Hemogenyx Pharmaceuticals Regulatory News (HEMO)

17 June 2024

Hemogenyx Pharmaceuticals plc 

("Hemogenyx Pharmaceuticals" or the "Company")

Operations Update

Hemogenyx Pharmaceuticals plc (LSE: HEMO), the clinical stage biopharmaceutical group developing treatments for cancers and viral diseases, is pleased to provide an update on its ongoing activities and progress.

1. HEMO-CAR-T

Clinical Trials Progress:

· Additional Clinical Trial Site: The Company has added an additional prestigious US medical center to its list of clinical trial sites. This will enhance the scope and expedite the timeline for the implementation of clinical trials.

· Clinical Site Setup: The setup of clinical sites at the University of Pennsylvania ("PENN") and the new medical centre is underway. This multi-step process involves thorough internal reviews by the science review committee and the internal review board of both clinical sites, as well as budget negotiations and logistics planning. The Company continues to work with Prevail Infoworks, a contract research organization ("CRO"), to manage and oversee the planning for the clinical trials.

Expansion into Pediatric Indications:

Pediatric AML and ALL: The Company is seeking to expand the HEMO-CAR-T indication 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 currently under review by third party experts. If approved, the Company will seek to implement the clinical trials for pediatric AML at the newly established clinical site. This area is of particular concern, and there is an urgent need for effective treatments for these conditions, which the Company believes HEMO-CAR-T will be able to provide.

2. Chimeric Bait Receptor ("CBR") Platform

The Company's CBR platform is an advanced immunotherapy designed to reprogram or redirect innate immune cells, such as macrophages, to prevent and combat infections from both existing and emerging viral threats, as well as to eliminate specific types of cancer.

Development and Testing:

· CBR Constructs: Scientists at Hemogenyx Pharmaceuticals are developing and testing multiple CBR constructs to identify the best candidates for targeting rare cancers such as epithelial ovarian carcinoma. Selected candidates will undergo rigorous testing to advance them to investigational new drug (IND) enabling studies.

mRNA-Based Delivery of CBR:

· Intranasal Delivery for Viral Infections: The Company continues to develop mRNA-based delivery of CBRs for treating airborne viral infections via intranasal administration. Recent improvements in the stability of mRNA-based CBRs are expected to enhance the effectiveness of this treatment.

3. CDX - Bispecific Antibody

IND-Enabling Studies:

· Progress: The Company is advancing IND-enabling studies for CDX, a bispecific antibody designed for treating relapsed and/or refractory AML, a subset of ALL, and for conditioning in bone marrow transplants.

Dr Vladislav Sandler, CEO & Co-Founder of Hemogenyx Pharmaceuticals, commented: "We are excited about the progress we are making across our various programs. The addition of a world-renowned medical center to our HEMO-CAR-T clinical trial sites marks a significant step forward in our mission to develop life-saving therapies. Our expansion into pediatric indications for HEMO-CAR-T highlights our commitment to addressing unmet medical needs in both adult and pediatric populations.

"Furthermore, our advancements in the CBR platform and the development of mRNA-based delivery systems for treating airborne viral infections demonstrate our innovative approach to tackling complex diseases. The progress in our CDX bispecific antibody program also underscores our dedication to bringing effective treatments to patients with relapsed or refractory AML and other severe conditions.

"We are diligently pursuing non-dilutive financing options to support these initiatives and remain focused on translating our scientific discoveries into clinical success. We look forward to updating our shareholders and the market as we continue to make strides in our development programs."

Market Abuse Regulation (MAR) Disclosure

Certain information contained in this announcement would have been inside information for the purposes of Article 7 of Regulation No 596/2014 (as it forms part of UK domestic law by virtue of the European Union (Withdrawal) Act 2018) until the release of this announcement.

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About Hemogenyx Pharmaceuticals plc

Hemogenyx Pharmaceuticals is a publicly traded company (LSE: HEMO) headquartered in London, with its US operating subsidiaries, Hemogenyx Pharmaceuticals LLC and Immugenyx LLC, located in New York City at its state-of-the-art research facility.

The Company is a clinical-stage biopharmaceutical group developing new medicines and treatments for life-threatening diseases. Hemogenyx Pharmaceuticals is developing several distinct and complementary product candidates, as well as a platform technology that it uses as an engine for novel product development.