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.

Un­lock­ing ESG strate­gies for growth with Gilead Sci­ences

RBC Capital Markets explores what is material in ESG for biopharma companies with the ESG leads at Gilead Sciences. Gilead has long focused on sustainability but recognized a more robust framework was needed. Based on a materiality assessment, Gilead’s ESG strategy today focuses first on drug access and pricing, while also addressing D&I and climate change. Find out why Gilead’s board is “acutely aware” of the contribution that ESG makes to firm’s overall success.

What con­tro­ver­sy? Eli Lil­ly plots Alzheimer's BLA fil­ing lat­er this year as FDA taps more an­ti-amy­loid drugs as break­throughs

The FDA is keeping the good news coming for Alzheimer’s drug developers. And Eli Lilly is taking them up on it.

Amid continued controversy around whether Biogen’s new flagship drug, Aduhelm, should have been approved at all — and swelling, heated debates surrounding its $56,000 price tag — the agency had no issue handing them and their Japanese partner Eisai a breakthrough therapy designation for a second anti-amyloid beta antibody, lecanemab, late Wednesday.

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Hervé Hoppenot, Incyte CEO (Jeff Rumans)

ODAC echoes FDA con­cern over In­cyte PD-1, as Paz­dur sig­nals broad­er shift for ac­cel­er­at­ed ap­proval

After the FDA lambasted their PD-1 ahead of an adcomm earlier this week, Incyte ran into new trouble Thursday as ODAC panelists voted against an accelerated OK by a wide margin.

Members of the Oncologic Drugs Advisory Committee recommended with a 13-4 vote to defer a regulatory decision on Incyte’s retifanlimab until after more data can be collected from a placebo-controlled trial. The PD-1 therapy is due for a PDUFA date in late July after receiving priority review earlier this year.

New FDA doc­u­ments show in­ter­nal dis­sent on Aduhelm ap­proval

In a lengthy review document and a pair of memos from top officials, the FDA released on Tuesday night its most detailed argument yet for approving Biogen’s intensely controversial Alzheimer’s drug aducanumab.

The documents amount to an agency attempt to quench the firestorm their decision kindled, as outside advisors members resigned and experts warned that an unproven drug now could stretch Medicare’s budget to a breaking point. Ultimately, the documents show how CDER director Patrizia Cavazzoni and Office of New Drugs director Peter Stein both concurred with FDA neuroscience head Billy Dunn on the accelerated approval while the staff at FDA’s Office of Biostatistics did not think an approval was warranted.

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Karen Flynn, Catalent

Q&A: When the pan­dem­ic struck, Catal­en­t's CCO had just joined the team

Karen Flynn came aboard Catalent’s team just in time.

The company was going through a surge of changes, and she had been brought over from her role as CCO of West Pharmaceutical Services to serve in the same capacity for the New Jersey-based CDMO. Then a few months later, the pandemic was in full-force.

Since then, Catalent’s been in hyper-expansion mode. In early May, it acquired Promethera’s Hepatic Cell Therapy Support SA subsidiary and its 32,40-square-foot facility in Gosselies, Belgium. Prior to that, the company acquired Belgian CDMO Delphi Genetics, wrapped up the expansion of an already-existing site in Madison, WI and added an ultra-low temperature freezer partner in Sterling. As Emergent has botched millions of doses of AstraZeneca’s vaccine, the company has swooped in to move that production to its Maryland plant as well.

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Richard Pazdur (vis AACR)

FDA en­cour­ages in­clud­ing in­cur­able can­cer pa­tients in tri­als, re­gard­less of pri­or ther­a­pies

The FDA on Thursday called to include those with incurable cancers (when there is no potential for cure or for prolonged/near normal survival) in appropriate clinical trials, regardless of whether they have received existing alternative treatments.

Historically, many cancer clinical trials have required that participating patients previously received multiple therapies, according to Richard Pazdur, director of the FDA’s Oncology Center of Excellence.

On heels of Aduhelm ap­proval, Bris­tol My­ers jumps back in­to Alzheimer's race

Bristol Myers Squibb last put major resources behind an Alzheimer’s drug nearly a decade ago, when their own attempt at targeting amyloid flamed out in mid-stage studies. They invented another molecule, a Tau-targeted antibody, but jettisoned it to Biogen in 2017 as they dropped out of neuroscience altogether.

But on Thursday, the New York pharma announced they were getting back in the game. Bristol Myers exercised an $80 million option to bring a tau-targeted antibody from Prothena into a Phase I study. The opt-in, which Bristol Myers triggered ahead of analyst expectations, opens the door for another $1.7 billion in milestones down the road.

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Ab­b­Vie snaps up a bis­pe­cif­ic for mul­ti­ple myelo­ma in TeneoOne buy­out; Ver­tex launch­es $1.5B share buy­back pro­gram

Following a positive interim Phase I readout, AbbVie is exercising an option to acquire TeneoOne and its BCMA candidate TNB-383B for relapsed or refractory multiple myeloma.

AbbVie inked a deal with TeneoOne back in 2019 to develop and commercialize TNB-383B, a bispecific antibody that targets BCMA and CD3. The treatment is designed to direct the body’s immune system against BCMA-expressing tumor cells. And according to interim results, the candidate showed a 79% objective response rate in a Phase I study. Sixty-three percent of patients saw a “very good partial response” or better, and 29% saw a complete response at doses greater than or equal to 40 mg at a median follow-up of 6.1 months.

James Peyer, Cambrian

Can a cell ther­a­py treat mus­cu­lar dy­s­tro­phy? A Ger­man bil­lion­aire's an­ti-ag­ing start­up is try­ing to find out

Gene therapy companies have faced huge hurdles trying to deliver healthy genes into muscular dystrophy patients’ muscle cells, so here’s an idea: Why don’t we just replace the muscle cells themselves?

Over the last two years, Vita Therapeutics has been exploring that possibility, building on early stem cell work from Johns Hopkins professor Peter Andersen. And on Tuesday they announced a $32 million Series A to begin to move their first therapy into the clinic, where they hope it will help rebuild muscle in patients with a type of dystrophy that afflicts the arms and legs.