Pawel Przewiezlikowski, Ryvu Therapeutics CEO

Up­dat­ed: EU­'s lend­ing arm grants Pol­ish biotech $22M+ in debt fi­nanc­ing to ad­vance pipeline

Many US biotechs have been tight­en­ing their pock­et­books in an ef­fort to keep them­selves run­ning. But over in Poland, one com­pa­ny is nab­bing a debt fi­nanc­ing to push it­self to­wards more clin­i­cal tri­als, with the help of one of Eu­rope’s largest lenders.

Ryvu Ther­a­peu­tics put out word ear­ly Wednes­day that the Eu­ro­pean In­vest­ment Bank, the lend­ing arm of the Eu­ro­pean Union, is pro­vid­ing the biotech with $22.3 mil­lion in debt fi­nanc­ing — or €22 mil­lion. As part of the debt fi­nanc­ing, the Eu­ro­pean Fund for Strate­gic In­vest­ments is back­ing it with a “first loss guar­an­tee,” en­sur­ing that the EIB can at least re­coup some of its in­vest­ment if the com­pa­ny’s projects go south, al­low­ing it to in­vest in projects that could have a high­er lev­el of risk.

Tere­sa Cz­er­wińs­ka

EIB VP Tere­sa Cz­er­wińs­ka said in a state­ment that fi­nanc­ing projects with­in R&D are a top pri­or­i­ty for the lender, not­ing, “The EIB’s in­vest­ment will strength­en Ryvu Ther­a­peu­tics’ re­search, de­vel­op­ment and in­no­va­tion ca­pac­i­ty and com­pet­i­tive­ness for the wider so­cial ben­e­fit.”

Ryvu will use the fi­nanc­ing to con­tin­ue ad­vanc­ing its pipeline of on­col­o­gy small mol­e­cule can­di­dates through the dis­cov­ery and pre­clin­i­cal phas­es and in­to clin­i­cal tri­als, CEO Pawel Przewie­z­likows­ki said in a state­ment. The biotech is go­ing af­ter such tar­gets as PRMT5 and WRN in syn­thet­ic lethal­i­ty, STING in an an­ti­body-drug con­ju­gate, STING as a stand­alone and HPK1 in I/O, ac­cord­ing to Ryvu’s web­site.

The com­pa­ny had reached a part­ner­ship with Bel­gian biotech Gala­pa­gos back in 2020, fo­cus­ing on drug dis­cov­ery and de­vel­op­ing small mol­e­cules with in­flam­ma­tion tar­gets. Late last year, Gala­pa­gos uti­lized its ex­clu­sive op­tion to li­cense an in­flam­ma­tion pro­gram orig­i­nal­ly dis­cov­ered by Ryvu, with world­wide rights and no men­tion as to how much cash Ryvu has got­ten or will get from roy­al­ties and mile­stones.

Przewie­z­likows­ki told End­points News via email that Ryvu, with around 160 em­ploy­ees, is sole­ly fo­cused on on­col­o­gy for the time be­ing. On top of the pro­gram Ryvu out-li­censed to Gala­pa­gos, the biotech spun out its in­flam­ma­some as­sets in­to UK-based NodThera in 2016, where the com­pa­ny re­mains a share­hold­er.

The biotech’s clin­i­cal pipeline al­so in­cludes two part­nered mol­e­cules: RVU120, cur­rent­ly in Phase I for AML/MDS and sol­id tu­mors; and SEL24 for AML, which is cur­rent­ly in a Phase II study with new da­ta ex­pect­ed some­time in Q4.

The EIB has in­vest­ed mil­lions in­to biotech and drug com­pa­nies over the years since it was found­ed back in the 1950s. Some of its in­vest­ments last year in­clud­ed a $101.7 mil­lion loan to BioN­Tech, and $24 and $25 mil­lion fi­nanc­ing to Ger­man com­pa­nies Atri­va and Im­mu­nic to de­vel­op med­i­cines for hos­pi­tal­ized Covid-19 pa­tients.

While the av­er­age in­vest­ment from the EIB in­to the health and life sci­ences space is ap­prox­i­mate­ly $1.4 bil­lion a year, 2020 sig­nif­i­cant­ly de­vi­at­ed from the av­er­age, where more than $5 bil­lion in in­vest­ments were signed, like­ly ex­ac­er­bat­ed by the Covid-19 pan­dem­ic. The EIB al­so be­came one of the part­ners in Gavi’s Covid-19 ini­tia­tive, which se­cured $4.8 bil­lion in pledged funds back in April.

Ed­i­tor’s note: this sto­ry has been up­dat­ed with com­ment from Ryvu Ther­a­peu­tics CEO Pawel Przewie­z­likows­ki.

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.

Illustration: Assistant Editor Kathy Wong for Endpoints News

As mon­ey pours in­to dig­i­tal ther­a­peu­tics, in­sur­ance cov­er­age crawls

Talk therapy didn’t help Lily with attention deficit hyperactivity disorder, or ADHD. But a video game did.

As the 10-year-old zooms through icy waters and targets flying creatures on the snow-capped planet Frigidus, she builds attention skills, thanks to Akili Interactive Labs’ video game EndeavorRx. She’s now less anxious and scattered, allowing her to stay on a low dose of ADHD medication, according to her mom Violet Vu.

