Koenraad Wiedhaup (file photo)

GV wa­gers on sea­soned team's in­tranasal 'tem­po­rary' pre­ven­ta­tive ap­proach to virus­es — with ex-Gilead CEO John Mar­tin jump­ing on board

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.

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His­toric drug pric­ing re­forms pass; Pfiz­er ac­quires GBT; The long search for non-opi­oid pain drugs; and more

Welcome back to Endpoints Weekly, your review of the week’s top biopharma headlines. Want this in your inbox every Saturday morning? Current Endpoints readers can visit their reader profile to add Endpoints Weekly. New to Endpoints? Sign up here.

The Endpoints Weekly has officially crossed the 60,000 mark on subscribers — thanks to all of your support. As the editorial team grows, we’ve been able to do a lot more, with many of those on display this week. Be sure to check out Lei Lei Wu’s deep dive on pain R&D. If you missed it, you may also rewatch her companion panel here.

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Gold for adults, sil­ver for in­fants: Pfiz­er's Pre­vnar 2.0 head­ed to FDA months af­ter Mer­ck­'s green light

Pfizer was first to the finish line for the next-gen pneumococcal vaccine in adults, but Merck beat its rival with a jab for children in June.

Now, two months after Merck’s 15-valent Vaxneuvance won the FDA stamp of approval for kids, Pfizer is out with some late-stage data on its 20-valent shot for infants.

Known as Prevnar 20 for adults, Pfizer’s 20vPnC will head to the FDA by the end of this year for an approval request in infants, the Big Pharma said Friday morning. Discussions with the FDA will occur first and more late-stage pediatric trials are expected to read out soon, informing the regulatory pathway in other countries and regions.

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Seagen interim CEO Roger Dansey and Daiichi Sankyo CEO Sunao Manabe

Paving the way for Mer­ck­'s buy­out, Seagen los­es ar­bi­tra­tion dis­pute with Dai­ichi over ADC tech

As Seagen awaits a final buyout offer from Merck that could be in the territory of $40 billion, Seagen revealed Friday afternoon that it lost an arbitration dispute with Daiichi Sankyo relating to the companies’ 2008 collaboration around the use of antibody-drug conjugate (ADC) technology.

But that loss likely won’t matter much when it comes to Merck’s deal.

After breaking off its pact with Daiichi in mid-2015, the two companies battled over “linker” tech — a chemical bridge between an ADC’s antibody component and the cytotoxic payload — that Seagen claims Daiichi would improve upon and implement in its current generation of ADCs.

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Tony Coles, Cerevel CEO

Cerev­el takes the pub­lic of­fer­ing route, with a twist — rais­ing big mon­ey thanks to ri­val da­ta

As public biotechs seek to climb out of the bear market, a popular strategy to raise cash has been through public offerings on the heels of positive data. But one proposed raise Wednesday appeared to take advantage not of a company’s own data, but those from a competitor.

Cerevel Therapeutics plans to raise $250 million in a public offering and another $250 million in debt, the biotech announced Wednesday afternoon, even though it did not report any news on its pipeline. However, the move comes days after rival Karuna Therapeutics touted positive Phase III data in schizophrenia, a field where Cerevel is pursuing a similar program.

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House pass­es his­toric drug pric­ing re­forms, lin­ing up decades-in-the-mak­ing win for Biden and De­moc­rats

The US House of Representatives today voted along party lines (all Dems voted for it), 220-207 to pass new, wide-ranging legislation that will allow Medicare drug price negotiations for the first time ever, and cap seniors’ drug expenses to $2,000 per year and seniors’ insulin costs at $35 per month.

Setting up a major victory for President Joe Biden, representatives returned from their summer recess to pass the Inflation Reduction Act, even as many noted the bill would only modestly reduce inflation.

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Senate Finance Committee Chair Ron Wyden (D-OR) (Francis Chung/E&E News/POLITICO via AP Images)

Sen­ate Fi­nance chair con­tin­ues his in­ves­ti­ga­tion in­to phar­ma tax­es with re­quests for Am­gen

Amgen is the latest pharma company to appear on the radar of Senate Finance Committee Chair Ron Wyden (D-OR), who is investigating the way pharma companies are using subsidiaries in low- or zero-tax countries to lower their tax bills.

Like its peers Merck, AbbVie and Bristol Myers Squibb, Wyden notes how Amgen uses its Puerto Rico operations to consistently pay tax rates that are substantially lower than the U.S. corporate tax rate of 21%, with an effective tax rate of 10.7% in 2020 and 12.1% in 2021.

FDA ap­proves sec­ond in­di­ca­tion for As­traZeneca and Dai­ichi's En­her­tu in less than a week

AstraZeneca and Daiichi Sankyo’s antibody-drug conjugate Enhertu scored its second approval in less than a week, this time for a subset of lung cancer patients.

Enhertu received accelerated approval on Thursday to treat adults with unresectable or metastatic non-small cell lung cancer (NSCLC) whose tumors have activating HER2 (ERBB2) mutations, and who have already received a prior systemic therapy.

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J&J to re­move talc prod­ucts from shelves world­wide, re­plac­ing with corn­starch-based port­fo­lio

After controversially spinning out its talc liabilities and filing for bankruptcy in an attempt to settle 38,000 lawsuits, Johnson & Johnson is now changing up the formula for its baby powder products.

J&J is beginning the transition to an all cornstarch-based baby powder portfolio, the pharma giant announced on Thursday — just months after a federal judge ruled in favor of its “Texas two-step” bankruptcy to settle allegations that its talc products contained asbestos and caused cancer. An appeals court has since agreed to revisit that case.