Vec­talys and Flash­Cell merge in­to Flash Ther­a­peu­tics, loaded with RNA pipeline and man­u­fac­tur­ing set-up

Pas­cale Bouil­lé (La Tri­bune Toulouse / Bor­deaux, YouTube)

Two gene ther­a­py com­pa­nies in France are merg­ing to cre­ate one ven­ture called Flash Ther­a­peu­tics, com­bin­ing man­u­fac­tur­ing know-how with a pipeline of RNA drug prospects.

The merg­er is be­tween Vec­talys, a Toulouse-based mak­er of lentivi­ral vec­tors, and its spin­out start­up Flash­Cell, which launched out of Vec­talys just last year to tack­le RNA car­ri­ers for drug ap­pli­ca­tions.

The CEO of the com­bined com­pa­ny, Pas­cale Bouil­lé, tells me the merg­er part­ly came down to bio­man­u­fac­tur­ing in­dus­tri­al log­ic.

“Man­u­fac­tur­ing ca­pa­bil­i­ty is crit­i­cal to the suc­cess of this new field, so it makes sense to in­te­grate man­u­fac­tur­ing with the ther­a­peu­tics busi­ness and to lever­age our lentivi­ral de­vel­op­ment and man­u­fac­tur­ing ex­per­tise with oth­er in­dus­try play­ers,” Bouil­lé said.

Flash will be tasked with ad­vanc­ing nov­el RNA drugs based on the com­pa­ny’s Lenti­Flash tech­nol­o­gy, a pro­pri­etary lentivi­ral de­liv­ery method. Lentivirus­es, a sub­class of retro­virus­es, are used as vec­tors for gene ther­a­py thanks to their abil­i­ty to in­te­grate in­to the genome of non-di­vid­ing cells. That’s a unique fea­ture, as oth­er retro­virus­es can in­fect on­ly di­vid­ing cells.

Bouil­lé tells me cur­rent lentivi­ral vec­tors are a lead­ing de­liv­ery method for CAR-T and oth­er ge­net­ic dis­eases that re­quire sta­ble, long-term ex­pres­sion. But some next-gen im­munother­a­py (for ex­am­ple, those in­volv­ing cell types be­yond T cells) may need tran­sient ex­pres­sion rather than in­te­gra­tive, long-term ex­pres­sion. En­ter Lenti­Flash, which is “non-in­te­gra­tive,” al­low­ing tran­sient and short-term RNA ex­pres­sion.

Flash Ther­a­peu­tics will take on the dis­cov­ery and de­vel­op­ment of “stand­alone pro­grams in the ar­eas of liv­er and blood dis­ease” that were based on Lenti­Flash and cul­ti­vat­ed at Flash­Cell over the past year.

The com­pa­ny’s lentivi­ral de­vel­op­ment and pro­duc­tion busi­ness, which will con­tin­ue to op­er­ate un­der the Vec­talys man­u­fac­tur­ing plat­form name, will ex­pand as part of Flash Ther­a­peu­tics to in­clude GMP man­u­fac­tur­ing ca­pa­bil­i­ties. The GMP fa­cil­i­ty, which is ex­pect­ed to be­come ful­ly op­er­a­tional in 2019, is be­ing es­tab­lished through a re­cent­ly signed, three-year part­ner­ship with Hos­pi­tal Saint-Louis, Lari­boisière, Fer­nand Vi­dal to de­vel­op and pro­duce gene and cell ther­a­py drugs.

Michel Vounatsos, Biogen CEO (via YouTube)

UP­DAT­ED: Bio­gen spot­lights a pair of painful pipeline set­backs as ad­u­canum­ab show­down looms at the FDA

Biogen has flagged a pair of setbacks in the pipeline, spotlighting the final failure for a one-time top MS prospect while scrapping a gene therapy for SMA after the IND was put on hold due to toxicity.

Both failures will raise the stakes even higher on aducanumab, the Alzheimer’s drug that Biogen is betting the ranch on, determined to pursue an FDA OK despite significant skepticism they can make it with mixed results and a reliance on post hoc data mining. And the failures are being reported as Biogen was forced to cut its profit forecast for 2020 as a generic rival started to erode their big franchise drug.

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A new chap­ter in the de­cen­tral­ized clin­i­cal tri­al ap­proach

Despite the promised decentralized trial revolution, we haven’t yet moved the needle in a significant way, although we are seeing far bolder commitments to this as we continue to experience the pandemic restrictions for some time to come. The vision of grandeur is one thing, but operationalizing and execution are another and recognising that change, particularly mid-flight on studies, is worthy of thorough evaluation and consideration in order to achieve success. Here we will discuss one of the critical building blocks of a Decentralized and Remote Trial strategy: TeleConsent; more than paper under glass, it is a paradigm change and key digital enabler.

Pfiz­er scoops up an an­tibi­ot­ic in rare M&A deal, bag­ging a vir­tu­al start­up op­er­at­ing on a shoe­string bud­get

Pfizer is stepping up with a rare antibiotics buyout deal today, grabbing Palo Alto, CA-based Arixa Pharmaceuticals in a bid to add a new oral version of avibactam, a beta lactamase inhibitor — or BLI — approved back in 2015 as part of the IV treatment Avycaz.

