Joshua Liang (Clover)

Fu­eled by Covid prospects, Chi­nese vac­cine de­vel­op­er scores $230M to up­scale the whole pipeline

The Covid tides are float­ing more than US or Eu­ro­pean boats.

Take Clover Bio­phar­ma­ceu­ti­cals, the Cheng­du, Chi­na-based de­vel­op­er of a CEPI-fund­ed vac­cine that’s just closed $230 mil­lion in a Se­ries C. That means the biotech is of­fi­cial­ly $400 mil­lion rich­er than it was be­fore the pan­dem­ic struck — and po­ten­tial­ly stand­ing much clos­er to the com­mer­cial mar­ket.

“Over the last 12 months, we have grown our head­count from ~175 FTEs in Chi­na to now ~500 FTEs across over a dozen coun­tries,” CEO Joshua Liang told End­points News in an email.

It’s al­so tak­en a vac­cine can­di­date through ear­ly hu­man stud­ies, test­ing SCB-2019 with both Glax­o­SmithK­line’s and Dy­navax’s ad­ju­vants be­fore drop­ping the col­lab­o­ra­tion with the phar­ma gi­ant. The Phase II/III tri­al is slat­ed to start in the first half of 2021.

All of that puts Clover’s Trimer-Tag tech­nol­o­gy plat­form on an ac­cel­er­at­ed path not un­like mR­NA, with a slate of oth­er pro­grams whose prospects now shine brighter with the new­found val­i­da­tion.

For Clover, the next pri­or­i­ties will be on oth­er vac­cines — in­clud­ing mul­ti­va­lent ones against SARS-CoV-2 vari­ants — as well as can­cer ther­a­pies (in fact, the first com­pound it put in the clin­ic back in 2018 was an on­col­o­gy drug).

Their plat­form, Liang ex­plained, is a new way of mak­ing pro­tein-based vac­cines by specif­i­cal­ly tar­get­ing virus­es that have “nat­u­ral­ly trimer­ic spike anti­gens.”

“These virus­es uti­lize these trimer­ic spikes to bind to re­cep­tors on our cells (such as ACE2 for SARS-CoV-2) and gain en­try to repli­cate and in­fect us,” he wrote. “Thus, in or­der to in­duce a neu­tral­iz­ing and pro­tec­tive im­mune re­sponse against the virus, the vac­cine anti­gen should pre­serve the na­tive trimer­ic struc­ture of the spike pro­tein. Our re­search has demon­strat­ed that com­pared to non-na­tive con­for­ma­tions of the spike pro­tein (such as dimer­ic spike pro­tein), our S-Trimer in­duces around 15-fold high­er lev­els of neu­tral­iz­ing an­ti­bod­ies.”

The re­sult­ing vac­cines can re­main sta­ble un­der stan­dard re­frig­er­a­tion of 2 to 8 de­grees Cel­sius, he added, and store at least two months at room tem­per­a­ture.

With the vac­cine sup­ply deficit “read­i­ly ap­par­ent” even in places where they are be­ing rolled out, Clover reck­ons there’s plen­ty of need to be served around the world. The com­pa­ny will of­fer its jab to the CO­V­AX mech­a­nism for dis­tri­b­u­tion if it’s au­tho­rized, Liang said, and they will be ready with ca­pac­i­ty to pro­duce over 1 bil­lion dos­es an­nu­al­ly, start­ing from its ex­ist­ing com­mer­cial-scale man­u­fac­tur­ing site in Changx­ing, Chi­na.

“The pan­dem­ic has af­fect­ed the en­tire world, not just the de­vel­oped world,” he not­ed.

GL Ven­tures — a unit of Hill­house Cap­i­tal — and Temasek co-led the Se­ries C, with par­tic­i­pa­tion from Ocean­pine Cap­i­tal, Or­biMed and ex­ist­ing in­vestor De­los Cap­i­tal.

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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