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

Image courtesy of The Janssen Pharmaceutical Companies of Johnson & Johnson.

Pro­tect­ing the glob­al phar­ma­ceu­ti­cal in­no­va­tion ecosys­tem – what’s at stake?

We are living in a new era of healthcare that is rapidly advancing progress impacting patient outcomes and experiences. We’ve seen a remarkable pace of transformational innovation, applied research, and advanced clinical development over the last decade.

Despite this tremendous progress, there is much more work to be done, and patients are counting on us – now more than ever – to continue that momentum. At the heart of our industry is a focus on developing and delivering medicines for some of the world’s most challenging diseases, including those that have few or no effective treatments today.

Roger Perlmutter, Eikon Therapeutics CEO

Roger Perl­mut­ter builds Eikon's pipeline with deal-mak­ing flur­ry, rais­ing $106M more

Eikon Therapeutics announced three business development deals on Thursday, effectively dropping in a pipeline of cancer drugs alongside more than $100 million in fresh funding.

The Hayward, CA-based company has become one of biotech’s richest startups since its 2019 founding, having raised nearly $775 million. It’s developing a massive, automated research approach built around Nobel Prize-winning microscope science to peer inside cells and watch proteins in action. After its Series B last year, PitchBook reported a $3.02 billion valuation. And while CEO Roger Perlmutter declined to comment on that figure, he said its first tranche of nearly $106 million in Series C funding is a “meaningful step-up to our Series B valuation.”

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Eu­ro­pean Par­lia­ment calls mem­ber states to ac­tion on an­timi­cro­bial re­sis­tance

Members of the European Parliament have called on EU countries to develop national action plans against antimicrobial resistance (AMR), calling it a top-three priority health threat.

Parliament on Thursday announced recommendations for the fight against AMR, including national action plans that must be updated at least every two years, an EU-level database tracking AMR and antimicrobial use and increased partnership between the pharma industry, patient groups and academia.

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Bay­er buys li­cense to Cedil­la pre­clin­i­cal can­cer pro­gram; MEI Phar­ma says no to un­so­licit­ed of­fer

Bayer has acquired exclusive rights to Cedilla Therapeutics’ preclinical cancer drug candidates for an undisclosed amount.

Bayer announced Thursday morning that it is acquiring the license for Cedilla’s preclinical Cyclin E1/CDK2 complex inhibitors. Cyclin E1 activates CDK2, and the two drive cancer progression and are overexpressed in cancer cells.

Bayer did not disclose what indications it will be pursuing under this partnership. The deal is structured traditionally — Bayer will pay Cedilla an undisclosed amount upfront, and the latter is also eligible for potential development and commercial milestones and royalties. — Lei Lei Wu

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Roche plans to di­vest from lega­cy Genen­tech man­u­fac­tur­ing fa­cil­i­ty in Cal­i­for­nia

Roche is planning to make some changes to its subsidiary’s manufacturing network in California.

The Swiss pharma announced Wednesday that it plans to divest from Genentech’s manufacturing facility in Vacaville, CA, around 58 miles northeast of San Francisco. According to a statement from Roche, the move is part of a “broader strategy” to bring its manufacturing capabilities in line with its future pipeline. Roche is starting the process of finding a buyer for the site but has not named any candidates yet.

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Peter van de Sande, Synaffix CEO

Lon­za shells out $107M cash to snap up Synaf­fix and its ADC plat­form

After lining up a string of partnerships over the years, Dutch antibody-drug conjugate specialist Synaffix has found a new home: Lonza, the contract development and manufacturing giant.

Lonza is paying about $107 million (€100 million) in cash to acquire Synaffix, with up to $64 million (€60 million) in “additional performance-based consideration” on the table. Synaffix’s ADC tech platform will now become part of Lonza’s offering for biopharma clients, lending its bioconjugate technologies to not just ADCs but also targeted gene therapy, immune cell engagers and other applications.

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Who's con­fi­dent­ly in­vest­ing in biotech star­tups dur­ing these tense days? We've got some an­swers

We’ve got a changeup to our event schedule in Boston next week, where we’ll be doing a mix of live/streaming events at our base at The Seaport Hotel as part of a two-day lineup of webinars, virtual firesides and a cocktail hour Q&A with a veteran of the biotech financing scene.

The 9:30-10:30 am ET live slot on Tuesday, June 6, will now feature a panel conversation on the current state of affairs for VC investing in biotech, focusing on what startups are getting cash — and how. Alaa Halawa, head of US ventures at Mubadala, is confirmed, along with Brian Goodman at MPM and Geoff von Maltzahn, a general partner at Moderna-buoyed Flagship. I have a couple of other invites out and will let you know how that plays out.

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The Modulo Bio team with CEO Michael Horowitz (fourth from right in semicircle)

Ex­clu­sive: With $8M, neu­ro start­up Mod­u­lo Bio emerges to test small mol­e­cules for ALS, de­men­tia in CEO’s per­son­al mis­sion

Embarking on a personal mission after his best friend’s mother was diagnosed with a mutation-driven case of frontotemporal dementia, Michael Horowitz has pulled together $8 million in venture funding at Modulo Bio to create small molecules for neurodegenerative diseases.

The San Diego and Bay Area biotech will select its lead development candidate and some backup options within six months and then raise a Series A to investigate therapeutics for C9orf72 mutation-driven cases of ALS and frontotemporal dementia, Horowitz told Endpoints News.

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Albert Bourla, Pfizer CEO (Michel Euler/AP Images, Pool)

FDA ap­proves Pfiz­er’s RSV shot for old­er adults, tee­ing up a com­pet­i­tive $17B vac­cine mar­ket

The FDA approved Pfizer’s RSV vaccine called Abrysvo for older adults on Wednesday, placing another Big Pharma onto the commercial stage ahead of the next RSV season.

Pfizer’s approval comes weeks after GSK won approval for its rival shot, Arexvy. Those two vaccines are both approved for use in adults 60 years and older and will be reviewed by a CDC panel in June before they’re expected to commercially launch this fall. Wall Street analysts see RSV as the next multibillion-dollar vaccine market, with Jefferies analysts recently forecasting the RSV market will grow to $17 billion over the next decade.

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