A San Diego mR­NA biotech is look­ing to ex­pand its ef­forts in in­fluen­za, and a fed­er­al award will bring it clos­er to that goal.

Arc­turus Ther­a­peu­tics said Wednes­day that it won an award from HHS’s BAR­DA worth $63.2 mil­lion, a grant that was award­ed as part of the en­ti­ty’s pan­dem­ic in­fluen­za ef­forts. The grant will be divvied out over the next three years to boost Arc­turus’ self-am­pli­fy­ing mR­NA vac­cine plat­form tech on mul­ti­ple as­pects, such as pre­clin­i­cal re­search, man­u­fac­tur­ing, non-clin­i­cal safe­ty stud­ies and reg­u­la­to­ry sup­port.

The goal, per an Arc­turus state­ment, is to push a can­di­date for in­fluen­za from pre­clin­i­cal through Phase I clin­i­cal stud­ies.

CEO Joseph Payne tells End­points News that there’s a big dif­fer­ence be­tween sea­son­al in­fluen­za and pan­dem­ic in­fluen­za. One is the kind for which some­one gets their an­nu­al shot, and the oth­er is one that could mu­tate and be­come more of a threat.

“This pan­dem­ic flu is some­thing that is of sig­nif­i­cant con­cern for the Unit­ed States gov­ern­ment, be­cause it could be very lethal — far more lethal than Covid ever was,” Payne added.

The CEO not­ed that there’s in­creased en­er­gy in the US and around the world to be more proac­tive on pan­dem­ic pre­pared­ness, and right now there’s a fo­cus on pan­dem­ic flu.

In the mean­time, the next im­me­di­ate step for Arc­turus is to start pre­clin­i­cal re­search.

“We’re go­ing to be work­ing with the Unit­ed States gov­ern­ment to make sure that we’re go­ing af­ter the strains that are of most con­cern in the pan­dem­ic flu space,” Payne said.

Arc­turus’ vac­cine de­sign, ac­cord­ing to Payne, hinges on its abil­i­ty to be self-am­pli­fy­ing, es­sen­tial­ly the abil­i­ty to ex­press an anti­gen for a week or two once it en­ters a cell, in­stead of one or two days. The CEO not­ed that it would al­low the vac­cine dose to be no big­ger than five µg, a sub­stan­tial dif­fer­ence com­pared to re­cent mR­NA boost­ers at 30 or 50 µg.

On top of that, the fi­nal prod­uct that the com­pa­ny hopes to de­liv­er to BAR­DA would by lyophilized, or freeze-dried, and would al­low for po­ten­tial­ly mul­ti-year stor­age in the na­tion­al strate­gic stock­pile.

The biotech pre­vi­ous­ly had shared re­sults from a “Phase I/II/III study” in late April from its lead can­di­date, a Covid-19 mR­NA vac­cine. While it was 55% ef­fec­tive at stop­ping symp­to­matic Covid-19 in­fec­tion and 95% ef­fec­tive at pre­vent­ing se­vere dis­ease, the da­ta came out af­ter more than a third of Amer­i­cans had al­ready got­ten their first boost­er. In­vestors sent the stock price $ARCT down 15%.

Fast for­ward to to­day, where the stock price is up 2% as of Thurs­day morn­ing.

BAR­DA, for its part, has been busy in re­cent months. On top of mul­ti­ple or­ders of Bavar­i­an Nordic’s mon­key­pox vac­cine Jyn­neos, the of­fice gave out $11 mil­lion to Grand Riv­er Asep­tic Man­u­fac­tur­ing ear­li­er this week, which had agreed to pro­vide fill and fin­ish ser­vices for Bavar­i­an Nordic’s vac­cine.

The FDA’s Oncology Center of Excellence has been a bright spot within the agency in terms of speeding new treatments to patients. That flexibility was on full display this morning as FDA released new draft guidance spelling out exactly how oncology drug developers can fulfill both the accelerated and full approval’s requirements with just a single randomized controlled trial.

While Congress recently passed legislation that will allow FDA to require confirmatory trials to be recruiting and ongoing prior to granting an accelerated approval, the agency is now making clear that the initial trial used to win the AA, if designed appropriately, can also serve as the trial for converting the accelerated approval into a full approval.

US regulators cleared an ultra-rare drug from Pharming Group, by way of Novartis, on Friday afternoon.

The Dutch biotech said the FDA greenlit leniolisib for an immunodeficiency disease known as activated phosphoinositide 3-kinase delta (PI3Kδ) syndrome, or APDS. People 12 years and older can receive the oral drug, to be marketed as Joenja, beginning early next month, Pharming said, five days ahead of the decision deadline set by the FDA as part of a priority review.