Cell therapy weekly: NK-cell therapy fast-tracked by FDA Copy
This week: NK-cell therapy fast-tracked by FDA, Immusoft receives US$8 million for the first clinical trial of an engineered B-cell therapy and Cellinfinity Bio announces the publication and licensing of key technology for directed evolution of cells.
The news highlights:
NK-cell therapy fast-tracked by FDA
Artiva Biotherapeutics (CA, USA), a clinical-stage oncology company focusing on the delivery of highly effective, off-the-shelf, allogeneic NK cell-based therapies, announced that its lead program, AB-101, has been granted Fast Track Designation by the US FDA for the treatment of relapsed/refractory non-Hodgkin lymphoma of B-cell origin. AB-101 is an allogeneic NK-cell therapy candidate derived from cord blood it is designed for use in combination with innate-cell engagers or monoclonal antibodies.
Thorsten Graef, Chief Medical Officer of Artiva, stated: “We are excited to announce this advantageous regulatory designation as we continue our clinical evaluation of the AB-101/rituximab combination in the treatment of relapsed/refractory B-cell [non-Hodgkin lymphoma], including in patients who have failed prior CAR-T treatment. We are encouraged by the early clinical data we are seeing with AB-101 and look forward to expanding its evaluation in this indication as well as with additional biologic therapy combinations through internal and partnered clinical programs.”
Immusoft receives US$8 million for the first clinical trial of an engineered B-cell therapy
Clinical-stage cell therapy company Immusoft (CA, USA) has been awarded a grant of US$8 million by the California Institute for Regenerative Medicine (USA). The funding will support the first-ever clinical study of an engineered B-cell therapy. The Phase I clinical study will evaluate the safety and tolerability of ISP-001 in Mucopolysaccharidosis type I (MPS I), a rare genetic disease affecting the body’s ability to produce alpha-L-iduronidase. ISP-001 utilizes the company’s Immune System Programming (ISP™) technology platform to reprogram patient B-cells to produce alpha-L-iduronidase.
Immusoft’s Chief Scientific Officer, Robert Hayes, stated: “Cell-based gene therapy for MPS I such as ISP-001 has the potential to offer long-term disease control and prevent debilitating complications. This novel approach also holds the potential to provide patients with durable delivery of the therapeutic 24/7. We are honored that [the California Institute for Regenerative Medicine] has recognized the potential of ISP-001 and we look forward to advancing our candidate in MPS I, a rare, genetic childhood disease where patients currently have limited options.”
Cellinfinity Bio announces the publication and licensing of key technology for directed evolution of cells
Key technology for the directed evolution of cells has been published and licensed by Cellinfinity Bio (CT, USA). Published in Nature Biotechnology, CLASH (CRISPR-based Library-scale AAV perturbation with Simultaneous HDR knock-in) is a platform that enables the generation of a large library of cellular variants through site-specific parallel knock-in of a large pool of transgenes. Cellinfinity Bio has exclusively licensed the CLASH technology from Yale University (CT, USA) to develop novel cell therapy products, including engineered CAR-T and CAR-NK therapies.
Founder of Cellinfinity Bio, Sidi Chen stated: “The founding vision of Cellinfinity Bio is that we believe cells have infinite potential to cure human diseases. We develop highly versatile platforms such as CLASH and other technologies to engineer multiple types of primary human cells in order to bring advanced treatments to patients.”
Cell therapy weekly: NK-cell therapy fast-tracked by FDA
This week: NK-cell therapy fast-tracked by FDA, Immusoft receives US$8 million for the first clinical trial of an engineered B-cell therapy and Cellinfinity Bio announces the publication and licensing of key technology for directed evolution of cells. (more…)