote neu­ro­plas­tic­i­ty. Psy­che­delics re­search has slow­ly emerged from the shad­ows in the last cou­ple decades, with the FDA ap­prov­ing the first psy­che­del­ic drug, es­ke­t­a­mine, to treat de­pres­sion in 2019. A hand­ful of com­pa­nies are now test­ing the ef­fects of oth­er com­pounds like psilo­cy­bin — the psy­choac­tive in­gre­di­ent in mag­ic mush­rooms — on a suite of men­tal health dis­or­ders.

In the pa­per, Ol­son wrote “one lit­tle line” about his lab’s work on nov­el analogs of psy­che­delics that could have sim­i­lar ther­a­peu­tic ben­e­fits, but were non-hal­lu­cino­genic.

“One of our co-founders, Nick Haft at OMX Ven­tures, he read that line and he con­tact­ed me right away,” Ol­son said. “It was a time when I was look­ing for a busi­ness part­ner, I was look­ing for some­one to bring this com­pa­ny to­geth­er.”

In 2019, they launched Delix Ther­a­peu­tics, tap­ping Shire neu­ro­science vet Mark Rus to guide the Boston-based biotech in­to the clin­ic. And on Mon­day, they un­veiled a $70 mil­lion Se­ries A round led by AR­TIS Ven­tures, RA Cap­i­tal Man­age­ment and OMX.

“It’s a group that’s all re­al­ly ex­cit­ed by the new hope that psy­che­del­ic and psy­choplas­to­gen ef­fi­ca­cy and ear­ly da­ta and emerg­ing da­ta has promised,” Rus, CEO, told End­points News.

Ol­son’s lab coined the term “psy­choplas­to­gen” to de­scribe small mol­e­cules that pro­duce rapid and long-last­ing psy­che­del­ic- and ke­t­a­mine-like ef­fects on neu­ronal struc­ture. Their non-hal­lu­cino­genic psy­choplas­to­gens pro­duced “sus­tained ther­a­peu­tic ef­fects” in pre­clin­i­cal mod­els, ac­cord­ing to Delix, and their first two can­di­dates are slat­ed to en­ter the clin­ic in 2022.

David Ol­son in his lab (UC-Davis), cour­tesy of Delix

Click on the im­age to see the full-sized ver­sion

While Rus hasn’t re­vealed which in­di­ca­tions Delix is tar­get­ing first, he said the com­pa­ny is look­ing to go af­ter a large swath of men­tal health dis­or­ders, all of which have one thing in com­mon: some­thing called cor­ti­cal at­ro­phy.

If you think of neu­rons as trees in a part of the brain called the pre­frontal cor­tex, Rus ex­plained, den­drites would be the branch­es and synaps­es would be the leaves. The with­er­ing of those branch­es, in many cas­es, leads to less con­nec­tiv­i­ty and ef­fec­tive com­mu­ni­ca­tion with oth­er parts of the brain that in­flu­ence things like mo­ti­va­tion or re­ward.

“That’s why in many cas­es in neu­ropsy­chi­atric con­di­tions, you get de­pres­sion or you’ll get anx­i­ety, you get some cog­ni­tive chal­lenges, and you get a mix, de­pend­ing on the pa­tient,” he said. “A lot of neu­rode­gen­er­a­tive con­di­tions have cor­ti­cal at­ro­phy at their heart as well, and that’s some­thing that Delix’s plat­form over time will seek to pur­sue.”

Delix’s most ad­vanced com­pounds are non-hal­lu­cino­genic analogs of first-gen­er­a­tion psy­che­delics like psilo­cy­bin, LSD, DMT, and MD­MA. By curb­ing hal­lu­cino­genic ef­fect, Delix is hop­ing to avoid some of the safe­ty li­a­bil­i­ties of the ear­li­er gen­er­a­tion, as well as the need for in-clin­ic ad­min­is­tra­tion.

“While I def­i­nite­ly think that pa­tients will be helped by these first-gen­er­a­tion hal­lu­cino­genic med­i­cines, I think that we can help many, many more pa­tients with the non-hal­lu­cino­genic psy­choplas­to­gens, and so that’s re­al­ly, I think, what dif­fer­en­ti­ates us,” Ol­son said.

Of course, the com­pa­ny will have some catch­ing up to do. ATAI Life Sci­ences is al­ready rac­ing through the clin­ic with psilo­cy­bin- and R-ke­t­a­mine-based pro­grams. And Jonathan Sporn, the Har­vard sci­en­tist be­hind a cou­ple of ATAI’s pro­grams, launched his own com­pa­ny back in May to cre­ate analogs of some of the most com­mon psy­che­del­ic drugs.

When asked if an IPO is in the fu­ture, Rus re­spond­ed: “Our fo­cus is on the da­ta right now, but we’ll cer­tain­ly ex­am­ine all op­tions like any com­pa­ny would down the road.”

Late Fri­day ap­proval; Trio of biotechs wind down; Stem cell pi­o­neer finds new fron­tier; Biotech icon to re­tire; and more

Welcome back to Endpoints Weekly, your review of the week’s top biopharma headlines. Want this in your inbox every Saturday morning? Current Endpoints readers can visit their reader profile to add Endpoints Weekly. New to Endpoints? Sign up here.

