News brief­ing: UK biotech 4D phar­ma heads for Nas­daq via SPAC; Dr. Red­dy's shuts down man­u­fac­tur­ing af­ter cy­ber­at­tack

An­oth­er phar­ma com­pa­ny is in­tend­ing to use a SPAC to join the Nas­daq.

4D phar­ma, a UK-based biotech, is re­verse-merg­ing with a blank check com­pa­ny in a deal worth up to $37.6 mil­lion. The move will give 4D phar­ma a new Nas­daq tick­er, which will be $LBPS, us­ing the Amer­i­can De­posi­tary Share pro­gram. 4D will con­tin­ue to trade on the Lon­don stock ex­change un­der its pre­vi­ous tick­er.

As a re­sult of the move, 4D phar­ma will gain $14.6 mil­lion in cash held by the blank check com­pa­ny, dubbed Longevi­ty $LOAC. The merg­er is ex­pect­ed to be com­plet­ed in ear­ly 2021, af­ter which shares will be im­me­di­ate­ly trade­able on Nas­daq.

4D’s Lon­don stock is ex­pect­ed to open at about $1.44 per share, rep­re­sent­ing about an 18% pre­mi­um on Wednes­day’s clos­ing price.

The com­pa­ny’s re­search fo­cus­es on har­ness­ing bac­te­ria from the hu­man gut to treat a wide range of dis­eases. Its lead pro­gram is cur­rent­ly in a Phase I/II study in com­bi­na­tion with Keytru­da ex­am­in­ing how it could af­fect sol­id tu­mors. 4D phar­ma al­so has clin­i­cal pro­grams in pan­cre­at­ic can­cer, asth­ma, Covid-19 and ir­ri­ta­ble bow­el syn­drome.

In­dia’s Dr. Red­dy’s the tar­get of an ap­par­ent cy­ber­at­tack

An ap­par­ent cy­ber­at­tack forced In­di­an drug­mak­er Dr. Red­dy’s to shut down all of its glob­al man­u­fac­tur­ing fa­cil­i­ties.

The at­tack oc­curred ear­ly Thurs­day morn­ing lo­cal time, ac­cord­ing to com­pa­ny reg­u­la­to­ry fil­ings. Dr. Red­dy’s in­formed the lo­cal stock ex­change that “in the wake of a de­tect­ed cy­ber-at­tack, we have iso­lat­ed all da­ta cen­ter ser­vices to take re­quired pre­ven­tive ac­tions.”

It was not im­me­di­ate­ly clear what kind of cy­ber­at­tack hit the com­pa­ny, be it ran­somware or some­thing else. CIO Mukesh Rathi said in the fil­ing that he ex­pects the com­pa­ny’s op­er­a­tions to be back up and run­ning at full ca­pac­i­ty with­in 24 hours.

Thurs­day’s at­tack comes less than a week af­ter In­di­an reg­u­la­tors ap­proved a Phase II/III study of Rus­sia’s Covid-19 vac­cine to com­mence in the coun­try.

Haystack Sci­ences ac­quired by in­sitro, bol­ster­ing ma­chine learn­ing ca­pa­bilites

AI and ma­chine learn­ing have long been the­o­rized as one of the next steps in drug R&D evo­lu­tion, and Thurs­day saw a deal aim­ing to cap­i­tal­ize on that front.

The ma­chine learn­ing-dri­ven com­pa­ny in­sitro an­nounced that it is ac­quir­ing Haystack Sci­ences, a pri­vate com­pa­ny de­vel­op­ing its own ma­chine learn­ing plat­form to help en­able drug dis­cov­ery. Fi­nan­cial terms of the deal were not dis­closed.

Haystack’s ap­proach fo­cus­es on syn­the­siz­ing, breed­ing and an­a­lyz­ing di­verse chem­i­cal li­braries en­cod­ed by unique DNA se­quences called DNA-en­cod­ed li­braries, or DELs. The tech can al­so ex­e­cute rapid fol­low-up and pos­sess­es a pro­pri­etary se­mi-quan­ti­ta­tive screen­ing tech­nol­o­gy that gen­er­ates datasets with high­er res­o­lu­tion than con­ven­tion­al “pan­ning” ap­proach­es.

All that goes in­to in­sitro’s ap­proach of gen­er­at­ing pre­dic­tive mod­els that the com­pa­ny us­es to ac­cel­er­ate tar­get se­lec­tion and de­vel­op their ther­a­pies.

Has the mo­ment fi­nal­ly ar­rived for val­ue-based health­care?

RBC Capital Markets’ Healthcare Technology Analyst, Sean Dodge, spotlights a new breed of tech-enabled providers who are rapidly transforming the way clinicians deliver healthcare, and explores the key question: can this accelerating revolution overturn the US healthcare system?

Key points

Tech-enabled healthcare providers are poised to help the US transition to value, not volume, as the basis for reward.
The move to value-based care has policy momentum, but is risky and complex for clinicians.
Outsourced tech specialists are emerging to provide the required expertise, while healthcare and tech are also converging through M&A.
Value-based care remains in its early stages, but the transition is accelerating and represents a huge addressable market.

