CEO Lex Rovner (64x Bio)

A George Church spin­out fight­ing the vi­ral vec­tor bot­tle­neck in cell and gene ther­a­py lands $55M

A syn­thet­ic bi­ol­o­gy com­pa­ny spun out of George Church’s lab is set to tack­le the gene ther­a­py man­u­fac­tur­ing bot­tle­neck, and it just land­ed $55 mil­lion in a Se­ries A fi­nanc­ing round to do so.

George Church

64x Bio comes out of the Har­vard De­part­ment of Ge­net­ics. CEO Lex Rovn­er and her team — which right now, sits around 10 peo­ple — are look­ing to tack­le a key hur­dle for ma­jor com­pa­nies: man­u­fac­tur­ing cell and gene ther­a­pies.

Rovn­er met Church while get­ting her PhD at Yale, and went on to do a post­doc­tor­al re­search fel­low­ship in his lab, and, when talk­ing to folks in the in­dus­try, found a mas­sive vi­ral vec­tor man­u­fac­tur­ing bot­tle­neck that wasn’t be­ing talked about.

Af­ter a seed fund­ing round and the com­pa­ny’s launch in 2020, it made some noise in the in­dus­try, par­tic­u­lar­ly as Covid-19 made bot­tle­neck is­sues more vis­i­ble. There’s a wait­list to get a vec­tor from man­u­fac­tur­ers, and not much of a so­lu­tion to the prob­lem

“In a lot of cas­es, in-house vec­tor man­u­fac­tur­ing ca­pac­i­ty is al­ready ex­ceed­ed for even the small­est dis­ease pop­u­la­tions. And once you get in­to the more wide­spread dis­eases, man­u­fac­tur­ing ca­pac­i­ty can be off by or­ders of mag­ni­tude,” Rovn­er said in an in­ter­view with End­points News. “It’s very like­ly go­ing to be im­pos­si­ble to out­source that much man­u­fac­tur­ing…It’s re­al­ly no se­cret that this is a prob­lem, that is and will con­tin­ue to lim­it the ther­a­pies for each pa­tient if this is left un­solved.”

Life­force Cap­i­tal led the round, with North­pond Ven­tures, Fu­ture Ven­tures, the for­mer Alde­vron CEO Michael Cham­bers, First Round Cap­i­tal, CEO of Re­cur­sion Chris Gib­son and Al­ix Ven­tures all par­tic­i­pat­ing as well. The funds will go to­ward ad­vanc­ing Vec­torS­e­lect, a plat­form that us­es ma­chine learn­ing to test mil­lions of dif­fer­ent cells for how well virus­es grow in them, mak­ing for a faster, and more ef­fec­tive process.

Once it’s test­ed mil­lions of po­ten­tial cell lines — all si­mul­ta­ne­ous­ly — 64x screens for com­bi­na­tions of genes that make for high­ly pro­duc­tive cells. So far, there’s been suc­cess with ade­no-as­so­ci­at­ed virus­es, the most com­mon vec­tor used in gene ther­a­py, and Rovn­er and her team are look­ing to ex­plore oth­er mar­kets too.

“The prob­lem is more fun­da­men­tal than phys­i­cal in­fra­struc­ture,” she said. “This is a ge­net­ics prob­lem and the so­lu­tions are go­ing to be in tai­lor­ing how a cell in­ter­acts with the vi­ral com­po­nents.”

Church said in a state­ment: “Un­til now, ge­net­ic tai­lor­ing of man­u­fac­tur­ing cells has failed to de­liv­er. Over­com­ing the cel­lu­lar bar­ri­ers to vi­ral pro­duc­tion will re­quire many cel­lu­lar mu­ta­tions in com­bi­na­tion, which means test­ing po­ten­tial­ly tril­lions of mu­tant cells. Ex­ist­ing cell line en­gi­neer­ing and screen­ing tech­nolo­gies have not been up to the chal­lenge.”

64x will “dra­mat­i­cal­ly” grow its em­ploy­ee base, from 10 em­ploy­ees right now to about 50, Rovn­er said. That will start with the ex­pan­sion of its man­age­ment team. It’s al­so go­ing to ex­pand its part­ner­ships with oth­er biotechs, and while the com­pa­ny isn’t ready to an­nounce any­thing just yet, news on that front could be com­ing in the near fu­ture.

Ed­i­tor’s Note: For more news and ex­clu­sive cov­er­age from the man­u­fac­tur­ing beat, sub­scribe to the End­points Man­u­fac­tur­ing week­ly re­port in your read­er pro­file.

The Big Phar­ma dis­card pile; Lay­offs all around while some biotechs bid farewell; New Roche CEO as­sem­bles top team; and more

Welcome back to Endpoints Weekly, your review of the week’s top biopharma headlines. Want this in your inbox every Saturday morning? Current Endpoints readers can visit their reader profile to add Endpoints Weekly. New to Endpoints? Sign up here.

With earnings seasons in full swing, we’ve listened in on all the calls so you don’t have to. But news is popping up from all corners, so make sure you check out our other updates, too.

