As killer virus out­breaks hit un­prece­dent­ed lev­els, non­prof­it hands $37.5M to Themis to tack­le Las­sa/MERS vac­cines

A non­prof­it formed in the af­ter­math of the re­cent Ebo­la out­break is hand­ing an Aus­tri­an biotech $37.5 mil­lion to put two killer dis­eases on its vac­cine to-do list: Las­sa fever and MERS.

It’s the first deal signed since the 2017 launch of the non­prof­it, which calls it­self CEPI (pro­nounced “sep­py”) – short for the Coali­tion for Epi­dem­ic Pre­pared­ness In­no­va­tions. The group’s goal is to build a glob­al vac­cine de­vel­op­ment fund, de­vot­ed to ready­ing pan­dem­ic de­fens­es dur­ing peace­time. It was formed by the gov­ern­ments of Nor­way, Ger­many, In­dia, and Japan, along with the Bill and Melin­da Gates Foun­da­tion, Well­come, and the World Eco­nom­ic Fo­rum.

The group hopes to raise $1 bil­lion for the fund, which it would dole out to wor­thy re­search ef­forts. They’ve al­ready raised $630 mil­lion.

This first in­fu­sion of cash is go­ing in tranch­es over a five-year pe­ri­od to Themis Bio­science, which has a plat­form tech based on the measles vac­cine that might be use­ful against mul­ti­ple virus­es.

These two in­fec­tious dis­eases are a high pri­or­i­ty for CEPI right now, and right­ly so. MERS, which hides out in camels and has been cir­cu­lat­ing the Mid­dle East since 2012, has killed a third of the peo­ple it’s in­fect­ed. And Las­sa fever, en­dem­ic to the same parts of Africa re­cent­ly hit by Ebo­la, is ex­pe­ri­enc­ing a pe­ri­od of un­prece­dent­ed out­break. Las­sa fever nor­mal­ly has a fa­tal­i­ty rate of 1%, but in the cur­rent Niger­ian out­break it is thought to be clos­er to 20%, ac­cord­ing to the CDC.

Richard Hatch­ett

“Es­tab­lish­ing our part­ner­ship with Themis rep­re­sents not on­ly an im­por­tant step in our jour­ney to­wards tack­ling these dis­eases, but al­so a break­through in how we can part­ner and work with vac­cine de­vel­op­ers when tra­di­tion­al mar­ket in­cen­tives for de­vel­op­ment have failed,” said CEPI’s CEO Richard Hatch­ett.

Themis’ CEO and founder Erich Tauber tells me there’s not enough fi­nan­cial up­side to tack­ling these dis­eases, which is why vac­cines aren’t be­ing de­vel­oped.

“The out­breaks oc­cur once every five or six years, and that’s not enough mar­ket push to get the vac­cines de­vel­oped,” Tauber said. “If a com­pa­ny like Themis went to ven­ture cap­i­tal­ists and asked for in­vest­ment to de­vel­op vac­cines for Las­sa or MERS, chances are no­body would pay us mon­ey to de­vel­op those vac­cines be­cause they are com­mer­cial risks.”

Erich Tauber

The mon­ey from CEPI will help bridge that gap. The com­pa­ny hopes the funds will take the com­pa­ny through Phase II, where de­vel­op­ment might end.

The hope, Tauber said, is to prove the vac­cines ef­fi­ca­cious in an­i­mal stud­ies and safe in large co­horts.

“But from there, the vac­cine will most like­ly have to be used on emer­gency rules,” Tauber said.

These two lat­est vac­cine projects will be added to Themis’ port­fo­lio, which in­cludes an ad­vanced pro­gram for a vac­cine against chikun­gun­ya virus, a mos­qui­to-trans­mit­ted dis­ease that can have de­bil­i­tat­ing long-term side ef­fects. That pro­gram is in Phase II tri­als in 600 pa­tients.

With its measles virus plat­form, Themis is al­so de­vel­op­ing vac­cines against Zi­ka, RSV, and norovirus, among oth­er ar­eas.

Im­age: Vi­ral dis­ease out­break. Shut­ter­stock

BiTE® Plat­form and the Evo­lu­tion To­ward Off-The-Shelf Im­muno-On­col­o­gy Ap­proach­es

Despite rapid advances in the field of immuno-oncology that have transformed the cancer treatment landscape, many cancer patients are still left behind.1,2 Not every person has access to innovative therapies designed specifically to treat his or her disease. Many currently available immuno-oncology-based approaches and chemotherapies have brought long-term benefits to some patients — but many patients still need other therapeutic options.3

Fangliang Zhang (Imaginechina via AP Images)

The big mon­ey: Poised to make drug R&D his­to­ry, a Chi­na biotech un­veils uni­corn rac­ing am­bi­tions in a bid to raise $350M-plus on Nas­daq

Almost exactly three years after Shanghai-based Legend came out of nowhere to steal the show at ASCO with jaw-dropping data on their BCMA-targeted CAR-T for multiple myeloma, the little player with Big Pharma connections is taking a giant step toward making it big on Wall Street. And this time they want to seal the deal on a global rep after staking out a unicorn valuation in what’s turned out to be a bull market for biotech IPOs — in the middle of a pandemic.

