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.

What Will it Take to Re­al­ize the Promise and Po­ten­tial of Im­mune Cell Ther­a­pies?

What does it take to get to the finish line with a new cancer therapy – fast? With approvals in place and hundreds of immune cell therapy candidates in the pipeline, the global industry is poised to create a fundamental shift in cancer treatments towards precision medicine. At the same time, unique challenges associated with cell and process complexity present manufacturing bottlenecks that delay speed to market and heighten cost of goods sold (COGS) — these hurdles must be overcome to make precision treatments an option for every cancer patient. This series of articles highlights some of the key manufacturing challenges associated with the production of cell-based cancer therapies as well as the solutions needed to transcend them. Automation, process knowledge, scalability, and assured supply of high-quality starting material and reagents are all critical to realizing the full potential of CAR-based therapies and sustaining the momentum achieved in recent years. The articles will highlight leading-edge technologies that incorporate these features to integrate across workflows, accelerate timelines and reduce COGS – along with how these approaches are enabling the biopharmaceutical industry to cross the finish line faster with new treatment options for patients in need.

The biggest ques­tions fac­ing gene ther­a­py, the XLMTM com­mu­ni­ty, and Astel­las af­ter fourth pa­tient death

After three patients died last year in an Astellas gene therapy trial, the company halted the study and began figuring out how to safely get the program back on track. They would, executives eventually explained, cut the dose by more than half and institute a battery of other measures to try to prevent the same thing from happening again.

Then tragically, Astellas announced this week that the first patient to receive the new regimen had died, just weeks after administration.

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Lat­est news: It’s a no on uni­ver­sal boost­ers; Pa­tient death stuns gene ther­a­py field; In­side Tril­li­um’s $2.3B turn­around; 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.

Next week is shaping up to be a busy one, as our editor-in-chief John Carroll and managing editor Kyle Blankenship lead back-to-back discussions with a great group of experts to discuss the weekend news and trends. John will be spending 30 minutes with Jake Van Naarden, the CEO of Lilly Oncology, and Kyle has a brilliant panel lined up: Harvard’s Cigall Kadoch, Susan Galbraith, the new head of cancer R&D at AstraZeneca, Roy Baynes at Merck, and James Christensen at Mirati. Don’t miss out on the action — sign up here.

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President Biden and Pfizer CEO Albert Bourla (Patrick Semansky/AP Images)

Chaot­ic ad­comm sees Pfiz­er/BioN­Tech boost­ers re­ject­ed for gen­er­al pop­u­la­tion, but rec­om­mend­ed for old­er and high-risk pop­u­la­tions

With just days before President Joe Biden’s Covid-19 booster rollout is set to go into effect, an FDA advisory committee appeared on the verge of not recommending boosters for anyone in the US before a last-minute change of wording laid the groundwork for older adults to have access to a third dose.

The FDA’s adcomm on Vaccines and Related Biological Products (VRBPAC) roundly rejected Pfizer/BioNTech booster shots for all individuals older than 16 by a 16-2 vote Friday afternoon. Soon after, however, the agency posed committee members a new question limiting booster use to the 65-and-older population and individuals at high risk of disease due to occupational exposure or comorbidities.

As­traZeneca, Dai­ichi Sanky­o's ADC En­her­tu blows away Roche's Kad­cy­la in sec­ond-line ad­vanced breast can­cer

AstraZeneca and Japanese drugmaker Daiichi Sankyo think they’ve struck gold with their next-gen ADC drug Enhertu, which has shown some striking data in late-stage breast cancer trials and early solid tumor tests. Getting into earlier patients is now the goal, starting with Enhertu’s complete walkover of a Roche drug in second-line breast cancer revealed Saturday.

Enhertu cut the risk of disease progression or death by a whopping 72% (p=<0.0001) compared with Roche’s ADC Kadcyla in second-line unresectable and/or metastatic HER2-positive breast cancer patients who had previously undergone treatment with a Herceptin-chemo combo, according to interim data from the Phase III DESTINY-Breast03 head-to-head study presented at this weekend’s #ESMO21.

Merck Research Laboratories CMO Roy Baynes

Mer­ck­'s Keytru­da un­corks full da­ta on lat­est ad­ju­vant win — this time in melanoma — adding bricks to ear­ly can­cer wall

In recent months, the battle for PD-(L)1 dominance has spilled over into early cancer with Merck’s Keytruda and Bristol Myers Squibb’s Opdivo all alone on the front lines. Keytruda now has another shell in its bandolier, and it could spell a quick approval.

Keytruda cut the risk of relapse or death by 35% over placebo (p=0.00658) in high-risk, stage 2 melanoma patients who had previously undergone surgery to remove their tumors, according to full data from the Phase III KEYNOTE-716 presented Saturday at #ESMO21.

Mer­ck flesh­es out Keytru­da win in first-line cer­vi­cal can­cer, adding more fire­pow­er to its ear­ly can­cer push

Merck has worked hard to bring its I/O blockbuster Keytruda into earlier and earlier lines of therapy, and now the wonder drug appears poised to make a quick entry into early advanced cervical cancer.

A combination of Keytruda and chemotherapy with or without Roche’s Avastin cut the risk of death by 33% over chemo with or without Avastin (p=<0.001) in first-line patients with persistent, recurrent or metastatic cervical cancer, according to full data from the Phase III KEYNOTE-826 study presented Saturday at #ESMO21.

Skin tu­mors in mice force Pro­tag­o­nist to halt lead pro­gram, crush­ing stock

Protagonist Therapeutics just can’t catch a break.

Six months after the Newark, CA-based biotech unveiled grand plans to launch its lead candidate for blood disorders into a Phase III trial, the FDA has slapped the program with a clinical hold. The halt — which applies to all trials involving the candidate, rusfertide — comes after skin tumors were discovered in mice treated with the drug, according to Protagonist.

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Chi­nese biotech Ever­est signs $550M+ li­cens­ing deal for BTK in­hibitors on heels of Covid-19 pact

Everest Medicines is on a roll with two licensing deals in one week.

The Shanghai-based biotech has paid Sinovent and SinoMab $12 million upfront for the rights to a BTK inhibitor for renal diseases, the company announced Thursday. The deal comes just days after Everest came away with rights to a Covid-19 vaccine in China, Taiwan, Singapore, Thailand and Indonesia.

Everest will pay Sinovent and SinoMab up to $549 million in milestone payments and royalties. The agreement includes tech transfer of Sinovent and SinoMab’s manufacturing process for the candidate, named XNW1011.