- Hemogenyx Pharmaceuticals has completed the manufacturing tech transfer of its HG-CT-1 CAR-T therapy to CDMO Made Scientific and submitted comparability data to the FDA.
- The company is preparing to begin recruitment for a higher-dose adult cohort and expand its Phase 1 trial into pediatric patients with relapsed/refractory AML.
Hemogenyx Pharmaceuticals has completed the technology transfer of its HG-CT-1 CAR-T cell therapy manufacturing process to Made Scientific, a CDMO, and submitted a comparability data package to the U.S. Food and Drug Administration (FDA) as part of its clinical development program for relapsed/refractory acute myeloid leukemia (R/R AML).
The company stated that the submitted data demonstrate comparability between HG-CT-1 manufactured internally and at Made Scientific. This confirms consistency in the manufacturing process across sites and supports the transition to external contract manufacturing.
Hemogenyx Pharmaceuticals is now preparing to initiate recruitment of adult patients at a second, increased dose level in its ongoing Phase 1 clinical trial. At the same time, the company plans to begin enrolling pediatric patients, who will receive the lowest dose level of HG-CT-1, marking an expansion of the study population.
The program is focused on developing a treatment option for patients with relapsed or refractory AML, a group with limited therapeutic alternatives. In parallel with the clinical trial, the company continues to progress its additional product candidates, CDX and CBR.
“We are pleased to have successfully completed the tech transfer of HG-CT-1 manufacturing and to have demonstrated comparability between internally and externally manufactured products. With recruitment set to begin at the next dose level in adults and to expand into pediatric patients, we are well-positioned to accelerate the development of HG-CT-1 for patients with relapsed or refractory AML who have limited treatment options.”
Dr. Vladislav Sandler, CEO and Co-Founder of Hemogenyx Pharmaceuticals
