AI up­start grabs $40M launch round; Sanofi backs a gene ther­a­py play­er; Ax­some hits a snag at the FDA

Boston AI-fo­cused biotech Deep­Cure closed a $40 mil­lion Se­ries A, ac­cord­ing to a com­pa­ny an­nounce­ment this morn­ing — adding more than five times the amount of mon­ey the com­pa­ny had be­fore: from $7 mil­lion raised since the com­pa­ny’s found­ing in 2018 to $47 mil­lion to­tal.

Their goal? To have an R&D process that has drugs ful­ly de­signed, syn­the­sized and test­ed by AI, ac­cord­ing to a com­pa­ny state­ment.

The round was led by Morn­ing­side Ven­tures — elic­it­ing par­tic­i­pa­tion from pre­vi­ous in­vestors such as TLV Part­ners, Sapir Ven­ture Part­ners, and Benon Group.

Kfir Schreiber

“We are de­light­ed to wel­come a top-tier syn­di­cate of lead­ing health­care in­vestors led by Morn­ing­side Ven­tures that sup­port our vi­sion of de­vel­op­ing an end-to-end drug dis­cov­ery pipeline de­signed, op­ti­mized, syn­the­sized, and an­a­lyzed by AI,” said Deep­Cure CEO and co-founder Kfir Schreiber.

The mon­ey will be used to ex­pand Deep­Cure’s pipeline with five ad­di­tion­al on­col­o­gy pro­grams and de­vel­op an au­to­mat­ed ro­bot­ic wet lab to fur­ther its goal of AI-in­volved R&D. The fund­ing will al­so be used to hire more drug dis­cov­ery sci­en­tists and tech­nol­o­gists — dou­ble what the com­pa­ny cur­rent­ly has in tan­dem with Deep­Cure’s planned glob­al ex­pan­sion with the launch of two new sites in Greece and Is­rael.

“This in­vest­ment po­si­tions us to ad­vance our first nov­el small mol­e­cule com­pound to file for IND, ad­vance our pipeline and re­al­ize our vi­sion of mak­ing a sig­nif­i­cant im­pact for pa­tients,” added Deep­Cure’s CSO and oth­er co-founder Joseph Ja­cob­son. — Paul Schloess­er

UK biotech Gy­ro­scope to re­ceive eq­ui­ty in­vest­ment from Sanofi six months af­ter abrupt­ly post­pon­ing IPO

Gy­ro­scope Ther­a­peu­tics an­nounced that Sanofi has com­mit­ted up to $60 mil­lion in an eq­ui­ty in­vest­ment.

The eye dis­ease-fo­cused gene ther­a­py biotech said this morn­ing in a state­ment that the French Big Phar­ma will in­vest $40 mil­lion as an ini­tial eq­ui­ty in­vest­ment in­to Gy­ro­scope ini­tial­ly, at a pre­mi­um to Gy­ro­scope’s pre­vi­ous $148 mil­lion Se­ries C fi­nanc­ing. The ad­di­tion­al $20 mil­lion will be in­vest­ed based on a fu­ture qual­i­fy­ing in­vest­ment round — and sub­ject to cer­tain clos­ing con­di­tions.

The biotech star­tled in­vestors and an­a­lysts af­ter post­pon­ing its IPO in May, cit­ing mar­ket con­di­tions.

Khurem Fa­rooq

“We are thrilled to wel­come Sanofi on­board as an in­vestor in Gy­ro­scope,” said Gy­ro­scope CEO Khurem Fa­rooq. “We be­lieve our lead in­ves­ti­ga­tion­al gene ther­a­py, GT005, has the po­ten­tial to be the first gene ther­a­py for ge­o­graph­ic at­ro­phy.”

Ge­o­graph­ic at­ro­phy is chron­ic pro­gres­sive de­gen­er­a­tion of the back of the eye and can be seen as part of late-stage age-re­lat­ed mac­u­lar de­gen­er­a­tion, or AMD.

An un­named Sanofi R&D ex­ec­u­tive will join Gy­ro­scope’s clin­i­cal ad­vi­so­ry board to ad­vise on mat­ters re­lat­ed to the de­vel­op­ment of GT005 for ge­o­graph­ic at­ro­phy. Ad­di­tion­al­ly, Gy­ro­scope has grant­ed Sanofi ex­clu­sive right of first re­fusal on cer­tain po­ten­tial fu­ture trans­ac­tions for GT005 in se­lect mar­kets.

