Temasek leads $85M round for Chi­nese biotech aim­ing for cheap­er, faster, bet­ter CAR-T ther­a­pies

The land­mark ap­provals of CAR-T ther­a­pies have been her­ald­ed, but emerg­ing sup­ply chain hur­dles cat­alyzed by the com­plex man­u­fac­tur­ing process for the cel­lu­lar ther­a­pies have pushed mak­ers to look for ways to stream­line and quick­en the process to aug­ment prod­uct vol­umes and shore up adop­tion. Chi­na’s Gra­cell is look­ing to cap­i­tal­ize on these tech­ni­cal wob­bles, with its crop of new, low cost cell ther­a­pies, with the back­ing of sto­ried in­vestor Temasek.

On Mon­day, Gra­cell said it had scored $85 mil­lion in Se­ries B fund­ing, led by Temasek and fea­tur­ing par­tic­i­pa­tion from Lil­ly Asia Ven­tures, King­ton Cap­i­tal, King Star Cap­i­tal and Cheng­du Miao­ji, to shep­herd its pre­clin­i­cal CAR-T prod­ucts in­to hu­man tri­als.

Wei (William) Cao

The com­pa­ny was es­tab­lished in 2017 by Wei (William) Cao — who pre­vi­ous­ly found­ed and led Cel­lu­lar Bio­med­i­cine Group $CB­MG — and was ini­tial­ly sup­port­ed by 6 Di­men­sions in a Se­ries A round soon af­ter the Suzhou-based firm’s for­ma­tion. 

“Im­mune cell gene ther­a­py is ex­pect­ed to be­come a pil­lar of mod­ern med­i­cine, but the in­dus­try is still in its in­fan­cy. Chal­lenges and op­por­tu­ni­ties co­ex­ist,” Cao said in a state­ment.

Gra­cell is itch­ing to al­le­vi­ate some of these con­straints: high pro­duc­tion costs, lengthy man­u­fac­tur­ing process, a pauci­ty of off-the-shelf prod­ucts and a short du­ra­tion of ther­a­peu­tic ef­fects, with its raft of ear­ly-stage CAR-T prod­ucts. The no­tion is com­mend­able, but there is a long road ahead.

Cell ther­a­py man­u­fac­tur­ing is con­vo­lut­ed. Es­sen­tial­ly, the jour­ney be­gins with the col­lec­tion of cells from the pa­tient (with their spe­cif­ic ge­net­ic back­ground and med­ical his­to­ry) and ends with the ad­min­is­tra­tion of the ther­a­py to the same pa­tient — but in be­tween there are var­i­ous process­es that must take place be­fore these cells are turned in­to a ther­a­peu­tic, un­like a sim­ple off-the-shelf tra­di­tion­al chem­i­cal drug.

These man­u­fac­tur­ing chal­lenges are the pri­ma­ry rea­son be­hind the tepid sales of No­var­tis’ $NVS CAR-T Kym­ri­ah — in the fourth quar­ter, the drug gen­er­at­ed a pal­try $28 mil­lion. How­ev­er, the Swiss drug­mak­er is do­ing its best to shore up man­u­fac­tur­ing, hav­ing bought cell and gene ther­a­py man­u­fac­tur­er Cell­for­Cure.

Health­care Dis­par­i­ties and Sick­le Cell Dis­ease

In the complicated U.S. healthcare system, navigating a serious illness such as cancer or heart disease can be remarkably challenging for patients and caregivers. When that illness is classified as a rare disease, those challenges can become even more acute. And when that rare disease occurs in a population that experiences health disparities, such as people with sickle cell disease (SCD) who are primarily Black and Latino, challenges can become almost insurmountable.

Jacob Van Naarden (Eli Lilly)

Ex­clu­sives: Eli Lil­ly out to crash the megablock­buster PD-(L)1 par­ty with 'dis­rup­tive' pric­ing; re­veals can­cer biotech buy­out

It’s taken 7 years, but Eli Lilly is promising to finally start hammering the small and affluent PD-(L)1 club with a “disruptive” pricing strategy for their checkpoint therapy allied with China’s Innovent.

