1-Year Data on Omidubicel Shows Sustained Benefits, Reduced Infection Rates

This article originally appeared on our sister site, Pharmacy Times.

One-year post-transplant data in patients who underwent treatment with Gamida Cell's omidubicel showed sustained clinical benefits with the therapy as demonstrated by significant reduction in infectious complications. The findings were presented by Mitchell Horwitz, MD, professor of medicine at Duke Cancer Institute, at the Transplantation & Cellular Therapy Meetings of ASTCT and CIBMTR (2022 Tandem Meetings), held in Salt Lake City, Utah, and virtually April 23-26, 2022.

The findings also showed a reduction in non-relapse mortality and no significant increase in relapse rates with omidubicel at 23% compared with UCBT at 18%.

Investigators concluded that hematopoietic stem cell transplantation (HSCT) with omidubicel resulted in rapid hematopoietic recovery, reduced rates of infection, and no increase in graft versus host disease rates compared with standard UCBT.

There was a continued trend toward improvement of overall survival with omidubicel at 73% compared with UCBT at 60%.

The overall and sustained clinical benefit of omidubicel makes the drug an important addition to options for allogeneic HSCT, investigators said.

“In allo-HSCT, early engraftment and lower infections are the key predictors of long-term success for patients,” Julian Adams, PhD, CEO of Gamida Cell, said in a statement.

“We are encouraged by the continuous positive and sustained results from patients involved in the phase 3 trial of omidubicel, now 1-year out from treatment. These results provide promising rationale that omidubicel could become a compelling treatment option for patients in need of an allo-HSCT transplant,” Adams said.

The company initiated a rolling biologics license application (BLA) submission for omidubicel in the first quarter of 2022 and is on-track to complete submission of all modules of the BLA in the second quarter. In total, the company presented 2 oral and 6 poster presentations at the conference.

Omidubicel is an advanced cell therapy under development as a potential life-saving allogeneic hematopoietic stem cell transplant for individuals with hematologic malignancies. It has been granted breakthrough status and orphan drug designation by the FDA.

Additionally, omidubicel is being evaluated in a phase 1/2 clinical study in individuals with severe aplastic anemia.

It is an investigative therapy and the efficacy and safety profiles have not been established by the FDA or other health authorities.

Gamida cell has been developing NAM-enabled cell therapies, which are designed to enhance the number and functionality of target cells for individuals with hematological and solid cancers and other serious diseases.

NAM-enabled technology enables investigators to enhance, expand, and metabolically modulate multiple cell types, including natural kicker and stem cells, with appropriate growth factors to maintain the cells’ active phenotype and potency.

Reference

Gamida Cell presents updated one-year post-transplant follow up data from phase study of omidubicel at 2022 Transplantation & Cellular Therapy Meetings of ASTCT and CIBMTR Tandem Meetings. News release. Gamida Cell. April 27, 2022. https://investors.gamida-cell.com/news-events/press-releases/news-release-details/gamida-cell-presents-updated-one-year-post