Gy­ro­scope plans to use pro­ceeds from this in­vest­ment to sup­port fund­ing of on­go­ing clin­i­cal tri­als of GT005, as the drug has been grant­ed fast track des­ig­na­tion by the FDA. — Paul Schloess­er

Se­lec­ta shows promis­ing re­sults in gene ther­a­py de­liv­ery and re-dos­ing pa­tients in Phase I tri­al

Gene ther­a­py sci­en­tists see a ben­e­fit in re­dos­ing pa­tients af­ter the first dose of a ther­a­py. But the is­sue of an im­mune re­sponse against ade­no-as­so­ci­at­ed virus­es (AAVs) has pushed com­pa­nies to try and get around it.

Se­lec­ta Bio­sciences thought it found a way to tamp down the body’s im­mune re­sponse back in Oc­to­ber — and Take­da doled out more than $1 bil­lion to get in on the ac­tion.

Now to­day, the biotech re­vealed re­sults from a Phase I tri­al look­ing in­to the body’s im­mune re­sponse to their Imm­TOR plat­form — and the re­sults may be promis­ing.

With AskBio, Se­lec­ta un­veiled top-line re­sults this morn­ing from a Phase I ran­dom­ized, place­bo con­trolled, dou­ble blind, dose-es­ca­la­tion study. The goal is to eval­u­ate Se­lec­ta’s Imm­TOR plat­form in mit­i­gat­ing the for­ma­tion of neu­tral­iz­ing an­ti­bod­ies against an AAV8 cap­sid — which is used in gene ther­a­pies.

At day 30, in sub­jects who were ad­min­is­tered a sin­gle 0.3 mg/kg dose of Imm­TOR, Se­lec­ta ob­served a me­di­an an­ti-AAV8 neu­tral­iz­ing an­ti­body titer of 1:5 — 250 times low­er than that ob­served in sub­jects dosed with AAV8 cap­sid alone, ac­cord­ing to a Se­lec­ta state­ment.

“We look for­ward to lever­ag­ing these ex­cit­ing and nov­el find­ings in the clin­ic across our whol­ly owned gene ther­a­py pipeline and along­side our world class gene ther­a­py part­ners to achieve our goal of im­prov­ing the lives of those liv­ing with mono­genic dis­eases,” said Se­lec­ta pres­i­dent and CEO Carsten Brunn.

In the Phase I study, re­searchers eval­u­at­ed the ad­min­is­tra­tion of a sin­gle IV dose of a AAV8 emp­ty cap­sid con­tain­ing no DNA with and with­out a sin­gle dose of Imm­TOR in 23 sub­jects. — Paul Schloess­er

Ax­some de­pres­sion drug hits a CMC hur­dle at the FDA

Ax­some’s de­pres­sion drug AXS-05 has hit a snag at the FDA.

The biotech $AXSM re­port­ed Mon­day morn­ing that reg­u­la­tors no­ti­fied the com­pa­ny that they will not hit the PDU­FA tar­get ac­tion date — set all the way back on Aug. 22 — af­ter cit­ing CMC de­fi­cien­cies.

Ac­cord­ing to their state­ment:

The Com­pa­ny was re­cent­ly in­formed of two de­fi­cien­cies re­lat­ed to an­a­lyt­i­cal meth­ods in the Chem­istry, Man­u­fac­tur­ing, and Con­trols (CMC) sec­tion of the NDA, which must be ad­dressed pri­or to the FDA tak­ing ac­tion on the NDA. The Com­pa­ny be­lieves these de­fi­cien­cies are ad­dress­able and is con­firm­ing the de­tails of the re­quest with the FDA.

— John Car­roll

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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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.

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.

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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John Rim, Samsung Biologics CEO (Samsung/PR Newswire)

Sam­sung Bi­o­log­ics spells out ex­pan­sion plans in South Ko­rea and US

The CDMO arm of one of South Korea’s largest conglomerates has posted its year-end results and plans for 2023, which include new construction.

Samsung Biologics netted north of KRW 3 trillion ($2.4 billion) in 2022 revenue and an operating profit of KRW 983.6 billion ($799 million), which the company touted on Friday as “record-high earnings.” The revenue boost was 55% compared to 2021.

No­var­tis' ap­proved sick­le cell dis­ease drug fails to beat place­bo in PhI­II

Novartis’ sickle cell drug, approved in 2019 and branded as Adakveo, has failed an ongoing Phase III, according to preliminary results.

The Swiss pharma giant unveiled early data from the ongoing STAND Phase III study on Friday, saying that crizanlizumab showed no statistically significant difference between the drug at two different dose levels compared to placebo in annualized rates of vaso-occlusive crises that lead to a healthcare visit over the first year since being randomized into the trial.