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.

2023 Spot­light on the Fu­ture of Drug De­vel­op­ment for Small and Mid-Sized Biotechs

In the context of today’s global economic environment, there is an increasing need to work smarter, faster and leaner across all facets of the life sciences industry.  This is particularly true for small and mid-sized biotech companies, many of which are facing declining valuations and competing for increasingly limited funding to propel their science forward.  It is important to recognize that within this framework, many of these smaller companies already find themselves resource-challenged to design and manage clinical studies themselves because they don’t have large teams or in-house experts in navigating the various aspects of the drug development journey. This can be particularly challenging for the most complex and difficult to treat diseases where no previous pathway exists and patients are urgently awaiting breakthroughs.

Rick Modi, Affinia Therapeutics CEO

Ver­tex-part­nered gene ther­a­py biotech Affinia scraps IPO plans

Affinia Therapeutics has ditched its plans to go public in a relatively closed-door market that has not favored Nasdaq debuts for the drug development industry most of this year. A pandemic surge in 2020 and 2021 opened the doors for many preclinical startups, which caught Affinia’s attention and gave the gene therapy biotech confidence in the beginning days of 2022 to send in its S-1.

But on Friday, Affinia threw in the S-1 towel and concluded now is not the time to step onto Wall Street. The biotech has put out few public announcements since the spring of this year. Endpoints News picked the startup as one of its 11 biotechs to watch last year.

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Up­dat­ed: FDA re­mains silent on or­phan drug ex­clu­siv­i­ty af­ter last year's court loss

Since losing a controversial court case over orphan drug exclusivity last year, the FDA’s Office of Orphan Products Development has remained entirely silent on orphan exclusivity for any product approved since last November, leaving many sponsors in limbo on what to expect.

That silence means that for more than 70 orphan-designated indications for more than 60 products, OOPD has issued no public determination on the seven-year orphan exclusivity in the Orange Book, and no new listings of orphan exclusivity appear in OOPD’s searchable database, as highlighted recently by George O’Brien, a partner in Mayer Brown’s Washington, DC office.

Albert Bourla, Pfizer CEO (Efren Landaos/Sipa USA/Sipa via AP Images)

Pfiz­er makes an­oth­er bil­lion-dol­lar in­vest­ment in Eu­rope and ex­pands again in Michi­gan

Pfizer is continuing its run of manufacturing site expansions with two new large investments in the US and Europe.

The New York-based pharma giant’s site in Kalamazoo, MI, has seen a lot of attention over the past year. As a major piece of the manufacturing network for Covid-19 vaccines and antivirals, Pfizer is gearing up to place more money into the site. Pfizer announced it will place $750 million into the facility, mainly to establish “modular aseptic processing” (MAP) production and create around 300 jobs at the site.

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Vas Narasimhan, Novartis CEO (Thibault Camus/AP Images, Pool)

No­var­tis bol­sters Plu­vic­to's case in prostate can­cer with PhI­II re­sults

The prognosis is poor for metastatic castration-resistant prostate cancer (mCRPC) patients. Novartis wants to change that by making its recently approved Pluvicto available to patients earlier in their course of treatment.

The Swiss pharma giant unveiled Phase III results Monday suggesting that Pluvicto was able to halt disease progression in certain prostate cancer patients when administered after androgen-receptor pathway inhibitor (ARPI) therapy, but without prior taxane-based chemotherapy. The drug is currently approved for patients after they’ve received both ARPI and chemo.

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Pfiz­er-backed Me­di­ar Ther­a­peu­tics ropes in an­oth­er Big Phar­ma in­vestor

A biotech centered on treating fibrosis — born out of Mass General and Brigham and Women’s Hospital — has received a financial boost.

According to an SEC filing, the company has raised $31,761,186 in its latest funding round, which includes 17 investors. The filing lists six names attached to the company, including Meredith Fisher, a partner at Mass General Brigham Ventures and Mediar’s acting CEO.

Ken Greenberg, SonoThera CEO

Gene ther­a­py goes acoustic as ARCH-backed biotech launch­es with ul­tra­sound gene de­liv­ery plat­form

After co-founding two biotechs off virus-based therapies, one for pain and one for cancer, Ken Greenberg decided to go in a different direction for his newest biotech, SonoThera.

Based out of San Francisco, SonoThera announced Monday morning that it raised $60.75 million to develop new gene therapies — but delivered by ultrasound, which Greenberg says can address the major challenges facing more conventional viral gene therapies.

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Af­ter M&A fell through, Ther­a­peu­tic­sMD sells hor­mone ther­a­py, con­tra­cep­tive ring for $140M cash plus roy­al­ties

TherapeuticsMD, a women’s health company whose one-time billion-dollar valuation seems a distant memory as its blockbuster aspirations petered out, is finally cashing out.

Australia’s Mayne Pharma is paying $140 million upfront to license essentially TherapeuticsMD’s whole portfolio, including two prescription drugs that treat conditions relating to menopause, a contraceptive vaginal ring as well as its prescription prenatal vitamin brands.

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Big week for Alzheimer’s da­ta; As­traZeneca buys cell ther­a­py start­up; Dig­i­tal ther­a­peu­tics hits a pay­er wall; 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.

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