Arovella Therapeutics Ltd. is heading toward the clinic with its lead product, ALA-101, which consists of a chimeric antigen receptor (CAR) targeting CD19 and invariant natural killer T (iNKT) cells.
Our immune cells are not just “defenders” against deadly viruses and pathogens but also a great balancer for tissue homeostasis. For neurological disorders, understanding the neuro-immune axis could be key to treating previously untreatable conditions such as autism spectrum disorder, according to Jun R. Huh, professor of immunology at Harvard Medical School.
Arovella Therapeutics Ltd. is heading toward the clinic with its lead product, ALA-101, which consists of a chimeric antigen receptor (CAR) targeting CD19 and invariant natural killer T (iNKT) cells.
Secretome Therapeutics Inc. has closed a $20.4 million round of financing to support its development of therapies derived from neonatal cardiac progenitor cells.
When it comes to cell therapy, Alloplex Biotherapeutics Inc. CEO Frank Borriello said he believes that autologous, personalized therapy is the only thing that makes sense. “The allure of an off-the-shelf therapy has been such a magnet. It sucked in a lot of companies into that dream, and I'm sorry to say, it hasn't really worked out for them,” he told BioWorld. Instead, Borriello said he envisioned a cell training platform that doesn’t just tweak a single immune pathway but instead harnesses multiple immune pathways to turn the tables on cancer.
When it comes to cell therapy, Alloplex Biotherapeutics Inc. CEO Frank Borriello said he believes that autologous, personalized therapy is the only thing that makes sense. “The allure of an off-the-shelf therapy has been such a magnet. It sucked in a lot of companies into that dream, and I'm sorry to say, it hasn't really worked out for them,” he told BioWorld. Instead, Borriello said he envisioned a cell training platform that doesn’t just tweak a single immune pathway but instead harnesses multiple immune pathways to turn the tables on cancer.
Astrazeneca plc has selected a candidate to progress under its type 1 diabetes regulatory T cell (Treg) therapy program with Quell Therapeutics Ltd. The company has exercised its exclusive option to license the therapy for further development and commercialization, resulting in a milestone payment to Quell of $10 million.
On the heels of U.S. FDA approval of its first T-cell therapy, Adaptimmune Therapeutics plc reported positive results from a pivotal study for its second candidate, letetresgene autoleucel, expected to support a rolling BLA submission in 2025 that could bolster the firm’s offerings as it narrows its focus on the rare sarcoma space.
Autolus Therapuetics plc has been granted FDA approval for Aucatzyl (obecabtagene autoleucel) for the treatment of acute lymphoblastic leukemia in adults, becoming the first marketed CAR T therapy that does not have a risk evaluation and mitigation strategy attached to its label. The approval of Aucatzyl was based on results of the Felix clinical trial in relapsing/remitting ALL, which showed a strong safety profile compared to existing CAR T-cell therapies. The conduct of the trial was dogged by the COVID-19 pandemic, but of the 65 patients from an initial dosed cohort of 95 for whom efficacy was evaluated by the FDA, 63% achieved overall complete remission.
Cell and gene therapy companies are the beneficiaries of positive changes along the regulatory path that the U.S. FDA is paving for them, according to a panel of executives who spoke at the BioFuture 2024 conference in New York.
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