Af­ter some care­ful think­ing, Cel­gene strikes a $295M dis­cov­ery deal on neu­rode­gen­er­a­tion

Bob Hug­in, Cel­gene

A year ago, Cel­gene’s Bob Hug­in told a room­ful of re­porters at JP Mor­gan — which in­clud­ed me — that af­ter some care­ful con­tem­pla­tion he had con­clud­ed that any com­pa­ny that in­tend­ed to have a big im­pact on health in 10 years would have to be in­volved in de­vel­op­ing new drugs for neu­rode­gen­er­a­tion.

To­day, the big biotech $CELG, known for its dizzy­ing string of col­lab­o­ra­tions aimed at main­tain­ing its dom­i­nant role in mul­ti­ple myelo­ma and blood can­cers, said it would pay Evotec $45 mil­lion up­front and up to $250 mil­lion in mile­stones to get start­ed on a dis­cov­ery pro­gram aimed at a wide range of neu­rode­gen­er­a­tive con­di­tions.

The deal cov­ers 5 years and brings Evotec’s iP­SC plat­form in­to play. As part of the col­lab­o­ra­tion, Cel­gene added that it may al­so choose to screen com­pounds from its CELMoD li­brary us­ing Evotec’s iP­SC plat­form to eval­u­ate ac­tiv­i­ty in mod­els of neu­rode­gen­er­a­tive dis­eases.

The move by Cel­gene to launch in­to neu­rode­gen­er­a­tive dis­eases comes af­ter a long line­up of phar­ma gi­ants like As­traZeneca and Glax­o­SmithK­line ei­ther ex­it­ed the field or ex­e­cut­ed a ma­jor re­treat. At the same time, new com­pa­nies like De­nali have been jump­ing in­to the game, pur­su­ing new ge­net­ic in­sights in­to these dis­eases even as a big play­er like Bio­gen makes re­al progress in search­ing for a drug that can slow or stop Alzheimer’s, which re­mains the Holy Grail of neu­rode­gen­er­a­tive R&D ef­forts. Cel­gene’s ar­rival now sends a new sig­nal about a brew­ing turn­around.

The clin­i­cal record in this field, though, would test the per­se­ver­ance of any­one in­volved in drug dis­cov­ery and de­vel­op­ment. The last 10 years has been lit­tered with re­peat fail­ures, capped by Eli Lil­ly’s dev­as­tat­ing fail­ure on solanezum­ab, its third straight set­back on the same ther­a­py.

Cel­gene be­lieves it can beat those odds, and plans to be a play­er when the win­nings are be­ing count­ed by Hug­in’s dead­line, in 2026.

Op­ti­miz­ing Cell and Gene Ther­a­py De­vel­op­ment and Pro­duc­tion: How Tech­nol­o­gy Providers Like Corn­ing Life Sci­ences are Spurring In­no­va­tion

Remarkable advances in cell and gene therapy over the last decade offer unprecedented therapeutic promise and bring new hope for many patients facing diseases once thought incurable. However, for cell and gene therapies to reach their full potential, researchers, manufacturers, life science companies, and academics will need to work together to solve the significant challenges facing the industry.

Amid mon­key­pox fears, biotechs spring to ac­tion; Mod­er­na’s CFO trou­ble; Cuts, cuts every­where; Craft­ing the right pro­teins; and more

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Bay­er sounds re­treat from a $670 mil­lion CAR-T pact in the wake of a pa­tient death

Two months after Atara Biotherapeutics hit the hold button on its lead CAR-T 2.0 therapy following a patient death, putting the company under the watchful eye of the FDA, its Big Pharma partners at Bayer are bowing out of a $670 million global alliance. And the move is forcing a revamp of Atara’s pipeline plans, even as research execs vow to continue work on the two drugs allied with Bayer 18 months ago, which delivered a $60 million cash upfront.