The Arixa acquisition follows some encouraging Phase I responses demonstrating that 60% to 80% of the oral drug is absorbed into the bloodstream. Only 7% of the IV version is absorbed orally, far below the 30% threshold Arixa has pointed to as a therapeutic threshold. The buyout gives Pfizer’s hospital group a line on a new oral combo with antibiotics like ceftibuten to go after drug-resistant cases of urinary tract infections and other ailments.

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Stephen Hoge, Moderna president (Moderna)

On morn­ing of FDA Covid-19 ad­comm, Mod­er­na com­pletes PhI­II en­roll­ment, putting them neck-and-neck with Pfiz­er

Weeks away from a potential EUA application, Moderna announced they have completed enrollment in their 30,000-person Phase III Covid-19 vaccine trial, with over a third of volunteers non-white and a quarter over the age of 65.

The announcement caps what has been the most closely-watched recruitment race in the history of drug development, as Pfizer and Moderna rushed to get enough volunteers to prove whether or not experimental vaccines could actually protect people from contracting Covid-19. Pfizer reached that mark on Sept. 15. Moderna said around the same time that they would slow down enrollment to ensure they enrolled enough participants from minority and at-risk groups.

Jean-Pierre Sommadossi, Atea president and CEO (file photo)

Roche wades deep­er in­to Covid-19 fight, ink­ing an­tivi­ral pact with $350M cash fol­low­ing Re­gen­eron deal

Roche is making its first bet on an antiviral against Covid-19 in style, shelling out $350 million in cash to grab ex-US rights.

The drug comes from Atea Pharmaceuticals, the 7-year-old biotech created by Pharmasset co-founder Jean-Pierre Sommadossi, which essentially rebranded itself as a Covid-19 fighter in May when it closed a whopping $215 million venture round. Over a dozen investors bought in, including marquee names like Bain Capital and RA Capital.

John Maraganore, Alnylam CEO (Scott Eisen/Bloomberg via Getty Images)

With lumasir­an on the FDA's doorstep, Al­ny­lam reads out new PhI­II da­ta in PH1

Just over a month away from its December PDUFA date, Alnylam flaunted new data from two Phase III studies to back lumasiran in primary hyperoxaluria type 1 (PH1), a rare liver condition.

The Cambridge, MA-based biotech snagged a priority review for the candidate back in June, and got positive feedback from the EMA’s Committee for Medicinal Products for Human Use just last week. Lumasiran uses RNA interference (RNAi) to silence the gene for glycolate oxidase, an enzyme used in the production of oxalate.

Jason Kelly, Gingko Bioworks CEO (Mike Blake/Reuters via Adobe)

Ex­clu­sive: Eye­ing big Covid-19 test­ing ex­pan­sion, Gink­go rolls out 50M rapid anti­gen di­ag­nos­tics

In what they hope will be a key part of an extensive effort to boost Covid-19 testing in the US, Ginkgo Bioworks is acquiring and distributing 50 million rapid antigen tests that can potentially be used for virus surveillance in schools and communities and for quick, on the ground diagnoses.

The tests, developed by SD Biosensor, are in line with proposals from the Rockefeller Foundation and Harvard epidemiologists, among others, to blanket the country with fast, low-cost tests. Although not yet authorized in the US, they are a key part of testing efforts from the Bill and Melinda Gates Foundation, who announced plans last month to distribute 120 million of them in low and middle income countries. Roche has commercialized the diagnostic in Europe.

David Hung (file photo)

Mas­ter deal­mak­er David Hung re­tools a SPAC sedan in­to a fi­nanc­ing mus­cle ve­hi­cle that leaves his can­cer start­up with $850M and a place on Wall Street

It’s only right that one of the industry’s top dealmakers just completed one of the biggest SPAC-related deals in the pipeline.

David Hung, of Medivation fame, has completed a back flip into the market, merging with EcoR1 Capital’s SPAC Panacea and landing neatly on Wall Street with an $NUVB stock ticker after filling out the blank check in his name. In addition to the $144 million held in the SPAC — provided none of the investors opt out — Hung is getting ahold of $500 million more being chipped in by a slate of institutional investors who feel that Hung could have the keys to another Medivation-style success.

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News brief­ing: UK biotech 4D phar­ma heads for Nas­daq via SPAC; Dr. Red­dy's shuts down man­u­fac­tur­ing af­ter cy­ber­at­tack

Another pharma company is intending to use a SPAC to join the Nasdaq.

4D pharma, a UK-based biotech, is reverse-merging with a blank check company in a deal worth up to $37.6 million. The move will give 4D pharma a new Nasdaq ticker, which will be $LBPS, using the American Depositary Share program. 4D will continue to trade on the London stock exchange under its previous ticker.

As a result of the move, 4D pharma will gain $14.6 million in cash held by the blank check company, dubbed Longevity. The merger is expected to be completed in early 2021, after which shares will be immediately tradeable on Nasdaq.