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.

Biotech Half­time Re­port: Af­ter a bumpy year, is biotech ready to re­bound?

The biotech sector has come down firmly from the highs of February as negative sentiment takes hold. The sector had a major boost of optimism from the success of the COVID-19 vaccines, making investors keenly aware of the potential of biopharma R&D engines. But from early this year, clinical trial, regulatory and access setbacks have reminded investors of the sector’s inherent risks.

RBC Capital Markets recently surveyed investors to take the temperature of the market, a mix of specialists/generalists and long-only/ long-short investment strategies. Heading into the second half of the year, investors mostly see the sector as undervalued (49%), a large change from the first half of the year when only 20% rated it as undervalued. Around 41% of investors now believe that biotech will underperform the S&P500 in the second half of 2021. Despite that view, 54% plan to maintain their position in the market and 41% still plan to increase their holdings.

Man­u­fac­tur­ing woes for No­vavax’s Covid jab bad­ly dis­rupt plans for roll­out to the poor — re­port

Production problems at a Novavax facility in Maryland have led to delays in the Covax vaccine sharing program. Now, a shortage of 1 billion doses is expected, as the supplier tries to navigate producing a shot up to regulators’ standards, Politico reported Tuesday.

The company has run into trouble with the purity of the vaccine. Novavax has had trouble proving it can produce a shot consistently up to standards, and it has caused significant delays in the rollout to low- and middle-income countries. This follows several delays at Novavax that has put the executive crew on the defensive.

David Livingston (Credit: Michael Sazel for CeMM)

Renowned Dana-Far­ber sci­en­tist, men­tor and bio­phar­ma ad­vi­sor David Liv­ingston has died

David Livingston, the Dana-Farber/Harvard Med scientist who helped shine a light on some of the key molecular drivers of breast and ovarian cancer, died unexpectedly last Sunday.

One of the senior leaders at Dana-Farber during his nearly half century of work there, Livingston was credited with shedding light on the genes that regulate cell growth, with insights into inherited BRCA1 and BRCA2 mutations that helped lay the scientific foundation for targeted therapies and earlier detection that have transformed the field.

No­vo CEO Lars Fruer­gaard Jør­gensen on R&D risk, the deal strat­e­gy and tar­gets for gen­der di­ver­si­ty

 

I kicked off our European R&D summit last week with a conversation involving Novo Nordisk CEO Lars Fruergaard Jørgensen. Novo is aiming to launch a new era of obesity management with a new approval for semaglutide. And Jørgensen had a lot to say about what comes next in R&D, how they manage risk and gender diversity targets at the trendsetting European pharma giant.

John Carroll: I’m here with Lars Jørgensen, the CEO of Novo Nordisk. Lars, it’s been a really interesting year so far with Novo Nordisk, right? You’ve projected a new era of growing sales. You’ve been able to expand on the GLP-1 franchise that was already well established in diabetes now going into obesity. And I think a tremendous number of people are really interested in how that’s working out. You have forecast a growing amount of sales. We don’t know specifically how that might play out. I know a lot of the analysts have different ideas, how those numbers might play out, but that we are in fact embarking on a new era for Novo Nordisk in terms of what the company’s capable of doing and what it’s able to do and what it wants to do. And I wanted to start off by asking you about obesity in particular. Semaglutide has been approved in the United States for obesity. It’s an area of R&D that’s been very troubled for decades. There have been weight loss drugs that have come along. They’ve attracted a lot of attention, but they haven’t actually ever gained traction in the market. My first question is what’s different this time about obesity? What is different about this drug and why do you expect it to work now whereas previous drugs haven’t?

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Sur­geons suc­cess­ful­ly at­tach pig kid­ney to a hu­man for the first time, us­ing tech from Unit­ed's Re­vivi­cor

In a first, researchers reportedly successfully transplanted a pig kidney into a human without triggering an immediate immune response this week. And the technology came from the biotech United Therapeutics.

Surgeons spent three days attaching the kidney to the patient’s blood vessels, but when all was said and done, the kidney appeared to be functioning normally in early testing, Reuters and the New York Times were among those to report. The kidney came from a genetically altered pig developed through United’s Revivicor unit.

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Break­ing: Bio­gen sells just $300K worth of Aduhelm in Q3, as ques­tions on long term vi­a­bil­i­ty re­main

Barely anyone is accessing Biogen’s controversial Alzheimer’s treatment, with the company reporting just $0.3 million in Aduhelm sales in the third quarter. Although investors will be looking to the longer term, when CMS may decide to cover the drug and open the floodgates for more coverage, use of the drug is currently stalled.

Since June, when the FDA first signed off on the drug under its accelerated pathway, Biogen said Wednesday that it’s sold a total of $2 million worth of Aduhelm. Biogen said on its earnings call that about 120 sites so far have infused at least one patient with Aduhelm, which is priced at $56,000 annually. Morgan Stanley previously predicted about 14,000 patients will access Aduhelm by the end of 2022.

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Bill Gates at the Global Investment Summit in London, Oct. 19, 2021 (Leon Neal/Pool via AP Images)

Gates Foun­da­tion pledges $120M to ramp up gener­ic sup­ply of Mer­ck­'s Covid-19 pill while ac­tivists blast Pfiz­er's dis­pro­por­tion­ate pow­er

Merck’s molnupiravir may not be officially authorized anywhere in the world yet, but who will get access to it has shaped up to be a huge issue. The Bill & Melinda Gates Foundation is now stepping up to ensure lower-income countries won’t be left behind — and calling on others to follow its lead.

The oral antiviral pill, which was shown to dramatically cut the risk of severe Covid-19 disease and death in a Phase III study, is the latest rallying symbol in the battle against not just the coronavirus but the inequality it’s exposed.

With hun­dreds of mil­lions spent on failed ac­cel­er­at­ed ap­provals, re­searchers call for faster FDA with­drawals

Between 2017 and 2019, Medicare spent more than $220 million on cancer drugs for which the indications were either voluntarily pulled by their applicants or FDA’s oncology adcomm had recommended their withdrawal.

That kind of massive spending on cancer drugs lacking overall survival benefit is wasteful and risks harming people’s health, a research letter published in JAMA Internal Medicine on Monday said. The researchers from Harvard and the London School of Economics called on the FDA to move faster in both requiring timely postmarketing trials and accelerating the speed in pulling these dangling approvals when the confirmatory studies fail.

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Raymond Stevens, ShouTi Pharma CEO

A new Schrödinger-backed start­up emerges from the sci­en­tist who mapped the first hu­man GPCR

One of the most popular targets in drug development, representing about a third of existing drugs, are G-protein coupled receptors — the tiny but integral membrane proteins responsible for recognizing things like light, taste, smell, hormones and pain.

But due to challenges in mapping their structure, the protein family remains largely unexplored.

A slate of companies has emerged over the last few years to change that. If one can figure out the structure of these elusive membrane receptors, it might be possible to create small molecule drugs that overcome the limitations of, say, biologic and peptide therapies. That promise is what gets serial entrepreneur Raymond Stevens out of bed in the morning.