Dirk Lange (KBI)

KBI plans $150M fa­cil­i­ty in Re­search Tri­an­gle Park with mys­tery co-in­vestor

A month af­ter un­veil­ing plans for a new man­u­fac­tur­ing fa­cil­i­ty in Gene­va, KBI Bio­phar­ma has al­ready pegged the lo­ca­tion for its next site: a $150 mil­lion fa­cil­i­ty in Re­search Tri­an­gle Park, North Car­oli­na.

The 140,000-square-foot fa­cil­i­ty will be ful­ly op­er­a­tional by Q1 2022, and the con­tract ser­vices com­pa­ny says it will be home to more than 200 op­er­a­tions and qual­i­ty as­sur­ance staffers. A mys­tery part­ner is chip­ping in on the fa­cil­i­ty to man­u­fac­ture its pro­tein ther­a­pies, though KBI is keep­ing mum about who.

“Ex­pan­sion of our US-based cell cul­ture op­er­a­tions is a key in­vest­ment to sup­port our client’s com­mer­cial­iza­tion strate­gies,” KBI pres­i­dent and CEO Dirk Lange said in a state­ment.

The new site is about a five-minute dri­ve from Pa­tri­ot Park, where KBI’s mam­malian drug de­vel­op­ment labs are al­ready lo­cat­ed. The com­pa­ny says its new fa­cil­i­ty will house up to six 2,000-liter, sin­gle-use biore­ac­tor sys­tems and as­so­ci­at­ed har­vest and pu­rifi­ca­tion equip­ment, which could pump out more than 100 com­mer­cial batch­es a year. KBI tout­ed that the fa­cil­i­ty will al­so in­clude elec­tron­ic batch records, elec­tron­ic log­books, pa­per­less ma­te­ri­als man­age­ment and Lab­o­ra­to­ry In­for­ma­tion Man­age­ment Sys­tems (LIMS) for qual­i­ty con­trol da­ta man­age­ment.

“By ex­pand­ing our com­mer­cial man­u­fac­tur­ing foot­print with this fa­cil­i­ty, we are able to pro­vide our part­ners with launch ma­te­r­i­al and mar­ket sup­ply,” Lange said. “We chose to build this new fa­cil­i­ty in the Re­search Tri­an­gle Park be­cause it gives us ac­cess to high­ly-spe­cial­ized re­sources. The com­bi­na­tion of tal­ent, tech­ni­cal and aca­d­e­m­ic train­ing in this re­gion is out­stand­ing, which is crit­i­cal as we are ex­pand­ing our im­pact by serv­ing more clients and pa­tients from this new fa­cil­i­ty.”

RTP, close to three of the state’s top re­search uni­ver­si­ties, is home to a grow­ing num­ber of CD­MOs and bio­phar­ma com­pa­nies. Back in Jan­u­ary, Eli Lil­ly re­served $470 mil­lion for a new man­u­fac­tur­ing site in the area to be­gin pro­duc­tion of in­jectable prod­ucts and de­liv­ery de­vices.

Da­ta Lit­er­a­cy: The Foun­da­tion for Mod­ern Tri­al Ex­e­cu­tion

In 2016, the International Council for Harmonisation (ICH) updated their “Guidelines for Good Clinical Practice.” One key shift was a mandate to implement a risk-based quality management system throughout all stages of a clinical trial, and to take a systematic, prioritized, risk-based approach to clinical trial monitoring—on-site monitoring, remote monitoring, or any combination thereof.

Pfiz­er's big block­buster Xel­janz flunks its post-mar­ket­ing safe­ty study, re­new­ing harsh ques­tions for JAK class

When the FDA approved Pfizer’s JAK inhibitor Xeljanz for rheumatoid arthritis in 2012, they slapped on a black box warning for a laundry list of adverse events and required the New York drugmaker to run a long-term safety study.

That study has since become a consistent headache for Pfizer and their blockbuster molecule. Last year, Pfizer dropped the entire high dose cohort after an independent monitoring board found more patients died in that group than in the low dose arm or a control arm of patients who received one of two TNF inhibitors, Enbrel or Humira.

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Covid-19 roundup: EU and As­traZeneca trade blows over slow­downs; Un­usu­al unions pop up to test an­ti­bod­ies, vac­cines

After coming under fire for manufacturing delays last week, AstraZeneca’s feud with the European Union has spilled into the open.

The bloc accused the pharma giant on Wednesday of pulling out of a meeting to discuss cuts to its vaccine supplies, the AP reported. AstraZeneca denied the reports, saying it still planned on attending the discussion.

