Cell therapy weekly: Phase I trial for autoimmune CAR-T therapy
This week: Precision BioSciences (NC, USA) strengthens its leadership to advance its in vivo gene editing programs, Leveragen (MA, USA) and Moonlight Bio (WA, USA) partner on next-generation T-cell therapies, and Allogene Therapeutics (CA, USA) secures FDA clearance to evaluate an allogeneic CAR-T therapy for autoimmune diseases.
The news highlights:
- Precision BioSciences announces leadership updates
- A collaboration for next-generation T-cell therapies
- Phase I trial for autoimmune CAR-T therapy
Precision BioSciences announces leadership updates
Precision BioSciences, a clinical-stage gene editing company leveraging its proprietary ARCUS® platform, has announced leadership changes as it advances its in vivo gene editing programs. The company’s lead program, PBGENE-HBV, is progressing through a Phase I clinical trial with additional programs in development.
Cindy Atwell has been promoted to Chief Development and Business Officer, overseeing clinical, translational and regulatory functions, along with business development and alliance management. Additionally, Cassie Gorsuch has been appointed Chief Scientific Officer, leading non-clinical development and gene therapy discovery. Gorsuch will oversee preclinical research and Investigational New Drug (IND)-enabling studies while continuing to support external engagement on Precision’s gene editing efforts.
A collaboration for next-generation T-cell therapies
Leveragen, a biotech company specializing in genetic models for antibody discovery, has announced a partnership with Moonlight Bio to advance T-cell therapies for difficult-to-treat cancers. The collaboration will combine Leveragen’s Singularity Sapiens Mouse platform, which generates fully human single-domain antibodies, with Moonlight Bio’s T-cell engineering expertise. Leveragen will lead antibody discovery, while Moonlight Bio will handle preclinical development. This partnership aims to enhance T-cell therapy efficacy and persistence, addressing key challenges in solid tumor treatment.
Weisheng Chen, CEO and founder of Leveragen, stated: “Leveragen’s mission is to drive innovation in the fight against life-threatening diseases, and expanding our fully human single-domain antibody technology into transformative T-cell therapies aligns seamlessly with this vision. Through this partnership with Moonlight Bio, we are combining our state-of-the-art antibody discovery platform with their advanced cell engineering capabilities to develop T-cell therapies that have the potential to make a meaningful difference for patients.”
Phase I trial for autoimmune CAR-T therapy
Allogene Therapeutics has received FDA clearance for its IND application to evaluate ALLO-329, an allogeneic CAR-T therapy, in a Phase I basket trial for autoimmune diseases. The RESOLUTION trial will assess the safety and early efficacy of ALLO-329 in patients with systemic lupus erythematosus, lupus nephritis, idiopathic inflammatory myopathies and systemic sclerosis.
ALLO-329 is designed to target both CD19+ B cells and CD70+ activated T cells, addressing key drivers of immune dysregulation in autoimmune diseases. This dual-targeting approach aims to restore immune balance by eliminating dysfunctional immune cells.
“A year ago, we unveiled the concept of ALLO-329, an allogeneic CAR-T product specifically designed to address the unique challenges faced by patients with autoimmune diseases. Today, with the FDA’s clearance of our IND, that vision has become a reality, achieved at an extraordinary pace thanks to Allogene’s unparalleled expertise in research, manufacturing and clinical development,” said David Chang, President, CEO and cofounder of Allogene.