I hope your weekend is off to a nice start, wherever you are reading this email. As for me, I’m trying to catch the tail of the Lunar New Year festivities.

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Pfiz­er lays off em­ploy­ees at Cal­i­for­nia and Con­necti­cut sites

Pfizer has laid off employees at its La Jolla, CA, and Groton, CT sites, according to multiple LinkedIn posts from former employees.

The Big Pharma confirmed to Endpoints News it has let go of some employees, but a spokesperson declined to specify how many workers were impacted and the exact locations affected. Earlier this month, the drug developer had confirmed to Endpoints it was sharpening its focus and doing away with some early research on areas such as rare disease, oncology and gene therapies.

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Rodney Rietze, iVexSol CEO

Bris­tol My­ers, Charles Riv­er join Se­ries A fund­ing for iVex­Sol

Massachusetts-based iVexSol has secured funding to the tune of $23.8 million in its latest Series A round. The new investors include Bristol Myers Squibb, manufacturer Charles River Laboratories and Asahi Kasei Medical.

iVexSol is a manufacturer of lentiviral vectors (LVV), used in making gene therapies, and this latest round of fundraising brings its total Series A total over $39 million, which will be used to recruit more employees and bolster its technology.

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Jake Van Naarden, Loxo@Lilly CEO

Lil­ly en­ters ripe BTK field with quick FDA nod in man­tle cell lym­phoma

Eli Lilly has succeeded in its attempt to get the first non-covalent version of Bruton’s tyrosine kinase, or BTK, inhibitors to market, pushing it past rival Merck.

The FDA gave an accelerated nod to Lilly’s daily oral med, to be sold as Jaypirca, for patients with relapsed or refractory mantle cell lymphoma.

The agency’s green light, disclosed by the Indianapolis Big Pharma on Friday afternoon, catapults Lilly into a field dominated by covalent BTK inhibitors, which includes AbbVie and Johnson & Johnson’s Imbruvica, AstraZeneca’s Calquence and BeiGene’s Brukinsa.

Filip Dubovsky, Novavax CMO

No­vavax gets ready to take an­oth­er shot at Covid vac­cine mar­ket with next sea­son plans

While mRNA took center stage at yesterday’s FDA vaccine advisory committee meeting, Novavax announced its plans to deliver an updated protein-based vaccine based on new guidance.

Vaccines and Related Biological Products Advisory Committee (VRBPAC) members voted unanimously in favor of “harmonizing” Covid vaccine compositions, meaning all future vaccine recipients would receive a bivalent vaccine, regardless of whether they’ve gotten their primary series.

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Eliot Forster, F-star CEO (Rachel Kiki for Endpoints News)

F-star gets down to the wire with $161M sale to Chi­nese buy­er as na­tion­al se­cu­ri­ty con­cerns linger

With the clock ticking on F-star Therapeutics’ takeover by a Chinese buyer, the companies are still scrambling to remove a hold on the deal from the US government’s Committee on Foreign Investment in the United States.

F-star and invoX Pharma said they are “actively negotiating” with CFIUS “about the terms of a mitigation agreement to address CFIUS’s concerns regarding potential national security risks posed by the transaction.”

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CBER Director Peter Marks (Susan Walsh/AP Images)

FDA ad­vi­so­ry com­mit­tee votes unan­i­mous­ly in fa­vor of bi­va­lent Covid shots re­plac­ing pri­ma­ry se­ries

The FDA’s Vaccines and Related Biological Products Advisory Committee (VRBPAC) voted unanimously in favor of “harmonizing” Covid vaccine compositions, meaning all current vaccine recipients would receive a bivalent vaccine, regardless of whether they’ve gotten their primary series.

The vote marks an effort to clear up confusion around varying formulations and dosing schedules for current primary series and booster vaccines, as well as “get closer to the strains that are circulating,” according to committee member Paul Offit, professor of pediatrics at the Children’s Hospital of Philadelphia.

John Rim, Samsung Biologics CEO (Samsung/PR Newswire)

Sam­sung Bi­o­log­ics spells out ex­pan­sion plans in South Ko­rea and US

The CDMO arm of one of South Korea’s largest conglomerates has posted its year-end results and plans for 2023, which include new construction.

Samsung Biologics netted north of KRW 3 trillion ($2.4 billion) in 2022 revenue and an operating profit of KRW 983.6 billion ($799 million), which the company touted on Friday as “record-high earnings.” The revenue boost was 55% compared to 2021.

No­var­tis' ap­proved sick­le cell dis­ease drug fails to beat place­bo in PhI­II

Novartis’ sickle cell drug, approved in 2019 and branded as Adakveo, has failed an ongoing Phase III, according to preliminary results.

The Swiss pharma giant unveiled early data from the ongoing STAND Phase III study on Friday, saying that crizanlizumab showed no statistically significant difference between the drug at two different dose levels compared to placebo in annualized rates of vaso-occlusive crises that lead to a healthcare visit over the first year since being randomized into the trial.