Hemogenyx Pharmaceuticals PLC Provides Operations Update - June 17, 2024

25 June 2024

Hemogenyx Pharmaceuticals plc, a clinical-stage biopharmaceutical company specializing in treatments for cancers and viral diseases, has released an update on its current initiatives and advancements.

HEMO-CAR-T Clinical Trials Progress:

Hemogenyx Pharmaceuticals has expanded its clinical trial sites by incorporating a renowned US medical center, which will accelerate the timeline and broaden the scope of its trials. The setup of clinical sites at the University of Pennsylvania and the newly added medical center is in progress. This process involves comprehensive internal reviews by the respective science review committees and internal review boards, alongside budget negotiations and logistical planning. The company collaborates with Prevail Infoworks, a contract research organization, to manage and oversee the clinical trial planning.

Expansion into Pediatric Indications:

The company is looking to extend the HEMO-CAR-T therapy to include pediatric acute myeloid leukemia (AML) and a subset of pediatric acute lymphoblastic leukemia (ALL) patients. An amendment to the clinical protocol to include pediatric AML is under review by third-party experts. If approved, clinical trials for pediatric AML will be initiated at the newly established clinical site. The company acknowledges the urgent need for effective treatments for these conditions and believes HEMO-CAR-T can provide a solution.

Chimeric Bait Receptor (CBR) Platform:

Hemogenyx Pharmaceuticals' CBR platform is an advanced immunotherapy method designed to reprogram or redirect innate immune cells, such as macrophages, to combat infections from existing and emerging viral threats and to eliminate certain cancer types.

Development and Testing:

Scientists at Hemogenyx are working on developing and testing multiple CBR constructs to find the most effective candidates for targeting rare cancers, such as epithelial ovarian carcinoma. Once identified, selected candidates will undergo rigorous testing to advance to investigational new drug (IND) enabling studies.

mRNA-Based Delivery of CBR:

The company is also developing mRNA-based delivery of CBRs for the treatment of airborne viral infections via intranasal administration. Improvements in the stability of mRNA-based CBRs are expected to enhance the effectiveness of this treatment method.

CDX - Bispecific Antibody:

Progress is being made in IND-enabling studies for CDX, a bispecific antibody designed to treat relapsed and/or refractory AML, a subset of ALL, and for conditioning in bone marrow transplants.

Dr. Vladislav Sandler, CEO and Co-Founder of Hemogenyx Pharmaceuticals, expressed enthusiasm about the progress across various programs. The addition of a prestigious medical center to the HEMO-CAR-T clinical trial sites represents a significant advancement towards developing life-saving therapies. The expansion into pediatric indications for HEMO-CAR-T underscores the company's commitment to addressing unmet medical needs in both adult and pediatric populations.

Furthermore, the advancements in the CBR platform and the development of mRNA-based delivery systems for treating airborne viral infections highlight the innovative approach taken by Hemogenyx Pharmaceuticals to tackle complex diseases. The progress in the CDX bispecific antibody program also highlights their dedication to providing effective treatments for patients with relapsed or refractory AML and other severe conditions.

The company is actively pursuing non-dilutive financing options to support these initiatives and remains focused on translating scientific discoveries into clinical success. Hemogenyx Pharmaceuticals looks forward to providing further updates to shareholders and the market as it continues to advance its development programs.

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