Emily Leproust, Twist

Twist Bio­science plots its 'fac­to­ry of the fu­ture' in Ore­gon, seeks to ex­pand syn­thet­ic DNA client base

One of the lead­ing play­ers at the fore­front of syn­thet­ic DNA pro­duc­tion, Cal­i­for­nia-based Twist Bio­science has al­ready had a busy 2020. Now, seek­ing to ex­pand its client base and tech­nol­o­gy ca­pa­bil­i­ties even fur­ther, it’s build­ing its “fac­to­ry of the fu­ture.”

Twist, which man­u­fac­tures syn­thet­ic DNA by writ­ing it on a sil­i­con chip plat­form, will build a 110,000-square-foot fa­cil­i­ty near Port­land, Ore­gon, that will more than dou­ble its cur­rent pro­duc­tion ca­pac­i­ty by the time the fa­cil­i­ty is op­er­a­tional in 2022.

Emi­ly Lep­roust, Twist co-founder and CEO, said in a state­ment that the fac­to­ry will al­low Twist to serve client pop­u­la­tions in the biotech sphere that it sim­ply can’t with the com­pa­ny’s cur­rent pro­duc­tion ca­pac­i­ty—hence the name “fac­to­ry of the fu­ture.”

“We are ex­pand­ing our cus­tomer base and ramp­ing pro­duc­tion of our prod­ucts at an ex­cep­tion­al rate,” she said. “The (fac­to­ry) al­lows us to sup­port the in­creas­ing needs of our cus­tomers as they scale glob­al­ly and plan for ag­gres­sive growth in­to syn­thet­ic bi­ol­o­gy and bio­phar­ma mar­ket seg­ments we can­not serve to­day.”

The cap­i­tal out­lay as­so­ci­at­ed with the fa­cil­i­ty, lo­cat­ed more specif­i­cal­ly in Wilsonville, was kept un­der wraps. How­ev­er, Twist said it ex­pect­ed the plant to bring some 400 jobs to the area by the time it’s up and run­ning.

Be­yond its “fac­to­ry of the fu­ture,” Twist has had a busy 2020. Most re­cent­ly, the com­pa­ny in Oc­to­ber an­nounced a col­lab­o­ra­tion with Neo­gene to study CAR-T and TCR ther­a­pies for can­cer pa­tients. Twist will cre­ate a TCR li­brary — a self-pro­claimed “li­brary of li­braries” — to aid Neo­gene’s search for en­gi­neered TCRs against tar­gets in can­cer, and Twist will al­so use the li­brary to dis­cov­er an­ti­bod­ies for fu­ture Neo­gene CAR-T can­di­dates.

In Ju­ly, the com­pa­ny tapped Erin Smith to be its se­nior vice pres­i­dent of gov­ern­ment af­fairs and pub­lic pol­i­cy, a new­ly-cre­at­ed po­si­tion. Smith had pre­vi­ous­ly helped lead the ex­pan­sion of a gov­ern­ment af­fairs pro­gram at Gilead.

And in Feb­ru­ary, Twist and Lep­roust spent $22.5 mil­lion to set­tle one of the biggest is­sues hang­ing over the com­pa­ny — a four-year le­gal bat­tle over Lep­roust’s de­par­ture from Ag­i­lent. Ag­i­lent, a 20-year old syn­thet­ic DNA man­u­fac­tur­er, al­leged that Lep­roust mis­ap­pro­pri­at­ed trade se­crets and was in breach of con­tract when she left Ag­i­lent to start Twist with co-founders Bill Banyai and Bill Peck.

In that set­tle­ment, nei­ther Ag­i­lent nor Twist ad­mit­ted any li­a­bil­i­ty or wrong­do­ing.

Biotech and Big Phar­ma: A blue­print for a suc­cess­ful part­ner­ship

Strategic partnerships have long been an important contributor to how drugs are discovered and developed. For decades, big pharma companies have been forming alliances with biotech innovators to increase R&D productivity, expand geographical reach and better manage late-stage commercialization costs.

Noël Brown, Managing Director and Head of Biotechnology Investment Banking, and Greg Wiederrecht, Ph.D., Managing Director in the Global Healthcare Investment Banking Group at RBC Capital Markets, are no strangers to the importance of these tie-ups. Noël has over 20 years of investment banking experience in the industry. Before moving to the banking world in 2015, Greg was the Vice President and Head of External Scientific Affairs (ESA) at Merck, where he was responsible for the scientific assessment of strategic partnership opportunities worldwide.

No­var­tis' sec­ond at­tempt to repli­cate a stun­ning can­cer re­sult falls flat

Novartis’ hopes of turning one of the most surprising trial data points of the last decade into a lung cancer drug has taken another setback.

