Will initiate a first-in-human Phase 1
clinical trial for INT2104, its first-in-class in vivo targeted
gene therapy, creating CAR cells for the treatment of B cell
malignancies in 4Q24
PHILADELPHIA, July 9, 2024
/PRNewswire/ -- Interius BioTherapeutics, a leading developer of
in vivo cell-specific gene medicines, today announced that
it has been granted Human Research Ethics Committee (HREC)
approval and Clinical Trial Notification (CTN)
clearance by the Australian Therapeutic Goods Administration
(TGA) to commence a first-in-human Phase 1 clinical trial of
INT2104, its lead in vivo CAR candidate for treatment of B-cell
malignancies.
"Receiving HREC approval and CTN clearance for our first
clinical trial is a significant milestone for Interius. We are very
pleased that the regulators have approved the start of our
first-in-human clinical trial for INT2104. The approval allows us
to enroll patients in our first clinical study and recognizes the
potential of our novel in vivo targeted gene therapy
candidate, INT2104, to address an unmet medical need for patients
with B cell malignancies," said Interius President and Chief
Executive Officer Phil Johnson, M.D. "We look forward to
continuing to work closely with the TGA and other regulators in the
future to bring this innovative therapy to patients as quickly as
possible."
The CTN clearance was granted based on HREC approval in
Australia which included extensive
review of Interius's preclinical data and study protocol. Interius
intends to begin the trial in the fourth quarter of 2024 and is
well positioned to deliver key program milestones as early as the
first quarter of 2025.
About the INT2104 Clinical Program
Interius's Phase 1 trial (INVISE, Injectable Vectors for In Situ
Engineering) will evaluate the safety of a single INT2104 infusion
in adults with refractory/relapsing B cell malignancies. The Phase
1 study is a global, two-part, multicenter, open-label, single dose
design with a dose escalation portion designed to inform the dose
of INT2104 to be used in the dose confirmation part of the trial
and future studies.
About INT2104
INT2104 is a wholly-owned investigational gene therapy candidate,
which specifically targets CD7-positive T and NK cells and delivers
a CAR transgene to create effector CAR-T and CAR-NK cells in
vivo. The CAR cells target CD20-positive B cells for the
treatment of B cell malignancies. Unlike ex vivo CAR-T
therapies, INT2104 is an off-the-shelf, single dose treatment,
administered systemically through intravenous infusion without the
need for lymphodepletion or for any special equipment or
training.
About Interius BioTherapeutics
Interius
BioTherapeutics, a leading biotechnology company, is developing
novel off-the-shelf gene therapies enabling the generation of
autologous chimeric antigen receptor (CAR) cells in vivo
using targeted lentiviral vector technology. The company's lead
program is an intravenous in vivo CAR therapy to treat B cell
lymphomas, in which proprietary engineering delivers exquisite
specificity for target tissues. The company is developing a second
program to treat autoimmune diseases. Interius has created a
differentiated new therapeutic modality for precision delivery of
gene medicines, which could be available to patients without
delays, without preconditioning chemotherapy, and in expanded care
settings. For more information, visit www.interiusbio.com.
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SOURCE Interius BioTherapeutics, Inc.