CinCor Pharma CEO Marc de Garidel (Eric Piermont/AFP via Getty Images)

Qui­et Cin­Cor Phar­ma makes some noise with $143M, new tri­al plans for blood pres­sure drug

Cin­Cor Phar­ma has been fair­ly qui­et since emerg­ing in the hy­per­ten­sion space a cou­ple of years ago with a for­mer Roche pro­gram in tow. Not any­more.

Jon Isaac­sohn

On Tues­day, the Cincin­nati-based biotech un­wrapped a $143 mil­lion Se­ries B round led by Gen­er­al At­lantic. And judg­ing by the size of the raise and the syn­di­cate of blue-chip in­vestors, it seems like­ly that CEO Marc de Garidel has the S-1 pa­pers ready to go.

Cin­Cor’s lead pro­gram is an oral al­dos­terone syn­thase in­hibitor called CIN-107, which founder Jon Isaac­sohn li­censed from Roche for an undis­closed amount back in 2019. Al­dos­terone, a hor­mone linked to in­creased blood pres­sure, has long been a tar­get of in­ter­est for the treat­ment of hy­per­ten­sion. Se­lec­tiv­i­ty, how­ev­er, has been a chal­lenge.

Oth­er com­pa­nies like Min­eralys and Phase­Bio have emerged with can­di­dates to in­hib­it CYP11B2, an en­zyme re­spon­si­ble for al­dos­terone syn­the­sis. But the dif­fi­cul­ty lies in do­ing so with­out al­so in­hibit­ing an­oth­er en­zyme in prox­im­i­ty called CYP11B1, which con­trols the syn­the­sis of cor­ti­sol. Re­duc­ing cor­ti­sol es­sen­tial­ly coun­ters the blood pres­sure low­er­ing ef­fect of al­dos­terone re­duc­tion.

Like the teams at Min­eralys and Phase­Bio, Cin­Cor claims CIN-107 is “high­ly se­lec­tive.” It’s cur­rent­ly in two Phase II tri­als for treat­ment-re­sis­tant hy­per­ten­sion and pri­ma­ry al­dos­tero­nism, the for­mer of which kicked off last Oc­to­ber. The Se­ries B cash will be used to com­plete those tri­als, and ini­ti­ate two new ones in pa­tients with un­con­trolled hy­per­ten­sion and chron­ic kid­ney dis­ease. The com­pa­ny de­clined an in­ter­view re­quest by End­points News. 

“De­spite the avail­abil­i­ty of mul­ti­ple an­ti-hy­per­ten­sive agents, of­ten used in com­bi­na­tion, a sub­stan­tial num­ber of ad­her­ent hy­per­ten­sive pa­tients are not able to re­duce their blood pres­sures to op­ti­mal lev­els,” Isaac­sohn said in a state­ment last year. The for­mer CEO hand­ed the reins to de Garidel back in Ju­ly. He’s stick­ing around, though, lead­ing CIN-107’s de­vel­op­ment as CSO.

Ja­son Pitts

It’s a close race so far, with Min­eralys ex­pect­ing to read out hy­per­ten­sion da­ta in 2022 they hope will pave the way for a piv­otal launch at the be­gin­ning of 2023. Phase­Bio is right be­hind Min­eralys and Cin­Cor, with a pro­gram ex­pect­ed to en­ter the clin­ic next year. An­gion al­so has a CYP11B2 in­hibitor in the works, which is still in pre­clin­i­cal stud­ies, ac­cord­ing to its web­site.

“There has been lit­tle in­no­va­tion in the treat­ment of hy­per­ten­sion in the past sev­er­al decades, along with a lack of in­cor­po­rat­ing tar­get­ed ap­proach­es seen in oth­er fields,” Ja­son Pitts, VP of Gen­er­al At­lantic, said in a state­ment.

In ad­di­tion to Gen­er­al At­lantic, a slate of new and old in­vestors chipped in on the Se­ries B, in­clud­ing Per­cep­tive Ad­vi­sors, BVF Part­ners, ven­Bio Part­ners, Adage Cap­i­tal Man­age­ment, Omega Funds, Rock Springs Cap­i­tal, RTW In­vest­ments, Lil­ly Asia Ven­tures, Six­ty De­gree Cap­i­tal, Sofinno­va In­vest­ments, Sofinno­va Part­ners, 5AM Ven­tures and Cin­Rx.

