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.

Biotech Half­time Re­port: Af­ter a bumpy year, is biotech ready to re­bound?

The biotech sector has come down firmly from the highs of February as negative sentiment takes hold. The sector had a major boost of optimism from the success of the COVID-19 vaccines, making investors keenly aware of the potential of biopharma R&D engines. But from early this year, clinical trial, regulatory and access setbacks have reminded investors of the sector’s inherent risks.

RBC Capital Markets recently surveyed investors to take the temperature of the market, a mix of specialists/generalists and long-only/ long-short investment strategies. Heading into the second half of the year, investors mostly see the sector as undervalued (49%), a large change from the first half of the year when only 20% rated it as undervalued. Around 41% of investors now believe that biotech will underperform the S&P500 in the second half of 2021. Despite that view, 54% plan to maintain their position in the market and 41% still plan to increase their holdings.

So — that pig-to-hu­man trans­plant; Po­ten­tial di­a­betes cure reach­es pa­tient; Ac­cused MIT sci­en­tist lash­es back; 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.

We’re incredibly excited to welcome Beth Bulik, seasoned pharma marketing reporter, to the team. You can find much of her work in our new Marketing channel — and in her weekly newsletter, Endpoints PharmaRx, which will launch in early November. Add it to your subscriptions here.

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NYU surgeon transplants an engineered pig kidney into the outside of a brain-dead patient (Joe Carrotta/NYU Langone Health)

No, sci­en­tists are not any clos­er to pig-to-hu­man trans­plants than they were last week

Steve Holtzman was awoken by a 1 a.m. call from a doctor at Duke University asking if he could put some pigs on a plane and fly them from Ohio to North Carolina that day. A motorcyclist had gotten into a horrific crash, the doctor explained. He believed the pigs’ livers, sutured onto the patient’s skin like an external filter, might be able to tide the young man over until a donor liver became available.

UP­DAT­ED: Agenus calls out FDA for play­ing fa­vorites with Mer­ck, pulls cer­vi­cal can­cer BLA at agen­cy's re­quest

While criticizing the FDA for what may be some favoritism towards Merck, Agenus on Friday officially pulled its accelerated BLA for its anti-PD-1 inhibitor balstilimab as a potential second-line treatment for cervical cancer because of the recent full approval for Merck’s Keytruda in the same indication.

The company said the BLA, which was due for an FDA decision by Dec. 16, was withdrawn “when the window for accelerated approval of balstilimab closed,” thanks to the conversion of Keytruda’s accelerated approval to a full approval four months prior to its PDUFA date.

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How to col­lect and sub­mit RWD to win ap­proval for a new drug in­di­ca­tion: FDA spells it out in a long-await­ed guid­ance

Real-world data are messy. There can be differences in the standards used to collect different types of data, differences in terminologies and curation strategies, and even in the way data are exchanged.

While acknowledging this somewhat controlled chaos, the FDA is now explaining how biopharma companies can submit study data derived from real-world data (RWD) sources in applicable regulatory submissions, including new drug indications.

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David Livingston (Credit: Michael Sazel for CeMM)

Renowned Dana-Far­ber sci­en­tist, men­tor and bio­phar­ma ad­vi­sor David Liv­ingston has died

David Livingston, the Dana-Farber/Harvard Med scientist who helped shine a light on some of the key molecular drivers of breast and ovarian cancer, died unexpectedly last Sunday.

One of the senior leaders at Dana-Farber during his nearly half century of work there, Livingston was credited with shedding light on the genes that regulate cell growth, with insights into inherited BRCA1 and BRCA2 mutations that helped lay the scientific foundation for targeted therapies and earlier detection that have transformed the field.

No­vo CEO Lars Fruer­gaard Jør­gensen on R&D risk, the deal strat­e­gy and tar­gets for gen­der di­ver­si­ty

 

I kicked off our European R&D summit last week with a conversation involving Novo Nordisk CEO Lars Fruergaard Jørgensen. Novo is aiming to launch a new era of obesity management with a new approval for semaglutide. And Jørgensen had a lot to say about what comes next in R&D, how they manage risk and gender diversity targets at the trendsetting European pharma giant.

John Carroll: I’m here with Lars Jørgensen, the CEO of Novo Nordisk. Lars, it’s been a really interesting year so far with Novo Nordisk, right? You’ve projected a new era of growing sales. You’ve been able to expand on the GLP-1 franchise that was already well established in diabetes now going into obesity. And I think a tremendous number of people are really interested in how that’s working out. You have forecast a growing amount of sales. We don’t know specifically how that might play out. I know a lot of the analysts have different ideas, how those numbers might play out, but that we are in fact embarking on a new era for Novo Nordisk in terms of what the company’s capable of doing and what it’s able to do and what it wants to do. And I wanted to start off by asking you about obesity in particular. Semaglutide has been approved in the United States for obesity. It’s an area of R&D that’s been very troubled for decades. There have been weight loss drugs that have come along. They’ve attracted a lot of attention, but they haven’t actually ever gained traction in the market. My first question is what’s different this time about obesity? What is different about this drug and why do you expect it to work now whereas previous drugs haven’t?

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René Russo, Xilio CEO (Alicia Petitti for Xilio)

Xilio Ther­a­peu­tics goes pub­lic as bio­phar­ma IPOs rum­ble for­ward in Q4

It’s been a busy fall on Wall Street — and this week, we’ve got another biotech going public after Ventyx yesterday.

Massachusetts solid-tumor biotech Xilio Therapeutics made its public debut today, joining 149 other biotechs that have gone public so far this year.

Back on October 1st, Xilio filed its S-1 with the SEC to make its IPO debut for $100 million — the next step in financing after completing a $95 million Series C back in February.

Luc Boblet, Egle Therapeutics CEO

A new Treg play­er emerges with $46M and back­ing from Take­da

In recent years, the chorus of biotechs and Big Pharma backers targeting regulatory T cells — also known as “Tregs” — for cancer and autoimmune diseases has only grown louder.

The newest voice is from Egle Therapeutics, which sang out a $46.4 million Series A round on Friday led by LSP and Bpifrance through their InnoBio 2 fund. Takeda’s venture arm also chipped in, about a year after the pharma struck a research pact with the Paris-based upstart.

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