Bernard Coulie (file photo)

With one ri­val down, No­var­tis-part­nered biotech scores $100M round to fund mid-stage tri­als of fi­bro­sis drug

When Pli­ant Ther­a­peu­tics bagged its $62 mil­lion B round al­most two years ago, CEO Bernard Coulie po­si­tioned its lead pro­gram in id­io­path­ic pul­monary fi­bro­sis right be­hind Bio­gen, which he sees as a fron­trun­ner 18 months ahead.

Com­ing in­to the Se­ries C, that’s no longer the case. Bio­gen scrapped its Phase II tri­al last Sep­tem­ber due to safe­ty con­cerns, leav­ing Pli­ant even more room to make a splash with the mid-stage pro­grams it now plans to run with $100 mil­lion of new cash in the bank.

While Pli­ant’s sci­en­tif­ic co-founder, Dean Shep­pard of UCSF, helped in­spire the ri­val pro­gram at Stromedix that was even­tu­al­ly sold to Bio­gen, his lat­est idea re­volves around a small mol­e­cule in­te­grin in­hibitor rather than an an­ti­body. Pli­ant’s drug, PLN-74809, al­so hits one more tar­get than BG00011: In ad­di­tion to αvβ6, it al­so blocks αvβ1 in­te­grins.

“For us, the les­son learned is stay away from an im­mune-stim­u­la­to­ry an­ti­body in a dis­ease pop­u­la­tion that is quite sen­si­tive to im­mune stim­u­la­tion,” Coulie told End­points News.

The new fund­ing — com­ing from new back­ers Red­mile Group, Far­al­lon Cap­i­tal Man­age­ment, Cor­morant As­set Man­age­ment, Sur­vey­or Cap­i­tal and Lo­gos Cap­i­tal as well as ex­ist­ing in­vestors in­clud­ing Even­tide As­set Man­age­ment, Cowen Health­care In­vest­ments, Schroder Ad­veq, Men­lo Ven­tures, S-Cubed Cap­i­tal, Agent Cap­i­tal and oth­ers — will foot the bill for two Phase IIa stud­ies in IPF as well as a Phase II in pri­ma­ry scle­ros­ing cholan­gi­tis.

Re­cent­ly com­plet­ed Phase I tri­als have giv­en them bi­o­log­i­cal proof-of-con­cept and con­fi­dence that a low dose, at 40 mg, is suf­fi­cient, Coulie said.

The the­o­ry is that block­ing these in­te­grins can pre­vent down­stream ac­ti­va­tion of TGF-β, which Pli­ant be­lieves is the main cul­prit of fi­bro­sis — whether in the lung or liv­er or bile duct.

It’s the same the­o­ry be­hind its sec­ond as­set, de­signed to stop the TGF-β ac­ti­va­tion it­self. Late last year No­var­tis hand­ed off $80 mil­lion to part­ner on PLN-1474 with an eye on treat­ing end-stage fi­bro­sis in NASH, a high­ly lu­cra­tive field with quite a few dif­fer­ent cor­ners to plough. Pli­ant is in the process of con­duct­ing a Phase I be­fore — as­sum­ing it’s suc­cess­ful — trans­fer­ring the as­set to its phar­ma gi­ant part­ner.

With its lead drug, Coulie said they plan to con­tin­ue go­ing it alone to prove its val­ue with IPF and PSC, both chal­leng­ing in­di­ca­tions that have elud­ed drug­mak­ers from Glob­al Blood Ther­a­peu­tics to CymaBay.

PSC re­mains an open field, he added, and there’s resur­gent in­ter­est in IPF.

“We’ve seen some re­cent deals ba­si­cal­ly es­tab­lish­ing the scarci­ty val­ue in this spe­cif­ic in­di­ca­tion,” he said, cit­ing Roche’s $1.4 bil­lion ac­qui­si­tion of Prome­dior based on “kind of OK” Phase IIb ef­fi­ca­cy, Gilead’s $5.1 bil­lion ex­pand­ed tie-up with Gala­pa­gos large­ly dri­ven by an IPF au­to­tax­in in­hibitor, and a num­ber of ear­ly deals by Boehringer In­gel­heim.

“So I think the com­peti­tors are quite clear,” Coulie said. “I think Fi­bro­Gen is one of them, Gala­pa­gos is the oth­er one, but I think with the mech­a­nisms that they are pur­su­ing ver­sus what we use, we think we have a bet­ter chance in terms of ef­fi­ca­cy ver­sus those drugs.”

We should find out in 2021 as da­ta from the three-month mid-stage stud­ies trick­le in, though the PSC tri­al might take a bit longer as it’s start­ing lat­er in the sec­ond quar­ter.

