Bridge­Bio grabs a sec­ond pri­or­i­ty re­view for the port­fo­lio — giv­ing Per­cep­tive start­up cause to cel­e­brate

Just weeks af­ter get­ting its first NDA in — and grab­bing pri­or­i­ty re­view from the FDA in the process — Bridge­Bio says it’s lined up a sec­ond po­ten­tial speedy ap­proval for the port­fo­lio.

The hon­or goes to Bridge­Bio af­fil­i­ate QED Ther­a­peu­tics, which is de­vel­op­ing in­fi­gra­tinib as a cholan­gio­car­ci­no­ma treat­ment. In par­tic­u­lar, it had filed for ap­proval in sec­ond- and lat­er-line use.

Neil Ku­mar

It’s al­so good news for Lian­Bio, the Per­cep­tive start­up boast­ing a new mod­el for bring­ing West­ern drugs to Chi­na. In­fi­gra­tinib is one of the an­chor drugs of its in-li­censed port­fo­lio; in fact, Bridge­Bio CEO Neil Ku­mar has point­ed to the pro­gram as an ex­am­ple of Lian­Bio’s cre­ative strate­gies in tai­lor­ing de­vel­op­ment pro­grams for Chi­na.

Co­in­ci­den­tal­ly, the com­pa­ny an­nounced Tues­day that it’s been cleared to start a Phase IIa tri­al of in­fi­gra­tinib in Chi­na for lo­cal­ly ad­vanced or metasta­t­ic gas­tric can­cer or gas­troe­sophageal junc­tion ade­no­car­ci­no­ma with FGFR2 gene am­pli­fi­ca­tion.

An in­hibitor of FGFR1-3, in­fi­gra­tinib was al­ready in Phase II tri­als at No­var­tis for pa­tients with bile duct can­cer with FGFR fu­sions be­fore the phar­ma gi­ant put it on sale.

Bridge­Bio grabbed the ki­nase in­hibitor, part­ly for its po­ten­tial in can­cer and part­ly to test it in a ge­net­ic form of dwarfism known as achon­dropla­sia. In line with the um­brel­la busi­ness mod­el, they spun out QED to house the drug.

QED went to the FDA with da­ta on over­all re­sponse rate, among oth­er things. Two oth­er tri­als — one Phase II open-la­bel and one Phase III head to head with gem­c­itabine plus cis­platin — are on­go­ing. Lian­Bio is part­nered on the Phase III tri­al, which tar­gets pa­tients with FGFR2 fu­sion pos­i­tive cholan­gio­car­ci­no­ma.

Per the com­pa­ny, 20,000 peo­ple in the US and EU suf­fer from the dis­ease each year, while FGFR2 ge­net­ic aber­ra­tions are present in 15% to 20% of them.

In ad­di­tion to pri­or­i­ty re­view, QED said the drug was al­so ac­cept­ed in­to the Re­al-Time On­col­o­gy Re­view (RTOR) pi­lot pro­gram.

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.

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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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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Two CRLs lat­er, Illi­nois-based CD­MO hit with FDA warn­ing let­ter over 's­pore-form­ing' bac­te­ria and fun­gi

Dupo, IL-based contract manufacturer Sterling Pharmaceuticals has had a long, tough year.

Last September, partner Verrica Pharmaceuticals’ NDA for a potential skin disease treatment was hit with a second CRL, with the company pinning the problems on Sterling. Eight months later, Verrica was hit with a third CRL due to further issues at Sterling, following a February reinspection by FDA of the Sterling site.