Orna Therapeutics to Present In Vivo CAR-T Data at ASH 2025, Plans Clinical Trial Application for CD19 Program
核心洞察
Orna Therapeutics (搜索) will present non-human primate data for its CD19 (搜索) and BCMA (搜索) panCAR programs at the 67th American Society of Hematology Annual Meeting in December 2025.
The company's circular RNA (搜索)-based in vivo CAR platform demonstrates deep and sustained B cell depletion across multiple doses in non-human primates for treating autoimmune diseases (搜索).
Orna has completed its pre-clinical package for the anti-CD19 (搜索) program and plans to submit a Clinical Trial Application this quarter.
Orna Therapeutics (搜索) announced it will present data supporting its in vivo CAR programs at the 67th American Society of Hematology (ASH) Annual Meeting, scheduled for December 6-9, 2025, in Orlando, Florida. The biotechnology company, which focuses on engineering immune cells in vivo to treat autoimmune and oncology diseases, will showcase non-human primate studies for its CD19 (搜索) and BCMA (搜索) panCAR programs through oral and poster presentations.
Clinical Development Milestone
Joseph Bolen, Ph.D., Chief Executive Officer of Orna Therapeutics (搜索), emphasized the significance of the upcoming data presentations. "We are excited to share new data at ASH from our NHP studies for our CD19 (搜索) and BCMA (搜索) panCAR programs," Bolen stated. "Data to be presented continues to demonstrate the best-in-class nature of our in vivo CAR platform in NHP for both our anti-CD19 and our anti-BCMA programs."
The company has reached a critical regulatory milestone, having completed its pre-clinical package for the anti-CD19 (搜索) program. Bolen announced that Orna will be submitting its Clinical Trial Application this quarter, marking the transition from preclinical development to potential human testing.
ASH 2025 Presentation Schedule
The company will deliver two presentations at the conference. The oral presentation, titled "In Vivo pan CAR Therapy Utilizing Circular RNA (搜索) for Treatment of Autoimmune Diseases (搜索)," will be delivered by Isin Dalkilic-Liddle, Ph.D., VP Discovery Sciences, on Saturday, December 6, 2025, from 9:45 AM to 10:00 AM ET in the OCCC Sunburst Room.
A poster presentation focusing on multiple myeloma (搜索) applications, "In Vivo pan CAR Therapy Utilizing Circular RNA (搜索) for Treatment of Multiple Myeloma," will be presented by Rebecca Silver, Ph.D., Principal Scientist, on Sunday, December 7, 2025, from 6:00 PM to 8:00 PM ET in the OCCC West Halls B3-B4.
Technology Platform and Therapeutic Approach
Orna's approach leverages circular RNA (搜索) (oRNA) technology combined with lipid nanoparticle (LNP) delivery systems to create in vivo panCAR therapies. The company's platform targets B-cell driven autoimmune diseases (搜索) through its anti-CD19 (搜索) program and selectively depletes plasma cells via its anti-BCMA (搜索) platform.
According to the company, new data to be presented at ASH will demonstrate the ability of Orna's oRNA panCAR (搜索) platform to generate deep and sustained B cell depletion in non-human primates across multiple doses in multiple therapeutic areas. The technology aims to benefit patients across multiple B-cell driven autoimmune diseases (搜索) by engineering immune cells directly within the patient's body rather than through traditional ex vivo CAR-T cell manufacturing approaches.