A Belgian cell therapy company has secured $60 million in funding to strengthen its manufacturing operations, and grow the cell and gene therapy ecosystem across the world.
Ncardia landed the funding from Kiniciti, a US investment platform backed by Welsh, Carson, Anderson & Stowe, a New York City private equity company. The move gives Kiniciti a controlling stake in Ncardia to enhance anything from discovery to clinical programs to commercialized production, the company said in a press release.
Ncardia will use the capital from Kiniciti to boost drug discovery though building additional human cellular models that have the ability to predict whether drugs are safe and effective earlier in the development process. It will also use new manufacturing technology to create iPSC-based allogenic platforms for immuno-oncology. This will hopefully expand access and drive down the cost of the cell therapies.
‘Combining Ncardia’s revolutionary, differentiated science with our ability to build global companies and supporting ecosystems will create significant value for therapeutic customers,’ Kiniciti CEO Geoff Glass said in a press release. ‘We’re excited to make Ncardia the centerpiece of an ecosystem that we will build to ensure that cell therapies claim their rightful place in advancing human health. Through this partnership, Ncardia’s customers will benefit from the company’s expanded cGMP capabilities in cell therapy and more robust offerings in discovery services.’
Ncardia uses induced pluripotent stem cells (iPSC), which can be generated directly from a somatic cell such as blood or skin.
The company entered a non-exclusive licensing agreement with Evotec back in 2017 that gave the German biotech access to Ncardia’s stem cell derived cellular disease modeling IP. That deal came just months after Ncardia announced it would enter a license agreement with Roche for its first-ever partnership.
In a 2020 interview with Drug Target Review, CEO Stefen Braam said that his company struggled with the scalability process for years and years. Now, the company generates large batches of cells and cryopreserves them to enable the usage of the same batch for development and the screen to minimize variability of the iPSCs.
‘Now, we’ve really got that under control,’ he said in the interview. ‘The key thing in solving that was changing the culturing methodology to suspension culture in bioreactors. With bioreactors, we have now reached sizes of approximately 20 billion cardiomyocytes in a single batch. The billion is the new million.’
For years, paper-based processes and individual point solutions dominated the clinical research landscape, and patient participation in clinical trials was largely an in-person engagement. But when the COVID-19 pandemic took a stronghold, traditional clinical trial methods emerged as inadequate, putting clinical trials and the life sciences industry at a crossroads. Practically overnight, the industry had to rapidly shift to decentralized clinical trial methods, while maintaining data quality and regulatory compliance.
Gilead is going all in — hook, line and sinker — on its oncology alliance with Arcus. And they are going for broke.
The big biotech unveiled a deal that now delivers $725 million in opt-in payments covering the clinical development programs for Arcus, ranging from their closely watched anti-TIGIT programs for domvanalimab and AB308 to etrumadenant (the A2a/A2b adenosine receptor antagonist) and quemliclustat, the small molecule CD73 inhibitor. Gilead will also cover half of the development costs, handing Terry Rosen’s biotech a deal that gives them a clear cash runway to achieving all its goals in oncology.
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Douglas Fambrough, Dicerna CEO (Dicerna via YouTube)
Early this year researchers at Novo Nordisk were beaming as they announced the first drug identified in their RNAi alliance with Dicerna was headed into the clinic. And now they’re coming back for the whole thing.
This morning the Copenhagen-based pharma giant put out word that it is buying Dicerna $DRNA — an RNAi pioneer that has had its up and downs over the years — for $3.3 billion. Novo is paying $38.25 a share — an 80% premium.
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Catherine Stehman-Breen and Vic Myer, Chroma CEO and CSO
A handful of the world’s most prominent gene editing-focused academics have been working for over a year on a new company built around a new approach for modifying DNA to treat disease. Known as Chroma Medicine, it launched on Wednesday with $125 million in early funding from Atlas, Newpath, Cormorant and several other VCs.
Chroma will focus on a markedly different way of modifying the genome than most of the gene editing biotechs that have arisen since CRISPR was pioneered nearly a decade ago. Instead of trying to erase or rewrite portions of a patient’s actual DNA — those As, Ts, Cs and Gs — Chroma will try to change the way that DNA is expressed in the cell.
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A 178-acre property on a stretch of the Pittsburgh riverfront used to be the home of an old steel mill that shut down in the 1990s. Now, it will get an upgrade from a $100 million grant out of the Richard King Mellon Foundation to turn it into a bio manufacturing facility run by the University of Pittsburgh.
The site, known as Hazelwood Green, is nearly half the size of Pittsburgh’s downtown and will be transformed into a home for cell and gene therapy. It will be dubbed Pitt BioForge, and offer research teams, commercial and research partners high-tech manufacturing capabilities, a wet lab and other spaces for innovation.
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Thermo Fisher CEO Mark Casper
Another week, another win for the North Carolina biotech community.
This time, it’s Thermo Fisher Scientific, the Massachusetts-based contract giant, that recently announced it had plans to build a manufacturing plant. The winner is? Mebane, NC, a 15,000-person town 25 miles northwest of Durham.
The 375,000-square-foot plant at the Buckhorn Industrial Park will manufacture pipette tips for laboratory research and bioscience use. It’s a result from a $192.5 million contract with the Department of Defense that was announced back in September, in which the company pledged to increase its ability to support Covid-19 testing.
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A new cell and gene therapy testing facility in Philadelphia’s Navy Yard is officially opened, WuXi ATU announced Monday.
The new facility includes 140,000 square feet worth of laboratories, and will enhance the company’s contract testing, development and manufacturing organization business model by tripling the company’s previous capacity.
The move helps strengthen the existing testing capacity and capability, and combines the company’s powerful testing capabilities with its advanced therapies’ process development and manufacturing platforms, such as TESSA technology for AAV manufacturing and XLenti stable solutions for lentiviral manufacturing, it says in a press release.
A few weeks after Jennifer Doudna introduced CRISPR/Cas9 genome editing to the world, one of her old students decided to take the central part of the biology-altering invention and kill it.
CRISPR/Cas9, as the name implies, is a two-part system: a string of letters called a guide RNA, that says where to cut the DNA. And an enzyme, Cas9, that does the cutting. Often compared to molecular scissors, it was the first system that allowed researchers to cut DNA with ease and precision, promising potential cures for genetic diseases such as sickle cell and cystic fibrosis.
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Michel Vounatsos (Biogen via YouTube)
RBC analyst Brian Abrahams is back with an update on the death of an Alzheimer’s patient on Biogen’s controversial aducanumab, and this time he says that there are solid reasons to believe that the event was likely drug related and may have been preventable.
Abrahams, a physician, notes that he obtained new information using FOIA, getting the ‘detailed case report’ about the aducanumab patient he was first to report on.
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