Months af­ter team­ing up on RTK in­hibitor Lenvi­ma, Ei­sai/Mer­ck win new FDA OK in liv­er can­cer

Ei­sai’s star can­cer drug Lenvi­ma — the sub­ject of a re­cent $300 mil­lion pact with Mer­ck — just got the green light from reg­u­la­tors to treat a new in­di­ca­tion in liv­er can­cer.

The drug, whose gener­ic name is lenva­tinib, was al­ready ap­proved by the FDA in 2015 to treat thy­roid can­cer, and in 2016 it won ap­proval for re­nal cell car­ci­no­ma. But the med has been lined up to take a shot at sev­er­al new in­di­ca­tions, in­clud­ing this lat­est OK in he­pa­to­cel­lu­lar car­ci­no­ma.

Roger Perl­mut­ter

Lenva­tinib be­longs to a group of drugs called RTK in­hibitors, de­vel­oped to di­al down the mu­tat­ed pro­teins that lead to run­away can­cer growth. While promis­ing, a big down­side to these in­hibitors is that pa­tients of­ten de­vel­op re­sis­tance to the tar­get­ed ther­a­pies, mak­ing progress short­lived. But that makes these drugs good can­di­dates for com­bi­na­tion ther­a­pies, in hopes that a com­ple­men­tary drug could fore­stall re­sis­tance.

That’s just what Mer­ck de­cid­ed to try when it signed a $300 mil­lion pact with Ei­sai on this drug ear­li­er this year in a deal that could be worth up to $5 bil­lion in mile­stones. The duo said it would test lenva­tinib in com­bi­na­tion with Mer­ck’s can­cer dar­ling Keytru­da, which is now in­volved in more than 700 clin­i­cal tri­als.

Ei­sai and Mer­ck teamed up to de­vel­op lenva­tinib as a monother­a­py and in com­bi­na­tion with the check­point, with the two shar­ing de­vel­op­ment costs. This new ap­proval in he­pa­to­cel­lu­lar car­ci­no­ma is the first FDA OK the duo has achieved af­ter ink­ing the deal. And they’re now work­ing to­geth­er on a pipeline tar­get­ing en­dome­tri­al can­cer, non-small cell lung can­cer, head and neck can­cer, blad­der can­cer and melanoma, as well as a bas­ket tri­al tar­get­ing mul­ti­ple can­cer types.

“To­geth­er with Ei­sai, we aim to max­i­mize the val­ue of Lenvi­ma for its cur­rent in­di­ca­tions while joint­ly pur­su­ing ad­di­tion­al ap­provals in com­bi­na­tion with Keytru­da across a wide range of can­cers,” said Mer­ck R&D chief Roger Perl­mut­ter at the time. “Through this col­lab­o­ra­tion, we will both broad­en our on­col­o­gy port­fo­lio and have the op­por­tu­ni­ty to help even more can­cer pa­tients around the world.”

Im­age: Shut­ter­stock

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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It’s always a bittersweet moment saying goodbye, but as Josh Sullivan goes off to new adventures we are grateful for the way he’s built up the Endpoints Manufacturing section — which the rest of the team will now carry forward. If you’re not already, this may be a good time to sign up for your weekly dose of drug manufacturing news. Thank you for reading and wish you a restful weekend.

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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