- Tumor control rate of 82% in recurrent
glioblastoma following one treatment with MDNA55
-
Median overall survival of 15 months in patients over-expressing
the IL4R
- Meetings with regulatory agencies
planned for early 2020
TORONTO and HOUSTON, Nov. 25,
2019 /PRNewswire/ - Medicenna Therapeutics Corp.
("Medicenna" or "the Company") (TSX: MDNA, OTCQB: MDNAF), a
clinical stage immuno-oncology company, has 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. John
Sampson, MD, PhD, a Robert H. and Gloria Wilkins
Distinguished Professor and Chair of Neurosurgery at Duke University School of Medicine at the
24th Society for Neuro-Oncology (SNO) annual meeting on
November 24th, 2019 at the
JW Marriott Desert Ridge Resort in Phoenix, Arizona. Dr. Sampson discussed
updated efficacy results from the Phase 2b clinical trial of MDNA55 in rGBM patients
using the interleukin 4 receptor (IL4R) as an immunotherapy target.
IL4R is a biomarker for a more aggressive form of GBM which is
overexpressed in 75% of glioblastoma patients, as well as in cells
that make up the brain tumor microenvironment (TME).
"In this trial, particularly for patients with IL4R
over-expression, a prognostic factor that is known to contribute to
poor survival, it is gratifying to see that a single treatment with
MDNA55 is able to produce impressive survival and tumor
control." stated Dr. Sampson. "By combining precise drug
delivery and a targeted therapy, MDNA55 could potentially provide
new hope to a large majority of brain cancer patients expressing an
important immunotherapeutic biomarker."
"We are delighted with the results of the Phase 2b trial thus far. We believe these results are
evidence of the opportunity for MDNA55 to become a leading
treatment option for a sizeable patient population with this
devastating disease," said Dr. Fahar
Merchant, President and CEO of Medicenna. "Results from 112
rGBM patients enrolled in this and earlier clinical trials show
substantial improvements in tumor control and survival rates when
compared to approved therapies for rGBM, and provide a
comprehensive data package for our planned meetings with regulatory
agencies early next year."
Highlights from the presentation include:
- With a single treatment with MDNA55, a therapy designed to
target the IL4R, the median overall survival (mOS) in
IL4RHigh subjects (n=21) is 15 months. This shows a
survival advantage of up to nine months when compared to approved
therapies (mOS of 5.4 to 9.2 months with Temozolomide, Avastin and
Lomustine).
- Among the 38 evaluable subjects, irrespective of IL4R
expression, 82% of the subjects experienced tumor shrinkage or
stabilization from nadir. The mOS of patients showing tumor control
(n=31) was significantly longer when compared to patients with
progressive disease (mOS of 15 months vs 8.4 months, respectively;
p-value of 0.0112)
- Updated analysis include the first 40 subjects treated with
MDNA55 continues to show an impressive overall survival rate at 12
months (OS-12) of 45%, irrespective of IL4R expression, and OS-12
of 58% in patients showing a treatment response (n=32). This is an
improvement of up to 150% when compared to approved therapies for
rGBM (OS-12 is 18-34%).
- Safety data continue to show a better safety profile when
compared to previous MDNA55 trials with no systemic toxicities or
drug related deaths.
"The consistent and extremely encouraging results presented by
Key Opinion Leaders at the SNO conference continues to add an
impressive data set for the safety and efficacy of MDNA55," added
Dr. Merchant. "We look forward to presenting additional analysis
and results at various conferences over the coming months."
"We now have readout from 87% of our trial population which
continue to show very promising outcomes with MDNA55," added Dr.
Martin Bexon, MD, Head of Clinical
Development at Medicenna. "A median survival of 15 months in IL4R
patients and a tumor control rate of 82% from nadir is especially
promising considering that patients in this study have a worse
prognosis than most due to the absence of IDH mutations, de
novo GBM at initial diagnosis and ineligibility for resection,
with more than half of the patients harbouring tumors with an
unmethylated MGMT promoter."
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 MDNA55 could
potentially provide new hope to a large majority of brain cancer
patients expressing an important immunotherapeutic biomarker, that
MDNA55 may become a leading treatment option for a sizeable patient
population, that MDNA55 has shown substantial improvements in tumor
control and survival rates when compared to approved therapies for
rGBM, that we will meet with regulatory agencies early next year
and statements related to the Phase 2b clinical trial of MDNA55 for the treatment of
rGBM 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.