Bob Azelby, Eliem CEO

Weeks out from an $80M launch, a pain and CNS start­up is back with a fresh raise. Can an IPO be far be­hind?

Not two months af­ter launch­ing out of RA Cap­i­tal’s in­cu­ba­tor, Eliem Ther­a­peu­tics is re­turn­ing to the firm — and oth­ers — to raise an­oth­er heap of cash. And this time, an IPO could po­ten­tial­ly be in the works.

Eliem has put to­geth­er a $60 mil­lion Se­ries B round co-led by RA Cap­i­tal as it seeks to fur­ther ad­vance two lead clin­i­cal can­di­dates across four tri­als. The biotech de­clined an in­ter­view and fur­ther de­clined to com­ment on an emailed ques­tion re­gard­ing fi­nanc­ing plans, sug­gest­ing they may be hun­ker­ing down in prepa­ra­tion for an S-1 fil­ing with the SEC.

Though the Se­ries B proved to be small­er than the $80 mil­lion launch round in March, Eliem has an­nounced $140 mil­lion in funds be­tween the 60-day span of the two an­nounce­ments.

Eliem spawned out of con­ver­sa­tions from RA man­ag­ing di­rec­tor An­drew Levin and long­time pain re­searcher Va­lerie Moris­set, who had re­cent­ly re­tired from biotech to start a new chap­ter in the VC world. Dis­cus­sions re­volved around the pro­drug of an en­do­cannabi­noid known as palmi­toylethanolamide, or PEA, and af­ter ini­tial skep­ti­cism Moris­set agreed to hop on board as pres­i­dent and CSO.

The pro­drug, dubbed ETX-810, is the lead pro­gram in a pipeline of four neu­ro as­sets Eliem even­tu­al­ly hopes to bring to pa­tients. It’s part of a fam­i­ly of en­do­cannabi­noid hope­fuls that have thus far come up short for Big Phar­mas look­ing to in­vest in the area. Part of what drew Moris­set to the com­pa­ny, she told End­points News in March, was the sheer amount of clin­i­cal lit­er­a­ture show­ing how PEA could be used for chron­ic pain con­di­tions.

They’re hope­ful that the pro­drug ap­proach can lead to bet­ter re­sults. ETX-810 is cur­rent­ly in two Phase IIa stud­ies look­ing at di­a­bet­ic pe­riph­er­al neu­ro­path­ic pain and lum­bosacral radic­u­lar pain, and Eliem is now putting timeta­bles on the da­ta read­outs for the first half of 2022.

In ad­di­tion to the pain-re­lat­ed in­di­ca­tions, how­ev­er, Eliem is al­so work­ing on a host of oth­er CNS can­di­dates. Next up be­hind ETX-810 is a GA­BA-pos­i­tive al­losteric mod­u­la­tor, al­so from RA Cap­i­tal, which the com­pa­ny is call­ing ETX-155. Eliem plans to take this pro­gram in­to two Phase IIa stud­ies for ma­jor de­pres­sive dis­or­der and hor­mone-re­lat­ed de­pres­sive dis­or­ders, as well as a Phase Ib tri­al for epilep­sy.

Da­ta here are ex­pect­ed in the sec­ond half of 2022 and the first half of 2023, re­spec­tive­ly.

Fur­ther down the pipeline are two pre­clin­i­cal pro­grams: a Kv7.⅔ chan­nel open­er dis­cov­ered in-house, where Eliem hopes to go in­to pain and epilep­sy, and an­oth­er ear­ly-stage re­search pro­gram po­ten­tial­ly for gen­er­al­ized anx­i­ety and de­pres­sion.

In­ter­me­di­ate Cap­i­tal Group co-led the round with RA Cap­i­tal. Oth­er in­vestors in­clud­ed Ac­cess Biotech­nol­o­gy, Sam­lyn Cap­i­tal, Acorn Bioven­tures and LifeArc.

At the In­flec­tion Point for the Next Gen­er­a­tion of Can­cer Im­munother­a­py

While oncology researchers have long pursued the potential of cellular immunotherapies for the treatment of cancer, it was unclear whether these therapies would ever reach patients due to the complexity of manufacturing and costs of development. Fortunately, the recent successful development and regulatory approval of chimeric antigen receptor-engineered T (CAR-T) cells have demonstrated the significant benefit of these therapies to patients.

Tillman Gerngross (Adagio)

Till­man Gern­gross on Omi­cron: 'It is a grim sit­u­a­tion...we’re go­ing to see a sig­nif­i­cant drop in vac­cine ef­fi­ca­cy'

Tillman Gerngross, the rarely shy Dartmouth professor, biotech entrepreneur and antibody expert, has been warning for over a year that the virus behind Covid-19 would likely continue to mutate, potentially in ways that avoid immunity from infection and the best defenses scientists developed. He spun out a company, Adagio, to build a universal antibody, one that could snuff out any potential mutation.

