Emily Leproust, Twist Bioscience CEO

Twist Bio­science’s 'fac­to­ry of the fu­ture' in Ore­gon could de­liv­er with com­pet­i­tive pric­ing, SVB Se­cu­ri­ties says

The syn­thet­ic DNA man­u­fac­tur­er Twist Bio­science has giv­en a peek be­hind the cur­tain to sev­er­al an­a­lysts in­to its “fac­to­ry of the fu­ture” as well as in­sight in­to the cost struc­ture, work­flow and tech­nol­o­gy at the site.

The 110,000-square-foot man­u­fac­tur­ing site in the city of Wilsonville, OR, just south of Port­land, which was an­nounced back in 2020, will dou­ble Twist’s pro­duc­tion ca­pac­i­ty and bring around 400 jobs to the area.

In a vis­it to the site by an­a­lysts from SVB Se­cu­ri­ties, Twist’s se­nior man­age­ment shared that the site will not on­ly ex­pand the man­u­fac­tur­ing ca­pac­i­ty for Twist, but it can al­so add new prod­uct ca­pa­bil­i­ties.

Ac­cord­ing to SVB’s analy­sis, the fac­to­ry cur­rent­ly has four “DNA writ­ers” which can each pro­duce around $50 mil­lion in an­nu­al rev­enue, and the fa­cil­i­ty has the room to add eight more. The fac­to­ry al­so pro­vides Twist with the space need­ed to ac­cel­er­ate pro­duc­tion speed more than its oth­er fa­cil­i­ty in San Fran­cis­co, CA.

Man­age­ment al­so told SVB that its prod­ucts can spend up to 50% of their time in stor­age, but the new fac­to­ry will ad­dress this by “con­sol­i­dat­ing in­stru­men­ta­tion and stream­lin­ing in the process.” This will be cru­cial if Twist plans to launch its “Fast Gene” prod­uct in 2023, which is go­ing to ac­cel­er­ate de­liv­ery time for its ex­ist­ing prod­ucts.

The analy­sis al­so em­pha­sized that the com­pa­ny is fo­cused on qual­i­ty con­trol and re­duc­ing er­rors. Be­cause the DNA is writ­ten on a sil­i­con chip plat­form, and these chips are man­u­fac­tured in-house, it lends more process con­trol. It was al­so re­port­ed that each chip that is made un­der­goes “ex­ten­sive” qual­i­ty con­trol and has been reach­ing an even low­er er­ror rate.

In terms of fu­ture rev­enue, Twist’s man­age­ment dis­closed a $35 to $45 “vari­able cost per gene,” with “a sig­nif­i­cant por­tion” of the com­pa­ny’s costs be­ing fixed, but it will aim to dri­ve more prof­its through new prod­ucts and com­pet­i­tive pric­ing. The new fac­to­ry al­so is lever­ag­ing learn­ing from its South San Fran­cis­co fa­cil­i­ty to try and im­prove speed and ef­fi­cien­cy.

“In our view, the Fac­to­ry of the Fu­ture vis­it demon­strates Twist could de­liv­er on gross mar­gins if vol­ume and growth was to ma­te­ri­al­ize. To dri­ve that vol­ume, Twist has to be com­pet­i­tive with pric­ing in the mar­ket, but the de­mand de­pends on the spend­ing en­vi­ron­ment in 2023 which now ap­pears more cau­tious vs. be­fore,” the analy­sis said.

In Twist’s fourth-quar­ter re­port, it an­nounced the fac­to­ry is on track to start ship­ping prod­ucts in Jan­u­ary of next year.

Late Fri­day ap­proval; Trio of biotechs wind down; Stem cell pi­o­neer finds new fron­tier; Biotech icon to re­tire; 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.

I hope your weekend is off to a nice start, wherever you are reading this email. As for me, I’m trying to catch the tail of the Lunar New Year festivities.

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Pfiz­er lays off em­ploy­ees at Cal­i­for­nia and Con­necti­cut sites

Pfizer has laid off employees at its La Jolla, CA, and Groton, CT sites, according to multiple LinkedIn posts from former employees.

The Big Pharma confirmed to Endpoints News it has let go of some employees, but a spokesperson declined to specify how many workers were impacted and the exact locations affected. Earlier this month, the drug developer had confirmed to Endpoints it was sharpening its focus and doing away with some early research on areas such as rare disease, oncology and gene therapies.

