Conference call and webcast today at
10:00AM EST to discuss MDNA19 results
with pre-clinical experts showing robust immune responses without
toxicity
TORONTO and HOUSTON, March 25,
2020 /CNW/ - Medicenna Therapeutics Corp.
("Medicenna" or "the
Company") (TSX: MDNA, OTCQB: MDNAF), a clinical stage
immunotherapy company developing Superkines and Empowered
Cytokines, will present pre-clinical data including non-human
primate (NHP) data from its IL-2 Superkine program during a
conference call and webcast today.
The presentation (details below) will highlight data from the
long-acting variant MDNA19, engineered to have enhanced binding to
CD122 without binding to CD25. This allows MDNA19 to specifically
activate naïve CD8 T cells and natural killer (NK) cells with
minimal stimulation of T regulatory cells (Tregs), thereby
circumventing toxicity and demonstrating potential for
best-in-class features.
"We are very excited by the overwhelmingly positive data for
MDNA19 following our pilot study in NHP which shows that, unlike
competing programs, MDNA19 is able to dramatically boost
cancer-killing immune cells for an extended duration without
underlying safety issues," said Dr. Fahar
Merchant, President and CEO, Medicenna. "These results
demonstrate for the first time, that unlike peglylated versions of
IL-2 which also tend to block activation of naïve CD8 T cells and
NK cells, a long-acting IL-2 super-agonist can deliver
best-in-class features without the complexity and limitations
associated with other competing approaches. These data are a
significant milestone for Medicenna as it paves the way for
advancing our IL-2 Superkine program into the clinic next year
having successfully closed a $35M
financing last week."
Highlights from the presentation include:
- Kinetic studies in NHP showed a dose-dependent upregulation of
Ki67 in CD8 T-cells lasting for almost two weeks post-MDNA19
administration, with no apparent side effects.
- When administered to NHP, MDNA19 increases the absolute number
of circulating CD8 T-cells in the absence of Treg and eosinophil
stimulation (the latter being a major source of IL-5 production
which is responsible for triggering vascular leak syndrome and
associated toxicity).
- MDNA19 administration as a monotherapy in syngeneic mice with
pre-established CT26 colon cancer led to 60% survival and induction
of strong and long-lasting memory responses correlating with
resistance to subsequent re-challenges.
- Furthermore, MDNA19 treatment of B16F10 tumors favored
activation of CD8 T cells over Tregs in the tumor microenvironment
driving a strong therapeutic effect.
"Several groups have focused on strategies to limit
the effects of IL-2 on Treg activation and expansion in order to
boost the anti-cancer activity of IL-2," states Dr. Moutih Rafei,
Head of Discovery at Medicenna. "Approaches such as
pegylation techniques, although effective in reducing binding to
CD25, have inadvertently led to reduced potency towards effector
CD8 T-cells and NK cells as well. MDNA19 is effective in both
directions (diminishing binding to CD25 while increasing affinity
to CD122) and the preclinical data demonstrate MDNA19's promise to
restore both NK cell and memory CD8 T cell compartments in both
small rodent and non-human primate models."
The full results will be presented in more detail on a
conference call today at 10:00am by
the following individuals:
Dr. Moutih Rafei, Associate Professor, Department of
Pharmacology and Physiology, Université de
Montréal
An immunologist by training, Dr.
Rafei is an expert in cellular and molecular immunology with major
focus on cell-based therapies and therapeutics. Dr. Rafei has
published his research in cytokine biology and designed novel
cytokine fusions and fusokines.
Dr. Peter Lloyd, Director,
KinDyn Consulting
More than 25 years pharmaceutical
development experience, mostly at Novartis, in both the early and
late development arena. Expertise in pharmacokinetics,
pharmacokinetic / pharmacodynamic models and exposure response
relationships with both small molecule NCEs and biologics. Most
recently he was Head of DMPK Biologics at Novartis.
Paul Smith, Managing Director,
MetisRA Consulting
A senior regulatory affairs professional
with 30 years of experience in drug development with over 20 years
at Amgen and more recently at Tusk Therapeutics, a pre-clinical
immuno-oncology company acquired by Roche.
Conference call and webcast details:
Date: March 25, 2020
Time: 10:00 am ET
To access the conference audio:
Local dial in: 416-764-8650
North American Toll Free: 1-888-664-6383
Conference ID No.: 22234399
To access the webcast and slide
presentation:
https://event.on24.com/wcc/r/2234112/BD716A8F0744C880AD83827518F67931
Following the event, the archived webcast and Medicenna
presentation will be available on the Company's website
at www.medicenna.com. The webcast will be archived for 30 days
after the event.
About MDNA19
Developed by scientists at Stanford University, MDNA109 is an engineered
version of IL-2 that binds up to 200 times more effectively to
IL-2Rβ (CD122), thus greatly increasing its ability to activate and
proliferate the immune cells needed to fight cancer. MDNA19 is a
long acting version of the IL-2 Superkine that preferentially
drives the expansion and responses of effector T cells and Natural
Killer (NK) cells over Treg cells. It is the only IL-2 in
development with a distinct mechanism by virtue of its high
affinity towards CD122 allowing it to effectively combat NK cell
anergy (exhaustion) which occurs frequently after cancer
immunotherapy.
About Medicenna Therapeutics Corp.
Medicenna is a
clinical stage immunotherapy company focused on the development of
novel, highly selective versions of IL-2, IL-4 and IL-13 Superkines
and first in class Empowered Cytokines™ (ECs) for the treatment of
a broad range of cancers. Medicenna's lead IL4-EC, MDNA55, has
completed a Phase 2b clinical trial for rGBM, the most
common and uniformly fatal form of brain cancer. MDNA55 has been
studied in five clinical trials involving 132 patients, including
112 adults with rGBM. MDNA55 has demonstrated compelling efficacy
and has obtained Fast-Track and Orphan Drug status from the FDA and
FDA/EMA respectively. Medicenna's lead long-acting IL2 Superkine
asset, MDNA19, is a best-in-class next-generation IL-2 in
development with superior CD122 binding without CD25 affinity and
therefore preferentially stimulating cancer killing effector T
cells and NK cells when compared to competing IL-2 programs.
It is anticipated that MDNA19 will be ready for the clinic in
2021. For more information, please
visit www.medicenna.com.
This news release contains forward-looking statements
relating to the future operations of the Company and other
statements that are not historical facts. Forward-looking
statements are often identified by terms such as "will",
"may", "should", "anticipate", "expects" and similar
expressions. All statements other than statements of historical
fact, included in this release, including, without limitation, that
MDNA19, demonstrated best-in-class features in a non-human
primate study, that the pilot study in NHP shows
overwhelmingly positive data for MDNA19, that the results
demonstrate for the first time a long-acting IL-2 super-agonist can
deliver best-in-class features without the complexity and
limitations associated with other competing approaches, that the
data is a significant milestone for Medicenna, that Medicenna's
IL-2 Superkine program will enter into the clinic next year
and statements related to the future plans and objectives of the
Company, are forward-looking statements that involve 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 annual information form of the Company dated
June 24, 2019 and in other filings
made by the Company with the applicable securities regulators from
time to time.
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 at the time of preparation, 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 of this news release and the Company will update or
revise publicly any of the included forward-looking statements only
as expressly required by Canadian securities law.
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SOURCE Medicenna Therapeutics Corp.