IPOs con­tin­ue to bus­tle as three more biotechs pre­pare to make the Nas­daq leap

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The biotech IPO mar­ket con­tin­ues to charge full-steam ahead, with three more com­pa­nies sub­mit­ting their Nas­daq pitch­es to the SEC late Fri­day.

The lead­ers among the pack are Ada­gio Ther­a­peu­tics and Cas­tle Creek Bio­sciences, each pen­cil­ing in $100 mil­lion ini­tial­ly. Fol­low­ing up the rear is Eliem Ther­a­peu­tics, jot­ting down $80 mil­lion for its raise es­ti­mate less than six months af­ter launch­ing out of RA Cap­i­tal’s in­cu­ba­tor.

Fri­day’s fil­ings come a week af­ter End­points News’ con­ver­sa­tion with Nas­daq of­fi­cial Jor­dan Saxe, who said the in­sti­tu­tion is in con­ver­sa­tions with about 250 biotechs over the next 12 to 18 months. Per the End­points tal­ly, the biotechs that have al­ready priced have raised more than $10 bil­lion com­bined.

In ad­di­tion to the three fil­ings, French biotech Dy­nacure with­drew its ap­pli­ca­tion for an IPO af­ter not pric­ing last week.

Our own John Car­roll took a deep look in­to Ada­gio’s high-pro­file quest for Nas­daq, which pre­mi­um sub­scribers can read here. For the best of the rest, check out the news be­low.

Cas­tle Creek takes for­mer Fi­bro­cell pro­grams pub­lic

Ahead of a high-stakes Phase III read­out in the sec­ond half of next year, Cas­tle Creek is seek­ing to join the Nas­daq ranks.

The Ex­ton, PA-based biotech is fo­cus­ing its ef­forts around a pro­gram called dabo­cema­gene aut­ofi­cel, or D-Fi, to treat re­ces­sive dy­s­troph­ic epi­der­mol­y­sis bul­losa, a some­times fa­tal rare dis­ease caused by a lack of col­la­gen in the skin re­sult­ing in un­con­trol­lable blis­ter­ing. It’s a pro­gram that comes from the small ac­qui­si­tion of the biotech Fi­bro­cell back in Sep­tem­ber 2019.

Cas­tle Creek has been work­ing on rare dis­eases in­volv­ing the skin since in­cep­tion, with a for­mer lead pro­gram in a broad­er epi­der­mol­y­sis bul­losa pop­u­la­tion. But that can­di­date, a top­i­cal re­for­mu­la­tion of the IL-1 be­ta an­ti-in­flam­ma­to­ry drug di­ac­ere­in, failed a Phase II study in Oc­to­ber 2018.

Jeff Aronin

Co-founder Michael Der­by had told End­points at the time that Cas­tle Creek planned to ad­vance the pro­gram in­to Phase III de­spite the fail­ure, but it’s un­clear if those plans ever came to fruition. Di­ac­ere­in is no longer list­ed among the biotech’s pipeline, and its on­ly men­tions in the S-1 re­volve around the old li­cens­ing agree­ments Cas­tle Creek signed to re-en­gi­neer it as a top­i­cal drug.

The biotech will con­tin­ue to charge for­ward with the new­er can­di­date, and plans to launch a sec­ond Phase III study be­fore the end of 2021 in the dom­i­nant ver­sion of dy­s­troph­ic epi­der­mol­y­sis bul­losa. Though Cas­tle Creek did not di­vulge ex­act fig­ures in its SEC pa­per­work, it’s ex­pect­ed a sig­nif­i­cant por­tion of these funds will go to­ward the two stud­ies and “pre-com­mer­cial” ac­tiv­i­ties for D-Fi.

There’s al­so an­oth­er Fi­bro­cell gene ther­a­py for mod­er­ate to se­vere lo­cal­ized scle­ro­der­ma in the works, and some IPO funds will be used to wrap up an on­go­ing Phase I/II tri­al, Cas­tle Creek not­ed. The biotech comes from maven Jeff Aronin and his port­fo­lio of com­pa­nies un­der the Paragon um­brel­la. Once it prices, Cas­tle Creek ex­pects to trade un­der the tick­er $CCBS.

