Mer­ck helps bankroll new part­ner Themis' game plan to fin­ish the chikun­gun­ya race and be­gin on­colyt­ic virus quest

As Themis gears up for a Phase III tri­al of its chikun­gun­ya vac­cine, the Vi­en­na-based biotech has closed out €40 mil­lion ($44 mil­lion) to foot the clin­i­cal and man­u­fac­tur­ing bills.

Erich Tauber

Its heavy­weight part­ners at Mer­ck — which signed a pact around a mys­te­ri­ous “block­buster in­di­ca­tion” last month — jumped in­to the Se­ries D, led by new in­vestors Far­al­lon Cap­i­tal and Hadean Ven­tures. Ad­ju­vant Cap­i­tal al­so joined, as did cur­rent in­vestors Glob­al Health In­vest­ment Fund, aws Gru­en­der­fonds, Omnes Cap­i­tal, Ven­tech and Welling­ton Part­ners Life Sci­ences.

Themis had planned to go pub­lic on Eu­ronext Am­s­ter­dam a year ago but end­ed up post­pon­ing the IPO due to mar­ket con­di­tions, lead­ing to the even­tu­al de­ci­sion to raise a pri­vate round, CEO Erich Tauber said.

With da­ta on the chikun­gun­ya vac­cine, MV-CHIK, ex­pect­ed in the sec­ond half of next year, Themis is in talks with reg­u­la­tors around the world about po­ten­tial ap­proval and any fol­low-up safe­ty stud­ies. The FDA’s pri­or­i­ty re­view vouch­er is a strong in­cen­tive for tar­get­ing US ap­proval first, Tauber said. Themis’ team of 30 — clus­tered in Vi­en­na with small of­fices in Boston and Zurich — might al­so seek help tack­ling what an­a­lysts have called a $500 mil­lion to $800 mil­lion com­mer­cial op­por­tu­ni­ty, but de­ci­sions about part­ner­ships are yet to be made, he added.

Themis is al­so al­lo­cat­ing parts of the new fund­ing to test in Phase I whether its measles virus vac­cine vec­tor tech­nol­o­gy — first li­censed from the In­sti­tut Pas­teur — can treat col­orec­tal can­cer.

Its ther­a­py comes in two parts: First pa­tients re­ceive the virus, which it­self has can­cer killing abil­i­ties, but al­so comes with a gene en­cod­ing for an en­zyme. That en­zyme cat­alyzes the con­ver­sion of an in­ac­tive pro­drug that pa­tients sub­se­quent­ly take, turn­ing it in­to a lo­cal chemother­a­py.

Max Planck in­ves­ti­ga­tor Ul­rich Lauer came up with the ap­proach and Themis gained ac­cess late last year.

They will like­ly com­bine this one-two punch ap­proach with check­point in­hibitors in clin­i­cal stud­ies, Tauber said.

Oth­er ap­pli­ca­tions of the measles virus vac­cine tech­nol­o­gy in­clude a slate of in­fec­tious dis­ease pro­grams rang­ing from Zi­ka and Las­sa fever to res­pi­ra­to­ry syn­cy­tial virus (RSV), cy­tomegalovirus (CMV), norovirus and Mid­dle East Res­pi­ra­to­ry Syn­drome (MERS). But those are fund­ed via pub­lic part­ner­ships or grants.

It’s un­clear whether Mer­ck is on­board for the more tra­di­tion­al vac­cine pro­grams or the im­muno-on­col­o­gy prospects.

“It’s a vote of con­fi­dence for us, and we’re al­so hap­py that we can use anti­gens from Mer­ck and test them in our sys­tem” is as far as Tauber was will­ing to go.

George Yancopoulos (Regeneron)

Re­gen­eron co-founder George Yan­copou­los of­fers a com­bat­ive de­fense of the po­lice at a high school com­mence­ment. It didn’t go well

Typically, the commencement speech at Yorktown Central School District in Westchester — like most high schools — is an opportunity to encourage students to face the future with confidence and hope. Regeneron president and co-founder George Yancopoulos, though, went a different route.

In a fiery speech, the outspoken billionaire defended the police against the “prejudice and bias against law enforcement” that has erupted around the country in street protests from coast to coast. And for many who attended the commencement, Yancopoulos struck the wrong note at the wrong time, especially when he combatively challenged someone for interrupting his speech with a honk for “another act of cowardness.”

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Tesla and SpaceX founder Elon Musk gestures to the audience after being recognized by President Trump following the successful launch of a Falcon 9 rocket at the Kennedy Space Center. (via Getty Images)

Tes­la chief Elon Musk teams up with Covid-19 play­er Cure­Vac to build 'R­NA mi­cro­fac­to­ries'

Elon Musk has joined the global tech crusade now underway to revolutionize vaccine manufacturing — now aimed at delivering billions of doses of a new mRNA vaccine to fight Covid-19. And he’s cutting right to the front.

In a late-night tweet Wednesday, the Tesla chief announced:

Tesla, as a side project, is building RNA microfactories for CureVac & possibly others

That’s not a lot to go on. But the tweet comes a year after Tesla’s German division in Grohmann and CureVac filed a patent on a “bioreactor for RNA in vitro transcription, a method for RNA in vitro transcription, a module for transcribing DNA into RNA and an automated apparatus for RNA manufacturing.” CureVac, in the meantime, has discussed a variety of plans to build microfactories that can speed up the whole process for a global supply chain.

