Neu­ro up­start launch­es out of RA Cap­i­tal’s low-pro­file in­cu­ba­tor with Big Phar­ma vets, clin­i­cal drugs and $80M

As a pain re­searcher of 20-plus years, Va­lerie Moris­set doesn’t get ex­cit­ed about new drug ideas eas­i­ly.

So when An­drew Levin from RA Cap­i­tal called to talk about a pro­drug of the en­do­cannabi­noid palmi­toylethanolamide, she was skep­ti­cal. Moris­set had just swapped out a ca­reer in biotech — most re­cent­ly head­ing up bi­ol­o­gy and trans­la­tion­al med­i­cine for Con­ver­gence Phar­ma­ceu­ti­cals through its ac­qui­si­tion by Bio­gen — for a VC perch at Bridge Val­ley Ven­tures , and to­geth­er with Si­mon Tate, the man­ag­ing di­rec­tor of In­ter­me­di­ate Cap­i­tal Group, they dived in for three months of due dili­gence.

Va­lerie Moriset

“At first, it is true, our in­tent was to ba­si­cal­ly kill it and move along to the next op­por­tu­ni­ty,” she told End­points News.

Rather, she would be­come the pres­i­dent and CSO of Eliem, the start­up tasked with steer­ing this — ETX-810 — and three oth­er neu­ro drugs to the fin­ish line with $80 mil­lion in fresh fund­ing.

Bob Azel­by, the for­mer chief com­mer­cial of­fi­cer at Juno and and re­cent chief of Alder who helped ne­go­ti­ate a $1.95 bil­lion buy­out by Lund­beck, is on board as CEO, lead­ing an of­fice in Seat­tle while Moris­set man­ages an R&D team in Cam­bridge, UK. A clin­i­cal de­vel­op­ment crew is al­so based in the US, where all tri­als are cur­rent­ly planned.

En­do­cannabi­noids — en­doge­nous neu­ro­trans­mit­ters that bind to cannabi­noid re­cep­tors — had en­thused Big Phar­ma for some years, send­ing them off on a search for CB2 ag­o­nists, pe­riph­er­al CB1 or oth­ers, but the ef­forts have large­ly turned up emp­ty, if not out­right dan­ger­ous. Oth­ers have tried go­ing af­ter a mas­ter mod­u­la­tor in­stead.

PEA, as Moris­set al­ready knew, is part of this group. What she was sur­prised to find, though, was the “ab­solute wealth” of clin­i­cal lit­er­a­ture on us­ing the nat­u­ral­ly oc­cur­ring mol­e­cule in a num­ber of chron­ic pain con­di­tions. Af­ter ask­ing a pro­fes­sor at the Uni­ver­si­ty of Rome to re­an­a­lyze da­ta from one of the biggest stud­ies avail­able and con­firm a dose-re­sponse re­la­tion­ship be­tween the ex­po­sure of PEA and the re­duc­tion of pain, they were con­vinced.

An­drew Levin

Tak­ing a pro­drug ap­proach, she not­ed, con­fers a three-fold high­er ex­po­sure, a longer half life, and bet­ter drug prop­er­ties over­all. They will first test it in two Phase IIa tri­als for lum­bosacral radic­u­lar pain (chron­ic sci­at­i­ca) and di­a­bet­ic pe­riph­er­al neu­ro­path­ic pain.

But Eliem wants to be more than a pain com­pa­ny; the fo­cus they’re giv­ing them­selves is neu­ronal ex­citabil­i­ty dis­or­ders, which could be any­thing from de­pres­sion to epilep­sy.

The com­mon theme of these dis­eases is that they arise from an im­bal­ance be­tween ex­ci­ta­tion and in­hi­bi­tion, not­ed Moris­set, an elec­tro­phys­i­ol­o­gist by back­ground.

“There is a lot of lit­er­a­ture de­scrib­ing pain, epilep­sy as hy­per­ex­citabil­i­ty dis­or­ders where ba­si­cal­ly neu­rons are fir­ing too fast,” she added.