Eliem for a dream: From stealth to Nas­daq in four months

Eliem Ther­a­peu­tics is aim­ing to com­plete a quick rise to Nas­daq af­ter launch­ing at the end of March.

There had been signs of an IPO af­ter the biotech’s $60 mil­lion Se­ries B, when com­pa­ny spokes­peo­ple de­clined in­ter­view re­quests ahead of the fil­ing. Eliem like­ly rep­re­sents one of the fastest Nas­daq push­es for biotech in re­cent mem­o­ry, go­ing from launch to fil­ing for an IPO in less than four months.

Should it price, Eliem will have a pipeline of four neu­ro as­sets led by a pro­drug of an en­do­cannabi­noid known as palmi­toylethanolamide, or PEA. The can­di­date is known as ETX-810, and CSO Va­lerie Moris­set pre­vi­ous­ly told End­points the biotech is look­ing at a va­ri­ety of chron­ic pain in­di­ca­tions.

ETX-810 is cur­rent­ly in two Phase IIa stud­ies look­ing at di­a­bet­ic pe­riph­er­al neu­ro­path­ic pain and lum­bosacral radic­u­lar pain. Da­ta read­outs are ex­pect­ed for the first half of 2022.

Eliem is al­so de­vel­op­ing a GA­BA-pos­i­tive al­losteric mod­u­la­tor, which the com­pa­ny is call­ing ETX-155. Re­searchers plan 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.

Both pro­grams come from RA Cap­i­tal, where the biotech was in­cu­bat­ed. Both will al­so be the pri­ma­ry fo­cus­es for the IPO raise.

Once Eliem goes pub­lic, it will trade un­der the tick­er $ELYM.

What Will it Take to Re­al­ize the Promise and Po­ten­tial of Im­mune Cell Ther­a­pies?

What does it take to get to the finish line with a new cancer therapy – fast? With approvals in place and hundreds of immune cell therapy candidates in the pipeline, the global industry is poised to create a fundamental shift in cancer treatments towards precision medicine. At the same time, unique challenges associated with cell and process complexity present manufacturing bottlenecks that delay speed to market and heighten cost of goods sold (COGS) — these hurdles must be overcome to make precision treatments an option for every cancer patient. This series of articles highlights some of the key manufacturing challenges associated with the production of cell-based cancer therapies as well as the solutions needed to transcend them. Automation, process knowledge, scalability, and assured supply of high-quality starting material and reagents are all critical to realizing the full potential of CAR-based therapies and sustaining the momentum achieved in recent years. The articles will highlight leading-edge technologies that incorporate these features to integrate across workflows, accelerate timelines and reduce COGS – along with how these approaches are enabling the biopharmaceutical industry to cross the finish line faster with new treatment options for patients in need.

The biggest ques­tions fac­ing gene ther­a­py, the XLMTM com­mu­ni­ty, and Astel­las af­ter fourth pa­tient death

After three patients died last year in an Astellas gene therapy trial, the company halted the study and began figuring out how to safely get the program back on track. They would, executives eventually explained, cut the dose by more than half and institute a battery of other measures to try to prevent the same thing from happening again.

Then tragically, Astellas announced this week that the first patient to receive the new regimen had died, just weeks after administration.

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Lat­est news: It’s a no on uni­ver­sal boost­ers; Pa­tient death stuns gene ther­a­py field; In­side Tril­li­um’s $2.3B turn­around; 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.

Next week is shaping up to be a busy one, as our editor-in-chief John Carroll and managing editor Kyle Blankenship lead back-to-back discussions with a great group of experts to discuss the weekend news and trends. John will be spending 30 minutes with Jake Van Naarden, the CEO of Lilly Oncology, and Kyle has a brilliant panel lined up: Harvard’s Cigall Kadoch, Susan Galbraith, the new head of cancer R&D at AstraZeneca, Roy Baynes at Merck, and James Christensen at Mirati. Don’t miss out on the action — sign up here.

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Mi­rati's KRAS drug looks like the fa­vorite in colon can­cer with new da­ta, putting the pres­sure square on Am­gen

With Amgen already providing proof-of-concept for KRAS inhibitors with its sotorasib, Mirati Therapeutics is piecing together a follow-up effort in lung cancer with data it thinks are superior. But in colon cancer, where solo sotorasib has turned in a dud, Mirati may now have a strong case for superiority.