Early Wednesday, an EU Commission spokeswoman said that “the representative of AstraZeneca had announced this morning, had informed us this morning that their participation is not confirmed, is not happening.” But an AstraZeneca spokesperson later called the reports “not accurate.”

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Pascal Soriot, AP

As­traZeneca CEO Pas­cal So­ri­ot sev­ers an un­usu­al board con­nec­tion, steer­ing clear of con­flicts while re­tain­ing im­por­tant al­liances

CSL Behring chief Paul Perreault scored an unusual coup last summer when he added AstraZeneca CEO Pascal Soriot to the board, via Zoom. It’s rare, to say the least, to see a Big Pharma CEO take any board post in an industry where interests can simultaneously connect and collide on multiple levels of operations.

The tie set the stage for an important manufacturing connection. The Australian pharma giant agreed to supply the country with 10s of millions of AstraZeneca’s Covid-19 vaccine, once it passes regulatory muster.

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Adeno-associated virus-1 illustration; the use of AAVs resurrected the gene therapy field, but companies are now testing the limits of a 20-year-old technology (File photo, Shutterstock)

Af­ter 3 deaths rock the field, gene ther­a­py re­searchers con­tem­plate AAV's fu­ture

Nicole Paulk was scrolling through her phone in bed early one morning in June when an email from a colleague jolted her awake. It was an article: Two patients in an Audentes gene therapy trial had died, grinding the study to a halt.

Paulk, who runs a gene therapy lab at the University of California, San Francisco, had planned to spend the day listening to talks at the American Association for Cancer Research annual meeting, which was taking place that week. Instead, she skipped the conference, canceled every work call on her calendar and began phoning colleagues across academia and industry, trying to figure out what happened and why. All the while, a single name hung in the back of her head.

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Mer­ck scraps Covid-19 vac­cine pro­grams af­ter they fail to mea­sure up on ef­fi­ca­cy in an­oth­er ma­jor set­back in the glob­al fight

After turning up late to the vaccine development game in the global fight against Covid-19, Merck is now making a quick exit.

The pharma giant is reporting this morning that it’s decided to drop development of 2 vaccines — V590 and V591 — after taking a look at Phase I data that simply don’t measure up to either the natural immune response seen in people exposed to the virus or the vaccines already on or near the market.

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Anthony Fauci, NIAID director (AP Images)

As new Covid-19 task force gets un­der­way, threat looms of vac­cine, mon­o­clon­al an­ti­body-re­sis­tant vari­ants

Hours before President Biden’s Covid-19 team gave their first virtual press conference, the famed AIDS researcher David Ho delivered concerning news in a new pre-print: SARS-CoV-2 B.1.351, the variant that emerged in South Africa, is “markedly more resistant” to antibodies from convalescent plasma and vaccinated individuals.

The news for several monoclonal antibodies, including Eli Lilly’s bamlanivimab, was even worse: Their ability to neutralize was “completely or markedly abolished,” Ho wrote. Lilly’s antibody cocktail, which was just shown to dramatically reduce the risk of hospitalizations or death, also became far less potent.

Jackie Fouse, Agios CEO

Agios scores its sec­ond pos­i­tive round of da­ta for its lead pipeline drug — but that won't an­swer the stub­born ques­tions that sur­round this pro­gram

Agios $AGIO bet the farm on its PKR activator drug mitapivat when it recently decided to sell off its pioneering cancer drug Tibsovo and go back to being a development-stage company — for what CEO Jackie Fouse hoped would be a short stretch before they got back into commercialization.

On Tuesday evening, the bellwether biotech flashed more positive topline data — this time from a small group of patients in a single-arm study. And the executive team plans to package this with its earlier positive results from a controlled study to make its case for a quick OK.

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Vir's CMO says he's sur­prised that a low dose of their he­pati­tis B drug ap­pears promis­ing in ear­ly slice of da­ta — shares soar

Initial topline data from a Phase I study of a new therapeutic for chronic hepatitis B virus was so promising that it surprised even the CMO of the company that produces it.

Vir Biotechnology on Tuesday announced that its VIR-3434 molecule reduced the level of virus surface antigens present in a blinded patient cohort after eight days of the trial with just a single 6 mg dose. Six of the eight patients in the cohort were given the molecule, and the other two a placebo—all six who received the molecule saw a mean antigen reduction of 1.3 log10 IU/mL, Vir said.

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