Fred Aslan, Artiva

Mer­ck part­ner Arti­va blue­prints San Diego R&D, man­u­fac­tur­ing site to take NK cell op­er­a­tion to the next lev­el

In Jan­u­ary, Arti­va Bio­ther­a­peu­tics CEO Fred Aslan said his com­pa­ny is look­ing to cre­ate CAR-NK ther­a­pies with best-in-class ef­fi­ca­cy made in a whol­ly owned man­u­fac­tur­ing process. Arti­va is now an­oth­er step clos­er to that goal.

Arti­va will open a 52,000 square-foot head­quar­ters in San Diego that will house its R&D and man­u­fac­tur­ing of NK cell ther­a­pies. The site will have a mul­ti-suite, cus­tom-built man­u­fac­tur­ing fa­cil­i­ty up to cur­rent GMP stan­dards and adds to its cur­rent man­u­fac­tur­ing op­er­a­tions at GC Lab­Cell’s 300,000-square-foot lo­ca­tion in South Ko­rea. This new site won’t re­place what’s go­ing on in Ko­rea but dou­ble down on the amount of ca­pac­i­ty the com­pa­ny has.

Pe­ter Fly­nn

“We have this man­u­fac­tur­ing sys­tem that will al­low us to make thou­sands of dos­es of cells from a batch … so we al­ready have a scaled process that’s al­lowed us to de­sign this new man­u­fac­tur­ing cen­ter in San Diego very ef­fi­cient­ly,” COO Pe­ter Fly­nn said in an in­ter­view. “It’s a cus­tom fa­cil­i­ty for our process, and it will al­low us not on­ly to think about pipeline ex­pan­sion, go­ing for­ward, but al­so al­low us to fur­ther re­fine the process to get ready for piv­otal and ul­ti­mate­ly reg­is­tra­tion of com­mer­cial man­u­fac­tur­ing. So re­al­ly, this is an eye on the fu­ture.”

The site is be­ing built out of an al­ready ex­ist­ing build­ing and is ex­pect­ed to be fin­ished in 2022. The of­fices will be filled short­ly af­ter, and Fly­nn said that man­u­fac­tur­ing will like­ly com­mence by the start of 2023. Right now, the 2.5-year-old com­pa­ny op­er­ates out of a 13,000-square-foot space in San Diego.

The move is a big step for the biotech, which gained at­ten­tion from Mer­ck at the start of this year and signed a col­lab­o­ra­tion agree­ment worth near­ly $2 bil­lion. That deal taps Arti­va’s tech to pre­serve, freeze and ship NK cell ther­a­pies with­out los­ing qual­i­ty.

In Feb­ru­ary, the biotech kicked off a $120 mil­lion Se­ries B fi­nanc­ing round, bring­ing its to­tal amount of funds raised to near­ly $200 mil­lion.

“The NK cell ther­a­py field is re­al­ly in­her­it­ing a lot of the orig­i­nal ex­cite­ment that was present with the CAR Ts,” Aslan said in a call with End­points Wednes­day. “We feel that NK cells re­al­ly will on­ly live up to their promise to can­cer pa­tients if they can be man­u­fac­tured and dis­trib­uted like oth­er bi­o­log­ic drugs like an­ti­bod­ies. ”

The site will be lo­cat­ed at 5505 More­house Dri­ve, ex­act­ly three miles from its cur­rent San Diego head­quar­ters.

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.

Dave Lennon, former president of Novartis Gene Therapies

Zol­gens­ma patent spat brews be­tween No­var­tis and Re­genxbio as top No­var­tis gene ther­a­py ex­ec de­parts

Regenxbio, a small licensor of gene therapy viral vectors spun out from the University of Pennsylvania, is now finding itself in the middle of some major league patent fights.

In addition to a patent suit with Sarepta Therapeutics from last September, Novartis, is now trying to push its smaller partner out of the way. The Swiss biopharma licensed Regenxbio’s AAV9 vector for its $2.1 million spinal muscular atrophy therapy Zolgensma.

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David Meek, new Mirati CEO (Marlene Awaad/Bloomberg via Getty Images)

Fresh off Fer­Gene's melt­down, David Meek takes over at Mi­rati with lead KRAS drug rac­ing to an ap­proval

In the insular world of biotech, a spectacular failure can sometimes stay on any executive’s record for a long time. But for David Meek, the man at the helm of FerGene’s recent implosion, two questionable exits made way for what could be an excellent rebound.