Mirati’s adagrasib, dosed solo or in combination with chemotherapy cetuximab, showed response rates grater than sotorasib solo  and as part of combination study in a similar patient population also revealed this week at #ESMO21. Mirati’s data were presented as part of a cohort update from the Phase II KRYSTAL-1 study testing adagrasib in a range of solid tumors harboring the KRAS-G12C mutation.

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President Biden and Pfizer CEO Albert Bourla (Patrick Semansky/AP Images)

Chaot­ic ad­comm sees Pfiz­er/BioN­Tech boost­ers re­ject­ed for gen­er­al pop­u­la­tion, but rec­om­mend­ed for old­er and high-risk pop­u­la­tions

With just days before President Joe Biden’s Covid-19 booster rollout is set to go into effect, an FDA advisory committee appeared on the verge of not recommending boosters for anyone in the US before a last-minute change of wording laid the groundwork for older adults to have access to a third dose.

The FDA’s adcomm on Vaccines and Related Biological Products (VRBPAC) roundly rejected Pfizer/BioNTech booster shots for all individuals older than 16 by a 16-2 vote Friday afternoon. Soon after, however, the agency posed committee members a new question limiting booster use to the 65-and-older population and individuals at high risk of disease due to occupational exposure or comorbidities.

The best of the rest: High­lights from the be­low-the-fold pre­sen­ta­tions at #ES­MO21

This year’s ESMO Congress has had a major focus on Big Pharma drugs — most notably candidates from Merck and AstraZeneca — but there have also been updates from smaller biotechs with data looking to challenge the big-name drugmakers.

Today, we’re highlighting some of the data releases that flew under the radar at #ESMO21 — whether from early-stage drugs looking to make a mark or older stalwarts with interesting follow-up data.

As­traZeneca, Dai­ichi Sanky­o's ADC En­her­tu blows away Roche's Kad­cy­la in sec­ond-line ad­vanced breast can­cer

AstraZeneca and Japanese drugmaker Daiichi Sankyo think they’ve struck gold with their next-gen ADC drug Enhertu, which has shown some striking data in late-stage breast cancer trials and early solid tumor tests. Getting into earlier patients is now the goal, starting with Enhertu’s complete walkover of a Roche drug in second-line breast cancer revealed Saturday.

Enhertu cut the risk of disease progression or death by a whopping 72% (p=<0.0001) compared with Roche’s ADC Kadcyla in second-line unresectable and/or metastatic HER2-positive breast cancer patients who had previously undergone treatment with a Herceptin-chemo combo, according to interim data from the Phase III DESTINY-Breast03 head-to-head study presented at this weekend’s #ESMO21.

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Merck Research Laboratories CMO Roy Baynes

Mer­ck­'s Keytru­da un­corks full da­ta on lat­est ad­ju­vant win — this time in melanoma — adding bricks to ear­ly can­cer wall

In recent months, the battle for PD-(L)1 dominance has spilled over into early cancer with Merck’s Keytruda and Bristol Myers Squibb’s Opdivo all alone on the front lines. Keytruda now has another shell in its bandolier, and it could spell a quick approval.

Keytruda cut the risk of relapse or death by 35% over placebo (p=0.00658) in high-risk, stage 2 melanoma patients who had previously undergone surgery to remove their tumors, according to full data from the Phase III KEYNOTE-716 presented Saturday at #ESMO21.

Mer­ck flesh­es out Keytru­da win in first-line cer­vi­cal can­cer, adding more fire­pow­er to its ear­ly can­cer push

Merck has worked hard to bring its I/O blockbuster Keytruda into earlier and earlier lines of therapy, and now the wonder drug appears poised to make a quick entry into early advanced cervical cancer.

A combination of Keytruda and chemotherapy with or without Roche’s Avastin cut the risk of death by 33% over chemo with or without Avastin (p=<0.001) in first-line patients with persistent, recurrent or metastatic cervical cancer, according to full data from the Phase III KEYNOTE-826 study presented Saturday at #ESMO21.