Gamida Cell Announces Dosing of First Patient for NK Cell Therapy Candidate GDA-201

Gamida Cell announced the dosing of the first patient in a company-sponsored phase 1/2 study (NCT05296525) evaluating a cryopreserved and readily available formulation of GDA-201 for the treatment of follicular and diffuse large B cell lymphomas.¹

“We are excited to further advance the development of GDA-201, a [nicotinamide] NAM-enabled natural killer (NK) cell therapy candidate which we believe has the potential to be a new readily available, cryopreserved treatment option for cancer patients with relapsed/refractory lymphoma,” Ronit Simantov, MD, chief medical and scientific officer of Gamida Cell, said in a statement.“Our NK cells elicited an adaptive immune response in patients in the previous investigator-sponsored study with the fresh formulation of GDA-201, potentially leading to durable remissions.” ¹

The phase 1 portion of the study consists of a dose-escalation phase, which is designed to evaluate the safety of GDA-201 and will include individuals with diffuse large B-cell lymphoma (DLBCL)/high grade B-cell lymphoma, follicular lymphoma (FL), mantel cell lymphoma, or marginal zone lymphoma.¹

Further, in the phase 2 expansion phase, investigators will evaluate the safety of GDA-201 in 63 individuals in 2 cohorts, including DLBCL and FL. The study will include individuals who have relapsed or refractory lymphoma after at least 2 prior treatments, which could include CAR-T or stemcell transplant.¹

“Interest in NK cell therapies [have] increased in recent years as a potential alternative to current cell therapies, as NK cells have the potential to be effective in hematological and solid tumors while avoiding common safety issues,” Veronika Bachanova, MD, PhD, from the University of Minnesota, said in the statement.¹

GDA-201 uses NAM-technology to expand the functionality and number of NK cells to direct tumor cell killing properties and antibody dependent cellular cytotoxicity. In an investigator-sponsored phase 1/2 study in patients with refractory or relapsed lymphoma, treatment with GDA-201 with rituximab demonstrated significant clinical activity.¹

Of 19 individuals with non-Hodgkin lymphoma (NHL), investigators saw 13 complete responses and 1 partial response, with an overall response rate of 74% and a complete response rate of 68%.¹

Two-year data on the outcomes and cytokine biomarkers associated with survival data demonstrated a median duration of response of 16 months and an overall survival at 2 years of 78%.¹

Investigators found that GDA-201 was well-tolerated in the study, and there were no dose-limiting toxicities observed in 19 individuals with NHL and 16 individuals with multiple myeloma.¹

The most common grade 3 and 4 adverse events include anemia, febrile neutropenia, hypertension, neutropenia, and thrombocytopenia. There were no incidents of cytokine release syndrome, graft versus host disease, marrow aplasia, or neurotoxic events.¹

In 2019, there were about 71,575 new reported cases of NHL in the United States, and 20,270 individuals died of NHL, according to the CDC.²

For every 100,000 individuals, there were 18 new cases and 5 individuals died of NHL, according to the CDC.²

References

1. Gamida Cell announces dosing of first patient in company-sponsored phase 1/2 study of NK cell therapy candidate GDA-201. News release. Gamida Cell. August 10, 2022. Accessed August 10, 2022. https://investors.gamida-cell.com/news-events/press-releases/news-release-details/gamida-cell-announces-dosing-first-patient-company

2. United States cancer statistics: data visualization. CDC. Updated June 2022. Accessed August 10, 2022. https://gis.cdc.gov/Cancer/USCS/#/AtAGlance/