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.

Dan O'Day, Gilead CEO (Andrew Harnik, AP Images)

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Hotly rumored for weeks, the 2 players have formalized a 10-year alliance that starts with rights to the PD-1, zimberelimab. O’Day also has first dibs on TIGIT and 2 other leading programs, agreeing to an opt-in fee ranging from $200 million to $275 million on each. There’s $500 million in potential TIGIT milestones on US regulatory events — likely capped by an approval — if Gilead partners on it and the stars align on the data. And there’s another $150 million opt-in payments for the rest of the Arcus pipeline.

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Sanofi brings in 4 new ex­ec­u­tives in con­tin­ued shake-up, as vac­cines and con­sumer health chief head out the door

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The company also said today that Alan Main, the head of their consumer healthcare unit, is out, and they named 4 executives to fill new or newly vacated positions, 3 of whom come from both outside both Sanofi and from Pharma.

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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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Pablo Legorreta, founder and CEO of Royalty Pharma AG, speaks at the annual Milken Institute Global Conference in Beverly Hills, California (Patrick T. Fallon/Bloomberg via Getty Images)

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Ab­b­Vie wins an ap­proval in uter­ine fi­broid-as­so­ci­at­ed heavy bleed­ing. Are ri­vals My­ovant and Ob­sE­va far be­hind?

Women expel on average about 2 to 3 tablespoons of blood during their time of the month. But with uterine fibroids, heavy bleeding is typical — a third of a cup or more. Drugmakers have been working on oral therapies to try and stem the flow, and as expected, AbbVie and their partners at Neurocrine Biosciences are the first to make it across the finish line.

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Paul Hudson, Sanofi CEO (Getty Images)

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Sanofi has reaped $11.1 billion after selling off a big chunk of its Regeneron stock at $515 a share. And now everyone on the M&A side of the business is focused on how CEO Paul Hudson plans to spend it.

After getting stung in France for some awkward politicking — suggesting the US was in the front of the line for Sanofi’s vaccines given American financial support for their work, versus little help from European powers — Hudson now has the much more popular task of managing a major cash cache to pull off something in the order of a big bolt-on. Or two.

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Roger Perlmutter, Merck R&D chief (YouTube)

Backed by BAR­DA, Mer­ck jumps in­to Covid-19: buy­ing out a vac­cine, part­ner­ing on an­oth­er and adding an­tivi­ral to the mix

Merck execs are making a triple play in a sudden leap into the R&D campaign against Covid-19. And they have more BARDA cash backing them up on the move.

Tuesday morning the pharma giant simultaneously announced plans to buy an Austrian biotech that has been working on a preclinical vaccine candidate, added a collaboration on another vaccine with the nonprofit IAVI and inked a deal with Ridgeback Biotherapeutics on an early-stage antiviral.

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As­traZeneca’s $7B ADC suc­ceeds where Roche failed, im­prov­ing sur­vival in gas­tric can­cer

Another day, another win for Enhertu.

The antibody-drug conjugate AstraZeneca promised up-to $7 billion to partner on has had a quite a few months, beginning with splashy results in a Phase II breast cancer trial, a rapid approval and, earlier this month, breakthrough designations in both non-small cell lung cancer and gastric cancer.

Now, at ASCO, the British pharma and their Japanese partner, Daiichi Sankyo, have shown off the data that led to the gastric cancer designation, which they’ll take back to the FDA. In a pivotal, 187-person Phase II trial, Enhertu shrunk tumors in 42.9% of third-line patients with HER2-positive stomach cancer, compared with 12.5% in a control arm where doctors prescribed their choice of therapy. Progression-free survival was 5.4 months for Enhertu compared to 3.5 months for the control.

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Back in 2016, when then-Shire CEO Flemming Ørnskov picked up a promising clinical-stage IBD drug from Pfizer, the Boston-based biotech dubbed it SHP647 and moved it into the gem section of the pipeline, with rosy expectations of registration-worthy Phase III data ahead.

This was a drug that the EC wanted Takeda to commit to selling off before it gave their blessing to its acquisition of Shire, to settle some deep-seated concerns revolving around the potential market overlap with their blockbuster rival Entyvio. And Takeda, which took on a heavy debt load to buy Shire, clearly wanted the cash to pay down debt.