Chas­ing Bio­gen, the Pli­ant crew banks a $62M round to fu­el their shot at fi­bro­sis tar­gets

South San Fran­cis­co-based Pli­ant Ther­a­peu­tics has just closed a $62 mil­lion round to take their id­io­path­ic pul­monary fi­bro­sis drug to the clin­ic — the first of many fi­brot­ic dis­ease-tar­get­ing drugs it hopes will come out of its dis­cov­ery en­gine.

The Se­ries B puts Pli­ant in a po­si­tion to progress to­ward clin­i­cal proof of con­cept for its lead small mol­e­cule drug, which is a dual in­hibitor of the αvβ1 and αvβ6 in­te­grins. As a fam­i­ly of trans­mem­brane re­cep­tors that usu­al­ly me­di­ate cell ad­he­sion, in­te­grins — as sci­en­tif­ic co-founder Dean Shep­pard has shown in his work at UCSF — are a key dri­ver in fi­bro­sis across dif­fer­ent or­gans.

Dean Shep­pard

That ap­proach is ev­i­dent in the com­pa­ny’s choice of in­di­ca­tions to tack­le first. Their lead drug, which doesn’t yet have a name, will be test­ed for id­io­path­ic pul­monary fi­bro­sis (IPF) and pri­ma­ry scle­ros­ing cholan­gi­tis (PSC). Both are rare dis­eases, but IPF af­fects the lung while PSC is found in the liv­er’s bile ducts.

CEO Bernard Coulie is quick to ad­mit that Pli­ant is run­ning af­ter a cou­ple of lead play­ers in the field. He es­ti­mates that they are 18 months be­hind Bio­gen, which has a mon­o­clon­al an­ti­body against αvβ6 mov­ing in­to Phase IIb for IPF.

“They are the first […] but we are sec­ond and we are not that far be­hind,” he tells me. “So I think that’s a re­al­ly good po­si­tion to be at.”

It al­so helps that their ther­a­py is a small mol­e­cule that binds to not one but two tar­gets.

Kevin Raidy

Be­sides, Coulie adds, not every­thing has to be a com­pe­ti­tion. In the hot field of NASH, he sees Pli­ant play­ing a role in de­vel­op­ing part of a com­bi­na­tion ther­a­py that com­ple­ments lipid-low­er­ing drugs.

To be clear, giv­en that even their ear­li­est clin­i­cal pro­grams won’t start un­til 2019, Pli­ant still has a ways to go be­fore they could nail a clin­ic-ready treat­ment for NASH or any of the oth­er fi­brot­ic dis­eases — from re­nal fi­bro­sis to Duchenne mus­cu­lar dy­s­tro­phy — they be­lieve they can tack­le. But Coulie takes con­fi­dence in the drug dis­cov­ery en­gine their team has built, us­ing fresh tis­sues tak­en from fi­bro­sis pa­tients to in­form tar­get se­lec­tion and bio­mark­er char­ac­ter­is­tics.

Per the com­pa­ny’s own es­ti­mates, this “de-risked” plat­form can gen­er­at­ed one to two drug can­di­dates every year. As it works on an ex­pand­ing port­fo­lio, its staff is ex­pect­ed to grow from 35 to 50 by the end of this year.

Cowen Health­care In­vest­ments, which led the round, was con­vinced — as were new in­vestors Even­tide As­set Man­age­ment, Schroder Ad­veq, Men­lo Ven­tures, SCubed Cap­i­tal, and Agent Cap­i­tal, among oth­ers.

“The unique bi­o­log­i­cal in­sights Pli­ant Ther­a­peu­tics has un­cov­ered about the role of in­te­grins as key dri­vers of fi­bro­sis will fu­el the dis­cov­ery of nov­el ther­a­peu­tics that have the po­ten­tial to ad­dress a range of fi­brot­ic dis­eases,” said Cowen’s man­ag­ing part­ner Kevin Raidy, who’s join­ing the board as part of the deal.

Im­age: Bernard Coulie. PLI­ANT

Biotech in­vestors and CEOs see two paths to growth, but are they equal­ly vi­able?

The dynamic in the biotech market has been highly volatile in the last few years, from the high peaks immediately after the COVID vaccine in 2021, to the lowest downturns of the last 20 years in 2022. This uncertainty makes calling the exact timing of the market’s turn something of a fool’s errand, according to Dr. Chen Yu, Founder and Managing Partner of TCG Crossover (TCG X). He speaks with RBC’s Noël Brown, Head of US Biotechnology Investment Banking, about the market’s road ahead and two possible paths for growth.

Casey McPherson shows his daughters Rose (left) and Weston around Everlum Bio, a lab that he co-founded to spark a treatment for Rose and others with ultra-rare conditions. (Ilana Panich-Linsman)

Fa­ther starts lab af­ter in­tel­lec­tu­al prop­er­ty is­sues stymie rare dis­ease drug de­vel­op­ment

Under bright lab lights, Casey McPherson holds his 6-year-old daughter, Rose. His free hand directs Rose’s gaze toward a computer screen with potential clues in treating her one-of-a kind genetic condition.

