-MDNA11, a long acting IL-2 super-agonist
shows potent and durable tumor control with strong memory response
in tumor models-
-Up to 10-fold expansion of
cancer-killing immune cells in non-human primates (NHP) without
underlying safety issues or immunogenicity-
TORONTO, May 29, 2020 /CNW/ - Medicenna Therapeutics
Corp. ("Medicenna" or "the Company") (TSX: MDNA, OTCQB:
MDNAF), a clinical stage immuno-oncology company, today announced
virtual presentation of data on MDNA11, one of its lead candidates
from the IL-2 Superkine program, at the 2020 American Society of
Clinical Oncology (ASCO) Annual Meeting.
The poster presentation by Dr. Moutih Rafei, PhD, (Associate
Professor of Pharmacology and Physiology at the University de
Montreal) focuses on new data
arising from MDNA11, Medicenna's novel long-acting interleukin-2
(IL-2) Superkine program.
"Recent transactions in the immuno-oncology and IL-2 space are
evidence of the industry demand for drug candidates that can
effectively boost the immune system of patients undergoing cancer
treatment. The data we are sharing at ASCO show that MDNA11 has the
potential to be a best-in-class IL-2 asset," says Dr. Fahar Merchant, Chief Executive Officer,
Medicenna. "We are impressed by MDNA11's preclinical profile,
including its selectivity for immune effector cells,
pharmacokinetics, safety and preclinical efficacy. We look forward
to progressing MDNA11 towards the clinic in the next 12 months and
to share these data with the ASCO community."
The poster presentation focuses on encouraging data in NHP for
MDNA11, a long-acting IL-2 variant engineered to have enhanced
affinity to CD122 without interacting with CD25. This allows MDNA11
to specifically expand cancer fighting naïve CD8 T cells as well as
natural killer (NK) cells with minimal stimulation of T regulatory
cells (Tregs) and eosinophils (associated with vascular leak
syndrome). As such, the use of MDNA11 circumvents both
immune-suppression and toxicity normally observed with standard
IL-2 (Proleukin). In addition, MDNA11 has several advantages over
other long-acting IL-2 variants as it permits enhanced accumulation
in the tumor vicinity and can be recycled in vivo thus exhibiting
prolonged circulation in the blood stream thereby reducing the
frequency of treatment.
Highlights from the presentation include:
- Half-life of MDNA11 (~7 hours) in mice is more than 20-fold
longer than native IL-2 (~0.3 hr). The half-life of MDNA11 is 13-25
hours in NHP, comparable if not longer than other long-acting IL-2
molecules in development. Due to its durable pharmacodynamic (PD)
effects that last up to 10 days, it circumvents the need for
frequent dosing to achieve therapeutic efficacy.
- In a pre-clinical tumor re-challenge study in a CT-26 mouse
colon cancer model, two doses of MDNA11 over 2 weeks resulted in
durable and complete responses in 60% of the mice when treated
alone and 100% complete response when combined with an anti-CTLA4
antibody. These responses were durable, lasting over 210 days (7
months) despite multiple re-challenges with no additional treatment
demonstrating sustained vaccine-like resistance. These results
suggest that MDNA11 provides a complementary mechanism of immune
activation when used alone or in combination with immune checkpoint
inhibitors.
- Kinetic studies in NHP showed a dose-dependent upregulation of
Ki67 in CD8 T-cells lasting for almost two weeks post-MDNA11
administration, significantly longer than pegylated IL-2, and
indicative of a prolonged PD effect.
- When administered to NHP, MDNA11 demonstrated a dose dependent
increase in absolute number of circulating CD8 T-cells, non-Treg
CD4 T-cells and NK cells with minimal effect on Treg).
- In spite of inducing a durable immune response, MDNA11 does not
trigger cytokine storm nor cause other undesirable immune related
side effects. These pre-clinical safety studies showed that MDNA11
did not lead to hypotension or vascular leak syndrome.
- Additional safety features of MDNA11 include lack of
immunogenicity (no anti-drug-antibody response), no change in liver
and kidney function and no pulmonary edema as confirmed by
histopathology.
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
long-acting IL2 Superkine assets, MDNA19 and MDNA11, are
best-in-class next-generation IL-2's 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
or MDNA11 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", "believes" and similar
expressions. All statements other than statements of historical
fact, included in this release, including, without limitation,
statements related to that MDNA11 has the potential to be a
best-in-class IL-2 asset, that the Company will progress MDNA11
towards the clinic in the next 12 months and 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
May 14, 2020 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 and that study results could change over time
as the study is continuing to follow up all patients and new data
are continually being received which could materially change study
results. 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.
