Replay and MD Anderson announce FDA clearance of IND application for first-in-class PRAME-targeted T-Cell Receptor Natural Killer (TCR-NK) cell therapy for hematological malignancies
April 30 2024 - 7:00AM
Replay and MD Anderson announce FDA
clearance of IND application for first-in-class PRAME-targeted
T-Cell Receptor Natural Killer (TCR-NK) cell therapy for
hematological malignancies
- Phase 1/2 study
in patients with relapsed/refractory AML and MDS, anticipated to
commence Q3 2024
- PRAME is Syena’s
second TCR-NK target and follows the NY-ESO-1-targeted TCR-NK
program, which has an ongoing clinical study in multiple myeloma
with a clinical study in advanced synovial sarcoma, and
myxoid/round cell liposarcoma anticipated to commence
imminently.
San Diego, California, London, UK, and
Houston, Texas, April 30, 2024 – Replay, a genome writing
company reprogramming biology by writing and delivering big DNA,
and The University of Texas MD Anderson Cancer Center, today
announced that the Food & Drug Administration (FDA) has issued
a ‘safe to proceed’ for the Investigational New Drug (IND)
application for PRAME TCR/IL-15 NK (SY-307), an engineered T-Cell
Receptor Natural Killer (TCR-NK) cell therapy for
relapsed/refractory myeloid malignancies. MD Anderson is the IND
sponsor.
PRAME TCR/IL-15 NK (SY-307) is being developed
by Syena, an oncology-focused product company launched by Replay
and MD Anderson based on the scientific discoveries of Katy
Rezvani, M.D., Ph.D., Professor of Stem Cell Transplantation &
Cellular Therapy at MD Anderson. Syena has an exclusive license to
Miltenyi Biotec’s PRAME (PReferentially expressed Antigen in
MElanoma) T-cell receptor (TCR). The engineered PRAME-targeted
TCR-NK cell therapy is developed from cord blood-derived natural
killer cells that express a high affinity TCR targeting the PRAME
tumor-associated neoantigen. PRAME is highly immunogenic and
expressed on numerous different cancer types, including hematologic
malignancies such as acute myeloid leukemia (AML) and
myelodysplastic syndromes (MDS), and solid tumors such as melanoma,
sarcoma, and ovarian, endometrial, lung, and breast cancer. The
ability of PRAME to elicit humoral and cellular immune responses
along with its restricted tissue expression, establishes it as a
compelling target for cell therapy-mediated cancer
immunotherapy.
The phase 1/2 open-label study will assess the
safety, tolerability, and preliminary efficacy of PRAME TCR/IL-15
NK (SY-307) in patients with relapsed/refractory AML and MDS. It
will be administered following lymphodepletion with standard doses
of fludarabine/cyclophosphamide (Flu/Cy) and decitabine. Up to 44
patients will be enrolled into the study, which is anticipated to
commence in Q3 2024.
Adrian Woolfson, Executive Chairman,
President, and Co-Founder of Replay, said: “PRAME is
expressed at high levels in multiple different tumor types, making
it a compelling target for engineered TCR-NK cancer immunotherapy.
The recent IND clearance of our PRAME TCR/IL-15 NK (SY-307) program
for AML and MDS represents a significant expansion of Syena’s
growing pipeline of ‘off-the-shelf’ engineered TCR-NK therapies and
complements our existing NY-ESO-1 targeted programs in myeloma and
sarcoma. This diversification of Syena’s TCR-NK portfolio takes us
a step closer to democratizing cell therapy for cancer patients
with high unmet medical needs and limited treatment options.”
Lachlan MacKinnon, CEO and Co-Founder of
Replay, said: “The recent FDA IND clearance of our PRAME
TCR/IL-15 NK (SY-307) cell therapy is demonstrative of the growing
momentum at Syena, as the second program enters the clinic. This is
illustrative of the strength of our business model to rapidly
progress the development of a commercial-scale supply of cell
therapy products with significant potential for patients.”
Dr Arun Balakumaran, Chief Medical
Officer of Replay, said: “PRAME is a well-known
cancer-testis antigen with re-expression in multiple cancer types,
including AML and solid tumors, and restricted expression on normal
tissues. This dichotomous expression pattern and its ability to
elicit spontaneous humoral and cellular immune responses render it
a promising target for cancer immunotherapy.”
Dr Katy Rezvani Professor of Stem Cell
Transplantation & Cellular Therapy at MD Anderson
said: “This is an exciting milestone in the development of
'off-the-shelf' engineered TCR-NK cell therapies to address
significant unmet medical needs. Our hope is the PRAME studies,
initially in hematological malignancies and then in solid tumors,
will further advance our understanding of the potential for
engineered TCR-modified NK cells to benefit patients with
relapsed/refractory myeloid malignancies.”
Ends
Disclosure
MD Anderson has an institutional conflict of
interest with Replay and Syena, and MD Anderson has implemented an
Institutional Conflict of Interest Management and Monitoring Plan
to manage these relationships.
About Replay
Replay is a genome writing company, which aims
to define the future of genomic medicine through reprogramming
biology by writing, designing, and delivering big DNA. The Company
has assembled a toolkit of platform technologies, including a high
payload capacity HSV platform, to address the challenges that
currently limit clinical progress and prevent genomic medicine from
realizing its full potential.
The Company’s hub-and-spoke business model
separates technology development within Replay from therapeutic
development in a portfolio of product companies that leverage its
technology platforms. Replay’s first-in-class engineered TCR-NK
cell therapy product company, Syena, uses technology developed by
Katy Rezvani, M.D., Ph.D., at The University of Texas MD Anderson
Cancer Center in Houston, Texas. Replay’s high payload capacity HSV
vector capable of delivering up to 30 times the payload of AAV, is
utilized by Replay’s gene therapy product companies, bringing big
DNA treatments to diseases affecting the skin, and eye. Replay is
led by a distinguished team of academics, entrepreneurs, and
seasoned industry experts.
The Company raised $55 million in seed financing
in July 2022 and is supported by an international syndicate of
investors including: KKR, OMX Ventures, ARTIS Ventures, and
Lansdowne Partners.
Replay is headquartered in San Diego,
California. For further information please visit www.replay.bio and
follow us on LinkedIn and X.
About MD Anderson
The University of Texas MD Anderson Cancer
Center in Houston ranks as one of the world's most respected
centers focused on cancer patient care, research, education and
prevention. The institution’s sole mission is to end cancer for
patients and their families around the world. MD Anderson is one of
only 53 comprehensive cancer centers designated by the National
Cancer Institute (NCI). MD Anderson is No. 1 for cancer in
U.S. News & World Report’s “Best Hospitals” rankings and has
been named one of the nation’s top two hospitals for cancer since
the rankings began in 1990. MD Anderson receives a cancer center
support grant from the NCI of the National Institutes of Health
(P30 CA016672).
Contacts:
Replay
Dr Adrian Woolfson/Lachlan MacKinnon
info@replay.bio
ICR Consilium – media relations
Amber Fennell/ David Daley
replay@consilium-comms.com
MD Anderson
Clayton Boldt, Ph.D.
CRBoldt@MDAnderson.org