George Simeon, Curevo Vaccine CEO

A small Seat­tle biotech wants to take on Glax­o­SmithK­line's emerg­ing Shin­grix block­buster. RA Cap­i­tal is on board

Glax­o­SmithK­line’s Shin­grix has quick­ly be­come one of the com­pa­ny’s best-sell­ing prod­ucts since first win­ning FDA ap­proval in 2017. But a new biotech be­lieves it can do bet­ter — and RA Cap­i­tal is lis­ten­ing.

Cure­vo Vac­cine, a Seat­tle-based com­pa­ny, de­buted a $60 mil­lion Se­ries A on Thurs­day led by the promi­nent life sci­ences VC, aim­ing to fund a Phase IIb study for its shin­gles vac­cine can­di­date. The pro­gram, known as CRV-101, will be mea­sured against Shin­grix as the con­trol and pits the two shots head-to-head.

CEO George Sime­on told End­points News he be­lieves Cure­vo’s shot can pro­vide sim­i­lar ef­fi­ca­cy lev­els to Shin­grix while tamp­ing down on the side ef­fects. That will be a tough task as Shin­grix proved 97% ef­fec­tive in pre­vent­ing shin­gles for healthy adults aged 50 to 69, and 91% ef­fec­tive in all such adults old­er than 50.

Re­searchers were en­cour­aged by the biotech’s Phase I study, Sime­on added, prompt­ing the push in­to the near­ly 700-pa­tient Phase IIb tri­al that start­ed en­rolling last month.

“We’re go­ing to be look­ing at im­mune re­spons­es” in the Phase II study, Sime­on said. “Of course, if there are shin­gles cas­es, we will look, but that re­quires a much larg­er tri­al to look for ac­tu­al clin­i­cal end­points. So now we’ll be look­ing at im­muno­log­ic end­points, look­ing at how the two vac­cines com­pare from a hu­moral and cell me­di­at­ed im­mune re­sponse per­spec­tive.”

The rea­son Cure­vo is so con­fi­dent lies in the ad­ju­vants the vac­cines are us­ing. Shin­grix’s ad­ju­vant con­tains a com­pound called QS-21 in which two main is­sues arise, Sime­on said. First, the emerg­ing con­sen­sus points to this com­pound as the pri­ma­ry dri­ver of Shin­grix ad­verse events — the shot caus­es a strong im­mune re­sponse and symp­toms can last for two to three days be­fore usu­al­ly re­solv­ing on their own.

And sec­ond, QS-21 is in high de­mand be­cause it can on­ly be made from cer­tain trees na­tive to Chile, Pe­ru and Bo­livia. The Covid-19 pan­dem­ic con­tin­u­ing to snarl the glob­al sup­ply chain is hard­ly help­ing things, Sime­on said.

Cure­vo’s ad­ju­vant, mean­while, is tai­lored to fit in­to the TLR4 re­cep­tor in an ef­fort to uti­lize the im­mune path­way and lessen the shot’s side ef­fects. It al­so goes af­ter the same anti­gen used in chick­en­pox vac­cines, Sime­on said, sav­ing Cure­vo the trou­ble of try­ing to val­i­date a com­plete­ly new tar­get.

This com­bi­na­tion, Sime­on be­lieves, will give the biotech a shin­gles vac­cine both non-in­fe­ri­or to Shin­grix and caus­es less side ef­fects.

“What we’re look­ing to show is that we elic­it the same im­mune re­spons­es,” he said. “We’d like to show that we’re non in­fe­ri­or in terms of ef­fi­ca­cy, but that we have a bet­ter tol­er­a­bil­i­ty pro­file than Shin­grix.”

Topline Phase IIb da­ta are ex­pect­ed at the be­gin­ning of next year, and if Cure­vo likes what it sees, it plans to un­der­take a piv­otal Phase III study com­par­ing CRV-101 to Shin­grix again in a much larg­er set­ting.

Shin­grix has le­git­imized Glax­o­SmithK­line’s vac­cine fran­chise, net­ting more than $1 bil­lion in sales in 2018, its first full year on the mar­ket. The shot pulled in near­ly $2.8 bil­lion for the com­pa­ny in 2020 and won a new ap­proval last year for use in all im­muno­com­pro­mised adults, but the pan­dem­ic sig­nif­i­cant­ly dent­ed sales growth as fig­ures fell to $2.33 bil­lion last year.

Cure­vo will have a long road ahead to com­pete with some­thing like that, with or with­out Covid-19 dis­rup­tions. Even so, it’s tak­ing an un­tra­di­tion­al route to fi­nance its vac­cine, hav­ing al­ready run its Phase I study be­fore any ma­jor ven­ture round and re­cruit­ing RA Cap­i­tal — which gen­er­al­ly in­vests in crossovers — for the hefty Se­ries A.

The shot it­self comes out of a non­prof­it re­search in­sti­tute and bio­phar­ma from South Ko­rea known as MOGAM and GC Phar­ma, re­spec­tive­ly. GC Phar­ma li­censed the vac­cine and fund­ed Cure­vo through Phase I, though the biotech has been run­ning all of the pre­clin­i­cal and clin­i­cal stud­ies.

“This is why we have a lit­tle bit of an atyp­i­cal Se­ries A,” Sime­on said. “I guess it would be more typ­i­cal to see this type of fundraise and this stage of com­pa­ny as a Se­ries B or C, but be­cause they pro­vid­ed that ini­tial fi­nan­cial sup­port, we were able to get to the end of our Phase I re­sults.”

