Results presented at the 3rd
SNO-SCIDOT Joint Conference show 12-month survival benefit of over
111% in patients over-expressing the IL-4 receptor
TORONTO and HOUSTON, Nov. 21,
2019 /CNW/ - Medicenna Therapeutics Corp. (TSX: MDNA,
OTCQB: MDNAF), a clinical stage immuno-oncology company, today
announced new positive results on drug distribution from the
recently completed Phase 2b clinical
trial of MDNA55 for the treatment of recurrent glioblastoma
("rGBM"), the most common and uniformly fatal form of brain
cancer.
The results were presented by Dr. Nicholas Butowski, MD, Professor of Neurological
Surgery and Director of Translational Research in Neuro-Oncology at
the Helen Diller Family Comprehensive Cancer Center, University of California San Francisco at the 3rd
Society for Neuro-Oncology and Society for CNS Interstitial
Delivery of Therapeutics Joint Conference ("SNO-SCIDOT") held on
November 20, 2019 at the JW Marriott
Desert Ridge Resort in Phoenix,
Arizona. Dr. Butowski provided an update on drug delivery
results from the MDNA55 clinical trial which uses a technique known
as Convection Enhanced Delivery ("CED") to treat adults with
rGBM.
"CED allows us to solve one of the fundamental problems in
trying to treat patients with brain tumors, and that is delivery,"
states Dr. Butowski. "By implementing new advances in CED that were
previously not available, we are able to bypass the blood-brain
barrier and deliver high concentrations of MDNA55 directly to the
tumor and the at-risk area immediately surrounding it, without
exposure to the rest of the body. Delivering MDNA55 to where it
needs to be, along with the ability to continuously monitor
distribution using real-time imaging, allows us to dramatically
improve drug delivery and maximize tumor coverage."
Highlights from the podium presentation include:
- The MDNA55-05 study showed nearly 50% coverage of the tumor,
with some patients achieving over 90% coverage of the target
volume. In contrast, a previous CED study in rGBM1,
without the advances implemented by Medicenna, was able to achieve
coverage of only 18% of the tumor and a 1cm high-risk margin around
it.
- Higher infusion volumes (up to 66 mL) and higher doses of
MDNA55 (up to 240 mg) did not result in increased toxicity.
- In the first 33 patients enrolled in the clinical trial,
subjects expressing high levels of the IL4 receptor (IL4R) showed
promising overall survival at 12 months (OS-12) of 57%, compared to
an OS-12 of 27% for patients expressing low levels of IL4R - an
improvement of 111%.
- The two IL4R groups did not reveal any differences in drug
distribution or tumor coverage, highlighting the importance of IL4R
expression in receiving optimal benefit from MDNA55.
"This trial clearly illustrates that directing therapy to a
relevant target in rGBM, such as the IL4 receptor, is key in order
to see improved patient outcomes," states Dr. Fahar Merchant, President and CEO of Medicenna.
"We are optimistic that the combination of a targeted therapy and
precision delivery of MDNA55 will enable us to provide maximum
benefit to patients."
Updated efficacy results from the Phase 2b clinical trial MDNA55-05 will be presented on
Sunday, November 24th,
2019 at the SNO Annual Meeting taking place immediately after the
SNO-SCIDOT conference.
Reference:
Sampson JH, Archer G, Pedain C, Wembacher-Schröder E, Westphal
M, Kunwar S, Vogelbaum MA, Coan A, Herndon JE, Raghavan R, Brady
ML, Reardon DA, Friedman AH, Friedman HS, Rodríguez-Ponce MI, Chang
SM, Mittermeyer S, Croteau D, Puri RK; PRECISE Trial Investigators.
Poor drug distribution as a possible explanation for the results of
the PRECISE trial. J Neurosurg. 2010 Aug;113(2):301-9.
About the MDNA55-05 Clinical Trial
MDNA55-05 is a Phase 2b study of
the safety and efficacy of MDNA55, an IL4R-directed toxin, in
patients with de novo GBM at first or second relapse where the
tumor is not amenable to surgical resection. In the study,
investigators administer MDNA55 once directly into the brain tumor
using a technique known as Convection Enhanced Delivery (CED). CED
allows precision delivery of MDNA55 into the tumor and the
surrounding healthy brain containing infiltrative tumor cells,
while avoiding systemic exposure.
The primary endpoint of the study is median Overall Survival
(mOS) comparing a null survival rate of 8.0 months (based on
historical control) with an alternative pursue rate of 11.5 months
(1-sided alpha = 0.10 and 80% power for 46 ITT subjects). The
secondary endpoint is objective response rate (ORR) assessed by the
modified Response Assessment in Neuro-Oncology (mRANO)-based
criteria incorporating advanced imaging modalities according to a
null response rate of 6% with alternative pursue rate of 18%
(1-sided alpha = 0.10 and 80% power for at least 35 subjects
evaluable for response).
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 combination
of a targeted therapy and precision delivery of MDNA55 will enable
us to provide maximum benefit to patients 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.
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June 24, 2019 and in other filings
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interim data results) may prove to be incorrect. Events or
circumstances may cause actual results to differ materially from
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although considered reasonable by management at the time of
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release and the Company will update or revise publicly any of the
included forward-looking statements only as expressly required by
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SOURCE Medicenna Therapeutics Corp.