MORRISVILLE, NC., July 8, 2024
/PRNewswire/ -- Immorna Biotherapeutics, Inc. (Immorna), a clinical
stage biotechnology company developing both self-replicating and
conventional mRNA-based therapeutics and vaccines, announced today
that the U.S. Food and Drug Administration (FDA) has cleared its
investigational new drug (IND) application for JCXH-211 intravenous
(IV), a novel, first-in-class self-replicating mRNA (srRNA)
encoding the engineered human interleukin (IL)-12 protein.
The IND clearance allows Immorna to initiate a Phase 1/2,
multi-center, open-label, dose escalation and expansion study of
JCXH-211 administered intravenously in patients with malignant
solid tumors. The goal of the study is to assess safety and
tolerability, determine the recommended Phase 2 dose (RP2D) for
JCXH-211 IV in combination with checkpoint inhibitor (CPI), and
assess preliminary efficacy of the combination at the RP2D.
"We are excited to have achieved this important milestone for
one of our key assets," said NgocDiep Le, M.D., Ph.D.,
President and Global Chief Medical Officer of Immorna. Based on
data from our preclinical studies, clinical data from our JCXH-211
intratumoral administration (IT) trial, and the candidate drug's
mechanism of action, we believe JCXH-211 IV in combination with CPI
has the potential to work synergistically to enhance anti-tumor
effect. We look forward to working with the investigators and
patients to bring this potential novel therapy to patients who are
in dire need of new and effective treatments."
JCXH-211 is a first-in-class lipid nanoparticle (LNP)
encapsulated srRNA, using Immorna's proprietary technology,
encoding the engineered human IL-12 protein. In multiple
preclinical animal and patient-derived xenograft (PDX) models, the
anti-viral innate response triggered by RNA replicon together with
the potent anti-cancer immunity stimulated by IL-12 conferred
JCXH-211 superior tumor-eradicating potency, which was better than
similar preclinical candidates employing conventional
(non-replicating) mRNA. Interim data from a Phase 1 trial of
JCXH-211 IT monotherapy has demonstrated excellent safety,
tolerability and significant anti-tumor biological activities,
including abscopal effect.
IL-12 is a naturally occurring cytokine that plays a key role in
the body's immune response against cancer. Despite consistently
showing potent antitumor activity in preclinical studies,
recombinant IL-12 protein treatment at tolerable doses in humans
failed to provide clinical benefit. One key challenge for IL-12
protein treatment is the non-overlap of tolerability window and
therapeutic window. Recombinant IL-12 is unstable in vivo
and have a very short half-life, and frequent intravenous
administration of recombinant human IL-12 protein was challenging
due to unacceptable toxicities. Thanks to the intrinsic feature of
our srRNA technology, JCXH-211 IV enables a prolonged expression of
IL-12 preferentially in tumor tissues rather than normal tissues,
leading to modulation of tumor microenvironment and activation of
antitumor immune responses, while minimizing systemic toxicity.
JCXH-211-IV demonstrated excellent safety profile in nonclinical
studies using rodents and non-human primates. If successful,
JCXH-211 IV may become another lifesaving yet easily accessible
therapy for cancer patients who have progressed on or are resistant
to currently available treatments.
More information can be found
at www.immorna.com.
About Immorna
Immorna is a rapidly expanding biotechnology company, focusing on
the development of RNA-based therapeutics and vaccines. Immorna is
utilizing multiple RNA platforms, including conventional,
self-replicating and circular RNAs.
Since its founding in 2019, Immorna has built a robust CMC
platform for RNA synthesis, purification, and analytical testing
that is well suited for clinical and commercial development. In
addition, with its state-of-the-art screening tools, Immorna has
developed an arsenal of RNA delivery vehicles, including polymers
and lipid nanoparticles featuring multiple proprietary ionizable
cationic lipids suitable for intramuscular, intravenous and
tissue-targeting delivery.
Immorna has a growing intellectual property portfolio and a
diverse RNA development pipeline spanning cancer immunotherapy,
infectious diseases, rare genetic diseases, and medical
cosmetology, and quickly advancing its oncology drug and infectious
disease vaccine candidates into clinical stages.
Website: www.immorna.com
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SOURCE Immorna Biotherapeutics, Inc.