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Sanofi and Re­gen­eron clear the fin­ish line in an in­flam­ma­to­ry esoph­a­gus dis­ease, leav­ing Take­da in the dust

With atopic dermatitis rivals breathing down Dupixent’s neck, Sanofi and Regeneron on Friday secured a first win in new territory in what Sanofi’s head of immunology and inflammation Naimish Patel called the fastest approval he’s ever seen.

The FDA approved Dupixent on Friday to treat patients 12 years and older with eosinophilic esophagitis (EoE), an inflammatory condition that causes swelling and scarring of the esophagus. The approval came just a couple months after regulators granted Dupixent priority review, and months ahead of its PDUFA date on Aug. 3.

Fu­ji­film con­tin­ues its biotech build­ing spree with new fa­cil­i­ty in Chi­na

A Japanese conglomerate is making a big play in China with the opening of a new facility, as it continues to expand.

Fujifilm Irvine Scientific has opened its new Innovation and Collaboration Center in Suzhou New District, China, an area in Jiangsu province specifically designated for technological and industrial development.

According to Fujifilm, the 12,000-square-foot site will be responsible for the company’s cell culture media optimization, analysis and design services. Cell culture media itself often requires customization of formulas and protocols to achieve the desired quantity and quality of therapeutic desired. Fujifilm Irvine Scientific is offering these services from its headquarters in California and Japan to its customers globally, as well as in China now.

Rob Etherington, Clene CEO

Mary­land of­fers loan to Clene de­spite ALS tri­al bumps

Even after Utah-based Clene failed to hit its primary endpoints for its ALS drug last year, the state of Maryland is putting its money at least behind Clene’s manufacturing facility.

The Maryland Board of Public Works has finalized a $3 million, 60-month loan facility with Clene Nanomedicine. The loan was provided by the state’s Neighborhood BusinessWorks program within the Maryland Department of Housing and Community Development.

Armon Sharei, SQZ founder and CEO

SQZ's out­side-the-box man­u­fac­tur­ing method slash­es pro­duc­tion time in ear­ly in study

At ASCO 2021 in June of last year, SQZ Biotech showcased a glimpse of its unorthodox cell therapy manufacturing tech. And on Wednesday, the Watertown, MA, company announced that its first-generation system showed comparable or better performance than a conventional clean-room-based manufacturing process.

The study was non-clinical. Clinical trials are expected by the first half of 2023.

SQZ’s device opens up a temporary window by cell-squeezing to deliver cargoes into cells. Its average processing time was less than six hours per batch, which is more than half the time than conventional methods. The company is planning to use the technology in its first red blood cell derived program for celiac disease. That IND is set to be submitted in the first half of 2023, the company said.

Bobby Sheng, Bora Pharmaceuticals CEO

With new ac­qui­si­tion, Bo­ra to ven­ture in­to bi­o­log­ics

Last week, Taiwan-based CDMO Bora Pharmaceuticals announced that it acquired Eden Biologics. Now, it says that purchase has helped established Bora Biologics, expanding into the biopharmaceutical market.

The acquisition of the company’s assets, which are located in the Hsinchu Biomedical Science Park in Taiwan, is helping Bora build its presence in the biopharma world by expanding production capacity of cell lines for the production of protein drugs. It will also improve the quality control and inspection specifications, as well as cell bank generation. The facility has four 500-liter bioreactors that have been approved by European and Taiwanese regulators.

Paul Chaplin, Bavarian Nordic president and CEO

With mon­key­pox cas­es ris­ing, one Eu­ro­pean coun­try is lock­ing down a small­pox vac­cine con­tract

As the global number of confirmed and suspected monkeypox cases continues to slowly climb, one country is trying to get a head start on potential vaccine stocking.

Bavarian Nordic signed a contract with an undisclosed European nation to supply its smallpox vaccine in response to new cases this month, the company announced Thursday morning. The continent saw its first monkeypox case confirmed about two weeks ago, with both the UK and Portugal seeing cases, according to the Washington Post.

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