ETX-155, a next-gen­er­a­tion GABAA pos­i­tive al­losteric mod­u­la­tor al­so from RA Cap­i­tal, is now in Phase I tri­als with plans to go in­to mid-stage stud­ies for ma­jor de­pres­sive dis­or­der, hor­mone-re­lat­ed mood dis­or­ders and fo­cal on­set seizures. Then there’s a pre­clin­i­cal Kv7.⅔ chan­nel open­er dis­cov­ered in house and an­oth­er ear­ly-stage re­search pro­gram.

Alder alum Erin Lavelle is tak­ing up the COO post, while phar­ma vets Amy Chap­pell and Jo Palmer-Phillips are fill­ing the chief med­ical of­fi­cer and chief de­vel­op­ment of­fi­cer po­si­tions, re­spec­tive­ly. Levin, who is cred­it­ed as co-founder along­side Moris­set, is chair­ing the board of di­rec­tors, which al­so in­volves Tate of ICG and Liam Rat­cliffe from Ac­cess Biotech­nol­o­gy, the two in­vestors who joined RA Cap­i­tal for the Se­ries A.

Bob Azel­by

“When you have a re­al­ly ex­pe­ri­enced team with clin­i­cal­ly val­i­dat­ed mech­a­nism of ac­tion, it’s a lot about ex­e­cu­tion,” Azel­by said, “mak­ing sure that you’re get­ting the right tri­al set up and ex­e­cute the right tri­al.”

It’s not just about the tech­ni­cal skills, ei­ther. As Eliem grows from the cur­rent head­count of 18 to 25 or 30 by the end of the year, Azel­by said a key at­tribute he will be look­ing for in re­cruit­ment is re­silience.

“You got­ta get peo­ple that are com­ing here and un­der­stand that, you know what? The boat may rock a lit­tle bit right be­cause bi­ol­o­gy,” he said. “And you want those folks that get ex­cit­ed when an is­sue aris­es so they can dig in and solve it.”

Forge Bi­o­log­ics’ cGMP Com­pli­ant and Com­mer­cial­ly Vi­able Be­spoke Affin­i­ty Chro­matog­ra­phy Plat­form

Forge Biologics has developed a bespoke affinity chromatography platform approach that factors in unique vector combinations to streamline development timelines and assist our clients in efficiently entering the clinic. By leveraging our experience with natural and novel serotypes and transgene conformations, we are able to accelerate affinity chromatography development by nearly 3-fold. Many downstream purification models are serotype-dependent, demanding unique and time-consuming development strategies for each AAV gene therapy product1. With the increasing demand to propel AAV gene therapies to market, platform purification methods that support commercial-scale manufacturing of high-quality vectors with excellent safety and efficacy profiles are essential.

Who’s spend­ing and who’s cut­ting from Big Phar­ma’s $127B R&D bud­get? Here are the top 15 play­ers

A couple of the Big 15 biopharma companies in R&D hit the gas on research spending last year. Merck and Sanofi still have lots to prove in the pipeline, and they’re willing to gamble large sums to make a better future for themselves.

Doing nothing would be infinitely worse.

But collectively, the top players rang up a modest 2.4% increase in spending in 2022, which didn’t cover inflationary pressures. And that set the tone for an extraordinarily cautious year for the industry — even as it laid out about $127 billion to advance new drugs or up the ante on approved therapies.

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Jeff Bluestone (R), Sonoma Biotherapeutics CEO

Jef­frey Blue­stone brings his start­up haul to $400M+, join­ing forces with Re­gen­eron on cell ther­a­pies

These days, when Jeffrey Bluestone gets together with his contemporaries in science, the conversation often turns to retirement plans.

But a little more than three years ago, Bluestone reached a momentous turning point in his career, exiting a prestigious post at UCSF, where he had spent decades in the scientific pursuit of new therapies. And it had nothing to do with retirement anytime in the near future.

