Medicenna Therapeutics Corp. (“Medicenna” or the “Company”) (TSX:
MDNA, OTCQB: MDNAF), a clinical-stage immunotherapy company focused
on the development of Superkines, announced today that, as planned
and previously announced, new data from two of its preclinical
programs were presented orally at the Promise of Interleukin-2
Conference held in Paris, France from September 4-7, 2024.
“Inspired by the promising Phase 1/2 clinical
results from the ABILITY-1 clinical trial of MDNA11, we are
leveraging the same IL-2 Superkine platform to advance our pipeline
of transformative medicines to treat not only cancer but also
autoimmune diseases,” said Fahar Merchant, Ph.D., President and CEO
of Medicenna. “We are encouraged by these preclinical data, which
validates the versatility of our IL-2 Superkines beyond cancer as
we further evaluate MDNA209 in GvHD and other disease models.
Additionally, our IL-13 Superkines enable us to precisely deliver
and localize BiSKITs to the tumor site which could potentially
benefit patients with cancers that have not responded to currently
approved checkpoint inhibitors, thereby addressing a huge unmet
need.”
MDNA209 and MDNA113 are preclinical assets based
on the MDNA109 platform also used to develop MDNA11, a long-acting
IL-2 Super-agonist, currently being evaluated in the Phase 1/2
ABILITY-1 clinical trial for the treatment of solid tumors.
- The first presentation outlined the
potential of MDNA209 to treat autoimmune diseases, including high
grade GvHD which has a 1-year survival rate of only 40%. Transplant
patients with GvHD experience significant morbidity and mortality
with limited therapeutic options to prolong survival. The initial
preclinical data presented on the MDNA209 platform highlight the
potential of the Company’s long-acting, high-affinity IL-2β biased
IL-2/IL-15 Super-antagonists to downregulate the immune system,
with therapeutic potential for GvHD and autoimmune diseases.
- The second presentation focused on
MDNA113, which is being developed as a novel, targeted and
bifunctional version (anti-PD1-IL-2 Superkine fusion) of a class of
blockbuster anti-PD1 therapies, with current annual sales of over
$30 billion but lose patent protection from 2028 onwards. Although
Anti-PD-1 checkpoint blockade has improved survival outcomes in
many types of solid tumors, approximately 70% of cancer patients do
not benefit. To further improve patient outcomes, Medicenna has
designed an anti-PD1-IL-2SK BiSKIT that uses an IL-13 Superkine to
simultaneously target and localize the BiSKIT to the TME while
masking the IL-2 domain during peripheral circulation and reducing
its toxicity. At the TME, tumor specific proteases cleave the IL-13
component, releasing the BiSKIT to engage with T-cells thereby
stimulating T-cell activity via the IL-2 domain and preventing
T-cell exhaustion via the anti-PD1 domain.
Key highlights from the presentations
are:
MDNA209, a High Affinity IL-2β Biased IL-2/IL-15
Super-antagonist, for the Treatment of Autoimmune Diseases
- MDNA209 is an IL-2 Super-antagonist
with enhanced affinity for IL-2Rβ but does not engage with the γc
subunit, therefore acting as a receptor clamp to exclude native
IL-2 as well as native IL-15.
- MDNA209 is fused to an Fc scaffold
(MDNA209-Fc) to extend its in vivo half-life, reducing the need for
frequent dosing.
- MDNA209-Fc inhibits both, IL-2 and
IL-15 induced p-STAT5 signaling, reduces IFNγ release and slows
immune cell proliferation without reducing Treg population.
- In an aggressive animal model of
acute GvHD, MDNA209 was able to extend overall survival by 400
percent, reduce weight loss and improve clinical scores.
MDNA113, an IL-13Rα2 Tumor Targeting and
Conditionally Activatable anti-PD1-IL-2SK BiSKIT Shows Enhanced
Safety and Potent Therapeutic Efficacy
- MDNA113 (masked version) showed
reduced capacity to induce IL-2R mediated pSTAT5 signaling compared
to anti-PD1-IL-2SK (non-mask version) in cell-based assay and human
CD8+ T cells without impacting PD1/PDL1 blockade.
- Proteolytic cleavage of MDNA113
releases anti-PD1-IL-2SK and fully restores its capacity to
activate IL-2R signaling.
- Mice treated with MDNA113 showed
reduced peripheral lymphocyte expansion compared to anti-PD1-IL-2SK
due to masking by the IL-13 Superkine.
- MDNA113 showed greater tolerability
than anti-PD1-IL-2SK following repeat dose administration in
mice.
- MDNA113, but not a non-cleavable
version, demonstrated similar efficacy as anti-PD1-IL-2SK in MC38
colon tumor model despite these tumors lacking IL-13Rα2
expression.
- Efficacy of MDNA113 is
substantially enhanced when tested in mice harboring MC38 tumors
that have been engineered to overexpress IL-13Rα2, resulting in
complete tumor regression in most animals.
- Variants of MDNA113 have also been
designed with tunable masking of the IL-2 Superkine underscoring
the versatility of the platform.
