Sanofi sharp­ens fo­cus on mR­NA for can­cer with eq­ui­ty in­vest­ment in Ger­many's BioN­Tech

Sanofi is beef­ing up its bet on mes­sen­ger RNA tech­nol­o­gy. Hav­ing al­ready set up al­liances with Ron Re­naud’s Trans­late Bio, and Ger­many’s Cure­Vac and BioN­Tech, the French drug­mak­er on Thurs­day said it was mak­ing an 80 mil­lion eu­ro (rough­ly $91.5 mil­lion) eq­ui­ty in­vest­ment in Mainz-based BioN­Tech, build­ing on the up to $1.5 bil­lion pact the two signed in 2015.

In late 2015, Sanofi gave BioN­Tech $60 mil­lion for the rights to 5 im­munother­a­pies de­vel­oped out of BioN­Tech’s mR­NA plat­form, and the French vac­cine mak­er pledged up to an ad­di­tion­al $300 mil­lion per pro­gram in mile­stone pay­ments. To­day, BioN­Tech said one of those can­di­dates will en­ter the clin­ic and the two part­ners will co-de­vel­op the drug in pa­tients with mul­ti­ple sol­id tu­mors. The un­spec­i­fied ex­per­i­men­tal ther­a­py is de­signed to be in­ject­ed di­rect­ly in­to the tu­mor, sub­vert­ing the tox­i­c­i­ty as­so­ci­at­ed with sys­temic ad­min­is­tra­tion.

BioN­Tech de­clined to pro­vide fur­ther de­tail on the pro­gram and its time­line, or the size of the Sanofi stake. The pri­vate com­pa­ny has three ther­a­peu­tic plat­forms that uti­lize its mR­NA tech in­clud­ing a per­son­al­ized vac­cine pro­gram for can­cer, a vac­cine plat­form for in­fec­tious dis­ease, and a nu­cle­o­side-mod­i­fied mR­NA plat­form for ap­pli­ca­tions such as pro­tein re­place­ment ther­a­py.

The uni­corn Mod­er­na $MR­NA — which re­cent­ly pulled off a his­toric US IPO — has al­so put its faith in mR­NA via its vac­cines work. Sanofi is no stranger to vac­cines, al­though its home­grown dengue vac­cine was mired in con­tro­ver­sy af­ter fears were stoked that the in­jec­tion could cause se­ri­ous harm in pa­tients who had nev­er been in­fect­ed. Still, the vac­cine is ap­proved in a pletho­ra of re­gions — it was ap­proved by the EU in De­cem­ber, and is un­der pri­or­i­ty re­view at the FDA.

Ear­li­er this week, part­ners Sanofi and Mer­ck won FDA ap­proval for their 6-in-1 shot Vax­elis for pe­di­atric pa­tients.

Im­age: Mar­ket square in Mainz, Ger­many — Shut­ter­stock

Qual­i­ty Con­trol in Cell and Gene Ther­a­py – What’s Re­al­ly at Stake?

In early 2021, Bluebird Bio was forced to suspend clinical trials of its gene therapy for sickle cell disease after two patients in the trial developed cancer. As company scientists rushed to assess whether there was any causal link between the therapy and the cancer cases, Bluebird’s stock value plummeted – as did those of multiple other biopharma companies developing similar therapies.

While investigations concluded that the gene therapy was unlikely to have caused cancer, investors and the public may be more skittish regarding the safety of gene and cell therapies after this episode. This recent example highlights how delicate the fields of cell and gene therapy remain today, even as they show great promise.

Law pro­fes­sors call for FDA to dis­close all safe­ty and ef­fi­ca­cy da­ta for drugs

Back in early 2018 when Scott Gottlieb led the FDA, there was a moment when the agency seemed poised to release redacted complete response letters and other previously undisclosed data. But that initiative never gained steam.

Now, a growing chorus of researchers are finding that a dearth of public data on clinical trials and pharmaceuticals means industry and the FDA cannot be held accountable, two law professors from Yale and New York University write in an article published Wednesday in the California Law Review.

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Novavax CEO Stanley Erck at the White House in 2020 (Andrew Harnik, AP Images)

As fears mount over J&J and As­traZeneca, No­vavax en­ters a shaky spot­light

As concerns rise around the J&J and AstraZeneca vaccines, global attention is increasingly turning to the little, 33-year-old, productless, bankruptcy-flirting biotech that could: Novavax.

