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