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.

Secretary of health and human services Alex Azar speaking in the Rose Garden at the White House (Photo: AFP)

Trump’s HHS claims ab­solute au­thor­i­ty over the FDA, clear­ing path to a vac­cine EUA

The top career staff at the FDA has vowed not to let politics overrule science when looking at vaccine data this fall. But Alex Azar, who happens to be their boss’s boss, apparently won’t even give them a chance to stand in the way.

In a new memorandum issued Tuesday last week, the HHS chief stripped the FDA and other health agencies under his purview of their rule making ability, asserting all such power “is reserved to the Secretary.” Sheila Kaplan of the New York Times first obtained and reported the details of the September 15 bulletin.

Two wild weeks for Grail end in $8B Il­lu­mi­na buy­out

Grail’s whirlwind two weeks have ended in the wealthy arms of its former founder and benefactors.

Illumina has shelled out $8 billion to reacquire the closely-watched liquid biopsy startup they spun out just 5 years ago and sold off much of its shares just 3 years ago. The deal comes nearly two weeks after the well-heeled startup filed for a potentially massive IPO — one that was disrupted just a week later when Bloomberg reported that Illumina was in talks to buy their former spinout for up to $8 billion.

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Roche vaults to the front of the NL­RP3 clin­i­cal race, pay­ing $448M up­front to bag In­fla­zome

Roche is going all in on NLRP3.

The pharma giant is putting down $448 million (€380 million) upfront to snatch Novartis-backed Inflazome, which makes it a clinical player in the space overnight.

Dublin and Cambridge, UK-based Inflazome is the second NLRP3-focused biotech Roche has acquired in less than two years, and although no numbers were disclosed in the Jecure buyout, this is almost certainly a much larger deal.

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Norbert Bischofberger, Kronos CEO

Three more biotechs look to jump on­to Nas­daq amid IPO boom, in­clud­ing Nor­bert Bischof­berg­er's Kro­nos

Three drug developers announced plans to go public on Friday, a sign that the IPO window for biopharma is wide open.

First up is Daly City, CA-based Spruce Biosciences. They filed for an $86 million IPO to develop their pipeline for classic congenital adrenal hyperplasia (CAH). Currently, only steroids are available to treat the condition, which affects the adrenal glands above the kidneys. Spruce’s tildacerfont, a non-steroidal option, is in a Phase IIb trial in adults with classic CAH and poor disease control. The company expects a topline readout here in the next 12 to 15 months. The small molecule is also in a Phase IIb study in adults with classic CAH and good disease control. Spruce expects topline data here in the first half of 2022.

Jonathan Rigby, Immune Regulation group CEO

Im­mune Reg­u­la­tion, tak­ing two clin­i­cal pro­grams to 're­set' the im­mune sys­tem, nets $53M+ Se­ries B

A little under two years after a company rebranding, Immune Regulation is taking an even bigger step toward advancing its goals.

Formerly known as Peptinnovate, the British biotech announced a $53.4 million Series B early Monday morning, helping to further advance two clinical programs in rheumatoid arthritis and asthma. Though those are the two initial indications the company is focusing on, CEO Jonathan Rigby told Endpoints News he hopes the candidates can be applied to a broad swath of autoimmune disorders.

News brief­ing: Bausch Health clos­ing in on deal to ac­quire Al­le­gro as­sets; PharmAbcine strikes deal with Sam­sung Bi­o­log­ics to de­vel­op an­ti­body pro­gram

Bausch Health is closing in on a deal that would allow it to buy out all of Allegro Ophthalmics’ eye-related assets — including the rights to lead candidate risuteganib — for $50 million.

The payment would be made in two tranches: $10 million at signing, and $40 million in 2021.

Risuteganib is in clinical development for intermediate dry Age-related Macular Degeneration (AMD). It’s expected to enter two concurrent Phase III trials for that indication in the next year. The drug is also being tested in patients with diabetic macular edema (DME), and last year met the primary endpoint in a Phase II study, with 48% of patients gaining 8 or more letters in visual acuity from baseline at week 28, compared to 7% in the control group at week 12.

Frank Zhang (AP Images)

Rocked by cus­toms in­ves­ti­ga­tion, Leg­end's CFO takes over as CEO Frank Zhang placed un­der house ar­rest

When Frank Zhang stepped down from GenScript — the contract research group he’s run for 18 years — to take up the CEO post at its CAR-T focused spinout Legend Biotech, he assured analysts that he was in for the long haul.

Just 49 days later, though, he’s been forced to hand back the title.

In a dramatic turn of events, Legend disclosed that Zhang is under house arrest in China as part of a customs investigation involving GenScript. While he remains the chairman, CFO Ying Huang has been tapped to double as interim CEO.

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Israel Lowy (Regeneron)

#ES­MO20: 'As good as any PD-1 out there': Re­gen­eron flash­es PD-(L)1 lung can­cer da­ta to ri­val Mer­ck

Regeneron entered the PD-(L)1 game late, so they devised a two-pronged strategy to catch up with Big Pharma rivals: They would push it into cancers where PD-1s had yet been tested, and they would prove that it’s as powerful in the big indications as any other on the market.

They cleared a hurdle on the first goal Friday, showing a 31% response in patients with the rare skin cancer basal cell carcinoma. And with the data they’re rolling out Monday, Regeneron cancer chief Israel Lowy is ready to declare success on the second.

As­traZeneca pub­lish­es Covid-19 vac­cine PhI­II pro­to­cols in lock­step with Mod­er­na and Pfiz­er. How are they dif­fer­ent?

Following in the steps of Moderna and Pfizer, the other two American drugmakers currently in Phase III trials for their Covid-19 vaccines, AstraZeneca posted its own study protocols over the weekend. The move is the latest in a series of rare peeks behind the curtain, as such blueprints are typically shared once such trials are completed.

“Given the unprecedented global impact of the Coronavirus pandemic and the need for public information, AstraZeneca has published the detailed protocol and design of our AZD1222 clinical trial. As with most clinical development, protocols are not typically shared publicly due to the importance of maintaining confidentiality and integrity of trials. AstraZeneca continues to work with industry peers to ensure a consistent approach to sharing timely clinical trial information,” the company said in a statement.