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Sen. Ron Wyden (D-OR) (Francis Chung/E&E News/Politico via AP Images)

In­fla­tion re­bates in­com­ing: Wyden calls on CMS to move quick­ly as No­var­tis CEO pledges re­ver­sal

Senate Finance Chair Ron Wyden (D-OR) this week sent a letter to the head of the Centers for Medicare & Medicaid Services seeking an update on how and when new inflation-linked rebates will take effect for drugs that see major price spikes.

The newly signed Inflation Reduction Act requires manufacturers to pay a rebate to Medicare when they increase drug prices faster than the rate of inflation.

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Raymond Stevens, Structure Therapeutics CEO

Be­hind Fri­day's $161M IPO: A star sci­en­tist, GPCR drug dis­cov­ery and a plan to chal­lenge phar­ma in di­a­betes

What does it take to pull off a $161 million biotech IPO these days?

In Structure Therapeutics’ case, it means having a star scientist co-founder paired with the computational drug discovery company Schrödinger, $198 million in private funding from blue-chip investors, almost six years of research work on G protein-coupled receptors and a slate of oral, small-molecule drugs, with an eye on the huge and growing diabetes and weight-loss market.

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Trodelvy notch­es a win in most com­mon form of breast can­cer

Following a promise last year to go “big and fast in breast cancer,” Gilead has secured a win for Trodelvy in the most common form.

The drug was approved to treat HR-positive, HER2-negative breast cancer patients who’ve already received endocrine-based therapy and at least two other systemic therapies for metastatic cancer, Gilead announced on Friday.

Trodelvy won its first indication in metastatic triple-negative breast cancer back in 2020, and has since added urothelial cancer to the list. HR-positive HER2-negative breast cancer accounts for roughly 70% of new breast cancer cases worldwide per year, according to senior VP of oncology clinical development Bill Grossman, and many patients develop resistance to endocrine-based therapies or worsen on chemotherapy.

Af­ter 13 years, Ramy Mah­moud steps in­to CEO seat at Opti­nose; Ru­pert Vessey set to ex­it Bris­tol My­ers in Ju­ly

After 13 years as president and COO at Optinose, Ramy Mahmoud has stepped into a new role as its CEO. He is taking the place of Peter Miller, who stepped down earlier this week, though Miller is still staying with the company as a consultant.

In 2010, the two business partners joined Optinose to take it in a new direction, transforming it from a delivery platform to product company. They previously worked together at Johnson & Johnson, when Miller was president at Janssen and Mahmoud headed medical affairs. Miller said after he learned about Optinose, “I did what I always do, which is find people smarter than me to talk with about the idea. And the first person I called was Ramy … and I said, ‘Hey, Ramy, what do you think of this technology?’”

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Uğur Şahin, BioNTech CEO (Andreas Arnold/picture-alliance/dpa/AP Images)

BioN­Tech opens new plas­mid DNA man­u­fac­tur­ing fa­cil­i­ty in Ger­many

German mRNA player BioNTech opened the doors to a new manufacturing facility on Thursday, this one just about 75 miles north of its headquarters in Mainz, Germany.

BioNTech announced on Thursday that it has completed the construction of its first plasmid DNA manufacturing facility in Marburg, Germany. The facility will produce materials for mRNA-based vaccines and therapies along with cell therapies.

Te­va drops out of in­dus­try trade group PhRMA

Following in AbbVie’s footsteps, Teva confirmed on Friday that it’s dropping out of the industry trade group Pharmaceutical Research and Manufacturers of America (PhRMA).

Teva didn’t give a reason for its decision to leave, saying only in a statement to Endpoints News that it annually reviews “effectiveness and value of engagements, consultants and memberships to ensure our investments are properly seated.”

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Sanofi CFO Jean-Baptiste de Chatillon (L) and CEO Paul Hudson (Romuald Meigneux/Sipa via AP Images)

Sanofi sees downtick in flu sales as it preps for launch of RSV an­ti­body

Sanofi expects its RSV antibody jointly developed with AstraZeneca will be available next season, executive VP of vaccines Thomas Triomphe announced on the company’s quarterly call.

Beyfortus, also known as nirsevimab, was approved in the EU back in November and is currently under FDA review with an expected decision coming in the third quarter of this year. The news comes as the FDA plans to hold advisory committee meetings over the next couple months to review RSV vaccines from Pfizer and GSK.

Christophe Weber, Takeda CEO (Photographer: Shoko Takayasu/Bloomberg via Getty Images)

Take­da fo­cus­es on ‘di­verse’ pipeline prospects on heels of two ac­qui­si­tions

After a whopping $4 billion asset buy from Nimbus Therapeutics, along with a $400 million deal with Hutchmed for a colorectal cancer drug, Takeda executives touted pipeline optimism on its latest earnings call this week.

That’s because the TYK2 inhibitor for psoriasis Takeda is getting from Nimbus, along with the Hutchmed fruquintinib commercialization outside of China, are just two of what it reports are 10 late-stage development programs of promising candidates.