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Jake Van Naarden, Loxo@Lilly CEO

Lil­ly en­ters ripe BTK field with quick FDA nod in man­tle cell lym­phoma

Eli Lilly has succeeded in its attempt to get the first non-covalent version of Bruton’s tyrosine kinase, or BTK, inhibitors to market, pushing it past rival Merck.

The FDA gave an accelerated nod to Lilly’s daily oral med, to be sold as Jaypirca, for patients with relapsed or refractory mantle cell lymphoma.

The agency’s green light, disclosed by the Indianapolis Big Pharma on Friday afternoon, catapults Lilly into a field dominated by covalent BTK inhibitors, which includes AbbVie and Johnson & Johnson’s Imbruvica, AstraZeneca’s Calquence and BeiGene’s Brukinsa.

Filip Dubovsky, Novavax CMO

No­vavax gets ready to take an­oth­er shot at Covid vac­cine mar­ket with next sea­son plans

While mRNA took center stage at yesterday’s FDA vaccine advisory committee meeting, Novavax announced its plans to deliver an updated protein-based vaccine based on new guidance.

Vaccines and Related Biological Products Advisory Committee (VRBPAC) members voted unanimously in favor of “harmonizing” Covid vaccine compositions, meaning all future vaccine recipients would receive a bivalent vaccine, regardless of whether they’ve gotten their primary series.

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Rodney Rietze, iVexSol CEO

Bris­tol My­ers, Charles Riv­er join Se­ries A fund­ing for iVex­Sol

Massachusetts-based iVexSol has secured funding to the tune of $23.8 million in its latest Series A round. The new investors include Bristol Myers Squibb, manufacturer Charles River Laboratories and Asahi Kasei Medical.

iVexSol is a manufacturer of lentiviral vectors (LVV), used in making gene therapies, and this latest round of fundraising brings its total Series A total over $39 million, which will be used to recruit more employees and bolster its technology.

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John Rim, Samsung Biologics CEO (Samsung/PR Newswire)

Sam­sung Bi­o­log­ics spells out ex­pan­sion plans in South Ko­rea and US

The CDMO arm of one of South Korea’s largest conglomerates has posted its year-end results and plans for 2023, which include new construction.

Samsung Biologics netted north of KRW 3 trillion ($2.4 billion) in 2022 revenue and an operating profit of KRW 983.6 billion ($799 million), which the company touted on Friday as “record-high earnings.” The revenue boost was 55% compared to 2021.

Ying Huang, Legend CEO

J&J, Leg­end say Carvyk­ti beat stan­dard ther­a­py in ear­li­er-line blood can­cer

J&J and Legend Biotech’s next step in turning their CAR-T therapy Carvykti into a potential megablockbuster has succeeded, the companies said Friday.

Carvykti achieved the primary endpoint — progression-free survival — in an open-label Phase III study testing the treatment in second- to fourth-line multiple myeloma patients. The CARTITUDE-4 trial, for which there aren’t any hard data yet, represents the biggest development for Carvykti’s ability to compete with Bristol Myers Squibb’s Abecma since its approval last February.

CBER Director Peter Marks (Susan Walsh/AP Images)

FDA ad­vi­so­ry com­mit­tee votes unan­i­mous­ly in fa­vor of bi­va­lent Covid shots re­plac­ing pri­ma­ry se­ries

The FDA’s Vaccines and Related Biological Products Advisory Committee (VRBPAC) voted unanimously in favor of “harmonizing” Covid vaccine compositions, meaning all current vaccine recipients would receive a bivalent vaccine, regardless of whether they’ve gotten their primary series.

The vote marks an effort to clear up confusion around varying formulations and dosing schedules for current primary series and booster vaccines, as well as “get closer to the strains that are circulating,” according to committee member Paul Offit, professor of pediatrics at the Children’s Hospital of Philadelphia.

FDA re­ports ini­tial 'no sig­nal' for stroke risk with Pfiz­er boost­ers, launch­es con­comi­tant flu shot study

The FDA hasn’t detected any potential safety signals, including for stroke, in people aged 65 years and older who have received Pfizer’s bivalent Covid booster, one senior official told members of the agency’s Vaccines and Related Biological Products Advisory Committee (VRBPAC) on Thursday.

The update comes as the FDA and CDC investigate a “preliminary signal” that may indicate an increased risk of ischemic stroke in older Americans who received Pfizer’s updated shot.