Ahead of US IPO, Leg­end Biotech adds $150M, top-tier in­vestors to back CAR-T pipeline

Last month Nan­jing Leg­end Biotech re­vealed that it sees, and was qui­et­ly plan­ning for, a fu­ture as a pub­lic com­pa­ny in the US, sep­a­rate but still tied to its for­mer par­ent, Chi­nese CRO Gen­Script. It’s ev­i­dent­ly a vi­sion that en­ticed in­vestors, draw­ing mar­quee names for a pre-IPO round.

The Se­ries A fetched a whop­ping $150.5 mil­lion from Hud­son Bay Cap­i­tal Man­age­ment, Lil­ly Asia Ven­tures, Vi­vo Cap­i­tal, RA Cap­i­tal Man­age­ment and JJDC, the ven­ture arm of J&J. The phar­ma gi­ant has helped fund Leg­end’s CAR-T work with the $350 mil­lion up­front pay­ment it hand­ed over to part­ner on the lead BC­MA pro­gram.

Known as JNJ-4528 or LCAR-B38M, the ther­a­py im­me­di­ate­ly be­came the biggest star in J&J’s ar­ma­men­tar­i­um for re­lapsed/re­frac­to­ry mul­ti­ple myelo­ma, just af­ter the an­ti-CD38 an­ti­body Darza­lex. It is now slat­ed for fil­ings in the US and EU in the sec­ond half of this year.

Gen­Script clar­i­fied in a pre­vi­ous fil­ing that the spin­off of Leg­end “is in­tend­ed to en­able op­er­a­tional fo­cus and strat­e­gy de­vel­op­ment,” bet­ter align man­age­ment re­spon­si­bil­i­ties and in­crease trans­paren­cy. But the Leg­end team — com­plete with its own CEO, Yuan Xu, CSO Frank Fan and a dozen se­nior ex­ecs — would still be con­sol­i­dat­ed un­der Gen­Script Group. Ex­ist­ing Gen­Script share­hold­ers are ex­pect­ed to own a ma­jor­i­ty in­ter­est in Leg­end even af­ter its US pub­lic de­but.

For now, pro­ceeds from Leg­end’s first in­de­pen­dent go at fundrais­ing would con­tin­ue to push R&D and po­ten­tial com­mer­cial­iza­tion of its pipeline, as well as ex­pand man­u­fac­tur­ing fa­cil­i­ties. Its cell ther­a­pies for blood can­cer span both au­tol­o­gous and al­lo­gene­ic, with ear­ly-stage pro­grams in sol­id tu­mors (gas­tric can­cer, pan­cre­at­ic can­cer) as well.

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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Try­ing to shake up the Parkin­son's par­a­digm, Ab­b­Vie sub­mits NDA for con­tin­u­ous, 24-hour in­fu­sion ther­a­py

AbbVie is approaching the FDA with a new therapy to potentially treat Parkinson’s disease, using prodrugs of two medications commonly used for the condition.

The Big Pharma submitted its NDA for ABBV-951, a solution of levodopa and carbidopa prodrugs being evaluated in advanced Parkinson’s patients who don’t respond well to oral therapy, AbbVie announced Friday morning. Researchers are hoping a positive Phase III study that reads out in late October will help move things along quickly at the agency.

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.

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.

Daisy Robinton, Oviva Therapeutics co-founder and CEO

A new spin­out wades in­to ovar­i­an ag­ing, armed with a seed round and ex­per­i­men­tal drugs from Mass Gen­er­al

There aren’t many biotechs emphasizing women’s health, but a new spinout is trying to change that.

Oviva Therapeutics, a pipeline company of New York-based Cambrian Biopharma, emerged from stealth earlier this week to dive into the idea of extending women’s “healthspans,” or what it says is the part of a person’s life spent in generally good health, with a specific focus on ovaries. The emergence comes both with a seed financing worth $11.5 million from Cambrian, and an in-licensing agreement with Massachusetts General Hospital for a trio of patents.

Emer Cooke, EMA director (AP Photo/Geert Vanden Wijngaert)

Ahead of FDA, EMA rec­om­mends au­tho­riz­ing new gene ther­a­py treat­ment for ul­tra-rare dis­ease

Aromatic amino acid decarboxylase (AADC) deficiency is an ultra-rare genetic disease that leaves patients unable to produce certain hormones in the brain, such as dopamine and serotonin, usually leading to developmental delays, weak muscle tone and inability to control the movement of the limbs. It can also lead to multiple organ failure.

To date, there have been no treatments approved for AADC deficiency, which has been identified in less than 150 patients.