In ad­di­tion to RA, oth­er in­vestors in­clud­ed Ad­ju­vant Cap­i­tal, which has ties to the Bill and Melin­da Gates Foun­da­tion, as well as Janus Hen­der­son In­vestors and EN In­vest­ment. GC Phar­ma al­so chipped in again.

Late Fri­day ap­proval; Trio of biotechs wind down; Stem cell pi­o­neer finds new fron­tier; Biotech icon to re­tire; 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.

I hope your weekend is off to a nice start, wherever you are reading this email. As for me, I’m trying to catch the tail of the Lunar New Year festivities.

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Pfiz­er lays off em­ploy­ees at Cal­i­for­nia and Con­necti­cut sites

Pfizer has laid off employees at its La Jolla, CA, and Groton, CT sites, according to multiple LinkedIn posts from former employees.

The Big Pharma confirmed to Endpoints News it has let go of some employees, but a spokesperson declined to specify how many workers were impacted and the exact locations affected. Earlier this month, the drug developer had confirmed to Endpoints it was sharpening its focus and doing away with some early research on areas such as rare disease, oncology and gene therapies.

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Rodney Rietze, iVexSol CEO

Bris­tol My­ers, Charles Riv­er join Se­ries A fund­ing for iVex­Sol

Massachusetts-based iVexSol has secured funding to the tune of $23.8 million in its latest Series A round. The new investors include Bristol Myers Squibb, manufacturer Charles River Laboratories and Asahi Kasei Medical.

iVexSol is a manufacturer of lentiviral vectors (LVV), used in making gene therapies, and this latest round of fundraising brings its total Series A total over $39 million, which will be used to recruit more employees and bolster its technology.

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Jake Van Naarden, Loxo@Lilly CEO

Lil­ly en­ters ripe BTK field with quick FDA nod in man­tle cell lym­phoma

Eli Lilly has succeeded in its attempt to get the first non-covalent version of Bruton’s tyrosine kinase, or BTK, inhibitors to market, pushing it past rival Merck.

The FDA gave an accelerated nod to Lilly’s daily oral med, to be sold as Jaypirca, for patients with relapsed or refractory mantle cell lymphoma.

The agency’s green light, disclosed by the Indianapolis Big Pharma on Friday afternoon, catapults Lilly into a field dominated by covalent BTK inhibitors, which includes AbbVie and Johnson & Johnson’s Imbruvica, AstraZeneca’s Calquence and BeiGene’s Brukinsa.

Tony Johnson, Goldfinch Bio CEO (Goldfinch via YouTube)

Kid­ney dis­ease drug­mak­er Goldfinch Bio shuts down

Goldfinch Bio, attempting to make treatments for kidney diseases and diabetic nephropathy, is shutting down.

President and CEO Tony Johnson confirmed to Endpoints News Friday afternoon that the biotech shut down after “fundraising challenges in the current macro-environment.” Fierce Biotech first reported the news.

Johnson, who joined in 2017 after a stint as SVP of early clinical development at AstraZeneca, said in a text that the company “entered the ABC process recently,” referring to an assignment for the benefit of the creditors, which provides a different wind-down avenue than a bankruptcy.

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Filip Dubovsky, Novavax CMO

No­vavax gets ready to take an­oth­er shot at Covid vac­cine mar­ket with next sea­son plans

While mRNA took center stage at yesterday’s FDA vaccine advisory committee meeting, Novavax announced its plans to deliver an updated protein-based vaccine based on new guidance.

Vaccines and Related Biological Products Advisory Committee (VRBPAC) members voted unanimously in favor of “harmonizing” Covid vaccine compositions, meaning all future vaccine recipients would receive a bivalent vaccine, regardless of whether they’ve gotten their primary series.

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Eliot Forster, F-star CEO (Rachel Kiki for Endpoints News)

F-star gets down to the wire with $161M sale to Chi­nese buy­er as na­tion­al se­cu­ri­ty con­cerns linger

With the clock ticking on F-star Therapeutics’ takeover by a Chinese buyer, the companies are still scrambling to remove a hold on the deal from the US government’s Committee on Foreign Investment in the United States.

F-star and invoX Pharma said they are “actively negotiating” with CFIUS “about the terms of a mitigation agreement to address CFIUS’s concerns regarding potential national security risks posed by the transaction.”

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CBER Director Peter Marks (Susan Walsh/AP Images)

FDA ad­vi­so­ry com­mit­tee votes unan­i­mous­ly in fa­vor of bi­va­lent Covid shots re­plac­ing pri­ma­ry se­ries

The FDA’s Vaccines and Related Biological Products Advisory Committee (VRBPAC) voted unanimously in favor of “harmonizing” Covid vaccine compositions, meaning all current vaccine recipients would receive a bivalent vaccine, regardless of whether they’ve gotten their primary series.

The vote marks an effort to clear up confusion around varying formulations and dosing schedules for current primary series and booster vaccines, as well as “get closer to the strains that are circulating,” according to committee member Paul Offit, professor of pediatrics at the Children’s Hospital of Philadelphia.

In­vestor 'misalign­men­t' leads to tR­NA biotech's shut­ter­ing

A small biotech looking to carve a lane in the tRNA field has folded, an investor and a co-founder confirmed to Endpoints News.

Similar to Flagship’s Alltrna and other upstarts like Takeda-backed hC Bioscience, the now-shuttered Theonys was attempting to go after transfer RNA, seen as a potential Swiss Army knife in the broader RNA therapeutics space. The idea is that one tRNA drug could be used across a galaxy of disorders and diseases.

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