- MDNA55 achieves up to 5 fold
increase in 12 month survival rate in aggressive, chemotherapy
resistant glioblastoma when compared to approved
therapies
TORONTO and HOUSTON, Dec. 12,
2019 /PRNewswire/ - Medicenna Therapeutics Corp.
("Medicenna" or "the Company") (TSX: MDNA, OTCQB: MDNAF), a
clinical stage immuno-oncology company, presented updated clinical
results from its Phase 2b trial of
MDNA55, in patients with recurrent glioblastoma (rGBM), the most
common and uniformly fatal form of brain cancer. The results were
presented by Dr. Fahar Merchant,
PhD, President and CEO of Medicenna Therapeutics, at the Inaugural
Glioblastoma Drug Development Annual Summit on December 11 at the Westin Boston Waterfront Hotel
in Boston, Massachusetts.
The presentation reported subgroup analysis from the first 40
patients treated with MDNA55 in a Phase 2b clinical trial for patients with rGBM. MDNA55
targets the interleukin 4 receptor (IL4R) known to be
over-expressed in GBM, and a biomarker for more aggressive disease.
Furthermore, unlike other trials, the MDNA55 study only enrolled
patients with rGBM that have genetic features which make the tumor
the most aggressive and resilient type of rGBM.
"We are very encouraged to see that by being the only oncology
company to target the IL4R, which is over-expressed in 76% of
patients with glioblastoma, we are achieving meaningful survival
benefits with MDNA55 in a population where the majority of patients
have the worst form of rGBM," said Dr. Fahar Merchant, President and CEO of Medicenna.
"Our full data set will be complete early in the new year, allowing
us to submit our package to the U.S. Food and Drug Administration
in Q1, 2020 prior to an End of Phase 2 Meeting enabling us to reach
a major milestone on the path to securing key partnerships."
The presentation highlighted that the patient characteristics in
the clinical study excluded patients that are known to have a much
better prognosis, such as patients that were, (a) eligible for
surgery to remove the tumor, (b) had a lower grade of brain cancer
at initial diagnosis (only de novo GBM patients were
enrolled), and (c) had a known mutation associated with better
prognosis (IDH mutation). Furthermore, the presentation emphasized
that despite enrolling only patients known to have a very poor
prognosis, patients actually did much better and were surviving
significantly longer following only one treatment with MDNA55,
particularly in patients with high expression of the IL4R
target.
Of particular interest, subjects receiving lower doses of
steroids (≤ 4mg of concurrent steroid per day) showed a trend
towards improved survival, particularly in the IL4R High group,
with a median overall survival (mOS) of 16.5 months with 88% of
patients being still alive at 12 months. In patients resistant to
approved chemotherapy Temodar (rGBM with unmethylated MGMT
promoter), MDNA55 treatment in IL4R High patients had a median
overall survival of 15.2 months and a 12 month survival rate of 69%
versus 22% for Lomustine and less than 19% for Avastin.
Additional data comparing the various prognostic factors on
MDNA55 outcome measures are provided in the slide presentation
available on-line at
https://ir.medicenna.com/events-and-presentations.
About Medicenna Therapeutics Corp.
Medicenna is a clinical stage immunotherapy company focused on
oncology and the development and commercialization 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. Supported by a US$14.1M
non-dilutive grant from CPRIT (Cancer Prevention and Research
Institute of Texas), Medicenna's
lead IL4-EC, MDNA55, has completed enrolling patients in a Phase
2b clinical trial for rGBM, the most
common and uniformly fatal form of brain cancer, at top-ranked
brain cancer centres in the US. 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. 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 we are
achieving meaningful survival benefits with MDNA55 in a
population where the majority of patients have the worst form of
rGBM, that our full data set will be complete early in the new
year, that this will allow us to submit our package to the U.S.
Food and Drug Administration in Q1, 2020 prior to an End of Phase 2
Meeting enabling us to reach a major milestone on the path to
securing key partnerships 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
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 (including, without
limitation, the ability of the Company to fully replicate these
interim data results) 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.
View original
content:http://www.prnewswire.com/news-releases/medicenna-presents-additional-encouraging-phase-2b-clinical-data-at-the-inaugural-glioblastoma-drug-development-annual-summit-300974017.html
SOURCE Medicenna Therapeutics Corp.