Jon Congleton, Mineralys

Min­eralys emerges with a new take on an old idea for the treat­ment of hy­per­ten­sion and $40M to play with

BT Slings­by

Al­dos­terone, a hor­mone linked to in­creased blood pres­sure, has long been a tar­get of in­ter­est for the treat­ment of hy­per­ten­sion, but se­lec­tiv­i­ty has been a chal­lenge. Now a new com­pa­ny has emerged from stealth to im­prove where oth­ers have failed.

Min­eralys Ther­a­peu­tics un­cloaked ear­ly Mon­day morn­ing with $40 mil­lion in Se­ries A funds to prep their lead can­di­date —  a se­lec­tive al­dos­terone syn­thase in­hibitor li­censed from Japan’s Mit­subishi Tan­abe — for a piv­otal study. The com­pa­ny was launched by Catalys Pa­cif­ic, the VC firm founder BT Slings­by put to­geth­er to cre­ate new biotechs around Japan­ese in­no­va­tion.

Al­dos­terone syn­thase in­hi­bi­tion is not a new idea. No­var­tis, Eli Lil­ly and Boehringer In­gel­heim have all pur­sued it, Slings­by said. At high­er lev­els, al­dos­terone ba­si­cal­ly tells the body to re­tain more sodi­um, and thus more wa­ter, lead­ing to an in­crease in blood vol­ume and pres­sure. CEO Jon Con­gle­ton com­pared the sit­u­a­tion to a wa­ter hose: The more wa­ter in the hose, the high­er the pres­sure.

The idea is to in­hib­it CYP11B2, an en­zyme re­spon­si­ble for al­dos­terone syn­the­sis. But the chal­lenge is do­ing so with­out off-tar­get ef­fects. An­oth­er en­zyme in prox­im­i­ty, CYP11B1, con­trols the syn­the­sis of cor­ti­sol. If a can­di­date isn’t se­lec­tive enough, it could in­hib­it both path­ways — and re­duc­ing cor­ti­sol es­sen­tial­ly coun­ters the blood pres­sure low­er­ing ef­fect of al­dos­terone re­duc­tion, Con­gle­ton said.

From the re­sults of four Phase II tri­als con­duct­ed by No­var­tis and pub­lished back in 2013:

Un­for­tu­nate­ly, the ob­served in­crease in 11-de­oxy­cor­ti­sol lev­els in­di­cat­ed off-tar­get in­hi­bi­tion of the 11β-hy­drox­y­lase ac­tiv­i­ty of CYP11B1 that re­sult­ed in the stim­u­la­tion of the HPA feed­back ax­is.

Min­eralys be­lieves it has a more se­lec­tive al­dos­terone syn­thase in­hibitor than past at­tempts. The biotech is about to head in­to a Phase II proof-of-con­cept study in Q2, and Con­gle­ton ex­pects to read out da­ta in the sec­ond half of 2022 which he hopes will pave the way for a piv­otal study launch at the be­gin­ning of 2023.

The Se­ries A funds should al­low the com­pa­ny to do that, as well as pre­clin­i­cal CMC and clin­i­cal phar­ma­col­o­gy work, and have cash go­ing in­to 2023, he said.

Con­gle­ton joined Min­eralys back in Oc­to­ber as em­ploy­ee No. 1. That was short­ly af­ter he left Im­pel Neu­roPhar­ma, where he served as pres­i­dent and CEO. The com­mute led him to leave Im­pel, he joked, adding that week­ly trips from Philadel­phia to Seat­tle were weigh­ing on him. But what at­tract­ed him to Min­eralys was the chance to bring a tar­get­ed ap­proach to the di­ag­no­sis, man­age­ment and treat­ment of hy­per­ten­sion.

In Jan­u­ary, the com­pa­ny tapped mi­Ra­gen, Ver­tex and No­var­tis In­sti­tutes for Bio­med­ical Re­search vet­er­an David Rod­man as CMO.

“We think re­al­ly bring­ing a more tar­get­ed ap­proach to the di­ag­no­sis man­age­ment and treat­ment of hy­per­ten­sion is long over­due,” Con­gle­ton said.

At the In­flec­tion Point for the Next Gen­er­a­tion of Can­cer Im­munother­a­py

While oncology researchers have long pursued the potential of cellular immunotherapies for the treatment of cancer, it was unclear whether these therapies would ever reach patients due to the complexity of manufacturing and costs of development. Fortunately, the recent successful development and regulatory approval of chimeric antigen receptor-engineered T (CAR-T) cells have demonstrated the significant benefit of these therapies to patients.

All about Omi­cron; We need more Covid an­tivi­rals; GSK snags Pfiz­er’s vac­cine ex­ec; Janet Wood­cock’s fu­ture at FDA; 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.

The slate of products we’re offering here at Endpoints is continuing to grow, and it’s not just limited to editorial. If you haven’t, do visit your reader profile to see if there are any other weekly newsletters you’re interested in — as each comes with its own exclusive content. And don’t miss the publisher’s note from Arsalan Arif on Endpoints Studio, our latest avenue for advertising on Endpoints.

