RA joins glob­al syn­di­cate to back a $98M round for CAN­bridge

A Bei­jing-based rare dis­ease and on­col­o­gy play­er has raised $98 mil­lion to help fund the ex­pan­sion of its pipeline as well as a com­mer­cial port­fo­lio.

CAN­bridge put out word Tues­day that the glob­al pri­vate eq­ui­ty play­er Gen­er­al At­lantic joined forces with Chi­nese CRO Wuxi AppTec to lead the Se­ries D, with both ready to chip in an ex­tra $10 mil­lion each un­der the right con­di­tions. The syn­di­cate in­cludes RA Cap­i­tal Man­age­ment, Hud­son Bay Cap­i­tal Man­age­ment, Yuan­Ming Pru­dence Fund and Tigermed.

The new in­fu­sion sets CAN­Bridge up for an IPO in a year or two, ac­cord­ing to CFO Glenn Has­san.

A spe­cial­ist in rare ge­net­ic dis­eases, CAN­bridge has been col­lab­o­rat­ing with WuXi Bi­o­log­ics, a sis­ter com­pa­ny of the CRO, on dis­cov­er­ing and de­vel­op­ing new drugs for its tar­get in­di­ca­tions.

Like a num­ber of top Chi­na drug play­ers, CAN­bridge is get­ting start­ed with some ex­ist­ing meds in-li­censed for the Asian mar­ket while fol­low­ing up with some more orig­i­nal work. Its drug Hunterase is an en­zyme re­place­ment ther­a­py un­der re­view now by Chi­nese reg­u­la­to­ry au­thor­i­ties. And the biotech has high hopes for Ner­l­ynx, the breast can­cer drug from Puma.

CAN­bridge has about 60 staffers on the ground in Chi­na, about half of whom sup­port the com­mer­cial or­ga­ni­za­tion, CEO James Xue told End­points News from their Cam­bridge, MA of­fice.

“We are def­i­nite­ly build­ing what I would say as one of the most ro­bust com­mer­cial plat­form for rare dis­ease in the Greater Chi­na re­gion that would re­al­ly en­able us to do what we call high-touch launch and op­er­a­tions of rare dis­ease prod­ucts,” he said.

Hav­ing repo­si­tioned the com­pa­ny to fo­cus on rare dis­ease rather than just on­col­o­gy, Xue — the for­mer gen­er­al man­ag­er of Gen­zyme — said the Chi­nese mar­ket is warm­ing up to rare dis­ease drugs. Take the up­take of Cerezyme, which launched in Chi­na in 2008 un­der his watch. It wasn’t un­til the end of 2012 that en­zyme re­place­ment ther­a­py re­ceived mu­nic­i­pal re­im­burse­ment from Shang­hai; but in the fol­low­ing years cov­er­age has ex­pand­ed in­to about 10 provinces and cities, with up to 100% cov­er­age.

Aware­ness is al­so clear­ly spread­ing from the pa­tient and physi­cian lev­el to the pol­i­cy­mak­ers, with rare dis­ease lan­guage and lists of­fi­cial­ly writ­ten in­to law. And the ag­gres­sive price ne­go­ti­a­tions that gov­ern­ment of­fi­cials have been do­ing for the Na­tion­al Re­im­burse­ment Drug List is a sign that they are mak­ing room for dis­eases cur­rent­ly com­plete­ly un­cov­ered, he added.

“Those are the el­e­ments or the mov­ing parts grad­u­al­ly in place that would al­low us to hope for and al­so plan for rare dis­ease mar­ket in a way that its re­im­bursed mar­ket is around the cor­ner,” he said.

So­cial im­age: James Xue, CAN­bridge CEO

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.

Stéphane Bancel, Moderna CEO

'This is not go­ing to be good': Mod­er­na CEO Ban­cel warns of a 'ma­te­r­i­al drop' in vac­cine ef­fi­ca­cy as Omi­cron spreads

Even as public health officials remain guarded about their comments on the likelihood Omicron will escape the reach of the currently approved Covid-19 vaccines, there’s growing scientific consensus that we’re facing a variant that threatens to overwhelm the vaccine barricades that have been erected.

