Chi­nese on­col­o­gy play­er is the lat­est to join the North Car­oli­na man­u­fac­tur­ing par­ty with 2 new plants in the off­ing

While Boston and the Bay Area reign supreme in terms of biotech hotspots, oth­er hubs are hav­ing their chance in the sun amid a flur­ry of cash flood­ing the in­dus­try. North Car­oli­na, for in­stance, has seen a ton of com­pa­nies look­ing to es­tab­lish a foot­print in the state — and now a Shang­hai-based on­col­o­gy play­er will join the fold.

CARs­gen Ther­a­peu­tics will open two new sites in Raleigh-Durham, cre­at­ing the com­pa­ny’s first man­u­fac­tur­ing hub that will com­ple­ment its clin­i­cal de­vel­op­ment site in Hous­ton, the com­pa­ny said Mon­day.

The plans in­clude build­ing a 37,000-square-foot man­u­fac­tur­ing fa­cil­i­ty to han­dle clin­i­cal and ear­ly-stage com­mer­cial man­u­fac­tur­ing as well as a 100,000-square-foot com­mer­cial plant near­by. The new fa­cil­i­ty will cost about $157 mil­lion, and cre­ate around 200 jobs, the North Car­oli­na De­part­ment of Com­merce said in a re­lease.

The com­pa­ny spe­cial­izes in CAR-T cell ther­a­pies, which can tar­get leukemia, lym­phoma and sol­id tu­mors. It cur­rent­ly has launched clin­i­cal stud­ies of CT053 and CT041 in the US, and CEO Zong­hai Li said in a state­ment that the new fa­cil­i­ties will help pro­duce those ther­a­pies.

In 2019, CT053 was grant­ed re­gen­er­a­tive med­i­cine ad­vanced ther­a­py des­ig­na­tion by the FDA to treat re­lapsed and/or re­frac­to­ry mul­ti­ple myelo­ma, based on da­ta from the com­pa­ny’s Phase I study in heav­i­ly pre-treat­ed mul­ti­ple myelo­ma pa­tients in Chi­na. It al­so re­ceived in­ves­ti­ga­tion­al new drug sta­tus for CT041 from the FDA. CT041 is the first CAR-Claudin18.2 treat­ment tar­get­ing sol­id tu­mors to en­ter clin­i­cal tri­als, the com­pa­ny said.

The com­pa­ny closed its Se­ries C fundrais­ing in No­vem­ber 2020 with $186 mil­lion from pri­vate eq­ui­ty firm Loy­al Val­ley Cap­i­tal and joined by Lil­ly Asia Ven­tures, Shiyu Cap­i­tal, and Sum­mer Cap­i­tal.

CARs­gen is just the lat­est com­pa­ny to set up its man­u­fac­tur­ing op­er­a­tions in the Raleigh-Durham area. In March, Fu­ji­film Diosynth Biotech­nolo­gies tapped Hol­ly Springs as the site for its $2 bil­lion cell cul­ture me­dia su­per­plant, pledg­ing to add 725 jobs in the area by 2028.

The plant will come on­line in spring 2025 and house eight 20,000-liter biore­ac­tors with the po­ten­tial to ex­pand and add a fur­ther 24 biore­ac­tors of the same size “based on mar­ket de­mand,” the com­pa­ny says. The site will al­so in­clude com­mer­cial-scale, au­to­mat­ed fill-fin­ish and as­sem­bly, pack­ag­ing and la­bel­ing ser­vices.

In­vi­tae Cor­po­ra­tion an­nounced the ad­di­tion of a 250,000-square-foot fa­cil­i­ty in the area in April. Around the same time, CD­MO Abzena un­veiled plans to spend $200 mil­lion to build a bi­o­log­ics cen­ter in San­ford. Abzena’s ex­pan­sion in the area will add 325 jobs, the com­pa­ny said.

Adap­tive De­sign Meth­ods Of­fer Rapid, Seam­less Tran­si­tion Be­tween Study Phas­es in Rare Can­cer Tri­als

Rare cancers account for 22 percent of cancer diagnoses worldwide, yet there is no universally accepted definition for a “rare” cancer. Moreover, with the evolution of genomics and associated changes in categorizing tumors, some common cancers are now characterized into groups of rare cancers, each with a unique implication for patient management and therapy.

Adaptive designs, which allow for prospectively planned modifications to study design based on accumulating data from subjects in the trial, can be used to optimize rare oncology trials (see Figure 1). Adaptive design studies may include multiple cohorts and multiple tumor types. In addition, numerous adaptation methods may be used in a single trial and may facilitate a more rapid, seamless transition between study phases.

Marianne De Backer (L) and Jeff Hatfield

Bay­er nabs star biotech Vi­vid­ion with a $2B buy­out and an ‘arms-length’ pact, pulling a part­ner out of the IPO con­ga line

Vividion is canceling that IPO it filed. Instead of following the industry-wide migration to Nasdaq, the biotech that has captured considerable attention for its still-preclinical work finding cryptic pockets to bind to on proteins is going to work for Bayer now.

