Survival improvement of over 150% seen in
MDNA55 subjects compared to a Synthetic Control Arm
TORONTO and HOUSTON, Jan 13,
2020 /PRNewswire/ - Medicenna Therapeutics Corp.
("Medicenna" or "the Company") (TSX: MDNA, OTCQB: MDNAF), a
clinical stage immuno-oncology company, today announced that it has
completed a retrospective study on subjects with recurrent
Glioblastoma (rGBM) who matched eligibility requirements of
subjects enrolled in the MDNA55-05 clinical trial.
This study was conducted to compare the survival of subjects
treated with MDNA55, an interleukin-4 receptor (IL4R) targeted
therapy, in the Phase 2b rGBM
clinical trial versus matched patients (Synthetic Control Arm or
SCA) recently treated using other approved therapies. The SCA
comprised of 81 rGBM patients receiving approved therapies
including Avastin, Lomustine and Temozolomide with similar baseline
features as patients treated in the MDNA55 trial such as age, tumor
size, ineligibility for surgery, interleukin-4 receptor (IL4R)
expression and other parameters known to affect survival.
"This first true apples-to-apples comparison of the data shows
that a single treatment with MDNA55 has the ability to more than
double the survival rates in patients with the most aggressive form
of rGBM," said Dr. Fahar Merchant,
President and CEO of Medicenna Therapeutics. "We hope that these
results are a watershed moment in the battle against this
aggressive and fatal disease, and are particularly meaningful
considering that an even modest improvement in survival of 25% has
not been demonstrated by any of the approved treatments of rGBM in
more than two decades."
Key data from the study are summarized below and have been
computed from the date of relapse rather than from the date of
treatment in results previously reported by the Company:
- When comparing IL4R High groups across the two populations, a
150% survival advantage is seen in patients who received
MDNA55.
-
- IL4R High subjects treated with MDNA55 (n=21) had a median
Overall Survival (mOS) of 15.8 months versus 6.2 months in the SCA
(n=17), a survival advantage of an impressive 9.6 months.
- The 12 month Overall Survival (OS-12) was 62% in the MDNA55 arm
versus 24% in the SCA.
- Regardless of IL4R status, subjects treated with MDNA55 (n=44
subjects comprising the complete per protocol analysis population)
demonstrated 112% increase in OS-12 than subjects in the SCA
(n=81).
-
- OS-12 for the MDNA55 arm was 53% versus 25% in the SCA.
- mOS in the MDNA55 arm was 12.4 versus 7.7 months in the
SCA.
"When compared to real-world data, our results show a
considerable increase in survival benefit particularly in patients
with high expression of the IL4R who are known to have very poor
prognosis, " adds Dr. Merchant. "We are thrilled with the results
from this new study which further solidifies our belief that MDNA55
could be breakthrough therapy for patients with rGBM and other
types of brain cancer.
The results of this analysis will be included in the End of
Phase 2 meeting package which will be submitted to the USFDA in the
first quarter of 2020.
The purpose of the new study was to obtain more reliable
survival results from a matched Synthetic Control Arm (SCA). As the
patient population in the MDNA55 clinical trial consisted of rGBM
tumors with the most aggressive disease and worse potential
outcomes which are not generally the subject of published
literature, results from the SCA more accurately reflects the
patient population that would have been enrolled in a control arm
setting. Furthermore, none of the published studies provide a
sub-analysis based on IL4R status. The SCA study allowed Medicenna
to use the same methods for IL4R analysis as was used in the MDNA55
clinical trial.
About the MDNA55 Synthetic Control Arm
Subjects in the Synthetic Control Arm (SCA) were identified from
patient registries at neurosurgery tissue banks under IRB-approved
protocols. Subjects were selected based on key eligibility criteria
of the MDNA55 trial: male or female subjects ≥ 18 years of age with
de novo WHO grade IV GBM at 1st or 2nd
relapse following standard first-line treatment(s) with surgery and
radio-chemotherapy; subjects must have tumor size no smaller than
1cm x 1cm and no larger than 4cm x 4cm, Karnofsky Performance
Status (KPS) of ≥ 70, must not be candidates for surgery/resection
at relapse, and must have no known mutation in either the
isocitrate dehydrogenase 1 (IDH1) and/or the IDH2 gene.
Demographic and clinical information were extracted from
clinical records. Archived GBM tumor tissue sample from initial
diagnosis was collected where available and analyzed for IL4R
expression using the same validated immunohistochemistry (IHC)
assay that was used in the MDNA55-05 trial. Survival time was
computed from date of relapse to the date of death. Median overall
survival was calculated using the Kaplan-Meier method. The log-rank
test was used for between-group comparisons. In order to avoid
potential bias, Medicenna remained blinded to the survival data
throughout the project. The blind on survival analysis was lifted
only after the IL4R results were reported in order to avoid
selection bias.
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 the SCA is a true
apples-to-apples comparison, that the disclosed results are a
watershed moment in the battle against an aggressive and fatal
disease, that the results from this new study further solidifies
that MDNA55 could be breakthrough therapy for patients with rGBM
and other types of brain cancer, that the End of Phase 2 meeting
package will be submitted to the USFDA in the first quarter of 2020
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.
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SOURCE Medicenna Therapeutics Corp.
