Hemogenyx Pharmaceuticals PLC HEMO-CAR-T pre-IND Meeting Request
16 Febbraio 2022 - 8:00AM
RNS Non-Regulatory
TIDMHEMO
Hemogenyx Pharmaceuticals PLC
16 February 2022
16 February 2022
Hemogenyx Pharmaceuticals plc
("Hemogenyx Pharmaceuticals" or the "Company")
HEMO-CAR-T pre-IND Meeting Request
Hemogenyx Pharmaceuticals plc (LSE: HEMO), the biopharmaceutical
group developing new therapies and treatments for blood diseases,
has received notification from the Food and Drugs Administration
("FDA") that the proposed pre-Investigational New Drug ("pre-IND")
meeting relating to the Company's lead product candidate Chimeric
Antigen Receptor ("CAR") T-cells ("HEMO-CAR-T") is to be deferred
until May 2022 as a result of a general FDA policy prioritizing
work on COVID-19. The deferment of the meeting is not causing any
delay in the development of the product candidate. In the meantime,
the process will be dealt with by written responses by the FDA to a
submission which is now being refined. A pre-IND meeting will then
be necessary only if the written responses leave any matters
unresolved. In light of this written process now implemented by
FDA, there is no anticipated impact from the deferment on the IND
filing for HEMO-CAR-T.
As noted above, the process for pre-IND meetings has been
amended by the FDA on a general basis, with the Agency stating as
follows: "In response to the Coronavirus Disease 2019 (COVID-19)
public health emergency, FDA's Center for Biologics Evaluation and
Research (CBER) has taken steps to prioritize work that advances
the nation's response during this national emergency."
In the meantime, work on manufacturability, quality, safety and
other key parts of the development HEMO-CAR-T continue in an
encouraging manner.
In addition, positive progress continues in relation to the
Company's CDX bispecific antibody product candidate for the
treatment of acute myeloid leukaemia, as well as its CBR platform
product candidate, a novel cell-based platform technology for the
treatment of emerging viral diseases and certain types of cancer.
The Company will continue to notify shareholders as key stages with
respect to all of its product candidates are reached.
Dr Vladislav Sandler, CEO & Co-Founder of Hemogenyx
Pharmaceuticals, commented: "The process toward our IND application
remains on track and the change in the FDA's process is not
expected to affect the outcome of the IND application or timetable
for clinical trials."
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 the 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.
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.
For more than 50 years, bone marrow transplantation has been
used to save the lives of patients suffering from blood diseases.
The risks of toxicity and death that are associated with bone
marrow transplantation, however, have meant that the procedure is
restricted to use only as a last resort. The Company's technology
has the potential to enable many more patients suffering from
devastating blood diseases such as leukemia and lymphoma, as well
as severe autoimmune diseases such as multiple sclerosis, aplastic
anemia and systemic lupus erythematosus (Lupus), to benefit from
bone marrow transplantation.
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