Calidi Biotherapeutics Announces FDA Authorization of IND for a Phase 1 Clinical Trial of NeuroNova in Patients with Recurrent High-Grade Glioma
LA JOLLA, CALIF (August 2, 2022) — Calidi Biotherapeutics, Inc. (Calidi), a clinical-stage biotechnology company that is pioneering allogeneic cell-based platforms to revolutionize oncolytic virus therapies, is pleased to announce that City of Hope has received U.S. Food and Drug Administration (FDA) authorization to proceed with a phase 1 physician-sponsored clinical trial that will use Calidi’s licensed oncolytic virotherapy platform, NSC-CRAd-S-pk7 (NeuroNova), a cutting-edge therapeutic candidate comprising tumor-tropic neural stem cells delivering an oncolytic adenovirus selectively to tumor sites in patients with recurrent high-grade glioma (Calidi’s NNV-2 program). [Read more…]
Stemmatters, a Portuguese Integrated Therapeutics Developer and Cell Therapy CDMO
Stemmatters is a Portuguese contract development and manufacturing (CDMO) organisation based in Barco, Guimarães. Originally a spin-off from University of Minho, it offers contract development and manufacturing services for cell-based advanced therapies, exosomes, blood-derived biologics, tissue products, biomaterials, and combination devices.
In the interview below, we explore Stemmatters history, services, manufacturing facilities, and future goals. Enjoy! [Read more…]
History of CAR-T Cell Therapy Spans 60+ Years
The groundbreaking approvals of two CAR-T therapies in 2017 was the climax of more than sixty years of devoted research. In the 1950s, the discovery of bone marrow transplantation laid the foundation for developing CAR-T therapy, as it was the first time that living cells were infused into blood cancer patients for the control of cancer.
As early as 1900s, researchers were becoming aware that T cells could easily search, recognize and kill cancer cells. To do this, the cells need a “guide” to direct them to the tumors, and thus, antibodies emerged as a valuable scientific and medical tool. [Read more…]
OrganaBio Initiates GMP Manufacturing Operations at its New Cell Therapy Manufacturing Facility
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With the commencement of GMP manufacturing operations, OrganaBio’s CDMO offers the cell therapy industry ready access to flexible manufacturing solutions and clinical grade cellular raw materials.
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OrganaBio, a cell therapy CDMO, expands manufacturing with ISO 7 cleanrooms for 3rd party manufacturing and GMP cellular starting material production.
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