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Douglas Love, Annexon CEO (Annexon)

IPO bound? A Bay Area biotech grabs a mega-round on the road to a piv­otal neu­rode­gen­er­a­tion pro­gram

South San Francisco-based Annexon has added $100 million to its cash reserves, along with a new roster of marquee investors backing their play on the classical complement pathway involved in neurodegeneration. And that may well fit the profile for an IPO — though right now everything seems to be working on that score.

Eighteen months after Bain and their syndicate partners put up $75 million to fuel clinical work, Annexon is back at the trough. And this time they’re adding Redmile Group for the lead role, with supporting investments from these new arrivals: BlackRock, Deerfield Management Company, Eventide Asset Management, Farallon Capital Management, Janus Henderson Investors and Logos Capital.

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Elias Zerhouni (Photo by Vincent Isore/IP3/Getty Images)

Elias Zer­houni dis­cuss­es ‘am­a­teur hour’ in DC, the de­struc­tion of in­fec­tious dis­ease R&D and how we need to prep for the next time

Elias Zerhouni favors blunt talk, and in a recent discussion with NPR, the ex-Sanofi R&D and ex-NIH chief had some tough points to make regarding the pandemic response.

Rather than interpret them, I thought it would be best to provide snippets straight from the interview.

On the Trump administration response:

It was basically amateur hour. There is no central concept of operations for preparedness, for pandemics, period. This administration doesn’t want to or has no concept of what it takes to protect the American people and the world because it is codependent. You can’t close your borders and say, “OK, we’re going to be safe.” You’re not going to be able to do that in this world. So it’s a lack of vision, basically just a lack of understanding, of what it takes to protect the American people.

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No­var­tis los­es biosim­i­lar ap­peal as court up­holds a 31-year mo­nop­oly by Am­gen's En­brel

A new court ruling has strengthened Amgen’s grip on the IP estate around Enbrel, keeping biosimilars of the autoimmune and inflammatory drug at bay until 2029.

Novartis, the patent challenger, isn’t throwing in the towel yet. In a statement noting the failed appeal, its generics division Sandoz noted its reviewing options, “including potential appeal to US Supreme Court.”

It’s been almost four years since the FDA approved Erelzi, Sandoz’s copycat version of Enbrel. While sales of the Pfizer-partnered drug in the US — the market Amgen is in charge of — have dipped slightly during that time, it remains a solid megablockbuster with 2019 revenue slightly above $5 billion.

Pfiz­er shares surge on pos­i­tive im­pact of their mR­NA Covid-19 vac­cine — part­nered with BioN­Tech — in an ear­ly-stage study

Pfizer and their partners at the mRNA specialist BioNTech have published the first glimpse of biomarker data from an early-stage study spotlighting the “robust immunogenicity” triggered by their Covid-19 vaccine, which is one of the leaders in the race to vanquish the global pandemic.

Researchers selected 45 healthy volunteers 18-55 years of age for the study. They were randomized to receive 2 doses, separated by 21 days, of 10 µg, 30 µg, or 100 µg of BNT162b1, “a lipid nanoparticle-formulated, nucleoside-modified, mRNA vaccine that encodes trimerized SARS-CoV-2 spike glycoprotein RBD.” Their responses were compared against the effect of a natural, presumably protective defense offered by a regular infection.

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Randy Schatzman, Bolt CEO (Bolt Biotherapeutics)

Bolt Bio­ther­a­peu­tics nabs $93.5M to push Provenge in­ven­tor's new idea deep­er in the clin­ic

A cancer-fighting concept from the inventor of the first cancer vaccine is nearing prime time, and its biotech developer has received a significant new infusion of cash to get it there.

Bolt Biotherapeutics announced a $93.5 million Series C round led by Sofinnova Investments and joined by more than 9 others, including Pfizer Ventures and RA Capital Management. That money will go toward pushing the San Francisco biotech’s platform of innate immune-boosting warheads through its first trial on metastatic solid tumors and into several more.

Sec­ond death trig­gers hold on Astel­las' $3B gene ther­a­py biotech's lead pro­gram, rais­ing fresh con­cerns about AAV

Seven months after Astellas shelled out $3 billion to acquire the gene therapy player Audentes, the biotech company’s lead program has been put on hold following the death of 2 patients taking a high dose of their treatment. And there was another serious adverse event recorded in the study as well, with a total of 3 “older” patients in the study affected.

The incidents are derailing plans to file for a near-term approval, which had been expected right about now.

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FDA ap­provals roundup: Zo­genix's Fin­tepla, Ul­tragenyx's Do­jolvi, and Genen­tech's Ph­es­go

A weekly update on new drug approvals and indications from the FDA:

New approvals

Fintepla gets the go-ahead for Dravet syndrome

Zogenix’s Fintepla (fenfluramine) has been approved for the treatment of seizures associated with Dravet syndrome in patients aged 2 years or older. The syndrome is a rare, life-threatening form of epilepsy.

The approval was based on findings from two clinical studies in 202 participants aged between 2 and 18 years, in which the change from baseline in frequency of convulsive seizures was measured. In both studies, children who received Fintepla had significantly greater reductions in the frequency of convulsive seizures, compared with those receiving placebo. The reductions were seen within 3-4 weeks of therapy initiation and remained generally consistent during the treatment periods of 14-15 weeks.