Copies of the two presentations are available on
the “Scientific Presentations” page of Medicenna’s
website.
About MDNA209
The Company’s MDNA209 platform consists of IL-2
muteins with targeted mutations enabling high-affinity IL-2
receptor antagonism. MDNA209 blocks the formation of the IL-2Rβγc
complex, preventing downstream signaling and blocking effector
T-cell functions. MDNA209 outcompetes IL-2 for IL-2Rβ and impedes
γc engagement, blocking downstream signaling and restraining
reactive effector immune cells, thereby offering therapeutic
potential for treating inflammatory and autoimmune diseases.
About MDNA113
MDNA113 is a novel, first-in-class
tumor-targeted and tumor-activated bi-functional anti-PD1-IL2
Superkine with exceptionally high affinity for IL-13Rα2 without
binding to the functional IL-13R⍺1. IL-13Rα2 is overexpressed in a
wide range of solid tumors, including cold tumors with minimal to
no expression in normal tissues. IL-13Rα2 expressing tumors also
have abundant matrix metalloprotease in the tumor microenvironment
that may efficiently activate MDNA113. IL-13Rα2 expression is
associated with poor clinical outcome in multiple tumor types
including prostate cancer, pancreatic cancer, ovarian cancer, liver
cancer, breast cancer and brain cancer, with an annual world-wide
incidence of over 2 million.
About Medicenna
Therapeutics
Medicenna is a clinical-stage immunotherapy
company focused on developing novel, highly selective versions of
IL-2, IL-4 and IL-13 Superkines and first-in-class Empowered
Superkines. Medicenna’s long-acting IL-2 Superkine, MDNA11, is a
next-generation IL-2 with superior affinity toward CD122 (IL-2
receptor beta) and no CD25 (IL-2 receptor alpha) binding, thereby
preferentially stimulating cancer-killing effector T cells and NK
cells. Medicenna’s IL-4 Empowered Superkine, bizaxofusp (formerly
MDNA55), has been studied in 5 clinical trials enrolling over 130
patients, including a Phase 2b trial for recurrent GBM, the most
common and uniformly fatal form of brain cancer. Bizaxofusp has
obtained FastTrack and Orphan Drug status from the FDA and FDA/EMA,
respectively. Medicenna’s early-stage high-affinity IL-2β biased
IL-2/IL-15 Super-antagonists, from its MDNA209 platform, are being
evaluated as potential therapies for autoimmune and graft-versus
host diseases. Medicenna’s early-stage BiSKITs™ (Bifunctional
SuperKine ImmunoTherapies) and the T-MASK™ (Targeted
Metalloprotease Activated SuperKine) programs are designed to
enhance the ability of Superkines to treat immunologically “cold”
tumors.
For more information, please
visit www.medicenna.com, and follow us on Twitter
and LinkedIn.
Forward-Looking Statements
This news release contains forward-looking
statements within the meaning of applicable securities laws.
Forward-looking statements include, but are not limited to, express
or implied statements regarding the future operations of the
Company, estimates, plans, strategic ambitions, partnership
activities and opportunities, objectives, expectations, opinions,
forecasts, projections, guidance, outlook or other statements that
are not historical facts, such as statements on the therapeutic
potential and safety profile of MDNA209 and MDNA113. Drug
development and commercialization involve a high degree of risk,
and only a small number of research and development programs result
in commercialization of a product. Results in early-stage
pre-clinical or clinical studies may not be indicative of full
results or results from later stage or larger scale clinical
studies and do not ensure regulatory approval. You should not place
undue reliance on these statements, or the scientific data
presented.
Forward-looking statements are often identified
by terms such as “will”, “may”, “should”, “anticipate”, “expect”,
“believe”, “seek”, “potentially” and similar expressions. and are
subject to risks and uncertainties. There can be no assurance that
such statements will prove to be accurate and actual results and
future events could differ materially from those anticipated in
such statements. Important factors that could cause actual results
to differ materially from the Company’s expectations include the
risks detailed in the latest annual information form of the Company
and in other filings made by the Company with the applicable
securities regulators from time to time in Canada.
The reader is cautioned that assumptions used in
the preparation of any forward-looking information may prove to be
incorrect. Events or circumstances may cause actual results to
differ materially from those predicted, as a result of numerous
known and unknown risks, uncertainties, and other factors, many of
which are beyond the control of the Company. The reader is
cautioned not to place undue reliance on any forward-looking
information. Such information, although considered reasonable by
management, may prove to be incorrect and actual results may differ
materially from those anticipated. Forward-looking statements
contained in this news release are expressly qualified by this
cautionary statement. The forward-looking statements contained in
this news release are made as of the date hereof and except as
required by law, we do not intend and do not assume any obligation
to update or revise publicly any of the included forward-looking
statements.
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information that is not deemed to be incorporated by reference in
this new release.
Investor/Media Contact:
Christina CameronInvestor Relations, Medicenna
Therapeutics(647) 953-0673ir@medicenna.com
Medicenna Therapeutics (TSX:MDNA)
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