The Swiss pharma announced Monday that its IL-1 inhibitor canakinumab did not significantly extend the lives or slow the disease progression of patients with previously untreated locally advanced or metastatic non-small cell lung cancer when compared to standard of-care alone.

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AstraZeneca CEO Pascal Soriot (Raphael Lafargue/Abaca/Sipa USA)

A com­bo of As­traZeneca's Imfinzi and chemo wins where oth­ers have failed in piv­otal bil­iary tract test

Looking to run with the big dogs in the PD-(L)1 class, AstraZeneca’s Imfinzi has a tall hill to climb to compete in an increasingly bustling market. An aggressive combo strategy for the drug has paid off so far, and now AstraZeneca is adding another notch to its belt.

A combo of Imfinzi (durvalumab) and chemotherapy significantly extended the lives of first-line patients with advanced biliary tract cancer over chemo alone, according to topline results from the Phase III TOPAZ-1 study revealed Monday.

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Sean Ianchulev, Eyenovia CEO and CMO

Re­cent court de­ci­sion push­es FDA to re­ject and re­clas­si­fy drug-de­vice com­bo, crush­ing shares

Back in April, the FDA lost a crucial court case in which its broad discretion of regulating medical products that might satisfy the legal definitions of either “drug” and/or “medical device” was sharply curtailed.

In addition to the appeals court ruling that Genus Medical Technologies’ contrast agent barium sulfate (aka Vanilla SilQ) should not be considered a drug, as the FDA had initially ruled, but as a medical device, the agency also was forced to spell out which drugs would transition to devices as a result of the ruling.

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Robert Califf (Pablo Martinez Monsivais, AP Images, File)

As buzz on Califf FDA nom heats up, in­dus­try and agency in­sid­ers of­fer a strong nod for the ‘per­fect’ choice

For once in this long, dramatic road to finding a new FDA commissioner, there’s been some continuity. Both CNN and Politico reported this weekend that Rob Califf met with President Biden to discuss the permanent commish role, following earlier news broken by the Washington Post that all signs point to Califf.

Although there may be a few Democrats who continue to grandstand about the dangers of COI (Califf has worked for Verily, sits on the board of Centessa Pharmaceuticals, and has other ties to industry research), with the pandemic ongoing and the need for some kind of continuity at FDA mounting, Califf is likely to meet the same fate as when he first won Senate confirmation in 2016, by a vote of 89-4 — Bernie Sanders and 6 others didn’t vote.

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Sim­mer­ing feud be­tween blue­bird and a ri­val con­tin­ues with al­le­ga­tions of patent fraud

Bluebird bio was hit with a patent infringement lawsuit last week from a Chicago-based biotech it has had an ongoing beef with calling for $2 billion to help cure the “irreparable harm” caused by alleged willful infringement.

Bluebird bio is facing a lawsuit from Errant Gene Therapeutics for violating patent law in two instances, the company says.

The suit alleges that bluebird infringed the rights of EGT’s recombinant vectors used in the gene therapy treatment of rare diseases such as sickle cell disease and beta thalassemia for its drugs Zynteglo and LentiGlobin. EGT has an exclusive license from the Memorial Sloan Kettering Cancer Center to patents titled “vector encoding human global gene and use thereof in treatment of Hemoglobinopathies.”

Sanofi, Re­gen­eron gear up for new Dupix­ent fil­ing af­ter clear­ing sec­ond PhI­II for eosinophilic esophagi­tis

This fall’s harvest is proving fruitful for Dupixent.

Days after touting a clean Phase III sweep in prurigo nodularis, Sanofi and Regeneron report that their blockbuster anti-inflammatory drug has passed another Phase III test with flying colors, paving the way for regulatory filings in 2022.

It’s the second trial where Dupixent has proven effective against eosinophilic esophagitis, meeting the co-primary endpoints by spurring significant improvements in both clinical and histologic disease measures.

Peter Greenleaf, Aurinia CEO

Af­ter pass­ing on Ac­celeron, Bris­tol My­ers eyes bolt-on ac­qui­si­tion of au­toim­mune spe­cial­ist — re­port

Bristol Myers Squibb is looking to beef up its autoimmune portfolio by scooping up Aurinia Pharmaceuticals, Bloomberg reported.

The recent overtures to Aurinia, relayed by anonymous insiders, came just as Bristol Myers turned down buyout talks with partners at Acceleron — which Merck ultimately struck a deal to acquire for $11.5 billion. Bristol Myers has reportedly decided to cash out on its minority stake, likely bagging $1.3 billion in the process, while keeping the royalty deals on two of Acceleron’s blood disorder drugs.

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So — that pig-to-hu­man trans­plant; Po­ten­tial di­a­betes cure reach­es pa­tient; Ac­cused MIT sci­en­tist lash­es back; and more

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