Shane Schaffer, Cingulate CEO

IPO fil­ings are back on the biotech menu as an AD­HD drug de­vel­op­er sub­mits its Nas­daq pa­per­work

Ed­i­tor’s note: In­ter­est­ed in fol­low­ing bio­phar­ma’s fast-paced IPO mar­ket? You can book­mark our IPO Track­er here.

The sum­mer months have brought the biotech IPO mar­ket to a near stand­still af­ter a record run, but ac­tiv­i­ty is slow­ly start­ing to ramp back up again as an­oth­er com­pa­ny is tak­ing the Nas­daq plunge.

AD­HD drug de­vel­op­er Cin­gu­late filed for an IPO on Thurs­day, pen­cil­ing in a mod­est $58 mil­lion for its raise. Based out of Kansas City, KS, Cin­gu­late has a Phase III-ready AD­HD pro­gram in ad­di­tion to a fol­low-up can­di­date soon to hit the clin­ic, as well as a third pro­gram still in ear­ly pre­clin­i­cal de­vel­op­ment for anx­i­ety.

Cin­gu­late got start­ed back in 2013 with a found­ing group of vet­er­an psy­chi­a­trists and a CEO in Shane Schaf­fer who spent more than 25 years in se­nior roles at Pfiz­er, No­var­tis and Sanofi. The group is pitch­ing an al­ter­na­tive de­liv­ery method for their AD­HD med­i­cines, bank­ing on “pre­ci­sion timed re­lease” to dif­fer­en­ti­ate it­self from oth­er play­ers.

Most AD­HD meds cur­rent­ly ap­proved, the biotech says in its S-1, are stim­u­lants tak­en in the morn­ing with quick-act­ing ef­fects, leav­ing pa­tients need­ing ad­di­tion­al pills in the af­ter­noon af­ter they ex­pe­ri­ence a “crash.” It’s a mar­ket Cin­gu­late be­lieves is ripe for dis­rup­tion, with stim­u­lants mak­ing up 91% of the $15 bil­lion-plus AD­HD pie.

Cin­gu­late’s lead can­di­date, known as CTx-1301, is de­signed to slow­ly re­lease its ac­tive in­gre­di­ents in three phas­es through­out the day. The first por­tion is an im­me­di­ate re­lease, ac­count­ing for about 35% of the to­tal med­i­cine con­tained in the pill, and is de­liv­ered over 30 min­utes. The sec­ond part, com­ing about three to four hours lat­er, com­pris­es 45% of the to­tal and is de­liv­ered over a 90-minute pe­ri­od.

These first two re­lease sched­ules are com­pa­ra­ble to some meds on the mar­ket such as Fo­calin, Cin­gu­late says, but CTx-1301 has a third timed re­lease built-in as a “boost­er” mak­ing up the re­main­ing 20%. This boost­er re­leas­es about sev­en hours af­ter tak­ing the pill and en­ters the blood­stream over the fol­low­ing 30 min­utes.

The pro­gram has al­ready passed a Phase I/II test com­par­ing it to Fo­calin, and a Phase III pro­gram is planned to start in the fourth quar­ter look­ing at chil­dren, ado­les­cents and adults with AD­HD. Should the piv­otal stud­ies prove suc­cess­ful, an NDA is ex­pect­ed to fol­low in the first half of 2023.

Cin­gu­late’s fol­low-up AD­HD can­di­date is aimed sole­ly at chil­dren, but re­lies on the same pre­ci­sion timed re­lease plat­form. For this pro­gram, which is ex­pect­ed to start a Phase I/II study in ear­ly 2022, re­searchers have de­signed the med­i­cine to re­lease in 45%-35%-20% por­tions, rather than the 35%-45%-20% sched­ule for the lead.

Funds from the IPO are ex­pect­ed to go to­ward both of these clin­i­cal pro­grams in ad­di­tion to a proof of con­cept study for the pre­clin­i­cal anx­i­ety med­ica­tion. Cin­gu­late hasn’t list­ed how much in its S-1 just yet, how­ev­er.

Al­so on Thurs­day, two biotechs set terms for their re­spec­tive IPOs: Kevin Ju­dice’s DiCE Ther­a­peu­tics and Tyra Bio­sciences. Both are ex­pect­ed to price next week with rais­es top­ping $100 mil­lion each, ac­cord­ing to Re­nais­sance Cap­i­tal.

Once DiCE and Tyra go pub­lic, biotech’s com­bined IPO raise will eclipse $13 bil­lion for 2021, per the End­points News tal­ly. With about three and a half months left in the year, ac­tiv­i­ty will like­ly need to ramp back up to ear­li­er lev­els to sur­pass 2020’s record raise of $16.5 bil­lion.

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.

Endpoints Premium

Premium subscription required

Unlock this article along with other benefits by subscribing to one of our paid plans.

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.

Endpoints News

Keep reading Endpoints with a free subscription

Unlock this story instantly and join 117,600+ biopharma pros reading Endpoints daily — and it's free.

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.

Endpoints News

Keep reading Endpoints with a free subscription

Unlock this story instantly and join 117,600+ biopharma pros reading Endpoints daily — and it's free.

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.

Endpoints News

Keep reading Endpoints with a free subscription

Unlock this story instantly and join 117,600+ biopharma pros reading Endpoints daily — and it's free.

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.