Rohan Palekar, 89bio CEO

89bio’s PhII da­ta add to quick suc­ces­sion of NASH read­outs as field seeks turn­around

89bio said its drug was better than placebo at lessening fibrosis without worsening nonalcoholic steatohepatitis, or NASH, in two of three dose groups.

The San Francisco biotech said it thinks the Phase IIb data pave the way for a potential Phase III, following in the footsteps of another biotech in its drug class, Akero Therapeutics. To fund a late-stage study, CEO Rohan Palekar told Endpoints News 89bio “would need to raise additional capital,” with the company having about $188 million at the end of last year.

Flare Therapeutics biochemists Yong Li (L) and Valerie Vivat

A $123M Flare will get Third Rock on­col­o­gy biotech in­to the clin­ic this year

Flare Therapeutics will start its first human trial this year with an investigational urothelial cancer drug after pulling together a $123 million Series B from Big Pharmas, VCs and its incubator, Third Rock Ventures.

Launched in 2021 on the idea that a biotech could finally succeed at drugging the much-sought-after but stubborn transcription factor, Flare Therapeutics said Wednesday it is now primed for the clinic after closing its large financing haul earlier this year. The raise is a relatively stark figure in a tough startup financing environment but further buoys the upbeat signals coming out of other Third Rock biotechs in recent weeks, including the $200 million CARGO Therapeutics and $100 million Rapport Therapeutics rounds.

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Roche and Lil­ly team up to de­vel­op blood test to de­tect ear­ly signs of Alzheimer's

Eli Lilly is teaming up with Roche to help develop a blood test to detect early signs of Alzheimer’s disease and determine whether a patient should go for further confirmatory testing.

Roche’s Elecsys Amyloid Plasma Panel (EAPP) measures pTau 181 protein assay and APOE E4 assay in human blood plasma – elevations in pTau 181 are present in the early stages of Alzheimer’s, while the presence of APO E4 is the most common genetic risk factor for the disease.

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Francesco Marincola, newly-appointed Sonata Therapeutics CSO

Kite's head of re­search leaves for Flag­ship start­up Sonata

Another leader is departing Kite Pharma, and will to spend the “last part” of his career exploring how cancer evades the immune system.

Kite’s senior VP and global head of cell therapy research Francesco Marincola left the Gilead CAR-T unit last week for Sonata Therapeutics. Flagship last May unveiled the startup, which was pieced together from two fledgling biotechs Inzen and Cygnal Therapeutics. As CSO, Marincola will lead Sonata’s push to reprogram cancer cells to make them more immunogenic.

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FDA in­di­cates will­ing­ness to ap­prove Bio­gen ALS drug de­spite failed PhI­II study

Ahead of Wednesday’s advisory committee hearing to discuss Biogen’s ALS drug tofersen, the FDA appeared open to approving the drug, newly released briefing documents show.

Citing the need for flexibility in a devastating disease like ALS, regulators signaled a willingness to consider greenlighting tofersen based on its effect on a certain protein associated with ALS despite a failed pivotal trial. The documents come after regulatory flexibility was part of the same rationale the agency expressed when approving an ALS drug last September from Amylyx Pharmaceuticals, indicating the FDA’s openness to approving new treatments for the disease.

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Josep Bassaganya-Riera, NImmune Biopharma

Ex­clu­sive: Af­ter get­ting his drug back, Lan­dos founder as­sem­bles new start­up for the big PhI­II test

By the time Josep Bassaganya-Riera stepped down as founding CEO of Landos Biopharma in 2021, the company had racked up Phase II data for its top autoimmune program, completed what he called a positive end-of-Phase-II meeting with the FDA and plans to launch pivotal Phase III trials.

Since then, though, the new leaders at Landos have reshuffled their plans for the drug, omilancor, first announcing they will run a Phase IIb ahead of a Phase III and eventually shelving it altogether.

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NIH re­jects an­oth­er at­tempt to 'march-in' on Astel­las' prostate can­cer drug over ex­ces­sive price

The National Institutes of Health has again declined to use so-called “march-in” rights to lower the price of Astellas and Pfizer’s prostate cancer drug Xtandi despite being invented at UCLA with grants from the US Army and NIH.

“Given the remaining patent life and the lengthy administrative process involved for a march-in proceeding, NIH does not believe that use of the march-in authority would be an effective means of lowering the price of the drug,” NIH told prostate cancer patients Robert Sachs and Clare Love, in a letter shared with Endpoints News. The institutes’ analyses found Xtandi “to be widely available to the public,” an indication that there was not a pressing need for the US to act.

No­vo Nordisk re­mains un­der UK scruti­ny as MHRA con­ducts its own re­view in 'in­cred­i­bly rare' case

The UK’s Medicines and Healthcare products Regulatory Agency is now reviewing Novo Nordisk’s marketing violation that resulted in its loss of UK trade group membership last week. Novo Nordisk was suspended on Thursday from the Association of the British Pharmaceutical Industry (ABPI) for two years after an investigation by its regulatory arm found the pharma broke its conduct rules.

MHRA said on Tuesday that its review of the Prescription Medicines Code of Practice Authority (PMCPA) investigation is standard practice. An MHRA spokesperson emphasized in an email to Endpoints News that the situation with Novo Nordisk is “incredibly rare” while also noting ABPI took “swift and proportionate action.”

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