IRB Approval for Phase I Clinical Trial

Hemogenyx Pharmaceuticals plc (LSE: HEMO), a biopharmaceutical company developing innovative therapies and treatments for blood diseases, is pleased to announce that the Institutional Review Board (IRB) of the Company's first clinical site has granted approval to initiate a Phase I clinical trial of the Company's lead asset, HEMO-CAR-T, which has now been given the formal designation HG-CT-1, for the treatment of relapsed/refractory (R/R) acute myeloid leukemia (AML) in adults.

The proposed Phase 1 clinical trial is designed as a dose escalation study to assess the safety of HG-CT-1 in adult patients with R/R AML. Secondary clinical objectives are crucial for evaluating the broader impact of HG-CT-1 and include:

• Estimating the efficacy of HG-CT-1 based on standard clinical response criteria for AML.
• Estimating overall survival (OS) in evaluable subjects.
• Estimating progression-free survival (PFS) in evaluable subjects.
• Estimating duration of response (DoR) in evaluable subjects who achieve a clinical response.

These objectives are pivotal for assessing the overall clinical impact of HG-CT-1 on patients with R/R AML, a population with few remaining therapeutic options. This IRB approval represents a significant milestone for Hemogenyx Pharmaceuticals, enabling the Company to advance this promising therapy into clinical testing at one of the world's most prestigious cancer research institutions.

Dr Vladislav Sandler, CEO & Co-Founder of Hemogenyx Pharmaceuticals, commented:

"We are excited to receive IRB approval to proceed with our Phase I clinical trial of HEMO-CAR-T. This trial is a critical step in the development of our CAR-T therapy for AML patients who have exhausted other treatment options. With this study, we aim to establish the safety profile of HG-CT-1 and gather preliminary efficacy data that could pave the way for future therapeutic development."

About AML and CAR-T Therapy