Stéphane Bancel, Endpoints JPM 2020 (Jeff Rumans)

Mod­er­na eyes $500M sec­ondary of­fer­ing on up­beat coro­n­avirus vac­cine up­date — al­most ready for the clin­ic

Among the army of biotechs that threw them­selves in­to the gold rush for 2019-nCoV vac­cines or ther­a­pies, Mod­er­na emerged as one of the most le­git­i­mate con­tenders: The NIH had signed it on as a part­ner, demon­strat­ing con­fi­dence in its mes­sen­ger RNA plat­form to pro­duce a vac­cine rapid­ly.

That has giv­en the Cam­bridge, MA-based biotech a nice bump on its uni­corn val­u­a­tion. And CEO Stéphane Ban­cel is seiz­ing it.

Mod­er­na, whose $604 mil­lion IPO set a record for the in­dus­try, is of­fer­ing more stocks on the pub­lic mar­ket in hopes of rais­ing an­oth­er $500 mil­lion to fund clin­i­cal de­vel­op­ment and drug dis­cov­ery, as well as ex­pand its mR­NA tech plat­form.

Its SEC fil­ing made no men­tion of the nov­el coro­n­avirus out­break emerg­ing out of Wuhan, Chi­na — or any oth­er spe­cif­ic pro­grams for that mat­ter — mere­ly stat­ing that its pipeline spans in­fec­tious dis­eases, im­muno-on­col­o­gy, rare dis­eases, au­toim­mune dis­eases and car­dio­vas­cu­lar dis­eases.

At the lat­est count, its 830-strong team is work­ing on 24 de­vel­op­ment can­di­dates across 23 pro­grams, 17 of which have en­tered the clin­ic.

Shares $MR­NA, though, fell 5.5% to $22.35 pre-mar­ket.

Mod­er­na has risen near­ly 20% to $23.65 since the mar­ket opened on Fri­day, buoyed by an up­date from the NIH say­ing that tests of its coro­n­avirus vac­cine in mice are on­go­ing with “no glitch­es so far” — and that it should be ready for hu­mans with­in 2.5 months.

In a sep­a­rate state­ment out Mon­day af­ter­noon, Mod­er­na re­port­ed that the first clin­i­cal batch of its 2019-nCoV vac­cine — dubbed mR­NA1273 — was com­plet­ed on Feb­ru­ary 7, in­clud­ing fills and fin­ish­ing of vials.

“This mR­NA vac­cine was de­signed and man­u­fac­tured in 25 days and is un­der­go­ing an­a­lyt­i­cal test­ing pri­or to re­lease to the NIH for use in their planned Phase 1 clin­i­cal tri­al in the U.S,” the com­pa­ny wrote.

The vac­cine en­codes for the vi­ral Spike pro­tein, which is con­sid­ered a cru­cial com­plex for mem­brane fu­sion and host cell in­fec­tion.

Adding to the good news, Mod­er­na al­so dis­closed that its Phase II tri­al for a CMV vac­cine is en­rolling more quick­ly than ex­pect­ed and in­ter­im da­ta can now be ex­pect­ed in the third quar­ter.

It al­so shed more light on two new de­vel­op­ment can­di­dates against Ep­stein-Barr virus (mR­NA-1189) and res­pi­ra­to­ry syn­cy­tial virus (mR­NA-1345) in young chil­dren, re­spec­tive­ly. The EBV can­di­date con­tains 5 mR­NAs that en­code vi­ral pro­teins known as gp350, gB, gp42, gH and gL, while the RSV vac­cine will be test­ed in com­bi­na­tion with an­oth­er one against hM­PV and PIV3 to launch a full front­ed at­tack against a no­to­ri­ous tar­get.

Nick Galakatos, Blackstone global head of life sciences

Nick Galakatos and the Black­stone team now have a record $4.6B to in­vest in bio­phar­ma, with a big fo­cus on push­ing com­pa­nies over the top

Nick Galakatos and his team at Blackstone Life Sciences have seen their biggest opportunities swell up in mostly established players who don’t have all the money they need to accomplish everything on the to-do list. And right now, with the industry booming, that’s a long list with some hefty needs.

The Blackstone team has neatly tied up the largest private fund ever raised in life sciences for making big dreams come true in biopharma. Late Thursday, Blackstone put out word that they had closed their highly anticipated fund with the projected $4.6 billion all in.

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Gilead boasts of pos­i­tive remde­sivir da­ta on mor­tal­i­ty — but their analy­sis pro­vokes the skep­tics

Gilead is surging again off data that suggest its antiviral remdesivir might improve survival.

The new data come from an analysis Gilead conducted comparing the death rate and recovery time of patients in one of its remdesivir trials to a group of 800 patients “with similar baseline characteristics and disease severity” who received only standard-of-care around the same time. The result, they said, suggested that patients who received remdesivir had a 62% better chance at surviving than those who did not.

Covid-19 roundup: BioN­Tech go­ing head-to-head with Mod­er­na as PhI­II mR­NA launch looms; Tri­al on Shin­zo Abe’s once-fa­vorite an­tivi­ral is in­con­clu­sive

It’s a race to the Phase III finish line now for the 2 leading mRNA vaccines in the pipeline for Covid-19.

BioNTech chief Ugur Sahin told the Wall Street Journal that his company will start Phase III testing of their vaccine later this month, setting them up to lateral the data to regulators before the end of this year.