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Covant acting CEO Matt Maisak (L) and CSO Iván Cornella

With Boehringer In­gel­heim’s help, Roivant churns out an­oth­er Vant to go up against En­deav­or, Im­pact founders

Roivant Sciences has added another branch to its family tree, unveiling Covant Therapeutics with a $10 million upfront commitment from Boehringer Ingelheim to turn up the heat in cancer.

The Boston-based drug discovery startup will jointly create a new small molecule immunotherapy with the private German pharma giant. The deal, made public Tuesday morning, includes up to $471 million in future payments and tiered royalties, should the product make it to market.

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Richard Murray, Jounce Therapeutics CEO

Jounce nix­es Redx of­fer as I/O biotech in­stead goes with Con­cen­tra Bio­sciences’ takeover bid

A minority shareholder has won out in the Jounce Therapeutics takeover battle, with the once-ambitious immunotherapy biotech now choosing to be acquired by Kevin Tang’s Concentra Biosciences rather than follow through with an already-announced deal that would have brought the UK’s Redx onto Nasdaq.

Via its new merger partner, Jounce is expected to get $1.85 per share from Concentra, which was formed by Tang Capital Partners, the owner of about 10% of Jounce shares. Two weeks ago, Concentra laid out a $1.80 per share proposal plus more for the ability to swoop up 80% of proceeds from licenses of legacy programs out of Jounce’s pipeline.

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Mihael Polymeropoulos, Vanda Pharmaceuticals CEO

Van­da wins court case against FDA over dis­clo­sure of CRL de­tails for sleep drug

DC District Court Judge Christopher Cooper today granted Vanda Pharma’s request to require the FDA to disclose more info on the complete response letter for its sleep disorder drug Hetlioz.

The melatonin receptor agonist is approved by the FDA to treat non-24-hour sleep-wake disorder, a circadian rhythm disorder. But in 2018 Vanda filed a supplemental application to market Hetlioz as a treatment for jet lag, which the FDA rejected in August 2019, with few details on what Vanda needed to correct course, according to the company.

Sally Susman, Pfizer EVP and chief corporate affairs officer

Q&A: Pfiz­er cor­po­rate com­mu­ni­ca­tions chief Sal­ly Sus­man dis­cuss­es book craft­ed in pan­dem­ic and per­son­al lessons

From the political arena to the finance and beauty industries to pharmaceuticals, Pfizer’s Sally Susman has broken barriers, stereotypes and conventions. And now the chief communicator is “Breaking Through,” the title of her first book about effective and innovative communications launching today. The full official title is “Breaking Through: Communicating to Open Minds, Move Hearts, and Change the World.”

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Max Colao, OncoVerity CEO

Tiny mul­ti­omics biotech se­cures for­mer J&J drug, new ex­ecs and new fi­nanc­ing

A new spinout from Belgium’s argenx seeks to give new life to a candidate once in-licensed to J&J.

OncoVerity announced Monday afternoon that it had in-licensed cusatuzumab from argenx. The biotech also appointed two new C-suite executives and secured a $30 million Series A round.

CEO Max Colao joins OncoVerity after working as Aurinia’s commercial chief, and stints at Alexion and Amgen. New CMO Clay Smith has been associate chief of the University of Colorado’s hematology division.

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Kevin Lee, Bicycle Therapeutics CEO

No­var­tis rides with Bi­cy­cle for new pact on tar­get­ed ra­dio­ther­a­pies

Novartis has inked a three-year deal with Bicycle Therapeutics to develop new targeted radiotherapies for cancer.

Novartis will pay Bicycle $50 million upfront, with downstream milestones adding up to a potential $1.7 billion. In exchange, Bicycle will use its virus-based platform to discover new bicyclic peptides, which it calls bicycles, that would be used for radiotherapies. Those bicycles would act as a homing beacon for radioactive isotopes, delivering them to cancer cells to kill the cells while limiting radiation to healthy tissue.

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