The FDA has approved the IND application of CTD402 for the treatment of pediatric and adult patients with relapsed/refractory T-ALL/LBL, allowing for the start of a single-arm, open-label phase 1b/2 trial. The study will utilize a dose-finding design and aims to optimize dosing of CTD402 and accelerate clinical development. CTD402 is a universal CAR T-cell therapy that works by targeting CD7 that comes from healthy donors.
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AZ to acquire EsoBiotec with CAR-T targeting BCMA in Phase 1 for up to $1 billion
CLINICAL AND REGULATORY
FDA approved trial of novel CAR T cell therapy in T-ALL/LBL
The agent is currently undergoing evaluation for the treatment of adult and pediatric patients with T-ALL/LBL. The product is genetically modified to avoid fratricide, graft-vs-host disease, and host-vs-graft rejection. At the same time, CTD402 may enhance antitumor activity. Further, CTD402 can be considered “off-the-shelf” as it can be prepared in a single batch for multiple patients in need of CAR T-cell therapy. In addition to CTD402, Bioheng Therapeutics is currently developing CTA311 for B-cell ALL and non-Hodgkin lymphoma, CTF50X for acute myeloid leukemia, CTB001 for gastric and pancreatic cancer, CTE001 for breast and ovarian cancer, and TAA for solid tumors.
DEALS AND FINANCING
Medigene and EpimAb entered a co-development partnership for TCR-guided T Cell engagers
Medigene and EpimAb Biotherapeutics announced that the companies have entered a strategic co-development agreement to research and develop off-the-shelf T cell receptor (TCR)-guided T Cell Engagers (TCR-TCEs) for the treatment of immune-related disorders, such as solid tumors. The multi-target collaboration combines the respective expertise of each company with Medigene’s 3S (sensitive, specific and safe) TCR generation and characterization capabilities and EpimAb’s proprietary CD3 antibody and T-FIT (TCR-Fab in tandem) platform. The resultant bispecific therapeutics are expected to provide highly specific targeted immune responses with minimized off-target effects and thus, improved patient outcomes. The companies aim to co-develop TCR-TCE constructs, which will be owned equally by both partners.
First cell therapy company lists on Oslo Stock Exchange
Zelluna, a company pioneering allogeneic ‘off the shelf’ T Cell Receptor based Natural Killer (TCR-NK) cells for the treatment of cancer, announced the successful completion of a business combination and private placement. The name change from Ultimovacs to Zelluna has also been registered with the Norwegian Register of Business Enterprises. The name change and the first day of trading is expected to be implemented on Euronext Oslo Børs on or about 4 March 2025. The ticker code of the company will change from “ULTI” to “ZLNA”. Zelluna has built a platform to take the curative potential of cell therapies to solid cancers at a global scale. Zelluna does this through a game changing and highly differentiated “off the shelf” cell therapy platform, which merges clinically validated components – TCR targeting with NK cells – to form TCR-NK. This novel TCR-NK platform is protected by strong intellectual property opening up the potential for an unprecedented opportunity to capture the market of an entire therapeutic field. The lead asset nearing the clinic is the world’s first MAGE-A4 targeting TCR-NK which can potentially be used to treat a range of solid cancers with unmet medical need in high value cancer markets.
