REG - Hemogenyx Pharma Plc - Operations Update

Hemogenyx PharmaceuticalsAnnouncement

17/06/2024 07:15

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RNS Number : 5984S  Hemogenyx Pharmaceuticals PLC  17 June 2024

 

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
(https://hemogenyx.com/announcements/hemogenyx-pharmaceuticals-announces-strategic-investment-from-prevail-partners-llc/)
, 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.

 

Enquiries:

 

 Hemogenyx Pharmaceuticals plc                                   https://hemogenyx.com (https://hemogenyx.com/)
 Dr Vladislav Sandler, Chief Executive Officer & Co-Founder      headquarters@hemogenyx.com (mailto:headquarters@hemogenyx.com)
 Peter Redmond, Director                                         peter.redmond@hemogenyx.com (mailto:peter.redmond@hemogenyx.com)

 SP Angel Corporate Finance LLP                                  Tel: +44 (0)20 3470 0470
 Matthew Johnson, Vadim Alexandre, Adam Cowl

 Peterhouse Capital Limited                                      Tel: +44 (0)20 7469 0930
 Lucy Williams, Duncan Vasey, Charles Goodfellow

 

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.

 

 

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