TORONTO and HOUSTON, May 2,
2018 /CNW/ - Medicenna Therapeutics Corp. ("Medicenna" or
the "Company") (TSX: MDNA, OTCQX: MDNA), a clinical stage
immunotherapy company, announced today that half the patients in
the ongoing Phase 2b study of MDNA55
in recurrent glioblastoma (rGBM) have been recruited and the data
to date demonstrate solid safety results and early signals of
efficacy based on the findings of the Safety Review and Clinical
Advisory Committees, comprised of key opinion leaders and study
investigators.
MDNA55 is a novel first in class Interleukin-4 empowered
cytokine (IL4-EC). This proprietary targeted therapy is designed to
harness the exceptional specificity and affinity of engineered
cytokines to selectively and simultaneously deliver cell killing
payloads to the bulk tumor, tumor microenvironment (TME) and cancer
stem cells (CSC). MDNA55 is administered directly into brain tumors
using a technique known as Convection Enhanced Delivery (CED),
which allows precision delivery of MDNA55 at high concentrations
into the tumor tissue while avoiding exposure to the rest of the
body. The clinical trial is currently enrolling adult patients with
rGBM at leading brain cancer centers in the US.
"We are pleased with the safety profile to date and early
efficacy signals of MDNA55. We are amending the protocol at the
recommendation of our clinical advisors to further improve the
chances for demonstrating increased therapeutic benefit for
patients living with this life-threatening disease," said
Fahar Merchant, PhD, President and
Chief Executive Officer of Medicenna.
Principal Investigator, John H.
Sampson MD, PhD, of Duke
University Medical Center Department of Neurosurgery,
commented, "The study has contributed substantially to the
improvement of Convection Enhanced Delivery of drugs directly into
brain tumors. More importantly, we are seeing definite biological
effects of MDNA55 in some patients as we await final study results
to see whether these translate into robust longer term
benefits."
"We have used the occasion of this recruitment milestone to
implement optimal methodologies in the amended protocol," commented
Martin Bexon MD, Head of Clinical
Development. "With the experience gleaned from the ongoing Phase
2b clinical trial of MDNA55 in rGBM,
we are able, for instance, to allow for more personalized dosing
based on the tumor load and incorporate advanced imaging modalities
to measure treatment responses more reliably, despite significant
changes due to necrosis and inflammation." Additionally, the
amendment will allow investigators to administer a second dose of
MDNA55 where appropriate.
Review of some patients who had been withdrawn from the study,
believing that their disease had progressed, found that the
apparent increases in tumor volumes, seen on brain scans, were, in
fact, due to tissue necrosis, inflammation and edema. This is a
known effect of immunotherapeutic agents such as MDNA55, called
pseudo-progression, which poses a challenge to patient retention,
management and data interpretation. When evaluating images from the
above patients, using multi-modal imaging, Medicenna found evidence
of biological activity of MDNA55 suggesting that these patients
were benefiting from the treatment, and in multiple cases following
withdrawal from the study, surgical resection showed significant
tumor necrosis. This amendment allows a biopsy and/or advanced
multi-modal imaging to more accurately discriminate between
necrosis/inflammation and true disease progression. It is believed
these tools will encourage subjects to remain in the study, where
appropriate, giving time for the pseudo-progression to resolve and
increase the likelihood of clinical responses.
It is anticipated that the protocol amendment will extend the
expected timing to complete enrollment in the study to Q42018. The
amended protocol is designed to fully leverage the safety profile,
the optimal delivery technique and the highest safe dose of MDNA55
to retain patients in the study and therefore improve the
likelihood of success of this clinical trial. Medicenna is in
frequent communication with the FDA concerning drug development,
the protocol amendment and review process. Available data will be
presented at a conference in the fall of 2018.
Details regarding the protocol amendment for MDNA55-05 will be
available on ClinicalTrials.gov.
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. Medicenna's 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. Supported by a significant non-dilutive
grant from CPRIT (Cancer Prevention and Research Institute of
Texas), Medicenna's lead IL4-EC,
MDNA55 is enrolling patients in a Phase 2b clinical trial for recurrent glioblastoma
(rGBM), the most common and uniformly fatal form of brain cancer,
at top-ranked brain cancer centres in the US. Our proprietary
technology platform supports a unique, multi-pronged treatment
paradigm that can precisely deliver MDNA55 to the tumor as well as
blunt the immunosuppressive tumor micro-environment without harming
healthy cells. MDNA55 has completed three clinical trials in 72
patients, including 66 adults with rGBM, demonstrated compelling
efficacy and 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, 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 the anticipated effects of the protocol amendment
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.
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SOURCE Medicenna Therapeutics Corp.