As the investments in cell and gene therapy manufacturing continue to grow across the world, Cincinnati Children’s Hospital and CTI Clinical Trial & Consulting Services have entered a $100 million agreement to produce clinical material locally. The joint venture enables the hospital to work on its Translational Core Laboratory, which manufactures and tests services for cell and gene therapy trials. This will help address the global gene and cell therapy shortage and prevent the lack of capacity from getting in the way of new development. About 15 C&G therapy products have been approved by regulatory agencies across the globe, and a study from the Alliance for Regenerative Medicine predicts another 10 to 20 per year by 2025.
‘Medicine is rapidly evolving toward cell- and gene-based therapies,’ said Steve Davis, the president and CEO of Cincinnati Children’s. ‘By melding the scientific expertise of Cincinnati Children’s with the operational expertise of CTI, this joint venture will ensure that our community, region and the world have ready access to the most innovative and effective therapies.’
The investment will bring a new clinical laboratory that’s set to take up 40,000 square feet, and house three dozen clean rooms. More than 30 clinical trials will be able to take place at once, the hospital said in a press release, and it will be located somewhere within the Cincinnati, OH and Northern Kentucky region, though the exact location has not yet been determined. The site will open sometime in 2023. About 150 new jobs are expected to be created, and the venture will result in a new company that will help build the region’s reputation as a research hub. The two parties have been in conversations for ‘some time,’ CTI CEO Tim Schroeder said in a press release, and the deal will help build on an already-existing relationship that will help maximize the expertise of the two companies.
There are still significant concerns about a commercial-scale manufacturing shortage. Nearly 90% of companies prefer to use CMOs and CDMOs for manufacturing, but the right amount of capacity is not yet available. While a ton of money has been pumped into expansion projects in the last two years, it takes about a year, sometimes two, for those projects to become operational.
Sensor-based technology for clinical trial data collection represents the latest medical paradigm shift. There are more than 700 clinical studies involving wearable devices currently underway in the United States. A study from Intel IT projects their inclusion in clinical trials will surge to 70% by 2025.
Apps, biosensors and patient-centered technologies increase visibility of comprehensive patient data. Pharma leaders anticipate the benefits of wearables to include better data (58%), faster results (33%) and lower trial costs (10%).
When Bristol Myers Squibb celebrated the approval of ozanimod — branded Zeposia — in ulcerative colitis earlier this year, the company touted the first gastrointestinal indication for an S1P receptor modulator.
Now Pfizer wants to give the pharma rival a run for its money.
Pfizer is dropping $6.7 billion to acquire Arena Pharmaceuticals, whose lead drug, etrasimod, targets the sphingosine 1-phosphate receptor.
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A Boston-based provider of lab space is tripling its footprint with the addition of a West Coast campus.
SmartLabs, a company with labs in three different neighborhoods in the Boston area, will open a new research and manufacturing center that will be located in the heart of the South San Francisco biotech corridor. The site will support end-to-end drug development and include 500L manufacturing bioreactors that can support allogeneic and autologous cell therapies.
Rob Califf, the famous cardiologist from Duke University, is likely to return to the top of the FDA, this time under the Biden administration.
At his confirmation hearing Tuesday, Democrats and Republicans on the Senate health committee offered their support for Califf, with Chair Patty Murray (D-WA) stressing the need for an experienced leader, like Califf, who can ensure that science comes first.
Sanofi head of development Dietmar Berger
Sanofi’s fitusiran has had a rough road in hemophilia, weathering clinical holds and program halts tied to its lingering safety woes. Now, the drug is nearing the finish line with late-stage data in hand, but will those same safety concerns slam the brakes on the program despite its deliriously effective results?
Fitusiran, an RNAi drug designed to silence the gene that overproduces a protein responsible for clotting suppression, significantly reduced the annualized rate of bleeding over on-demand factor therapy in hemophilia A/B patients without preexisting factor inhibitors in the blood, according to late-breaking data presented Tuesday at #ASH21.
Harpreet Singh, Immatics CEO (Credit: Allogeneic Cell Therapies Summit)
Just a few weeks after offering a positive readout on its first early clinical-stage offering, the transatlantic biotech Immatics is back with news that the research crowd around Rupert Vessey at Bristol Myers Squibb has anted up $150 million in cash to get on at the ground floor with one of their still-preclinical efforts.
This time the news is centered on IMA401, Immatics’ most advanced bispecific, which uses one binder to latch on to MAGEA4/8 while another is used to whip up T cell activity against tumor cells where that’s a common antigen. For now, that’s still a preclinical effort, with the first human trial set to launch in the first half of next year.
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Aamir Malik, Pfizer chief business innovation officer
Pfizer made a big splash in the M&A space Monday, announcing a $6.7 billion buyout of Arena Pharmaceuticals to chase Bristol Myers Squibb in the S1P race. But company execs suggested the company isn’t finished bringing on new assets.
In an investor call outlining the Arena acquisition, chief business innovation officer Aamir Malik took a moment to discuss Pfizer’s growth plans going forward. The strategy was made up of three pillars: advancing the internal pipeline, continuing to pursue outside opportunities and exploring the combination of technology and data to ‘accelerate’ growth.
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The current generation of cell therapies has proven a game changer in terms of treating aggressive blood cancers, but the tech has its limitations. Novartis, one of the biggies in the current generation of these drugs, is now taking lessons learned from CAR-T Kymriah to supercharge a ‘second-generation’ of CAR-Ts putting superior cells into patients faster.
Novartis on Monday rolled out early Phase I data for a pair of autologous CAR-T cell therapies developed through the drugmaker’s T-Charge platform, a process designed to promote T cell ‘stemness’ — a measure of a cell’s ability to self-renew — by cutting manufacturing times and spurring cell proliferation primarily in patients’ lymph nodes.
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Stéphane Bancel, Moderna CEO (Steven Ferdman/Getty Images)
Just two months after Moderna announced plans to build a $500 million mRNA vaccine factory in Africa, the biotech giant agreed ‘in principle’ yesterday on a new mRNA vaccine manufacturing facility — but instead of looking in the US, Europe or Africa again, Moderna is going to the land down under.
While the deal is not set in stone, Moderna said that the biotech and the Australian government are committed to finalizing the agreement. As for the financial aspects of the deal, they have not been publicly disclosed.
https://endpts.com/could-the-next-gene-therapy-manufacturing-hub-be-cincinnati-a-100m-bet-says-yes/