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.

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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Kenneth Galbraith, incoming Zymeworks CEO

Zymeworks re­places half its C-suite, aims to lay off 25% of to­tal work­force as new CEO takes over

New Zymeworks CEO Kenneth Galbraith is aiming to hit the ground running when his tenure officially begins next month, but he’ll be doing so with a much different looking team.

In a lengthy press release outlining the biotech’s 2022 goals, Galbraith said Zymeworks will be laying off at least 25% of its staff over the course of the year. Half of its C-suite will also be replaced immediately as Galbraith looks to remake the company in his image after Ali Tehrani, Zymeworks’ founder and CEO since 2003, stepped down two weeks ago.

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Crit­ics push back on Alzheimer’s As­so­ci­a­tion ad blitz to get Medicare to change its Aduhelm rul­ing: 'Dead wrong'

The latest Alzheimer’s Association advertising campaign encourages people to fight.

Not against the disease or for more research or treatments, but against the Centers for Medicare and Medicaid Services. More specifically, CMS’ recent reimbursement decision to only pay for Biogen and Eisai’s controversial Alzheimer’s drug Aduhelm for patients in clinical trials.

With CMS’ preliminary decision now in a 30-day comment period, patient advocates’ goal is to convince CMS to reverse its decision with a marketing blitz and public pressure.

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Dan O'Day, Gilead CEO (Jim Watson/AFP via Getty Images)

Fail­ing to con­firm clin­i­cal ben­e­fit, Gilead pulls 2 ac­cel­er­at­ed ap­proval in­di­ca­tions for can­cer drug

Gilead recently decided to pull two indications for its cancer drug Zydelig — in relapsed follicular B-cell non-Hodgkin lymphoma (FL) and relapsed small lymphocytic leukemia (SLL) — after failing to complete the confirmatory trials required as part of the accelerated approvals from 2014.

“As the treatment landscape for FL and SLL has evolved, enrollment into the confirmatory study has been an ongoing challenge,” Gilead said in a statement, noting it formally notified the FDA of its decision to voluntarily withdraw these indications.

Richard Pazdur (via AACR)

Time lim­its on ac­cel­er­at­ed ap­provals? FDA's on­col­o­gy chief Rick Paz­dur eyes po­ten­tial re­forms via in­ter­na­tion­al ap­proach­es

The spotlight on the accelerated approval pathway continues to shine bright, with the FDA’s top oncology official writing in an opinion that the pathway may be strengthened with bits and pieces of what other regulators in Europe and elsewhere have done with their expedited approval pathways, such as adding expiration dates for these faster approvals to ensure they confirm clinical benefit in a timely manner.

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Covid-19 roundup: HHS may strug­gle to ab­sorb Op­er­a­tion Warp Speed; Eu­rope has no plans for a fourth vac­cine dose

Operation Warp Speed, perhaps the greatest achievement of the former Trump administration, promptly delivered Covid-19 vaccine supplies nationwide when they became available, thanks to collaborations between HHS and the Department of Defense, while helping to fund and aid the manufacture of billions of doses.

But since the Biden administration took over a year ago, acting FDA commissioner Janet Woodcock transitioned out of her role as the therapeutics lead in Warp Speed, which has been converted into a new operation without the fancy name (now known as the “HHS-DOD COVID-19 Countermeasures Acceleration Group”), and as of the start of 2022, the Department of Defense is no longer helping HHS on the program.

Flori­da man con­vict­ed of fal­si­fy­ing clin­i­cal tri­al re­sults sen­tenced to over 2 years in prison

A Florida man who falsified medical records in connection to clinical trials was sentenced to 30 months in prison in federal court Thursday.

Daniel Tejeda, 35, of Clewiston, was also ordered to pay $2.1 million in restitution. Tejeda was a project manager and study manager for the CRO Tellus Clinical Research, and made it appear that subjects were participating in trials when they weren’t. Two other research workers from Florida were sentenced in the same case in August for 46 and 30 months, respectively.