TIDMHEMO
RNS Number : 5753K
Hemogenyx Pharmaceuticals PLC
05 January 2021
5 January 2021
Hemogenyx Pharmaceuticals plc
("Hemogenyx Pharmaceuticals" or the "Company")
CAR-T Master Translational Agreement with University of
Pennsylvania
Hemogenyx Pharmaceuticals plc (LSE: HEMO), the biopharmaceutical
group developing new therapies and treatments for blood diseases,
is pleased to announce that it has entered into a Master
Translational Research Services Agreement ("Agreement") with the
University of Pennsylvania ("Penn"). The goal of the Agreement is
to advance the Chimeric Antigen Receptor ("CAR") T-cells
("HEMO-CAR-T") developed by the Company toward and through clinical
trials.
Under the Agreement, the Company will retain Penn to conduct
translational research activities in support of the research being
performed under the existing Sponsored Research Agreement ("SRA"),
which was announced on August 11, 2020 . As with the research being
performed under the SRA, the research and development activities
contemplated by the Agreement (the "R&D Activities") will
involve Saar I. Gill, MD, PhD, an assistant professor of Medicine,
a hematologist-oncologist physician scientist and scientific
co-director of the Cell Therapy and Transplantation program in the
Perelman School of Medicine at the University of Pennsylvania. Dr.
Gill's laboratory is part of the Center for Cellular
Immunotherapies ("CCI") at Penn. The Agreement governs the R&D
Activities of various organizations within Penn and coordinates
such R&D Activities with the work of the Company. The intended
outcome of the complex of activities under the Agreement is the
clinical proof of concept for HEMO-CAR-T, including its variations
such as SAFE-HEMO-CAR-T, for the treatment of acute myeloid
leukemia ("AML").
The R&D Activities are intended to include:
i. vector manufacturing for the delivery of HEMO-CAR-T to the patient's T-cells;
ii. an investigational new drug ("IND") filing for permission to
conduct clinical trials; and
iii. clinical manufacturing of patient-specific HEMO-CAR programmed T-cells
Dr. Vladislav Sandler, CEO & Co-Founder of Hemogenyx
Pharmaceuticals, commented: " This is the next incredibly important
step on a direct path to clinical proof of concept for one of our
leading product candidates. We are very pleased to be collaborating
with Penn, which was the first institution to develop CAR-T
technology into an approved treatment for leukemias, and which has
already saved so many lives. We are confident that this
collaboration will further accelerate the development of our CAR-T
product candidate, which we believe will have a significant and
positive impact in the treatment of acute myeloid leukemia, for
which there is currently no real effective treatment."
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.
About the Center for Cellular Immunotherapies
CCI, under the directorship of Carl H. June, MD, Richard W.
Vague Professor in Immunotherapy in the department of Pathology and
Laboratory Medicine at Penn, is focused on coordinated
interdisciplinary approaches for the discovery and development of
core platform technologies for personalized cell and gene-based
therapies in cancer, autoimmune disease, infectious disease, and
organ and bone marrow transplantation. CCI interacts with a
coalition of investigators in nearly all departments and centers in
the Perelman School of Medicine, driving the clinical translation
of novel and investigational immune-based therapies. CCI's mission
is to accelerate and synergize efforts that quickly transition
fundamental immunobiology research into the clinic.
As mentioned above, CCI and the team of Dr. June have conducted
numerous clinical trials with CAR T-cells in patients with HIV
infection and diverse forms of cancer. The CD19 CAR T therapy
invented in the June Laboratory was awarded "Breakthrough Therapy"
status by the FDA for acute lymphoblastic leukemia ("ALL") in
children and adults in 2014 and lymphoma for adults in 2018. This
technology has been developed for widespread use by Novartis
culminating with the FDA approval of the first CAR T-cell therapy
Kymriah(R) (tisagenlecleucel) for the treatment of ALL in 2017.
About Dr. Saar Gill and the Gill Laboratory
Saar I. Gill, MD, PhD, obtained his medical degree from the
University of Melbourne in Australia in 1999. After internal
medicine residency at St Vincent's Hospital in Melbourne and a
hematology fellowship at the Peter MacCallum Cancer Centre, he
completed post-doctoral training at the laboratory of Robert
Negrin, MD at Stanford University. In 2011, Dr. Gill moved to the
University of Pennsylvania to study with Carl June, MD and David
Porter, MD. Dr Gill runs a highly translational research lab
dedicated to innovative cellular therapy approaches for the
treatment of cancer, and his chief research interest and focus of
his clinical practice is acute myeloid leukemia.
Market Abuse Regulation (MAR) Disclosure
Certain information contained in this announcement would have
been deemed inside information for the purposes of Article 7 of
Regulation No 596/2014 until the release of this announcement.
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 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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