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His­toric drug pric­ing re­forms pass; Pfiz­er ac­quires GBT; The long search for non-opi­oid pain drugs; 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 Endpoints Weekly has officially crossed the 60,000 mark on subscribers — thanks to all of your support. As the editorial team grows, we’ve been able to do a lot more, with many of those on display this week. Be sure to check out Lei Lei Wu’s deep dive on pain R&D. If you missed it, you may also rewatch her companion panel here.

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Gold for adults, sil­ver for in­fants: Pfiz­er's Pre­vnar 2.0 head­ed to FDA months af­ter Mer­ck­'s green light

Pfizer was first to the finish line for the next-gen pneumococcal vaccine in adults, but Merck beat its rival with a jab for children in June.

Now, two months after Merck’s 15-valent Vaxneuvance won the FDA stamp of approval for kids, Pfizer is out with some late-stage data on its 20-valent shot for infants.

Known as Prevnar 20 for adults, Pfizer’s 20vPnC will head to the FDA by the end of this year for an approval request in infants, the Big Pharma said Friday morning. Discussions with the FDA will occur first and more late-stage pediatric trials are expected to read out soon, informing the regulatory pathway in other countries and regions.

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No­var­tis re­ports two pa­tient deaths af­ter treat­ment with Zol­gens­ma

Two children with spinal muscular atrophy have died after receiving Novartis’ Zolgensma, a gene therapy designed as a one-time treatment for the rare fatal disease.

The deaths, which resulted from acute liver failure, occurred in Russia and Kazakhstan, Novartis confirmed in a statement to Endpoints News. Having notified health authorities across all the markets where Zolgensma is available, it will update the drug label “to specify that fatal acute liver failure has been reported,” a spokesperson wrote.

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House pass­es his­toric drug pric­ing re­forms, lin­ing up decades-in-the-mak­ing win for Biden and De­moc­rats

The US House of Representatives today voted along party lines (all Dems voted for it), 220-207 to pass new, wide-ranging legislation that will allow Medicare drug price negotiations for the first time ever, and cap seniors’ drug expenses to $2,000 per year and seniors’ insulin costs at $35 per month.

Setting up a major victory for President Joe Biden, representatives returned from their summer recess to pass the Inflation Reduction Act, even as many noted the bill would only modestly reduce inflation.

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Senate Finance Committee Chair Ron Wyden (D-OR) (Francis Chung/E&E News/POLITICO via AP Images)

Sen­ate Fi­nance chair con­tin­ues his in­ves­ti­ga­tion in­to phar­ma tax­es with re­quests for Am­gen

Amgen is the latest pharma company to appear on the radar of Senate Finance Committee Chair Ron Wyden (D-OR), who is investigating the way pharma companies are using subsidiaries in low- or zero-tax countries to lower their tax bills.

Like its peers Merck, AbbVie and Bristol Myers Squibb, Wyden notes how Amgen uses its Puerto Rico operations to consistently pay tax rates that are substantially lower than the U.S. corporate tax rate of 21%, with an effective tax rate of 10.7% in 2020 and 12.1% in 2021.

FDA ap­proves sec­ond in­di­ca­tion for As­traZeneca and Dai­ichi's En­her­tu in less than a week

AstraZeneca and Daiichi Sankyo’s antibody-drug conjugate Enhertu scored its second approval in less than a week, this time for a subset of lung cancer patients.

Enhertu received accelerated approval on Thursday to treat adults with unresectable or metastatic non-small cell lung cancer (NSCLC) whose tumors have activating HER2 (ERBB2) mutations, and who have already received a prior systemic therapy.

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J&J to re­move talc prod­ucts from shelves world­wide, re­plac­ing with corn­starch-based port­fo­lio

After controversially spinning out its talc liabilities and filing for bankruptcy in an attempt to settle 38,000 lawsuits, Johnson & Johnson is now changing up the formula for its baby powder products.

J&J is beginning the transition to an all cornstarch-based baby powder portfolio, the pharma giant announced on Thursday — just months after a federal judge ruled in favor of its “Texas two-step” bankruptcy to settle allegations that its talc products contained asbestos and caused cancer. An appeals court has since agreed to revisit that case.

CSL is gathering its four business units under a unified brand identity strategy (Credit: CSL company site)

CSL brings Se­qirus, Vi­for un­der par­ent um­brel­la brand in iden­ti­ty re­vamp

CSL is gathering its brands under the family name umbrella, renaming its vaccine and newly acquired nephrology specialty businesses with the parent initials.

CSL Seqirus and CSL Vifor join CSL Plasma and CSL Behring as the four now uniformly branded business units of the global biopharma. The Seqirus vaccine division was formed in 2015 with the combination of bioCSL and its purchase of Novartis’ flu vaccine business. CSL picked up Vifor Pharma late last year in an $11.7 billion deal for the nephrology, iron deficiency and cardio-renal drug developer.

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