Meek, most recently FerGene’s CEO and a past head at Ipsen, has become CEO at Mirati Therapeutics, taking the reins from founding CEO Charles Baum, who will step over into the role of president and head of R&D, according to a release.

Volker Wagner (L) and Jeff Legos

As Bay­er, No­var­tis stack up their ra­dio­phar­ma­ceu­ti­cal da­ta at #ES­MO21, a key de­bate takes shape

Ten years ago, a small Norwegian biotech by the name of Algeta showed up at ESMO — then the European Multidisciplinary Cancer Conference 2011 — and declared that its Bayer-partnered targeted radionuclide therapy, radium-223 chloride, boosted the overall survival of castration-resistant prostate cancer patients with symptomatic bone metastases.

In a Phase III study dubbed ALSYMPCA, patients who were treated with radium-223 chloride lived a median of 14 months compared to 11.2 months. The FDA would stamp an approval on it based on those data two years later, after Bayer snapped up Algeta and christened the drug Xofigo.

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Ex­elix­is pulls a sur­prise win in thy­roid can­cer just days ahead of fi­nal Cabome­tyx read­out

Exelixis added a thyroid cancer indication to its super-seller Cabometyx’s label on Friday — months before the FDA was expected to make a decision, and days before the company was set to unveil the final data at #ESMO21.

At a median follow-up of 10.1 months, differentiated thyroid cancer patients treated with Cabometyx (cabozantinib) lived a median of 11 months without their disease worsening, compared to just 1.9 months for patients given a placebo, Exelixis said on Monday.

Den­mark's Gubra to col­lab­o­rate with Bay­er on pep­tides; Sam­sung and Bio­gen re­ceive FDA ap­proval for Lu­cen­tis biosim­i­lar

Danish biotech Gubra announced a research collaboration and license agreement with Bayer to develop peptide therapeutics to treat cardiorenal diseases. The collaboration will utilize Gubra’s peptide drug discovery platform to identify potential candidates.

This is not the first time Gubra has partnered with a company on peptide therapeutics — they partnered with Boehringer Ingelheim back in 2017 to create peptide therapeutics to treat obesity.

Rafaèle Tordjman (Jeito Capital)

Con­ti­nu­ity and di­ver­si­ty: Rafaèle Tord­j­man's women-led VC firm tops out first fund at $630M

For a first-time fund, Jeito Capital talks a lot about continuity.

Rafaèle Tordjman had spotlighted that concept ever since she started building the firm in 2018, promising to go the extra mile(s) with biotech entrepreneurs while pushing them to reach patients faster.

Coincidentally, the lack of continuity was one of the sore spots listed in a report about the European healthcare sector published that same year by the European Investment Bank — whose fund is one of the LPs, alongside the American pension fund Teacher Retirement System of Texas and Singapore’s Temasek, to help Jeito close its first fund at $630 million (€534 million). As previously reported, Sanofi had chimed in €50 million, marking its first investment in a French life sciences fund.

Mi­rati tri­umphs again in KRAS-mu­tat­ed lung can­cer with a close­ly watched FDA fil­ing now in the cards

After a busy weekend at #ESMO21, which included a big readout for its KRAS drug adagrasib in colon cancer, Mirati Therapeutics is ready to keep the pressure on competitor Amgen with lung cancer data that will undergird an upcoming filing.

In topline results from a Phase II cohort of its KRYSTAL-1 study, adagrasib posted a response rate of 43% in second-line-or-later patients with metastatic non-small cell lung cancer containing a KRAS-G12C mutation, Mirati said Monday.

The biggest ques­tions fac­ing gene ther­a­py, the XLMTM com­mu­ni­ty, and Astel­las af­ter fourth pa­tient death

After three patients died last year in an Astellas gene therapy trial, the company halted the study and began figuring out how to safely get the program back on track. They would, executives eventually explained, cut the dose by more than half and institute a battery of other measures to try to prevent the same thing from happening again.

Then tragically, Astellas announced this week that the first patient to receive the new regimen had died, just weeks after administration.

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