The pharma giant is putting out word today that it has bought out Vividion for $1.5 billion in cash and another half-billion dollars in milestones.

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Tadataka Yamada (Photographer: Kiyoshi Ota/Bloomberg via Getty Images)

Sci­ence pi­o­neer, phar­ma re­search chief, glob­al health ad­vo­cate and biotech en­tre­pre­neur Tadata­ka ‘Tachi’ Ya­ma­da has died

Tadataka Yamada, a towering physician-scientist who made his name in academia before transforming drug development at GlaxoSmithKline and developing vaccines for malaria and meningitis at the Gates Foundation, died unexpectedly of natural causes at his home in Seattle Wednesday morning.

He was 76. Frazier Healthcare Partners’ David Socks confirmed his death.

Known widely by the mononym “Tachi,” Yamada had a globetrotting career and arrived in industry relatively late in life. A 2004 Independent article noted GSK had asked Yamada to stay on beyond his approaching 60th birthday, the company’s usual retirement age. Yamada would continue working for the next 17 years, steering the Gates Foundation’s global health division for 6 years, funding Jim Wilson’s gene therapy work when few would touch it, launching Takeda Vaccines and co-founding a series of high-profile biotechs.

UK re-in­ves­ti­gates Pfiz­er's eye-pop­ping price goug­ing on an epilep­sy drug

When a drugmaker raises the price of a drug in the US by more than 2,000% overnight, and without any particular reason for that increase, nothing typically happens to the company. No fines, no court orders, just business as usual.

Martin Shkreli’s decades-old anti-parasitic drug Daraprim was the perfect example — massive price spike on an old drug, lots of media attention, public outcry, Congressional committees dragging his former company through multiple hearings, and at the end of it? Nothing happened to the price or the company (until generic competition came).

Thomas Lingelbach, Valneva CEO

A small vac­cine de­vel­op­er fa­vored by the UK gov­ern­ment in Covid-19 touts a PhI­II first in chikun­gun­ya

Before Valneva garnered the favor of the UK government as a potential supplier of Covid-19 vaccines, the French biotech prided itself on being the first company to bring a chikungunya vaccine into Phase III.

It now has positive pivotal results to back up the breakthrough therapy designation the FDA granted just weeks ago.

There are currently no approved jabs to prevent chikungunya virus infection despite decades of R&D efforts, a fact that underscores just how arduous traditional vaccine development can be, particularly for neglected tropical disease. In a absence of a major commercial market, the US government and NGOs such as CEPI have deployed various grants and incentives to spur on a small crew of academics and industry players, with Merck, via its acquisition of Themis, claiming a spot in that race.

Josh Hoffman, outgoing Zymergen CEO (Zymergen)

UP­DAT­ED: Syn­bio uni­corn Zymer­gen jet­ti­sons found­ing CEO, cuts guid­ance as cus­tomers re­port lead prod­uct does­n't work

Zymergen, just months off a $500 million IPO that put the synthetic bio firm in rarified air, has now ejected its founding CEO and downgraded its revenue forecasts after customers reported its lead film product doesn’t work as advertised, the company said Tuesday afternoon.

CEO Josh Hoffman will leave his role and sacrifice his board seat immediately in favor of Jay Flatley, the former CEO of Illumina who will take the lead role on an interim basis as the company conducts a search for its next leader.

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Zymergen co-founders Zach Serber, Josh Hoffman, and Jed Dean (Zymergen via website)

Zymer­gen's sud­den im­plo­sion shocked biotech. A lin­ger­ing loan could make things even worse

As former synbio unicorn Zymergen picks up the pieces from its spectacular implosion Tuesday, an outstanding loan from Perceptive Advisors — the only blue-chip biotech crossover investor to touch Zymergen’s fundraising efforts — could make the situation worse, according to public documents.

In December 2019, more than a year before Zymergen filed for what would eventually become a $500 million IPO, the “biofacturing” firm signed a $100 million credit facility with Perceptive to help supplement the nearly $700 million the company had raised across four VC rounds.

Am­gen adds new NC plant to the list as part of $1B man­u­fac­tur­ing ex­pan­sion plans state­side

What can $1 billion buy? If you’re Amgen, it’s good for two manufacturing facilities in the US.

The California-based drug giant will invest close to $550 million in a drug substance plant in Holly Springs, NC, adding itself to an ever-growing list of biotech companies that have decided to call North Carolina home, and marking its second drug manufacturing announcement in a little more than a month.

Bio­gen, Ei­sai are push­ing for an­oth­er ac­cel­er­at­ed Alzheimer's OK — this time for BAN2401

Now that the door at the FDA has been opened wide for Alzheimer’s drugs that can demonstrate a reduction in amyloid, Biogen and its partners at Eisai are pushing for a quick OK on the next drug to follow in the controversial path of aducanumab.

In a presentation to analysts, Eisai neurology chief Ivan Cheung outlined some bullish expectations for their newly-approved treatment and set the stage for what he believes will be a fast follow for BAN2401 (lecanemab) — after a dry spell in new drug development that’s lasted close to 20 years.

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