Cog­nate dou­bles man­u­fac­tur­ing ca­pac­i­ties in Mem­phis, Eu­rope, as de­mand for cell and gene ther­a­pies sky­rock­ets

The mar­ket­place for gene and cell man­u­fac­tur­ing ther­a­peu­tics con­tin­ues to be scorch­ing.

Cog­nate Bio­Sciences, a lead­ing CD­MO spe­cial­iz­ing in gene and cell ther­a­py tech­nolo­gies, an­nounced plans Fri­day that will dou­ble its to­tal man­u­fac­tur­ing ca­pac­i­ties at sites in both the US and Eu­rope — in di­rect re­sponse to a “great de­mand of com­mer­cial ca­pac­i­ty with­in the bi­o­log­ics in­dus­try.”

The com­pa­ny pro­vid­ed most de­tails for its US ex­pan­sion, which will take place at its cur­rent head­quar­ters in Mem­phis, Ten­nessee near the Mem­phis In­ter­na­tion­al Air­port — cru­cial, it said, as Mem­phis is one of the world’s busiest car­go air­ports. Cog­nate will add two sep­a­rate fa­cil­i­ties to­tal­ing 250,000-square-feet: a GMP dis­tri­b­u­tion cen­ter to man­age glob­al sup­ply chain needs, and a third site for com­mer­cial man­u­fac­tur­ing.

J. Kel­ly Gan­jei

“Our ex­pan­sion plans in cell and gene ther­a­py, in the US and Eu­rope, and the close prox­im­i­ty to a glob­al ship­ping and lo­gis­tics hubs, pro­vide Cog­nate BioSer­vices, to­geth­er with Co­bra Bi­o­log­ics, a unique com­pet­i­tive ad­van­tage not avail­able to oth­er CD­MOs,” Cog­nate’s CEO J. Kel­ly Gan­jei said in a state­ment. “This is crit­i­cal­ly im­por­tant to our clients around the world who are com­mer­cial­iz­ing cell and gene ther­a­pies that re­quire rapid turn around and of­ten uti­lize re­al-time ship­ping and han­dling.”

The biotech is com­mit­ted, Gan­jei said, to “rapid­ly ex­pand­ing” its glob­al reach and ca­pac­i­ty for de­vel­op­ing cell and gene ther­a­pies. Fri­day’s an­nounced ex­pan­sion is part of a 15-year Ex­pan­sion PI­LOT (pay­ment-in-lieu-of-tax­es) ap­proval from the eco­nom­ic coun­cil in Mem­phis and Shel­by coun­ties, con­tin­u­ing a three-year in­vest­ment in Ten­nessee of some $200 mil­lion by var­i­ous health­care and life sci­ence com­pa­nies.

Co­bra Bi­o­log­ics, Cog­nate’s gene ther­a­py arm that it bought last Jan­u­ary, is al­ter­ing its plas­mid DNA ser­vices for vi­ral vec­tors through a four-fold in­crease in HQ DNA man­u­fac­tur­ing ca­pac­i­ty and new clin­i­cal and cGMP fa­cil­i­ties in Eu­rope. The HQ man­u­fac­tur­ing will pro­vide a six-week de­liv­ery time for clin­i­cal­ly man­u­fac­tur­ing im­muno-on­col­o­gy ther­a­pies, Cog­nate said.

UP­DAT­ED: Mer­ck pulls Keytru­da in SCLC af­ter ac­cel­er­at­ed nod. Is the FDA get­ting tough on drug­mak­ers that don't hit their marks?

In what could be an early shot in the battle against drugmakers that whiff on confirmatory studies to support accelerated approvals, the FDA ordered Bristol Myers Squibb late last year to give up Opdivo’s approval in SCLC. Now, Merck is next on the firing line — are we seeing the FDA buckling down on post-marketing offenders?

Merck has withdrawn its marketing approval for PD-(L)1 inhibitor Keytruda in metastatic small cell lung cancer as part of what it describes as an “industry-wide evaluation” by the FDA of drugs that do not meet the post-marketing checkpoints on which their accelerated nods were based, the company said Monday.

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The 2021 top 100 bio­phar­ma in­vestors: As the pan­dem­ic hit and IPOs boomed, VCs swung in­to ac­tion like nev­er be­fore

The global pandemic may have roiled economies, killed hundreds of thousands and throttled entire industries, but the only effect it had on biopharma venture investing was to help turbocharge the field to giddy new heights.

Below you’ll find the new top 100 venture investors in the industry, ranked by the number of deals they were publicly involved in, as tracked by DealForma chief Chris Dokomajilar. The numbers master then calculated the estimated amount of money they put into each deal — divvying up the cash by the number of players — to indicate how they managed their syndicates.