Endpoints News

Keep reading Endpoints with a free subscription

Unlock this story instantly and join 124,600+ biopharma pros reading Endpoints daily — and it's free.

Lisa Deschamps, AviadoBio CEO

Ex-No­var­tis busi­ness head hops over to a gene ther­a­py start­up — and she's reeled in $80M for a dash to the clin­ic

Neurologist and King’s College London professor Christopher Shaw has been researching neurodegenerative diseases like ALS and collaborating with drugmakers for the last 25 years in the hopes of pushing new therapies forward. But unfortunately, none of those efforts have come anywhere close to fruition.

“So, you know, after 20 years in the game, I said, ‘Let’s try and do it ourselves,’” he told Endpoints News. 

Merck's new antiviral molnupiravir (Quality Stock Arts / Shutterstock)

As Omi­cron spread looms, oral an­tivi­rals ap­pear to be one of the best de­fens­es — now we just need more

After South African scientists reported a new Covid-19 variant — dubbed Omicron by the WHO — scientists became concerned about how effective vaccines and monoclonal antibodies might be against it, which has more than 30 mutations in the spike protein.

“I think it is super worrisome,” Dartmouth professor and Adagio co-founder and CEO Tillman Gerngross told Endpoints News this weekend. Moderna CEO Stéphane Bancel echoed similar concerns, telling the Financial Times that experts warned him, “This is not going to be good.”

Endpoints News

Keep reading Endpoints with a free subscription

Unlock this story instantly and join 124,600+ biopharma pros reading Endpoints daily — and it's free.

Radek Spisek, Sotio CEO (Cellestia)

A qui­et Czech biotech bags $315M to dri­ve its blos­som­ing can­cer pipeline through the clin­ic

In the rather insular world of biotech, most innovation inevitably comes from a cluster of R&D hubs — Cambridge, San Francisco, etc. But sometimes success stories sprout from rocky soil, which is most certainly the case with Prague-based Sotio Biotech and its suddenly jam-packed pipeline of cancer drugs.

After years in quiet development, Sotio now has $315 million in new funds to play with from parent company PPF Group, an investment group founded in the Czech Republic, as the biotech looks to advance its growing pipeline through early- and mid-stage trials.

Endpoints News

Keep reading Endpoints with a free subscription

Unlock this story instantly and join 124,600+ biopharma pros reading Endpoints daily — and it's free.

In­cor­po­rat­ing Ex­ter­nal Da­ta in­to Clin­i­cal Tri­als: Com­par­ing Dig­i­tal Twins to Ex­ter­nal Con­trol Arms

Most drug development professionals are familiar with the nerve-racking wait for the read-out of a large trial. If it’s negative, is the investigational therapy ineffective? Or could the failure result from an unforeseen flaw in the design or execution of the protocol, rather than a lack of efficacy? The team could spend weeks analyzing data, but a definitive answer may be elusive due to insufficient power for such analyses in the already completed trial. These problems are only made worse if the trial had lower enrollment, or higher dropout than expected due to an unanticipated event like COVID-19. And if a trial is negative, the next one is likely to be larger and more costly — if it happens at all.

Ab­b­Vie tacks on a new warn­ing to Rin­voq la­bel as safe­ty frets crimp JAK class

The safety problems that continue to plague the JAK class as new data highlight some severe side effects are casting a large shadow over AbbVie’s Rinvoq.

As a result of a recent readout highlighting major adverse cardiac events (MACE), malignancy, mortality and thrombosis with Xeljanz a couple of months ago, AbbVie put out a notice late Friday afternoon that it is adding the new class risks to its label for their rival drug.

Endpoints News

Keep reading Endpoints with a free subscription

Unlock this story instantly and join 124,600+ biopharma pros reading Endpoints daily — and it's free.

Biospec­i­men M&A: Dis­cov­ery ac­quires Al­bert Li's he­pa­to­cyte project; PhI­II tri­al on Bay­er's Nube­qa reached pri­ma­ry end­point

Discovery Life Sciences has acquired what claims to be the Maryland-based host of the world’s largest hepatocyte inventory, known as IVAL, to help researchers select more effective and safer drug candidates in the future.

The combined companies will now serve a wider range of drug research and development scientists, according to Albert Li, who founded IVAL in 2004 and is set to join the Discovery leadership team as the CSO of pharmacology and toxicology.

Pfiz­er, Am­gen and Janssen seek fur­ther clar­i­ty on FDA's new ben­e­fit-risk guid­ance

Three top biopharma companies are seeking more details from the FDA on how the agency conducts its benefit-risk assessments for new drugs and biologics.

While Pfizer, Amgen and Janssen praised the agency for further spelling out its thinking on the subject in a new draft guidance, including a discussion of patient experience data as part of the assessment, the companies said the FDA could’ve included more specifics in the 20-page draft document.

Endpoints News

Keep reading Endpoints with a free subscription

Unlock this story instantly and join 124,600+ biopharma pros reading Endpoints daily — and it's free.