Hemogenyx Pharmaceuticals Completes Manufacturing Tech Transfer for HG-CT-1 CAR-T Therapy, Expands Clinical Trial to Pediatric AML Patients
核心洞察
Hemogenyx Pharmaceuticals (搜索) successfully completed technology transfer of HG-CT-1 CAR-T cell therapy manufacturing to Made Scientific (搜索) CDMO and submitted comparability data to the FDA.
The company is ready to initiate recruitment for the second, increased dose level in adult patients as part of its ongoing Phase 1 clinical trial for relapsed/refractory acute myeloid leukemia (搜索).
Clinical program expansion includes recruitment of pediatric patients who will receive the lowest dose level of HG-CT-1, marking an important milestone for treating R/R AML (搜索) in children.
Hemogenyx Pharmaceuticals (搜索) has achieved a critical manufacturing milestone for its HG-CT-1 CAR-T cell therapy, successfully completing technology transfer to an external manufacturing partner while expanding its clinical program to include pediatric patients with relapsed/refractory acute myeloid leukemia (搜索) (R/R AML (搜索)).
Manufacturing Tech Transfer Milestone
The biopharmaceutical company announced that technology transfer of the manufacturing process for HG-CT-1 has been successfully completed to Made Scientific (搜索), a contract development and manufacturing organization (CDMO). This transition represents a significant step toward scalable production of the CAR-T cell therapy.
A comprehensive comparability data package has been submitted to the U.S. Food and Drug Administration (搜索) (FDA), demonstrating that HG-CT-1 manufactured by Made Scientific (搜索) is comparable to that produced by Hemogenyx Pharmaceuticals (搜索). The data confirm the robustness and reproducibility of the manufacturing process across different sites, a critical requirement for advancing the therapy through clinical development.
Clinical Trial Expansion
With the manufacturing transfer complete, Hemogenyx Pharmaceuticals (搜索) is now positioned to initiate recruitment of adult patients for treatment with the second, increased dose level of HG-CT-1 as part of its ongoing Phase 1 clinical trial in R/R AML (搜索). This dose escalation represents the next phase of the company's systematic approach to determining the optimal therapeutic dose.
In a significant expansion of the clinical program, the company will begin recruitment of pediatric patients, who will receive the lowest dose level of HG-CT-1. This marks an important milestone in extending the potential benefits of the CAR-T therapy to younger patients suffering from R/R AML (搜索), a population with particularly limited treatment options.
Leadership Perspective
Dr. Vladislav Sandler, CEO & Co-Founder of Hemogenyx Pharmaceuticals (搜索), emphasized the significance of these developments: "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 product. This is a critical milestone as we advance our clinical program."
Sandler highlighted the clinical implications of the expanded program: "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."
Broader Development Pipeline
While the company's primary focus remains on the HG-CT-1 clinical trials, Hemogenyx Pharmaceuticals (搜索) continues to advance its CDX and CBR (搜索) product candidates where possible. The company expects to report further progress on these programs in due course, indicating a diversified approach to addressing blood diseases (搜索) and autoimmune conditions.
The London-based company, which trades on the London Stock Exchange under the ticker HEMO, operates through US subsidiaries Hemogenyx Pharmaceuticals (搜索) LLC and Immugenyx LLC, both located in New York City. As a clinical-stage biopharmaceutical group, the company is developing multiple distinct and complementary product candidates alongside platform technologies for novel product development.