That puts them essentially on the exact same schedule as Moderna is dedicated to. The Massachusetts rival to BioNTech also expects to launch Phase III this month. Lots of rumors have circulated about delays and conflict among the scientists advancing the Moderna jab, but the biotech has consistently stuck to its plan to start a late-stage pivotal this month.

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Regeneron CEO Leonard Schleifer speaks at a meeting with President Donald Trump, members of the Coronavirus Task Force, and pharmaceutical executives in the Cabinet Room of the White House (AP Photo/Andrew Harnik)

OWS shifts spot­light to drugs to fight Covid-19, hand­ing Re­gen­eron $450M to be­gin large scale man­u­fac­tur­ing in the US

The US government is on a spending spree. And after committing billions to vaccines defense operations are now doling out more of the big bucks through Operation Warp Speed to back a rapid flip of a drug into the market to stop Covid-19 from ravaging patients — possibly inside of 2 months.

The beneficiary this morning is Regeneron, the big biotech engaged in a frenzied race to develop an antibody cocktail called REGN-COV2 that just started a late-stage program to prove its worth in fighting the virus. BARDA and the Department of Defense are awarding Regeneron a $450 million contract to cover bulk delivery of the cocktail starting as early as late summer, with money added for fill/finish and storage activities.

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UP­DAT­ED: Bio­gen shares spike as ex­ecs com­plete a de­layed pitch for their con­tro­ver­sial Alzheimer's drug — the next move be­longs to the FDA

Biogen is stepping out onto the high wire today, reporting that the team working on the controversial Alzheimer’s drug aducanumab has now completed their submission to the FDA. And they want the agency to bless it with a priority review that would cut the agency’s decision-making time to a mere 6 months.

The news drove a 10% spike in Biogen’s stock $BIIB ahead of the bell.

Part of that spike can be attributed to a relief rally. Biogen execs rattled backers and a host of analysts earlier in the year when they unexpectedly delayed their filing to the third quarter. That delay provoked all manner of speculation after CEO Michel Vounatsos and R&D chief Al Sandrock failed to persuade influential observers that the pandemic and other factors had slowed the timeline for filing. Actually making the pitch at least satisfies skeptics that the FDA was not likely pushing back as Biogen was pushing in. From the start, Biogen execs claimed that they were doing everything in cooperation with the FDA, saying that regulators had signaled their interest in reviewing the submission.

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Hal Barron, GSK

Win or lose on the mar­ket­ing OK, the FDA just gunned down GSK’s bright hopes for their BC­MA ther­a­py

The FDA’s ODAC — the Oncologic Drugs Advisory Committee — has a well-known bias in favor of adding new cancer drugs to the market, even if efficacy is at best marginal and serious safety issues demand careful management.

Doctors want as many arrows in their quiver as they can get. And when patients are dying after failing multiple drugs, why not give it a go one more time?

GlaxoSmithKline, though, is about to test out how their new BCMA antibody drug conjugate belantamab mafodotin can do after being mauled in an in-house FDA review, ahead of the Tuesday expert panel discussion. Even if the agency goes ahead with an expected green light, this drug will likely be constrained to a small niche — icing any plans they may have for making waves in oncology anytime soon.

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Nello Mainolfi (Kymera via YouTube)

Out to re­vive R&D, a resur­gent Sanofi pays $150M cash to part­ner up with a pi­o­neer­ing pro­tein degra­da­tion play­er

Frank Nestle was appointed Sanofi’s global head of immunology and inflammation research therapeutic area just days before dupilumab, the blockbuster-to-be IL-4 antibody, would be accepted for priority review. After four years of consolidating immunology expertise from multiple corners of the Sanofi family and recruiting new talents to build the discovery engine, he’s set eyes on a Phase I-ready program that he believes can grow into a Dupixent-sized franchise.

Covid-19 roundup: CDC de­bat­ing who should get first avail­able vac­cines; EU in Gilead talks af­ter US gob­bled first remde­sivir dos­es

The federal government has now spent billions of dollars accelerating the development of a Covid-19 vaccine, and yet they’ve remained hush-hush on who, precisely, would actually get inoculated once the first doses are approved and available. Internally, though, they have been debating it.

The CDC and an advisory committee of outside health experts have been working since April to devise a ranking system that would determine who receives a vaccine and when, The New York Times reported. The question of who is first in line for inoculation is important because no matter how many doses developers can make or how quickly they can make them, doses will still come out in batches; 300 million inoculations will not appear overnight.

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Daniel O'Day, Gilead CEO (Kevin Dietsch/UPI/Bloomberg via Getty Images)

A new study points to $6.5B in pub­lic sup­port build­ing the sci­en­tif­ic foun­da­tion of Gilead­'s remde­sivir. Should that be re­flect­ed in the price?

By drug R&D standards, Gilead’s move to repurpose remdesivir for Covid-19 and grab an emergency use authorization was a remarkably easy, low-cost layup that required modest efficacy and a clean safety profile from just a small group of patients.

The drug OK also arrived after Gilead had paid much of the freight on getting it positioned to move fast.

In a study by Fred Ledley, director of the Center for Integration of Science and Industry at Bentley University in Waltham, MA, researchers concluded that the NIH had invested only $46.5 million in the research devoted to the drug ahead of the pandemic, a small sum compared to the more than $1 billion Gilead expected to spend getting it out this year, all on top of what it had already cost in R&D expenses.

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