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.

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In­no­v­a­tive MedTech De­mands Spe­cial­ist Clin­i­cal Tri­al Reg­u­la­to­ry Af­fairs and De­sign

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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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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.

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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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.

CSL is gathering its four business units under a unified brand identity strategy (Credit: CSL company site)

CSL brings Se­qirus, Vi­for un­der par­ent um­brel­la brand in iden­ti­ty re­vamp

CSL is gathering its brands under the family name umbrella, renaming its vaccine and newly acquired nephrology specialty businesses with the parent initials.

CSL Seqirus and CSL Vifor join CSL Plasma and CSL Behring as the four now uniformly branded business units of the global biopharma. The Seqirus vaccine division was formed in 2015 with the combination of bioCSL and its purchase of Novartis’ flu vaccine business. CSL picked up Vifor Pharma late last year in an $11.7 billion deal for the nephrology, iron deficiency and cardio-renal drug developer.

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Ab­bott pumps $450M+ in­to new Ire­land-based man­u­fac­tur­ing site project and hir­ing spree

As Ireland continues to see more investments and building projects from pharma companies, another contender is looking to place more investment in the Emerald Isle.

According to a report from The Irish Times on Friday, Abbott Laboratories is investing €440 million, or about $451 million, to build a new manufacturing plant in Kilkenny, located in the country’s southeast, to make more of its glucose monitors.

Tony Coles, Cerevel CEO

Cerev­el's Tony Coles is still count­ing his mon­ey as a ri­val's boost helps fu­el a po­ten­tial $609M wind­fall

These days in biotech, you never want to miss a chance to raise money for public companies. As much money as possible.

That survival strategy was in full view over the last 24 hours as Cerevel $CERE announced a major stock/debt raise, then upped the ante with a bigger debt load than initially planned.

The tally: $238 million – net — with a shot at boosting that to $274 million from the stock sale, provided the underwriters come back for more. And there’s $335 million from the debt, provided their first round buyers come back for an added bite. Rounding up, that’s $609 million with the add-on. Even without the add-ons, though, it’s still $530 million in the bank.

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Benjamin Oakes, Scribe Therapeutics CEO

CEO of Doud­na spin­out: With­in five years, genome ed­i­tors will have a 're­al­ly big im­pact' on pa­tients' lives

“CRISPR-by-design” is the idea behind Scribe Therapeutics, a company spun out from Jennifer Doudna’s Nobel-winning lab that’s competing in a closely-tracked field of genome editor companies just starting to make their way to the clinic.

After nabbing $100 million last March for its Series B funding round, Scribe is taking a different tack from some of its competitors, crafting a new enzyme isolated from bacteria called CasX, which has now been tweaked extensively and may be targeted to a range of genome-related diseases, offering a plethora of therapeutic options.

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