Hemogenyx Pharmaceuticals PLC Full FDA Review for HEMO-CAR-T IND (4200F)
July 10 2023 - 1:00AM
UK Regulatory
TIDMHEMO
RNS Number : 4200F
Hemogenyx Pharmaceuticals PLC
10 July 2023
10 July 2023
Hemogenyx Pharmaceuticals plc
("Hemogenyx Pharmaceuticals" or the "Company")
Full FDA Review for HEMO-CAR-T IND
Hemogenyx Pharmaceuticals plc (LSE: HEMO), the biopharmaceutical
group developing new therapies and treatments for blood diseases,
announces that the Company has received a full review letter from
the U.S. Food and Drug Administration ("FDA") regarding the
Investigational New Drug ("IND") application for the Company's
product candidate Chimeric Antigen Receptor ("CAR") T-cells
("HEMO-CAR-T") for the treatment of acute myeloid leukaemia ("AML")
to the effect that HEMO-CAR-T be put on clinical hold ("CH"). The
letter contains a detailed description of the rationale for the
decision to put HEMO-CAR-T IND on CH. The reason for the CH relates
to a splicing that occurs during the manufacturing process of the
lentivirus that is used to produce CAR-T cells. The Company has
identified the source of the splicing deficiency and has already
developed a method to eliminate it. The lentivirus is being
remanufactured. The CH letter also contains several suggestions on
how to improve the safety of HEMO-CAR-T. These suggestions do not
and would not contribute to the CH and can be dealt with
readily.
Dr Vladislav Sandler, CEO & Co-Founder of Hemogenyx
Pharmaceuticals, commented: " We are confident that we will be able
to address the FDA's questions and concerns regarding the IND. AML
has poor survival rates and we are eager to resolve this hold and
continue down the treatment development pathway toward saving
lives."
About AML and CAR-T Therapy
AML, the most common type of acute leukemia in adults, has poor
survival rates (a five-year survival rate of less than 30% in
adults) and is currently treated using chemotherapy, rather than
the potentially more benign and effective form of therapy being
developed by Hemogenyx Pharmaceuticals. The successful development
of a new therapy for AML would have a major impact on treatment and
survival rates for the disease.
CAR-T therapy is a treatment in which a patient's own T-cells, a
type of immune cell, are modified to recognize and kill the
patient's cancer cells. The procedure involves: isolating T-cells
from the patient; modifying the isolated T-cells in a laboratory
using a CAR gene construct (which allows the cells to recognize the
patient's cancer); amplifying (growing to large numbers) the newly
modified cells; and re-introducing the cells back into the
patient.
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. The person responsible for arranging for the release
of this announcement on behalf of Hemogenyx Pharmaceuticals plc is
Dr Vladislav Sandler, Chief Executive Officer & Co-Founder.
Enquiries:
Hemogenyx Pharmaceuticals plc https://hemogenyx.com
Dr Vladislav Sandler, Chief Executive
Officer & Co-Founder headquarters@hemogenyx.com
Peter Redmond, Director peter.redmond@hemogenyx.com
Tel: +44 (0)20 3470
SP Angel Corporate Finance LLP 0470
Matthew Johnson, Vadim Alexandre,
Adam Cowl
Tel: +44 (0)20 7469
Peterhouse Capital Limited 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 pre-clinical stage biopharmaceutical group
developing new medicines and treatments to treat blood and
autoimmune disease and to bring the curative power of bone marrow
transplantation to a greater number of patients suffering from
otherwise incurable 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.
This information is provided by RNS, the news service of the
London Stock Exchange. RNS is approved by the Financial Conduct
Authority to act as a Primary Information Provider in the United
Kingdom. Terms and conditions relating to the use and distribution
of this information may apply. For further information, please
contact rns@lseg.com or visit www.rns.com.
RNS may use your IP address to confirm compliance with the terms
and conditions, to analyse how you engage with the information
contained in this communication, and to share such analysis on an
anonymised basis with others as part of our commercial services.
For further information about how RNS and the London Stock Exchange
use the personal data you provide us, please see our Privacy
Policy.
END
MSCFFFFIDIIAIIV
(END) Dow Jones Newswires
July 10, 2023 02:00 ET (06:00 GMT)
Hemogenyx Pharmaceuticals (LSE:HEMO)
Historical Stock Chart
From Apr 2024 to May 2024
Hemogenyx Pharmaceuticals (LSE:HEMO)
Historical Stock Chart
From May 2023 to May 2024