Cell therapy weekly: First Investigational New Drug clearance for an allogeneic NK cell therapy for autoimmune disease
This week: The US FDA has cleared an Investigational New Drug (IND) application for Artiva Biotehrapeutics’ (CA, USA) AlloNK®, bluebird bio (MA, USA) announced that the US FDA has communicated that the advisory committee meeting will not be scheduled for the company’s sickle cell disease gene therapy, and Hebecell (MA, USA) and Logomix (Tokyo, Japan) have entered a strategic partnership focused on the research and development of gene-edited natural killer (NK) cell therapies.
The news highlights:
- First IND clearance for an allogeneic NK cell therapy for autoimmune disease
- Bluebird bio confirms FDA advisory committee will not meet for lovo-cel
- Strategic partnership for research and development of gene-edited NK cell therapies
First IND clearance for an allogeneic NK cell therapy for autoimmune disease
Artiva Biotherapeutics announced that the US FDA has cleared the company’s IND application for AlloNK (AB-101) for use in combination with rituximab for the treatment of systemic lupus erythematosus in patients with active lupus nephritis. Systemic lupus erythematosus is a chronic autoimmune disease with a range of clinical manifestations resulting from abnormal B cell function and autoantibody production.
This is the first IND clearance for an allogeneic NK or CAR-T cell therapy for autoimmune disease.
Fred Aslan, CEO of Artiva, stated: “AlloNK given in combination with rituximab, an anti-CD20 antibody that targets B-cells, is already driving complete responses in late line [B-cell non-Hodgkin lymphoma] patients in an ongoing Phase 1 study by enhancing the activity of rituximab. Our hypothesis is that AlloNK plus rituximab also has the potential to drive deep B-cell depletion in [lupus nephritis] patients with an off-the-shelf therapy that could be administered and managed in an outpatient setting.”
Bluebird bio confirms FDA advisory committee will not meet for lovo-cel
It has been confirmed by bluebired bio that the US FDA’s advisory committee will not meet regarding lovotibeglogene autotemcel (lovo-cel), the one-time gene therapy for sickle cell disease. The Agency previously granted lovo-cel orphan drug designation, fast track designation, regenerative medicine advanced therapy designation, and rare pediatric disease designation. In June, the Agency also accepted a Biologics License Application for priority review of lovo-cel, setting a Prescription Drug User Fee Act goal date of 20 December 2023.
“Lovo-cel is the most deeply studied gene therapy in development for sickle cell disease and represents the third lentiviral vector gene therapy that the Agency has reviewed from bluebird—giving us great confidence in the robustness and maturity of our [Biologics License Application] package,” said Andrew Obenshain, CEO of bluebird bio. “We remain focused on working with the Agency on its review in anticipation of a decision by the end of this year.”
Strategic partnership for research and development of gene-edited NK cell therapies
Hebecell and Logomix have entered a strategic partnership focused on the research and development of gene-edited NK cells. Logomix is a synthetic biology company with a genome editing platform capable of engineering complex genomic messages of ~Mb-scale into human cells. Under the terms of the agreement, Logomix will provide HebeCell with genome editing capabilities, which, along with HEbeCell’s proprietary manufacturing platform, will be utilized to develop next-generation designer protoNK cells (human NK cells derived from human pluripotent stem cells).
“We know our protoNK cells are strong cytotoxic cells. Our goal is to make PSC-derived protoNK more efficacious in vivo. This collaboration with Logomix will give us a very powerful toolbox to achieve that goal,” said John Lu, CEO of HebeCell. “This collaboration expands our efforts to develop unique NK cell therapies, and has the potential to create something new and never seen before in the NK therapeutic field.”
