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.

Biotech IPOs: New Steps to Suc­cess on the Road to Go­ing Pub­lic

By RBC Capital Markets

Key Points

2020 is on track to post the highest number of biotech IPOs in five years
COVID-19 has created a new roadmap for going public
Crossover investors are becoming even more active
Companies are going public with strong balance sheets

As the search for COVID-19 vaccines and therapeutics continues, investor interest in biotech IPOs has surged. 2020 is on track to post the highest number of biotech IPOs in five years.

TCR pi­o­neer Im­muno­core scores a first with a land­mark PhI­II snap­shot on over­all sur­vival for a rare melanoma

Bahija Jallal’s crew at TCR pioneer Immunocore says they have nailed down a promising set of pivotal data for their lead drug in a frontline setting for a solid tumor. And they are framing this early interim readout as the convincing snapshot they need to prove that their platform can deliver on a string of breakthrough therapies now in the clinic or planned for it.

In advance of the Monday announcement, Jallal and R&D chief David Berman took some time to walk me through the first round of Phase III data for their lead TCR designed to treat rare, frontline cases of metastatic uveal melanoma that come with a grim set of survival expectations.

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Simeon George, SR One CEO (SR One)

Scoop: SR One crew com­pletes a com­pli­cat­ed spin­out from Glax­o­SmithK­line. And now they have a $500M fund to in­vest on their own

It’s taken close to 2 years, but Simeon George and his team at SR One have completed their spinout from GlaxoSmithKline, ending a saga as one of the longest running venture arms of Big Pharma as they go out on their own to forge the next chapter with a new and independent $500 million fund.

GSK is sticking with the spinout, this time as a minority investor — though a big one. And I’m told that the R&D group at GSK will remain involved in evaluating their new plays, helping with the scientific due diligence involved in scouting the world for new opportunities during a period of explosive growth in biotech investing.

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CEO Matthew Kane (Precision BioSciences)

In an ap­par­ent R&D about-face, Eli Lil­ly part­ners with Pre­ci­sion Bio­Sciences on genome edit­ing in a deal worth up to near­ly $2.7B

As a large multinational corporation, Eli Lilly has their hands in boundless projects, from cancer and immuno-oncology to diabetes, psoriasis and Crohn’s disease. But Friday they signaled a shift in their R&D focus toward genome editing, leaping into a cutting-edge field CEO Dave Ricks had shied away from as recently as January 2019.

The big pharma is ponying up $100 million upfront to partner with Precision BioSciences, focusing initially on Duchenne muscular dystrophy and two other undisclosed in vivo targets. Lilly is also acquiring $35 million worth of the biotech’s stock, and has the option to develop three additional in vivo therapies.

The pri­ma­ry failed. The key sec­ondary failed. But this biotech still be­lieves it can win an FDA OK in ALS

Two years after the executive team at BrainStorm Cell Therapeutics decided to back off a controversial attempt to sell their stem cell therapy for ALS under the new ‘Right to Try’ legislation, the biotech is back with the top-line data from Phase III. And the data aren’t good.

Researchers say the drug — with a once-proposed price of $300,000 — failed the primary endpoint as well as the key secondaries on disease progression. But the executive crew still thinks it’s approvable. And in fact, the biotech also insists the FDA is eager to review it.

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Albert Bourla, Pfizer CEO (Steven Ferdman/Getty Images)

It's of­fi­cial: Pfiz­er and BioN­Tech have sub­mit­ted their Covid-19 vac­cine to the FDA -- and the agency cir­cled a date for the ad­comm

Pfizer and BioNTech’s request for emergency authorization of its Covid-19 vaccine is now in the FDA’s hands. Regulators caught the application Friday afternoon in an open field dash to the goal line.

The agency immediately marked Dec 10 on the calendar for an advisory committee meeting to discuss the request. Pfizer and BioNTech first announced the submission was coming on Friday morning, and Pfizer CEO Albert Bourla confirmed the filing in a video statement later that afternoon. The “historic day,” as Bourla called it, came just 248 days after the pharma first announced plans to develop the candidate with BioNTech — a process which typically takes years.

News brief­ing: ADC gets a speedy FDA re­view for their DL­B­CL ther­a­py; Qi­a­gen teams with the world's new fa­vorite biotech

The transatlantic biotech ADC Therapeutics is getting a speedy review for its anti-body drug conjugate loncastuximab tesirine (Lonca), developed for relapsed or refractory diffuse large B-cell lymphoma.

ADC $ADCT said Friday morning that the FDA put their drug on the fast lane, providing a priority review for the drug with a May 21 PDUFA date. The biotech won over regulators with Phase II data that reflected an overall response rate of 48.3% (70/145 patients) and a complete response rate of 24.1%.

Jen­nifer Zi­olkows­ki re­signs from CFO post at Sol­id Bio­sciences; Sean Bo­hen's Ole­ma On­col­o­gy adds San­dra Horn­ing to board of di­rec­tors

Jennifer Ziolkowski has decided to step down from Ilan Ganot’s team at Solid Biosciences “to pursue a new career opportunity,” according to an SEC document filed Friday. Ziolkowski will continue to be Solid’s CFO until Jan. 29, 2021. The day after she announced her resignation at the company, the Duchenne muscular dystrophy biotech entered into a consulting agreement with Danforth Advisors, at which point Danforth managing partner Stephen DiPalma was named interim CFO. DiPalma has been a CFO before at Forum Pharmaceuticals and Aquila Biopharmaceuticals, and he founded Catalyst Oncology and Athena Diagnostics.

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Albert Bourla, Pfizer CEO (Gian Ehrenzeller/Keystone via AP Images)

Pfiz­er and BioN­Tech are send­ing the first Covid-19 vac­cine to the FDA to­day

The first Covid-19 vaccine is heading to regulators.

Pfizer and BioNTech announced Friday morning that they would ask today for the FDA to issue an emergency use authorization for their Covid-19 candidate.

The submission, a major milestone in the fight against the pandemic and in history’s most intensive and closely-watched drug development race, will put the ball in the agency’s court, where regulators will pour over all the data the companies have generated since winter and solicit recommendations from outside advisors before making a decision.

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