Gray specks on the screen show her cells that scientists reprogrammed with the goal of zeroing in on a custom medicine. McPherson co-founded the lab, Everlum Bio, to spark a treatment for Rose — and others like her. A regarded singer-songwriter, McPherson never imagined going into drug development.

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Fireside chat between Hal Barron and John Carroll, UKBIO19

It’s time we talked about bio­phar­ma — live in Lon­don next week

Zoom can only go so far. And I think at this stage, we’ve all tested the limits of staying in touch — virtually. So I’m particularly happy now that we’ve revved up the travel machine to point myself to London for the first time in several years.

Whatever events we have lined up, we’ve always built in plenty of opportunities for all of us to get together and talk. For London, live, I plan to be right out front, meeting with and chatting with the small crowd of biopharma people we are hosting on October 12 at Silicon Valley Bank’s London headquarters. And there’s a lengthy mixer at the end I’m most looking forward to, with several networking openings between sessions.

Pfizer and BioNTech's original Marvel comic book links evolving Covid vaccine science to Avengers' evolving villain-fighting tools.(Source: Pfizer LinkedIn post)

Pfiz­er, BioN­Tech part­ner with Mar­vel for Avengers and Covid-fight­ing com­ic book

Pfizer and BioNTech are collaborating with Marvel to celebrate “everyday” people getting Covid-19 vaccines in a custom comic book.

In the “Everyday Heroes” digital comic book, an evolving Ultron, one of the Avengers’ leading villains, is defeated by Captain America, Ironman and others. The plotline and history of Ultron is explained by a grandfather who is waiting with his family at a clinic for Covid-19 vaccinations.

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Take­da to pull key hy­poparathy­roidism drug from the mar­ket af­ter years of man­u­fac­tur­ing woes

Takeda on Tuesday morning made an announcement that almost 3,000 people with the rare disease known as hypoparathyroidism were fearing.

Due to unresolved supply issues and manufacturing woes, Takeda said it will cut its losses and discontinue its hypoparathyroidism drug, known as Natpara (parathyroid hormone), halting all manufacturing of the drug by the end of 2024, but the entire inventory will be available until depleted or expired, a company spokesperson said via email.

Eli Lil­ly and Te­va pre­pare for court bat­tle over mi­graine med ri­val­ry

It looks like Eli Lilly and Teva Pharmaceuticals are going to trial.

A federal appeals court on Monday refused to invalidate three of Teva’s patents for its migraine treatment Ajovy, while also declining to issue a summary judgment in favor of either company, which would effectively end the case without a full trial.

Teva filed suit against Lilly back in 2018, alleging that the company infringed upon nine patents with its rival migraine drug Emgality. The rival drugs were both approved in September 2018 for the preventative treatment of migraine, and are designed to block calcitonin gene-related peptide (CGRP), a protein associated with the onset of migraine pain.

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Rep. Vern Buchanan (R-FL) (Bill Clark/CQ Roll Call via AP Images)

Af­ter cov­er­age re­stric­tions for Alzheimer's drugs, bi­par­ti­san House bill would force CMS to re­view drugs in­di­vid­u­al­ly

When Biogen’s controversial Alzheimer’s drug Aduhelm was hit with a national decision from CMS that restricted coverage to only randomized trials, practically guaranteeing a commercial flop in the near term, questions surfaced over why CMS also included all amyloid-targeted monoclonal antibodies for Alzheimer’s disease.

With Eisai and Biogen’s second Alzheimer’s drug, lecanemab, now showing it can slow the rate of cognitive decline versus placebo, lining up for a likely full approval next spring, the question now turns to whether that data, which is being presented at the Clinical Trials on Alzheimer’s Congress in San Francisco in late November, will be enough for CMS when it asks, “Does the anti-amyloid mAb meaningfully improve health outcomes (i.e., slow the decline of cognition and function) for patients in broad community practice?”

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FDA+ roundup: Ad­comm date set for Cy­to­ki­net­ics heart drug; New gener­ic drug guid­ance to re­duce fa­cil­i­ty de­lays

The FDA on Wednesday set Dec. 13 as the day that its Cardiovascular and Renal Drugs Advisory Committee will review Cytokinetics’ potential heart drug, meaning regulators aren’t likely to meet the Nov. 30 PDUFA date that was previously set.

The drug, known as omecamtiv mecarbil, read out its first Phase III in November 2020, hitting the primary endpoint of reducing the odds of hospitalization or other urgent care for heart failure by 8%. But it also missed a key secondary endpoint analysts had pegged as the key to breaking into the market, failing to significantly differ in reducing cardiovascular death from placebo.

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Af­ter Covid set­back, Val­ne­va lines up $100M for Pfiz­er-al­lied Ly­me dis­ease PhI­II

Valneva has secured €102.9 million (around $99.9 million USD) in a share offering to push forward its Pfizer-partnered Lyme disease vaccine and a jab for chikungunya that awaits an FDA decision.

The French vaccine maker largely snagged the near $100 million from Deep Track Capital and local state-owned Bpifrance, the company said Tuesday night. The capital injection is nearly equal to the amount Pfizer paid to nab equity in the company earlier this summer as part of the duo’s vaccine tie-up.