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

A new era of treat­ment: How bio­mark­ers are chang­ing the way we think about can­cer

AJ Patel was recovering from a complicated brain surgery when his oncologist burst into the hospital room yelling, “I’ve got some really great news for you!”

For two years, Patel had been going from doctor to doctor trying to diagnose his wheezing, only to be dealt the devastating news that he had stage IV lung cancer and only six months to live. And then they found the brain tumors.

“What are you talking about?” Patel asked. He had never seen an oncologist so happy.

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Katrine Bosley (AP Photo/Mark Lennihan)

For­mer Ed­i­tas CEO Ka­trine Bosley goes the VC route, join­ing ear­ly-stage in­vestor

More than three years after abruptly exiting Editas Medicine, Katrine Bosley is leaping to the venture capital side of things.

London-based early-stage investor Advent Life Sciences announced Thursday that Bosley is joining the firm as venture partner. It’s also adding two general partners to the team: Dominic Schmidt, formerly of Syncona, will be in the UK; and Satish Jindal, most recently the CEO of investment fund BioMotiv, will be based in Boston, just like Bosley.

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Serhat Gumrukçu, Enochian BioSciences co-founder (Seraph Research Institute)

LA biotech founder ar­rest­ed, charged in mur­der-for-hire scheme be­hind 2018 death

A biotech founder has been arrested and charged for his role in a murder-for-hire scheme that resulted in the death of a man in Vermont back in 2018.

Serhat Gumrukçu, the co-founder of Enochian BioSciences, was arrested in Los Angeles, where the company is based, according to the Department of Justice. He was charged alongside Berk Eratay of Las Vegas, and a third person, Jerry Banks of Colorado, was previously arrested for kidnapping and allegedly murdering the victim, Gregory Davis.

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Adam Russell, ARPA-H's incoming acting deputy director

NI­H's new, in­de­pen­dent break­through drug ac­cel­er­a­tor ARPA-H gets its first em­ploy­ee

Despite the controversy of housing it in NIH, HHS Secretary Xavier Becerra on Wednesday afternoon formally announced the establishment of the Advanced Research Project Agency for Health (ARPA-H) as an independent entity within the NIH, as HHS had previously stipulated that “NIH may not subject ARPA-H to NIH policies.”

Becerra also announced the appointment of ARPA-H’s inaugural employee, Adam Russell, who will serve as acting deputy director.

ProFound Therapeutics founding team

Flag­ship's lat­est biotech could turn some of the thou­sands of new pro­teins it dis­cov­ered in­to ther­a­pies — and it has $75M to start

Flagship Pioneering, the incubator of Moderna and dozens of other biotechs, says it has landed upon tens of thousands of previously undiscovered human proteins. The VC shop wants to potentially turn them into therapeutics.

Like other drug developers that have turned proteins into therapeutics (think insulin for diabetes), Flagship’s latest creation, ProFound Therapeutics, wants to tap into this new trove of proteins as part of its mission to treat indications ranging from rare diseases to cancer to immunological diseases.

Richard Silverman, Akava Therapeutics founder and Northwestern professor

This time around, Lyri­ca's in­ven­tor is de­vel­op­ing his North­west­ern dis­cov­er­ies at his own biotech

Richard Silverman was left in the dark for the last five years of clinical development of the drug he discovered. The Northwestern University professor found out about the first approval of Lyrica, in the last few days of 2004, like most other people: in the newspaper.

What became one of Pfizer’s top-selling meds, at $5 billion in 2017 global sales before losing patent protection in 2019, started slipping out of his hands when Northwestern licensed it out to Parke-Davis, one of two biotechs that showed interest in developing the drug in the pre-email days, when the university’s two-person tech transfer team had to ship out letters to garner industry appetite.

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David Ricks, Eli Lilly CEO (David Paul Morris/Bloomberg via Getty Images)

Eli Lil­ly set to in­vest $2.1B in home state man­u­fac­tur­ing boost

Eli Lilly is looking to expand its footprint in its home Hoosier State by making a major investment in manufacturing.

The pharma is investing $2.1 billion in two new manufacturing sites at Indiana’s LEAP Lebanon Innovation and Research District in Boone County, northwest of Lilly’s headquarters in Indianapolis.

The two new facilities will expand Lilly’s manufacturing network for active ingredients and new therapeutic modalities, including genetic medicines, according to a press release.

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Up­dat­ed: US sees spike in Paxlovid us­age as Mer­ck­'s mol­nupi­ravir and As­traZeneca's Evusheld are slow­er off the shelf

New data from HHS show that more than 162,000 courses of Pfizer’s Covid-19 antiviral Paxlovid were administered across the US over the past week, continuing a streak of increased usage of the pill, and signaling not only rising case numbers but more awareness of how to access it.

In comparison to this week, about 670,000 courses of the Pfizer pill have been administered across the first five months since Paxlovid has been on the US market, averaging about 33,000 courses administered per week in that time.

Pfiz­er and CD­MOs ramp up Paxlovid man­u­fac­tur­ing with Kala­ma­zoo plant ex­pan­sion lead­ing the way

As the Covid-19 pandemic continues to evolve, pharma companies and manufacturers are exploring how to step up production on antivirals.

Pfizer is planning to expand its Kalamazoo-area facility to increase manufacturing capabilities for the oral Covid-19 antiviral Paxlovid, according to a report from Michigan-based news site MLive. The expansion of the facility, which serves as Pfizer’s largest manufacturing location, is expected to create hundreds of “high-skilled” STEM jobs, MLive reported. No details about the project’s cost and timeline have been released, but according to MLive, Pfizer will announce the details of the expansion at some point in early June.

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