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Eli Lil­ly’s Alzheimer’s drug clears more amy­loid ear­ly than Aduhelm in first-ever head-to-head. Will it mat­ter?

Ahead of the FDA’s decision on Eli Lilly’s Alzheimer’s drug donanemab in February, the Big Pharma is dropping a first cut of data from one of the more interesting trials — but less important in a regulatory sense — at an Alzheimer’s conference in San Francisco.

In the unblinded 148-person study, Eli Lilly pitted its drug against Aduhelm, Biogen’s drug that won FDA approval but lost Medicare coverage outside of clinical trials. Notably, the study didn’t look at clinical outcomes, but rather the clearance of amyloid, a protein whose buildup is associated with Alzheimer’s disease, in the brain.

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Ei­sai’s ex­pand­ed Alzheimer’s da­ta leave open ques­tions about safe­ty and clin­i­cal ben­e­fit

Researchers still have key questions about Eisai’s investigational Alzheimer’s drug lecanemab following the publication of more Phase III data in the New England Journal of Medicine Tuesday night.

In the paper, which was released in conjunction with presentations at an Alzheimer’s conference, trial investigators write that a definition of clinical meaningfulness “has not been established.” And the relative lack of new information, following topline data unveiled in September, left experts asking for more — setting up a potential showdown to precisely define how big a difference the drug makes in patients’ lives.

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Lynn Baxter, Viiv Healthcare's head of North America

Vi­iV dri­ves new cor­po­rate coali­tion in­clud­ing Uber, Tin­der and Wal­mart, aimed at end­ing HIV

ViiV Healthcare is pulling together an eclectic coalition of consumer businesses in a new White House-endorsed effort to end HIV by the end of the decade.

The new US Business Action to End HIV includes pharma and health companies — Gilead Sciences, CVS Health and Walgreens — but extends to a wide range of consumer companies that includes Tinder, Uber and Walmart.

ViiV is the catalyst for the group, plunking down more than half a million dollars in seed money and taking on ringmaster duties for launch today on World AIDS Day, but co-creator Health Action Alliance will organize joint activities going forward. ViiV and the alliance want and expect more companies to not only join the effort, but also pitch in funding.

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Pfiz­er will in­vest $1.2B+ in Irish man­u­fac­tur­ing site, adding 500 em­ploy­ees

Covid-19 trailblazer Pfizer has confirmed its commitment to a large expansion project on the Emerald Isle.

The New York-based company announced on Thursday that it will make a €1.2 billion ($1.26 billion) capital investment into its manufacturing site at Grange Castle in Dublin.

The expansion of the site marks Pfizer’s largest expansion investment in Ireland to date. The expansion includes the construction of a new facility on the premises as well as adding in more laboratory space and will ultimately double the capacity for “biological drug substance manufacturing” in the oncology and rare disease space as well as inflammation, immunology and internal medicines.

In­tel­lia and Iver­ic sell stocks to raise mon­ey, each net­ting $300M

Wednesday afternoon, Gene editing company Intellia and eye disease company Iveric Bio announced that they had each raised $300 million by selling off some of their stocks. The two biotechs are the latest to raise money via public stock offerings, an increasingly popular tactic used by public companies as the industry falls back from its pandemic boom.

Intellia’s raise comes a few weeks after it posted an update on its hereditary angioedema program that uses CRISPR/Cas9 to directly edit the gene that makes the protein responsible for the attacks that occur with the disease. In that interim cut, Intellia showed that patients dosed with its one-time therapy became attack free (at least thus far) after an observation period of 16 weeks, with the longest patient remaining attack free for 10 months.

Matt Gline, Roivant Sciences CEO (Photo by John Sciulli/Getty Images for GLG)

Pfiz­er and Roivant team up again for an­oth­er 'Van­t', set­ting up an­ti-in­flam­ma­to­ry show­down with Prometheus

Pfizer and Roivant are teaming up to launch a new ‘Vant’ aimed at bringing a mid-stage anti-inflammatory drug to market, the pair announced Thursday.

There’s no name for the startup yet, nor are there any employees. Thus far, the new company and Roivant can be considered “one and the same,” Roivant CEO Matt Gline tells Endpoints News. But Pfizer is so enthusiastic about the target that it elected to keep 25% of equity in the drug rather than take upfront cash from Roivant, Gline said.

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Roche HQ in Basel, Switzerland. (Image credit: Kyle LaHucik/Endpoints News)

As com­peti­tors near FDA goal­post, Roche spells out its re­peat Alzheimer's set­back

Before Roche can turn all eyes on a new version of its more-than-once-failed Alzheimer’s drug gantenerumab, the Big Pharma had to flesh out data on the November topline failure at an annual conference buzzier than in years past thanks to hotly watched rivals in the field: Eisai and Biogen’s lecanemab, and Eli Lilly’s donanemab.

There was less than a 10% difference between Roche’s drug and placebo at slowing cognitive decline across two Phase III trials, which combined enrolled nearly 2,000 Alzheimer’s patients. In its presentation at the conference Wednesday, Roche said it saw less sweeping away of toxic proteins than it had anticipated. For years, researchers and investors have put their resources behind the idea that more amyloid removal would equate to reduced cognitive decline.

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