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In­cor­po­rat­ing Ex­ter­nal Da­ta in­to Clin­i­cal Tri­als: Com­par­ing Dig­i­tal Twins to Ex­ter­nal Con­trol Arms

Most drug development professionals are familiar with the nerve-racking wait for the read-out of a large trial. If it’s negative, is the investigational therapy ineffective? Or could the failure result from an unforeseen flaw in the design or execution of the protocol, rather than a lack of efficacy? The team could spend weeks analyzing data, but a definitive answer may be elusive due to insufficient power for such analyses in the already completed trial. These problems are only made worse if the trial had lower enrollment, or higher dropout than expected due to an unanticipated event like COVID-19. And if a trial is negative, the next one is likely to be larger and more costly — if it happens at all.

Iain McGill, Quell CEO

Eu­ro­pean in­vestors pour $156M to beat Blue­stone, Third Rock and RA Cap­i­tal in multi­bil­lion-dol­lar race to the clin­ic

Amid burgeoning efforts to create a new type of cell therapy out of regulatory T cells — whether by channeling or blocking their immunosuppressive power — Quell Therapeutics wants to shoot for a first.

If everything goes well, the Syncona-backed biotech will be in the clinic early next year, marking what it calls the historic feat of dosing a patient with a CAR-Treg with multiple edited genes.

Like the flu vac­cine every year, the FDA could move quick­ly on a vari­ant-tar­get­ed Covid vac­cine

In the same way that the FDA signs off on flu vaccines every year without requiring large clinical trials to measure their efficacy, the FDA may employ a similar strategy in authorizing variant-focused versions of the mRNA vaccines.

As the world braces for more data on the latest variant Omicron, which may reduce vaccine efficacy, top vaccine developers like Moderna and Pfizer-BioNTech have promised they can pull together a new vaccine targeted against a specific Covid variant in about 100 days. Since Omicron emerged last week, Pfizer-BioNTech, Moderna and J&J have all said they’ve begun work on Omicron-specific vaccines, if needed.

Jonathan Montagu (L) and Gerry Harriman, HotSpot co-founders

HotSpot gets hot­ter with $100M raise to push to­ward clin­ic

HotSpot Therapeutics, the allostery-focused biotech that works on what it calls “natural hotspots” — hence the name — is getting a bit hotter in its valuation from investors. And to that end they’ve raised $100 million.

The four-year-old AI computational biotech started by two former Nimbus execs announced this morning that it closed its Series C round right at the line of a 9-figure investment, courtesy of some big investors.

Thanks­giv­ing edi­tion: Top 15 End­points sto­ries of 2021; Can you name that vac­cine?; Mer­ck­'s Covid an­tivi­ral dis­ap­points; FDA nom­i­nee's in­dus­try ties; 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.

Happy Thanksgiving to all those who are celebrating it — although, if we are being honest, this week’s abbreviated edition is really for those who are not. Wherever you’re tuning in from, we appreciate your support, hope you find this recap helpful and we wish you a wonderful weekend.

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What were End­points read­ers tun­ing in­to this year? Here’s a look at our 15 most pop­u­lar re­ports of the year (so far)

At the beginning of this year, I laid out a basic objective for Endpoints News as we headed to our 5th anniversary. We’ve long been doing a fine job covering the breaking news in R&D — if I do say so myself — but we needed to expand our horizons on industry coverage, increase the staff and go much, much deeper when the stories demanded it.

In a phrase: broader and deeper.

It’s safe to say, based on our daily web traffic, that you all seemed to like this idea. We’ve doubled the staff — thanks to a growing group of paid subscribers — ramped up the daily report and now publish a regular slate of in-depth articles. And traffic — those clicks you always read about — have gone up in volume too. Monthly sessions are up 43%, to close to 1.5 million. Unique readers are up 63%, to 874,480 in October, after setting a record of close to a million the month before. Page views are running at 3 million-plus a month. And the overall number of subscribers has surged to 124,000.

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Ursula von der Leyen, President of the European Commission

Omi­cron: Re­searchers scram­ble as new coro­n­avirus mu­ta­tion takes flight around the globe — Pfiz­er/BioN­Tech, Mod­er­na vow swift re­sponse

As Americans were waking up for their Black Friday rituals, they were greeted with the news that a new mutation of the Covid-19 virus has appeared and been sequenced — after it caught an international flight to Hong Kong. And two of the leading Covid-19 vaccine developers promised delivery of a new vaccine “within 100 days” if necessary while a third spelled out its 3-prong strategy hours later.

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