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Gilead re­leas­es an­oth­er round of murky remde­sivir re­sults

A month after the NIH declared the first trial on remdesivir in Covid-19 a success, Gilead is out with new results on their antiviral. But although the study met one of its primary endpoints, the data are likely to only add to a growing debate over how effective the drug actually is.

In a Phase III trial, patients given a 5-day dose of remdesivir were 65% more likely to show “clinical improvement” compared to an arm given standard-of-care. The trial, though, gave little indication for whether the drug had an impact on key endpoints such as survival or time-to-recovery. And in a surprising twist, a 10-day dosing arm of remdesivir didn’t lead to a statistically significant improvement over standard of care.

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Len Schleifer (left) and George Yancopoulos, Regeneron (Vimeo)

Eyes on he­mo­phil­ia prize, Re­gen­eron adds a $100M wa­ger on joint de­vel­op­ment cam­paign with In­tel­lia

When George Yancopoulos first signed up Intellia to be its CRISPR/Cas9 partner on gene editing projects 4 years ago, the upstart smartly ramped up its IPO at the same time. Today, Regeneron $REGN is coming back in, adding $100 million in an upfront fee and equity to significantly boot up a whole roster of new development projects.

And they’re highlighting some clinical hemophilia research plans in the process.

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Iterum's fu­ture looks un­cer­tain, af­ter lead an­tibi­ot­ic fails con­sec­u­tive piv­otal stud­ies

While the market for antibiotics remains in tatters — unlike many of its bankrupt (or at the brink of bankruptcy) peers — Iterum is suffering not because its antibiotic isn’t selling, but because the compound has now failed back-to-back late-stage studies.

The experimental drug, sulopenem, was designed to tackle drug-resistant infections with an outpatient focus (in addition to hospitals), to avert those reimbursement challenges that incentivize hospitals to prescribe cheaper, generic broad-spectrum antibiotics.

Jean-Jacques Bienaimé, BioMarin chairman and CEO

Bio­Marin holds the line on bleeds with 4-year val­rox up­date on he­mo­phil­ia A — but what's this about an­oth­er de­cline in Fac­tor 8 lev­els?

BioMarin has posted some top-line results for their 4-year followup on the most advanced gene therapy for hemophilia A — extending its streak on keeping a handful of patients free of bleeds and off Factor VIII therapy, but likely stirring fresh worries over a continued drop in Factor VIII levels.

We just don’t know how big a drop.

We’ll see more data when the results are presented at the World Federation of Hemophilia in a couple of weeks. But in a statement out Sunday night, BioMarin $BMRN reported that none of the patients required Factor VIII treatment, adding:

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Covid-19 roundup: Did in­sid­ers cash in on pos­i­tive news re­port about Gilead be­fore pub­li­ca­tion?

A series of bullish trades on Gilead options just before the release of a favorable news story is raising questions among regulatory experts, Reuters reported.

On April 16, just hours before STAT published anecdotes from a Chicago hospital that served as one of the clinical sites to test Gilead’s remdesivir in Covid-19 patients, the California-based company’s shares were trading at around $75. Four large blocks of options were purchased for about $1.5 million each, betting that the stock would rise beyond that to as much as $87.5 by mid-August.

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Roche nabs front­line OK for Avastin/Tecen­triq in com­mon liv­er can­cer, best­ing an old Bay­er drug

For the first time in 12 years, the FDA has approved a new frontline treatment for the most common form of liver cancer.

The agency okayed a combination of Roche’s anti-VEGF antibody Avastin and their immunotherapy Tecentriq for patients with unresectable or metastatic hepatocellular carcinoma (HCC). The approval comes two weeks after Roche and their big biotech sub Genentech published Phase III results showing the combo improved both progression-free survival and, crucially, helped patients live longer than the long-running standard-of-care, Bayer’s Nexavar.

As­traZeneca trum­pets the 'mo­men­tous' da­ta they found for Tagris­so in an ad­ju­vant set­ting for NSCLC — but many of the ex­perts aren’t cheer­ing along

AstraZeneca is rolling out the big guns this evening to provide a salute to their ADAURA data on Tagrisso at ASCO.

Cancer R&D chief José Baselga calls the disease-free survival data for their drug in an adjuvant setting of early stage, epidermal growth factor receptor-mutated NSCLC patients following surgery “momentous.” Roy Herbst, the principal investigator out of Yale, calls it “transformative.”

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