In the now 16-month race to develop and deploy Covid-19 vaccines, Novavax has at times seemed like the pandemic’s most unsuspecting frontrunner and at times like an overhyped also-ran. Although they started the pandemic with only enough cash to last 6 months, they leveraged old connections and believers into $2 billion and emerged last summer with data experts said surpassed Pfizer and Moderna. They unveiled plans to quickly scale to 2 billion doses. Then they couldn’t even make enough material to run their US trial and watched four other companies beat them to the finish line.

FDA of­fers scathing re­view of Emer­gent plan­t's san­i­tary con­di­tions, em­ploy­ee train­ing af­ter halt­ing pro­duc­tion

The FDA wrapped up its inspection of Emergent’s troubled vaccine manufacturing plant in Baltimore on Tuesday, after halting production there on Monday. By Wednesday morning, the agency already released a series of scathing observations on the cross contamination, sanitary issues and lack of staff training that caused the contract manufacturer to dispose of millions of AstraZeneca and J&J vaccine doses.

Brad Bolzon (Versant)

Ver­sant pulls the wraps off of near­ly $1B in 3 new funds out to build the next fleet of biotech star­tups. And this new gen­er­a­tion is built for speed

Brad Bolzon has an apology to offer by way of introducing a set of 3 new funds that together pack a $950 million wallop in new biotech creation and growth.

“I want to apologize,” says the Versant chairman and managing partner, laughing a little in the intro, “that we don’t have anything fancy or flashy to tell you about our new fund. Same team, around the same amount of capital, same investment strategy. If it ain’t broke, don’t fix it.”

But then there’s the flip side, where everything has changed. Or at least speeded into a relative blur. Here’s Bolzon:

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Emma Walmsley, GlaxoSmithKline CEO (Kevin Dietsch/Pool via CNP/Alamy)

Glax­o­SmithK­line hus­tles the 7th PD-1 past the fin­ish line with Jem­per­li. But how big will up­take be?

Everything came up sevens for GlaxoSmithKline on Thursday as the pharma notched the seventh PD-1 approval seven years after the first such drugs were OK’ed in Keytruda and Opdivo. But will it bring GSK good fortune?

The FDA granted accelerated approval to dostarlimab, to be branded Jemperli, to treat recurrent or advanced endometrial cancer in a specific subset of patients following platinum-based chemo. It’s a drug that came to GSK through its buyout of Tesaro, which it snapped up for $5.1 billion back in December 2018.

Bio­phar­ma ramps up lob­by­ing spend as drug pric­ing leg­is­la­tion nears

The top biopharma companies in the world collectively spent more than $40 million in just the first quarter of 2021 on lobbying Congress as part of preparations to stave off major drug pricing legislation that’s expected later this year.

Although the numbers are not dramatically higher than what the companies collectively spent in the first quarter of 2020, some like GlaxoSmithKline, Teva, Merck and Johnson & Johnson have already increased their quarterly lobbying spend in 2021 by about $1 million more each when compared to recent quarters in 2020.

House Committee on Oversight and Reform Chairwoman Carolyn Maloney (Getty Images)

House De­moc­rats call on Emer­gent ex­ecs to tes­ti­fy on qual­i­ty is­sues next month

The House Oversight Committee is investigating Covid-19 vaccine producer Emergent BioSolutions, which secured a $628 million US government contract to make AstraZeneca and J&J vaccines despite “a long, documented history” of quality control issues, Democrats said in a letter to the contract manufacturer’s executives.

Emergent’s Baltimore plant, which was shuttered on Monday by FDA, has been embroiled in controversy after being forced to destroy millions of AstraZeneca and J&J doses due to an ingredient mix-up and possible contamination.

Sen. Patty Murray (D-WA) (Graeme Sloan/Sipa USA/Sipa via AP Images)

Sen­a­tors to NIH: Do more to pro­tect US bio­med­ical re­search from for­eign in­flu­ence

Although Thursday’s Senate health committee hearing was focused on how foreign countries and adversaries might be trying to steal or negatively influence biomedical research in the US, the only country mentioned by the senators and expert witnesses was China.

Committee chair Patty Murray (D-WA) made clear in her opening remarks that the US cannot “let the few instances of bad actors” overshadow the hard work of the many immigrant researchers in the US, many of which have won Nobel prizes for their work. But she also said, “There is more the NIH can be doing here.”