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GSK, Vir's hopes for a Covid-19 an­ti­body fall flat in NIH 'mas­ter pro­to­col' with no ben­e­fit in hos­pi­tal­ized pa­tients

GlaxoSmithKline and Vir Biotechnology were hopeful that one of their partnered antibodies would carve out a win after getting the invite to a major NIH study in hospitalized Covid-19 patients. But just like Eli Lilly, the pair’s drug couldn’t hit the mark, and now they’ll be left to take a hard look at the game plan.

The NIH has shut down enrollment for GSK and Vir’s antibody VIR-7831 in its late-stage ACTIV-3 trial after the drug showed negligible effect in achieving sustained recovery in hospitalized Covid-19 patients, the partners said Wednesday.

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Novartis' manufacturing hub in Stein, Switzerland (Novartis)

UP­DAT­ED: Swiss CD­MO Celonic finds a home at No­var­tis' Stein hub, plans to add 250 new jobs cen­tered on next-gen drugs

The outsourcing market for cell and gene therapies has stayed red-hot in recent months as some of the biggest CDMOs — and even major drugmakers — are diving in. Now, a Swiss CDMO wants a bigger piece of the action, and it’s looking to set up shop in Novartis’ fledgling life sciences hub in Stein.

Celonic plans to build a 91,500-square-foot manufacturing center focused on cell and gene therapies, next-gen vaccines and other “innovative” drugs as part of a two-part expansion at Novartis’ Rhine Valley hub, the CDMO said last week.

In­tro­duc­ing End­points FDA+, our new pre­mi­um week­ly reg­u­la­to­ry news re­port led by Zachary Bren­nan

CRLs. 483s. CBER, CDER and RWE. For biopharma professionals, these acronyms command attention because of the fundamental role FDA plays in drug development. Now Endpoints is doubling down on regulatory coverage, and launching a weekly report focusing on developments out of White Oak, with analysis and insight into what it all means.

Coverage will be led by our new senior editor, Zachary Brennan. He joins Endpoints from POLITICO, where he covered pharma. Prior to that he was the managing editor for Regulatory Focus, a news publication from the Regulatory Affairs Professionals Society.

Bob Nelsen (Photo by Michael Kovac/Getty Images)

With stars aligned and cash in re­serve, Bob Nelsen's Re­silience plans a makeover at 2 new fa­cil­i­ty ad­di­tions to its drug man­u­fac­tur­ing up­start

Bob Nelsen’s new, state-of-the-art drug manufacturing initiative is taking shape.

Just 3 months after gathering $800 million of launch money, a dream team board and a plan to shake up a field where he found too many bottlenecks and inefficiencies for the era of Covid-19, Resilience has snapped up a pair of facilities now in line for a retooling.

The company has acquired a 310,000-square-foot plant in Boston from Sanofi along with a 136,000-square-foot plant in Ontario to add to a network which CEO Rahul Singhvi says is just getting started on building his company’s operations up. The Sanofi deal comes with a contract to continue manufacturing one of its drugs.

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As Brain­Storm con­tin­ues to tout ‘clear sig­nal’ on ALS drug, the FDA of­fers a rare pub­lic slap­down on the da­ta

A little more than a week after BrainStorm acknowledged that regulators at the FDA had informed them that the biotech needed more data before it could expect to gain an approval for its ALS treatment NurOwn — while still touting a “clear signal” of efficacy and not ruling out an application — the agency has decided to clarify the record in a most unusual statement.

The FDA statement amounts to a straight slap own, offering a different set of efficacy numbers from the company’s public presentation last November and ruling out any chance of statistical significance.

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Eli Lil­ly claims suc­cess in a new JAK in­di­ca­tion: hair loss

Over the last decade, drugmakers have proven JAK inhibitors can treat a smattering of immune-related diseases ranging from rheumatoid arthritis to Covid-19. Now Eli Lilly has pulled out a new one.

Lilly and its biotech partner Incyte announced Wednesday that their JAK inhibitor baricitinib effectively regrew patients’ hair in a Phase III trial for alopecia areata, an autoimmune condition that can cause sudden, severe and patchy hair loss. Lilly didn’t break down the results from the 546-patient trial, but the primary endpoint was improvement on a standard score for alopecia symptoms.

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Thank you, next: Take­da hands Ovid $196M cash to rein back in Phase III-ready seizure drug, re­viv­ing bat­tered stock

Soticlestat made it.

Takeda is bringing the drug back into its fold more than four years after first entrusting the team at Ovid with the mid-stage clinical work. For all that — generating what they saw as positive Phase II data in Dravet syndrome and Lennox-Gastaut syndrome — the biotech has been rewarded with $196 million in upfront cash, with another $660 million reserved for regulatory and commercial milestones.

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