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.”

Biotech and Big Phar­ma: A blue­print for a suc­cess­ful part­ner­ship

Strategic partnerships have long been an important contributor to how drugs are discovered and developed. For decades, big pharma companies have been forming alliances with biotech innovators to increase R&D productivity, expand geographical reach and better manage late-stage commercialization costs.

Noël Brown, Managing Director and Head of Biotechnology Investment Banking, and Greg Wiederrecht, Ph.D., Managing Director in the Global Healthcare Investment Banking Group at RBC Capital Markets, are no strangers to the importance of these tie-ups. Noël has over 20 years of investment banking experience in the industry. Before moving to the banking world in 2015, Greg was the Vice President and Head of External Scientific Affairs (ESA) at Merck, where he was responsible for the scientific assessment of strategic partnership opportunities worldwide.

No­var­tis' sec­ond at­tempt to repli­cate a stun­ning can­cer re­sult falls flat

Novartis’ hopes of turning one of the most surprising trial data points of the last decade into a lung cancer drug has taken another setback.

The Swiss pharma announced Monday that its IL-1 inhibitor canakinumab did not significantly extend the lives or slow the disease progression of patients with previously untreated locally advanced or metastatic non-small cell lung cancer when compared to standard of-care alone.

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How Chi­na turned the ta­bles on bio­phar­ma's glob­al deal­mak­ing

Fenlai Tan still gets chills thinking about the darkest day of his life.

Three out of eight lung cancer patients who received a tyrosine kinase inhibitor developed by his company, Betta Pharma, died in the span of a month. Tan, the chief medical officer, was summoned to Peking Union Medical College Hospital, where the head of the clinical trial department told him that the trial investigators would be conducting an autopsy to see if the patients had died of the disease — they were all very sick by the time they enrolled — or of interstitial lung disease, a deadly side effect tied to the TKI class that’s been reported in Japan.

James Peyer, Cambrian CEO

Brent Saun­ders joins $100M Se­ries C for a com­pa­ny out to be the Bridge­Bio of ag­ing

About a year ago, James Peyer, a CEO and co-founder of the little known longevity biotech Cambrian Biopharma, was trying to find some R&D talent last year when he met with more than a bit of experience in that department: David Nicholson, the former R&D chief of the erstwhile pharma giant Allergan.

It turned out Nicholson already had an interest in Peyer’s field. In their Allergan days, he and COO Brent Saunders held weekly meetups where they tried to figure out how to take the company’s dominance in aesthetics — which, until recently, was often what people meant by anti-aging science — and expertise with more traditional drug development, and use it to make drugs that extend people’s lifespan.

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Ugur Sahin, AP Images

As pres­sure to share tech­nol­o­gy mounts, BioN­Tech se­lects Rwan­da for lat­est vac­cine site

BioNTech’s first mRNA-based vaccine site in Africa will call Rwanda home, and construction is set to start in mid-2022, the company announced Tuesday at a public health forum.

The German company signed a memorandum of understanding, after a meeting between Rwanda’s Minister of Health, Daniel Ngamije, Senegal’s Minister of Foreign Affairs Aïssata Tall Sall, and senior BioNTech officials. Construction plans have been finalized, and assets have been ordered. The agreement will help bring end-to-end manufacturing to Africa, and as many as several hundred million doses of vaccines per year, though initial production will be more modest.

No­var­tis dumps AveX­is pro­gram for Rett syn­drome af­ter fail­ing re­peat round of pre­clin­i­cal test­ing

Say goodbye to AVXS-201.

The Rett syndrome gene therapy drug made by AveXis — the biotech that was bought, kept separate, then renamed and finally absorbed by Novartis into its R&D division — has been dropped by the biopharma.

In Novartis’ third quarter financial report, the pharma had found that preclinical data did not support development of the gene therapy into IND-enabling trials and beyond. The announcement comes a year after Novartis told the Rett Society how excited it was by the drug — and its potential benefits and uses.

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Katie Fanning, Mozart Therapeutics CEO

Mozart Ther­a­peu­tics makes its of­fi­cial de­but, jump­ing in­to the hot Treg R&D field with some big-name in­vestors back­ing it

Treg cells have been getting more and more attention recently among autoimmune specialists. There’s been Jeff Bluestone’s Sonoma, the $157 million launch of GentiBio this summer and Egle Therapeutics — which launched just last week — to name a few.

Now, there’s a new Treg player jumping in that wants to distinguish itself in the market: Mozart Therapeutics. Today, the biotech is emerging from stealth in its official debut with a $55 million Series A — with a bunch of A-list Big Pharma names on board a syndicate led by ARCH.

Vas Narasimhan, Novartis CEO (Simon Dawson/Bloomberg via Getty Images)

With San­doz con­tin­u­ing to drag on No­var­tis, Vas Narasimhan says he may fi­nal­ly be ready for a sale or spin­off

After years of rehab work aimed at getting Sandoz in fighting trim to compete in a market overshadowed by declining prices, CEO Vas Narasimhan took a big step toward possibly selling or spinning off the giant generic drug player.

The pharma giant flagged plans to launch a strategic review of the business in its Q3 update, noting that “options range from retaining the business to separation.”

Analysts have been poking and prodding Novartis execs for years now as Narasimhan attempted to remodel a business that has been a drag on its performance during most of his reign in the CEO suite. The former R&D chief has made it well known that he’s devoted to the innovative meds side of the business, where they see the greatest potential for growth.

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FDA is much worse than its reg­u­la­to­ry peers at proac­tive­ly dis­clos­ing da­ta, re­searchers find

The European Medicines Agency and Health Canada continue to outpace the FDA when it comes to proactively releasing data on drugs and biologics the agency has reviewed, leading to further questions of why the American agency can’t be more transparent.

In a study published recently in the Journal of Law, Medicine, & Ethics, Yale and other academic lawyers and researchers found that between 2016 and April 2021, the EMA proactively released data for 123 unique medical products, while Health Canada proactively released data for 73 unique medical products between 2019 and April 2021. What’s more, the EMA and Health Canada didn’t proactively release the same data on the same drugs. In stark contrast, the FDA in 2018 only proactively disclosed data supporting one drug that was approved that year.

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