Last May, dur­ing the first lock­down in Eu­rope, Koen­raad Wied­haup found him­self in a so­cial­ly dis­tanced meet­ing with Jaap Goudsmit, Ronald Brus and Dinko Va­le­rio.

Jaap Goudsmit

The trio had worked to­geth­er at Cru­cell and cre­at­ed a vac­cine plat­form that J&J has made its sin­gle-shot Covid-19 vac­cine on, a decade af­ter the phar­ma gi­ant inked a $2.4 bil­lion buy­out. Im­pressed with the speed of vac­cine de­vel­op­ment, the group how­ev­er pon­dered if fu­ture pan­demics called for a dif­fer­ent kind of prod­uct: a nasal spray that can pro­tect peo­ple from a whole range of virus­es for a few days, be­fore vac­cines be­come avail­able or when they need to ven­ture out to a par­tic­u­lar­ly risky sit­u­a­tion.

The prod­ucts would work, Wied­haup said, by tar­get­ing cer­tain com­mon­al­i­ties among a virus fam­i­ly and pre­vent­ing them from en­ter­ing cells. And while he coudn’t de­tail the tech­nol­o­gy any fur­ther, in­vestors who got an in­side look were in­trigued enough to pool more than $47 mil­lion (€40 mil­lion) for Ley­den Labs to scale out the plat­form and ush­er the first prod­ucts to­ward the clin­ic.

Ronald Brus

GV (which still can’t shed the par­en­thet­i­cal Google Ven­tures brand) led the Se­ries A, with par­tic­i­pa­tion from F-Prime Cap­i­tal, Cas­din Cap­i­tal and Brook By­ers.

David Schenkein is rep­re­sent­ing GV on the board, which al­so fea­tures Stephen Knight of F-Prime, for­mer Gilead CEO John Mar­tin, Gala­pa­gos chief On­no van de Stolpe, ex-No­var­tis head of de­vel­op­ment James Shan­non and vi­rol­o­gist Richard Whit­ley.

Ley­den Labs will fo­cus on res­pi­ra­to­ry virus­es with po­ten­tial to cause pan­demics, said Wied­haup, who’s tak­ing up the CEO role af­ter a ca­reer span­ning acad­e­mia, biotech and con­sult­ing.

Dinko Va­le­rio

Coro­n­avirus­es and in­fluen­za, which are the tar­gets of a host of uni­ver­sal vac­cine and treat­ment pro­grams, loom large. But the biotech says it’s not look­ing to re­place any of the oth­er op­tions — just to of­fer a new, off-the-shelf op­tion that can stand at the ready. The idea is for peo­ple to ad­min­is­ter the pre­ven­ta­tive prod­uct them­selves when­ev­er they want the ex­tra pro­tec­tion.

“If you stop that right away from repli­cat­ing in the na­sopha­ryn­geal area and the in­tranasal area, then we can ac­tu­al­ly stop al­so fur­ther in­fec­tion to the lungs or pre­vent­ing peo­ple to trans­mit to oth­ers,” Wied­haup said.

Play­ing his cards close to the vest, the CEO is sim­i­lar­ly non-com­mit­tal about the clin­i­cal tri­al plans, say­ing on­ly that they are con­sid­er­ing chal­lenge tri­als as one pos­si­bil­i­ty. He de­clined to dis­cuss when that may hap­pen, al­though he not­ed the­o­ret­i­cal­ly the nasal spray could be used for SARS-CoV-2 and all its vari­ants.

“Peo­ple can use it for the times that they need — when they go out to ball­games, when they go out to work, to crowd­ed bus or a long haul flight, they can use the in­tranasal prod­ucts, the nasal sprays, to pro­tect them­selves tem­porar­i­ly,” he said.

89bio said its drug was better than placebo at lessening fibrosis without worsening nonalcoholic steatohepatitis, or NASH, in two of three dose groups.

The San Francisco biotech said it thinks the Phase IIb data pave the way for a potential Phase III, following in the footsteps of another biotech in its drug class, Akero Therapeutics. To fund a late-stage study, CEO Rohan Palekar told Endpoints News 89bio “would need to raise additional capital,” with the company having about $188 million at the end of last year.

The National Institutes of Health has again declined to use so-called “march-in” rights to lower the price of Astellas and Pfizer’s prostate cancer drug Xtandi despite being invented at UCLA with grants from the US Army and NIH.

“Given the remaining patent life and the lengthy administrative process involved for a march-in proceeding, NIH does not believe that use of the march-in authority would be an effective means of lowering the price of the drug,” NIH told prostate cancer patients Robert Sachs and Clare Love, in a letter shared with Endpoints News. The institutes’ analyses found Xtandi “to be widely available to the public,” an indication that there was not a pressing need for the US to act.