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.

Bio­mark­er 'roadmap­s' and the fu­ture of can­cer R&D; Cur­tain rais­es on #AS­CO22; Pfiz­er, No­var­tis tack­le drug ac­cess; 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.

While this was not a week for earth-shattering news, there were certainly a lot of interesting tidbits. If you found this recap helpful, please recommend it to your friends and colleagues. We’ll see you on the other side of the long weekend.

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Keep­ing pres­sure on Am­gen, Mi­rati draws mixed re­views on lat­est cut of KRAS da­ta

As the close runner-up to Amgen’s Lumakras in the KRAS race, any data cut from Mirati’s adagrasib continues to draw scrutiny from analysts. And the latest batch of numbers from ASCO is a decidedly mixed bag.

While a quick comparison suggests that adagrasib spurred slightly more responses and led to a longer overall survival than Lumakras among a group of non-small cell lung cancer patients, its duration of response appears shorter and the safety profile continues to spark concern.

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Switzer­land to de­stroy over 600,000 ex­pired dos­es of Mod­er­na Covid vac­cine

As concerns related to uptake and distribution continue to linger, Switzerland is among the first countries that plans to destroy hundreds of thousands of expired and unused Covid-19 vaccine doses.

The European country said it plans to destroy more than 600,000 doses of Moderna’s Spikevax Covid-19 vaccine as the doses have reached their expiration date.

However, Moderna CEO Stéphane Bancel told the World Economic Forum in Davos, Switzerland that he’s in the process of throwing 30 million doses in the garbage, exclaiming, “We have a big demand problem.”

Ann is one of ViiV Healthcare's newest spokespeople as the retired school administrator speaks up about her HIV status.

GSK's Vi­iV de­buts next evo­lu­tion in HIV med Dova­to cam­paign with new spokes­peo­ple and new mes­sage

When Ann saw the first TV commercials for HIV medicine Dovato, she didn’t see herself represented. So the 74-year-old retired school administrator who’s been living with HIV since 1998, reached out to GSK’s ViiV Healthcare and asked why not?

Now Ann is one of three people starring in ViiV’s latest Dovato campaign called “Detect This.” The next-step evolution in the branded campaign plays on the word “detect” — often used in describing HIV status under control as undetectable — but in this case, uses the word as a directive for people to understand they can use fewer medicines.

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Tran­si­tion to new Eu­ro­pean clin­i­cal tri­als in­fo sys­tem starts slow­ly

At the end of January, the European Medicines Agency officially launched its new clinical trials info system (CTIS), although the migration to the new platform has only really just begun, and sponsors have until the end of January 2023 before all initial trial applications must be submitted through CTIS.

Overall, 56 clinical trial applications have been submitted in CTIS during the first 3 months since the launch of the system on Jan. 31, according to new data posted by the EMA. By comparison, about 4,000 new trials are authorized each year across Europe.

Nassim Usman, Catalyst Biosciences CEO

Af­ter $60M Ver­tex deal, group of Cat­a­lyst share­hold­ers claims biotech could’ve sold as­sets three years ago

Catalyst Biosciences was down to five employees in March, and the biotech needed to do something after two rounds of layoffs, a nixed collaboration and a culling of its hemophilia program.

In came Vertex, with $60 million to buy up the South San Francisco biotech’s preclinical complement drugs, which target the system that bridges the body’s innate and adaptive immune response and a class most known for Ultomiris and Soliris. The deal includes CB 2782-PEG, the dry AMD drug that Biogen no longer wanted in March.

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Lina Khan, FTC chair (Graeme Jennings/Pool via AP Images)

Pile-on over PBMs con­tin­ues with FTC com­ments and a new bi­par­ti­san Sen­ate bill

More than 500 stakeholders sent comments to the FTC on whether the commission should look further into pharma middlemen, known as PBMs, with many of the commenters calling for more federal oversight.

Similar to the critical open comment period in a deadlocked FTC session last February, pharmacies and pharmacy groups are continuing to call out the lack of transparency among the top 3 PBMs, which control about 80% of the market.

Pharma brands are losing their shine with US consumers who are now thinking about the economy and inflation instead of Covid. (Credit: Shutterstock)

Phar­ma brands fade in an­nu­al Har­ris con­sumer vis­i­bil­i­ty poll: Mod­er­na drops off and Pfiz­er dips

As Covid-19 concerns are fading in the US, so is biopharma visibility. The annual Axios Harris Poll survey to determine and rank the 100 most top-of-mind brands in the US finds Moderna, which was No. 3 last year, not on the list at all for 2022, and Pfizer sinking 37 spots.

However, it’s not that Moderna or Pfizer did anything wrong, it’s just that Americans have moved on to other worries beyond Covid.

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HHS Secretary Xavier Becerra (Jacquelyn Martin/AP Images)

HHS fin­ish­es off Trump-era rule that would've erased ba­sic FDA regs with­out fre­quent re­views

HHS on Thursday finalized its decision to withdraw a rule, proposed just before former President Donald Trump left office, that would’ve caused thousands of HHS and FDA regulations to automatically expire if they weren’t reviewed within two years, and every 10 years thereafter.

The decision follows the filing of a lawsuit last March, in which several nonprofits alleged that the outgoing administration planted “a ticking timebomb” for HHS, essentially forcing it to devote an enormous amount of resources to the unprecedented and infeasible task of reviewing thousands of regulations regularly.