Lilly in-licensed global rights to sintilimab a year ago, building on the China alliance they have with Innovent. That cost the pharma giant $200 million in cash upfront, which they plan to capitalize on now with a long-awaited plan to bust up the high-price market in lung cancer and other cancers that have created a market worth tens of billions of dollars.

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The End­points 11: They've got mad mon­ey and huge am­bi­tions. It's time to go big or go home

These days, selecting a group of private biotechs for the Endpoints 11 spotlight begins with a sprint to get ahead of IPOs and the M&A teams at Big Pharma. I’ve had a couple of face plants earlier this year, watching some of the biotechs on my short list choose a quick leap onto Nasdaq or into the arms of a buyer.

Vividion, you would have been a great pick for the Endpoints 11. I’m sorry I missed you.

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Dave Lennon, former president of Novartis Gene Therapies

So what hap­pened with No­var­tis Gene Ther­a­pies? Here's your an­swer

Over the last couple of days it’s become clear that the gene therapy division at Novartis has quietly undergone a major reorganization. We learned on Monday that Dave Lennon, who had pursued a high-profile role as president of the unit with 1,500 people, had left the pharma giant to take over as CEO of a startup.

Like a lot of the majors, Novartis is an open highway for head hunters, or anyone looking to staff a startup. So that was news but not completely unexpected.

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Maureen Hillenmeyer, Hexagon Bio CEO

Hexa­gon Bio rais­es $61M to con­tin­ue ef­forts to turn fun­gi in­to drugs

A year after raising a $47 million launch round, the fungi-loving drug hunters at Hexagon Bio have more than doubled their coffers.

Hexagon announced today that it raised another $61 million for its efforts to design cancer and infectious disease drugs based on insights mined from the DNA in millions of species of fungi. The new financing brings Hexagon’s committed funding to over $108 million.

Who are the women su­per­charg­ing bio­phar­ma R&D? Nom­i­nate them for this year's spe­cial re­port

The biotech industry has faced repeated calls to diversify its workforce — and in the last year, those calls got a lot louder. Though women account for just under half of all biotech employees around the world, they occupy very few places in C-suites, and even fewer make it to the helm.

Some companies are listening, according to a recent BIO survey which showed that this year’s companies were 2.5 times more likely to have a diversity and inclusion program compared to last year’s sample. But we still have a long way to go. Women represent just 31% of biotech executives, BIO reported. And those numbers are even more stark for women of color.

FDA+ roundup: Bs­U­FA III ready for show­time, court tells FDA to re-work com­pound­ing plan, new guid­ance up­dates and more

The FDA has now spelled out what exactly will be included in the third iteration of Biosimilar User Fee Act (BsUFA) from 2023 through 2027, which similarly to the prescription drug deal, sets fees that industry has to pay for submitting applications, in exchange for firm timelines that the agency must meet.

This latest deal includes several sweeteners for the biosimilar industry, which has yet to make great strides in the US market, with shorter review timelines for safety labeling updates and updates to add or remove an indication that does not contain efficacy data.

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Jean Bennett (Brent N. Clarke/Invision/AP Images)

Lux­tur­na in­ven­tor Jean Ben­nett starts a new gene ther­a­py com­pa­ny to tack­le rare dis­eases left be­hind by phar­ma, VCs

A few years ago Jean Bennett found herself in a surprising place for a woman who invented the first gene therapy ever approved in the United States: No one, it seemed, wanted her work.

Bennett, who designed and co-developed Luxturna, approved in 2018 for a rare form of blindness, had kept building new gene therapies for eye diseases at her University of Pennsylvania lab. But although the results in animals looked promising, pharma companies and investors kept turning down the pedigreed ophthalmology professor.

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Blue­bird sends blood dis­or­der drug to FDA for ap­proval; CG On­col­o­gy en­ters col­lab­o­ra­tion with Roche for Tecen­triq

Bluebird bio announced it completed the rolling submission of its BLA to the FDA for betibeglogene autotemcel gene therapy.

The therapy, designed for patients with beta-thalassemia who require regular red blood cell transfusions, was previously granted breakthrough therapy designation for treating transfusion-dependent beta-thalassemia (TDT). If approved, beti-cel will be the first hematopoietic stem cell ex-vivo gene therapy for patients in the US.