Shane Schaffer, Cingulate CEO

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

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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.

ZS Per­spec­tive: 3 Pre­dic­tions on the Fu­ture of Cell & Gene Ther­a­pies

The field of cell and gene therapies (C&GTs) has seen a renaissance, with first generation commercial therapies such as Kymriah, Yescarta, and Luxturna laying the groundwork for an incoming wave of potentially transformative C&GTs that aim to address diverse disease areas. With this renaissance comes several potential opportunities, of which we discuss three predictions below.

Allogenic Natural Killer (NK) Cells have the potential to displace current Cell Therapies in oncology if proven durable.

Despite being early in development, Allogenic NKs are proving to be an attractive new treatment paradigm in oncology. The question of durability of response with allogenic therapies is still an unknown. Fate Therapeutics’ recent phase 1 data for FT516 showed relatively quicker relapses vs already approved autologous CAR-Ts. However, other manufacturers, like Allogene for their allogenic CAR-T therapy ALLO-501A, are exploring novel lymphodepletion approaches to improve persistence of allogenic cells. Nevertheless, allogenic NKs demonstrate a strong value proposition relative to their T cell counterparts due to comparable response rates (so far) combined with the added advantage of a significantly safer AE profile. Specifically, little to no risk of graft versus host disease (GvHD), cytotoxic release syndrome (CRS), and neurotoxicity (NT) have been seen so far with allogenic NK cells (Fig. 1). In addition, being able to harness an allogenic cell source gives way to operational advantages as “off-the-shelf” products provide improved turnaround time (TAT), scalability, and potentially reduced cost. NKs are currently in development for a variety of overlapping hematological indications with chimeric antigen receptor T cells (CAR-Ts) today, and the question remains to what extent they will disrupt the current cell therapy landscape. Click for more details.

Graphic: Kathy Wong for Endpoints News

What kind of biotech start­up wins a $3B syn­di­cate, woos a gallery of mar­quee sci­en­tists and re­cruits GSK's Hal Bar­ron as CEO in a stun­ner? Let Rick Klaus­ner ex­plain

It started with a question about a lifetime’s dream on a walk with tech investor Yuri Milner.

At the beginning of the great pandemic, former NCI chief and inveterate biotech entrepreneur Rick Klausner and the Facebook billionaire would traipse Los Altos Hills in Silicon Valley Saturday mornings and talk about ideas.

Milner’s question on one of those mornings on foot: “What do you want to do?”

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Hal Barron, Endpoints UKBIO20 (Jeff Rumans)

'Al­tos was re­al­ly a once-in-a-life­time op­por­tu­ni­ty': Hal Bar­ron re­flects on his big move

By all accounts, Hal Barron had one of the best jobs in Big Pharma R&D. He made more than $11 million in 2020, once again reaping more than his boss, Emma Walmsley, who always championed him at every opportunity. And he oversaw a global R&D effort that struck a variety of big-dollar deals for oncology, neurodegeneration and more.

Sure, the critics never let up about what they saw as a rather uninspiring late-stage pipeline, where the rubber hits the road in the Big Pharma world’s hunt for the next big near-term blockbuster, but the in-house reviews were stellar. And Barron was firmly focused on bringing up the success rate in clinical trials, holding out for the big rewards of moving the dial from an average 10% success rate to 20%.

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Executive Director of the EMA Emer Cooke (AP Photo/Geert Vanden Wijngaert)

Eu­ro­pean Par­lia­ment signs off on strength­en­ing drug reg­u­la­tor's abil­i­ty to tack­le short­ages

The European Parliament on Thursday endorsed a plan to increase the powers of the European Medicines Agency, which will be better equipped to monitor and mitigate shortages of drugs and medical devices.

By a vote of 655 to 31, parliament signed off on a provisional agreement reached with the European Council from last October, in which the EMA will create two shortage steering groups (one for drugs, the other for devices), a new European Shortages Monitoring Platform to facilitate data collection and increase transparency, and on funding for the work of the steering groups, task force, working parties and expert panels that are to be established.

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FDA+ roundup: FDA's neu­ro­science deputy de­parts amid on­go­ing Aduhelm in­ves­ti­ga­tions; Califf on the ropes?

Amid increased scrutiny into the close ties between FDA and Biogen prior to the controversial accelerated approval of Aduhelm, the deputy director of the FDA’s office of neuroscience has called it quits after more than two decades at the agency.

Eric Bastings will now take over as VP of development strategy at Ionis Pharmaceuticals, the company said Wednesday, where he will provide senior clinical and regulatory leadership in support of Ionis’ pipeline.

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Sec­ondary patents prove to be key in biosim­i­lar block­ing strate­gies, re­searchers find

While the US biosimilars industry has generally been a disappointment since its inception, with FDA approving 33 biosimilars since 2015, just a fraction of those have immediately followed their approvals with launches. And more than a handful of biosimilars for two of the biggest blockbusters of all time — AbbVie’s Humira and Amgen’s Enbrel — remain approved by FDA but still have not launched because of legal settlements.

Hal Barron (GSK via YouTube)

GSK R&D chief Hal Bar­ron jumps ship to run a $3B biotech start­up, Tony Wood tapped to re­place him

In a stunning switch, GlaxoSmithKline put out word early Wednesday that R&D chief Hal Barron is exiting the company after 4 years — a relatively brief run for the man chosen by CEO Emma Walmsley in late 2017 to turn around the slow-footed pharma giant.

Barron is being replaced by Tony Wood, a close associate of Barron’s who’s taking one of the top jobs in Big Pharma R&D. He’ll be closer to home, though, for GSK. Barron has been running a UK and Philadelphia-based research organization from his perch in San Francisco.

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Chamath Palihapitiya and Pablo Legorreta

Bil­lion­aires Chamath Pal­i­hapi­tiya and Pablo Legor­re­ta hatch an $825M SPAC for cell ther­a­py biotech

Three years after Royalty Pharma chief Pablo Legorreta led a group of investors to buy up a pair of biotechs and create a new startup called ProKidney, the biotech is jumping straight into an $825 million public shell created by SPAC king and tech billionaire Chamath Palihapitiya.

ProKidney was founded 6 years ago but really got going at the beginning of 2019 with the $62 million acquisition of inRegen, which was working on an autologous — from the patient — cell therapy for kidney disease. After extracting kidney cells from patients, researchers expand the cells in the lab and then inject them back into patients, aiming to restore the kidneys of patients suffering from CKD.

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Troy Wilson, Kura CEO

FDA lifts par­tial hold on Ku­ra's Phase Ib AML pro­gram as biotech re­dou­bles mit­i­ga­tion ef­forts

Kura Oncology is clear to resume studies for its early-stage leukemia program after the FDA lifted a clinical hold Thursday afternoon.

Regulators had placed the hold on a Phase Ib study of KO-539, an experimental oral treatment for some genetic subsets of acute myeloid leukemia last November after a patient died while taking the drug. Kura expects to begin enrolling patients again imminently, CEO Troy Wilson told Endpoints News.