TORONTO and HOUSTON, TX, Nov. 14,
2017 /PRNewswire/ - Medicenna Therapeutics Corp.
("Medicenna" or "the Company") (TSX "MDNA"), a
clinical stage immuno-oncology company, announced that that Dr.
Martin Bexon, MD, Head of Clinical
Development at Medicenna, will present today results from earlier
clinical trials at the Cancer Prevention and Research Institute of
Texas' ("CPRIT") Fifth Innovations
in Cancer Prevention and Research Conference held from November 13-14, 2017 in Austin, TX.
The poster presentation by Dr. Bexon provides an overview of the
safety and efficacy results from previous Phase 1 and 2 clinical
trials of the targeted immunotherapy, MDNA55, in 66 patients with
recurrent glioblastoma (rGBM), the most common and deadly form of
brain cancer.
In the MDNA55 Phase 1 multicenter study, an overall response
rate (ORR) of 56% was achieved, with a complete response rate of
20%. Rapid tumor necrosis was observed in ~50% of MDNA55
patients with a partial or a complete response indicating
MDNA55-depedent tumor cytotoxicity. Comparable ORR with other
therapeutics in rGBM patients in various clinical trials has ranged
from 4 to 6% (Levin VA, et al., Neuro-Oncology 17:vi1–vi26,
2015).
Analysis of efficacy data, across the MDNA55 Phase 1 and 2
studies, showed a median survival of 210 days post infusion in all
rGBM patients irrespective of the number of relapses. Among
patients with a partial or complete response median survival was
12.5 months with overall survival at 6 and 12 months (OS-6 and
OS-12) of 71% and 57%, respectively, following a single
administration of MDNA55.
In addition to promising efficacy data the clinical trial
demonstrated the excellent safety profile of MDNA55 including:
- No systemic toxicity following doses of 6 – 900 μg.
- No clinically significant laboratory abnormalities.
- No deaths attributed to MDNA55 in any of the trials.
- Drug-related adverse events were primarily neurological, mostly
an aggravation of pre-existing neurological deficits characteristic
of patients with GBM
- Most frequent drug-related Adverse Events were cerebral edema
and headache following infusion
- The maximum tolerated dose (MTD) was established at 240μg
"It is exciting to review these legacy data from 3 studies of
MDNA55 in patients with recurrent glioblastoma, most of which are
previously unpublished," said Dr. Martin
Bexon, Head of Clinical Development at Medicenna. "They
clearly show direct evidence of cytotoxicity by MDNA55 on the
tumors, high rates of survival at 6 months and with the number of
subjects surviving past 18 months substantially in excess of
expectation. It is a privilege to work on bringing this program
forward and we at Medicenna are grateful to CPRIT for their
support."
About Medicenna Therapeutics Corp.
Medicenna is a clinical stage immuno-oncology company developing
novel highly selective versions of IL-2, IL-4 and IL-13 Superkines™
and first in class Empowered Cytokines™ (ECs). Its wholly
owned subsidiary, Houston-based Medicenna BioPharma, is
specifically targeting the Interleukin-4 Receptor (IL4R), which is
over-expressed by at least 20 different types of cancer affecting
more than one million new cancer patients every year. Medicenna's
lead IL4-EC, MDNA55 is enrolling patients in a Phase 2b clinical
trial for rGBM at leading brain cancer centres in the US. MDNA55
has completed 3 clinical trials in 72 patients, including 66 adults
with rGBM, demonstrated compelling efficacy and obtained Fast-Track
and Orphan Drug status from USFDA. Unlike most other cancer
therapies, Medicenna's IL4-ECs have the potential to purge both the
tumor and the immunosuppressive tumor microenvironment, offering a
unique treatment paradigm for a large majority of cancer
patients.
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, statements regarding
future plans and objectives of the Company, statements related to
the ongoing status of the Phase 2b clinical trial of MDNA55 for the
treatment of recurrent glioblastoma and others 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 15, 2017 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.
SOURCE Medicenna Therapeutics Corp.