Stéphane Bancel, the CEO of Moderna, one of the leading mRNA players whose quick vault into the markets with a highly effective vaccine created an instant multibillion-dollar market, added his voice to the rising chorus early Tuesday. According to Bancel, there will be a significant drop in efficacy when the average immune system is confronted by Omicron. The only question now is: How much?

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Ap­peals court puts the fi­nal nail in the cof­fin for Tec­fidera patent, adding to Bio­gen's bur­geon­ing set­backs

In another setback for Biogen, the big biotech lost its appeal to revive a patent for the once-blockbuster drug Tecfidera, marking a likely conclusion to the case.

The US Court of Appeals for the Federal Circuit issued the ruling Tuesday morning, saying Biogen failed to satisfy the “written description” requirement for patent law. As a result, Mylan-turned-Viatris will be able to sell its multiple sclerosis generic without fear of infringement and Biogen will have to find a new revenue driver elsewhere.

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Philip Dormitzer, new GSK global head of vaccines R&D

Glax­o­SmithK­line poach­es Pfiz­er's vi­ral vac­cines lead in rush to cap­i­tal­ize on fu­ture of mR­NA

GlaxoSmithKline has appointed Philip Dormitzer, formerly chief scientific officer of Pfizer’s viral vaccines unit, as its newest global head of vaccines R&D, looking to leverage one of the leading minds behind Pfizer and BioNTech’s RNA collaboration that led to Covid-19 jab Comirnaty, the British drug giant said Tuesday.

Dormitzer had been with Pfizer for a little more than six years, joining up after a seven-year stint with Novartis, where he reached the role of US head of research and head of global virology for the company’s vaccines and diagnostics unit.

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In­tro­duc­ing End­points Stu­dio, a new way to ad­ver­tise with End­points-craft­ed brand­ing cam­paigns

Since our start in 2016, Endpoints has grown fast while executing our mission to cover biopharma’s most critical developments for industry pros worldwide. As readership has grown, our advertising business has too. Endpoints advertising partners support the mission and engage their desired audiences through announcements on our email and web platforms, brand recognition in our event coverage and sponsorships of Endpoints daily and weekly reports.

Tillman Gerngross (Adagio)

Till­man Gern­gross on Omi­cron: 'It is a grim sit­u­a­tion...we’re go­ing to see a sig­nif­i­cant drop in vac­cine ef­fi­ca­cy'

Tillman Gerngross, the rarely shy Dartmouth professor, biotech entrepreneur and antibody expert, has been warning for over a year that the virus behind Covid-19 would likely continue to mutate, potentially in ways that avoid immunity from infection and the best defenses scientists developed. He spun out a company, Adagio, to build a universal antibody, one that could snuff out any potential mutation.

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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.

Mar­ket­ingRx roundup: Ab­b­Vie’s Hu­mi­ra TV turns fo­cus to HS skin con­di­tion; Sanofi amps par­ent­ing pol­i­cy

After years as the top spending pharma TV advertiser, AbbVie’s Humira brand finally downshifted earlier this year, ceding much of its marketing budget to up-and-coming sibling meds Skyrizi and Rinvoq. However, now Humira is back on TV with ads for another condition — Hidradenitis suppurativa (HS).

The chronic and painful skin condition results in lumps and abscesses caused by inflammation or infection of sweat glands, most often in the armpits or groin. Humira was first approved to treat HS in 2015 and remains the only FDA-approved drug for the condition. Two TV ads both note more than 30,000 people with HS have been prescribed Humira.

As lead drug runs in­to a wall, De­ci­phera slims down its pipeline, puts 140 jobs on the chop­ping block

Barely a month after disappointing data shattered hopes for a major label expansion for the GI tumor drug Qinlock, Deciphera is making a major pivot — scrapping development plans for that drug and discarding another while it hunkers down and focuses on two remaining drugs in the pipeline.

As a result, 140 of its staffers will be laid off.

The restructuring, which claims the equivalent of 35% of its total workforce, will take place across all departments including commercial, R&D as well as general and administrative support functions, Deciphera said, as it looks to streamline Qinlock-related commercial operations in the US while concentrating only on a “select number of key European markets.”

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