- End of Phase 2
meeting package for MDNA55 to be submitted in Q2
2020-
- IND submission for IL-2
Superkine Platform calendar Q1
2021-
- Two abstracts to be
presented at ASCO 2020-
TORONTO and HOUSTON, May 15,
2020 /CNW/ - Medicenna Therapeutics Corp.
("Medicenna" or the "Company") (TSX: MDNA, OTCQB:
MDNAF), a clinical stage immunotherapy company, today announced its
operational and financial results for the year ended March 31, 2020.
"Fiscal 2020 was a year of considerable accomplishment on all
fronts for Medicenna. We had promising non-human primate
pre-clinical data with our IL-2 Superkine Platform, solid results
from our Phase 2b clinical trial for
MDNA55 and successful financings at higher prices than earlier
offerings with gross proceeds of over $47
million establishing a solid balance sheet to meet our next
set of milestones," said Dr. Fahar
Merchant, President and CEO of Medicenna.
"We are well-positioned for continued success in calendar 2020
and 2021, as we plan to submit our end of phase 2 (EoP2) meeting
package to the FDA this quarter, expect input from the agency in
calendar Q3 and planned listing on Nasdaq calendar Q4. We also
expect to complete our IND enabling studies for our MDNA109
Superkine Platform by Q1 of calendar year 2021" adds Dr. Merchant.
"While we are proud of what we've achieved thus far, we believe
that the best is yet to come."
Program highlights for the year ended March 31, 2020, along with recent developments,
include:
MDNA55: Recurrent Glioblastoma Program
- On April 30, 2019, completed
enrolment in the MDNA55 Phase 2b
clinical study for the treatment of recurrent glioblastoma
("rGBM").
- On June 3, 2019 a poster entitled
"MDNA55: A Locally Administered IL4 Guided Toxin as a Targeted
Treatment for Recurrent GliMDNA11oblastoma" was presented at the
55th Annual Meeting of ASCO. The presentation by Dr. Dina Randazzo, of Duke
University School of Medicine and a Principal Investigator,
focused on the development of a new biomarker test for the IL4R
that may enable better selection and superior treatment outcomes
for patients with rGBM.
- On June 18, 2019, Dr.
Fahar Merchant presented results
from the MDNA55 clinical trial at the Inaugural Immuno-Oncology
Pharma Congress. The presentation highlighted disease control in up
to 83% of the patients according to Immunotherapy Response
Assessment in Neuro-Oncology criteria which measure tumor response
relative to the largest tumor size post-treatment (nadir). In
addition, safety data from the Phase 2b clinical trial show a similar safety profile
to previous MDNA55 trials, with no systemic toxicities, no
clinically significant laboratory abnormalities and no drug-related
deaths.
- On November 21, 2019, Medicenna
announced new positive results on drug distribution MDNA55 clinical
trial. Implementing new advances in convection enhanced delivery
("CED"), that were previously not available allows us 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.
- On November 25, 2019, Medicenna
announced the presentation of updated MDNA55 clinical results by
Dr. John Sampson at the 24th Society
for Neuro-Oncology ("SNO") annual meeting. Dr. Sampson discussed
updated efficacy results from the clinical trial using the IL4R as
an immunotherapy target.
- On January 13, 2020, Medicenna
announced results from a retrospective study of subjects with rGBM
who matched eligibility requirements of subjects enrolled in the
MDNA55-05 clinical trial (Synthetic Control Arm, "SCA") receiving
standard therapies and compared their survival versus subjects
treated with MDNA55, in the Phase 2b
rGBM clinical. The SCA comprised 81 rGBM patients receiving
standard therapies with similar baseline features as patients
treated in the MDNA55 trial. When comparing IL4R High groups across
the two populations, a 150% survival advantage is seen in patients
who received MDNA55.
- Subsequent to the year end, on May 4,
2020, Medicenna announced the upcoming presentation at the
American Society of Clinical Oncology ("ASCO") Virtual Scientific
Program to be held from May 29 to May 31,
2020. An abstract on our MDNA55 rGBM program has been
selected for a poster discussion and will provide new data on tumor
response as well as survival outcomes compared to a matched
SCA.
MDNA11 and MDNA19 IL-2 Superkine Platform
- On June 20, 2019, Medicenna
presented a poster entitled "Engineering a long-acting CD122 biased
IL-2 superkine displaying potent anti-tumoral responses". The
presentation highlighted that MDNA19, when combined with checkpoint
inhibitors (a) demonstrated durable tumor control with strong
memory response; (b) enhancing activation of naive CD8 T cells and
NK cells (responsible for attacking tumor cells) and (c) attained
long term tumor control with fewer treatment cycles and a less
frequent dosing regimen.
- On September 26, 2019, Medicenna announced the publication of a
peer-reviewed article in the August 2019 edition of Nature
Communications providing independent third-party validation of
Medicenna's IL-2 Superkine platform, MDNA109.
- On September 30, 2019, Medicenna announced the presentation of
new preclinical data from our IL-2 Superkine program to support the
differentiating characteristics of long-acting MDNA109 variants and
their potency in vitro and in vivo from other long-acting IL-2
programs.
- On March 25, 2020, Medicenna presented preclinical data,
including non-human primate ("NHP") data from its IL-2 Superkine
program (lead candidates MDNA19 and MDNA11), highlighting data from
the long-acting variant MDNA19, engineered to have enhanced binding
to CD122 without binding to CD25. This allows MDNA19 to
specifically activate naive CD8 T cells and NK cells with minimal
stimulation of regulatory T cells, thereby circumventing toxicity
and demonstrating potential for best-in-class features which was
supported by the NHP data.
- Subsequent to the year end, on May 4, 2020, Medicenna announced
the upcoming presentation at the ASCO Virtual Scientific Program to
be held from May 29 to May 31, 2020. An abstract will present
preclinical data including non-human primate data for MDNA11, one
of the MDNA109 platform candidates.
Operational Highlights
- On May 1, 2019 and July 9, 2019, Medicenna received amounts of
US$757,940 and US$1,915,372, respectively, from CPRIT for
reimbursement of past expenses.
- On September 24, 2019, we
announced the appointment of Ms. Karen
Dawes to our Board of Directors. Ms. Dawes is an experienced
and highly regarded leader in the life sciences industry with
extensive strategic expertise and considerable commercial
background.
- On October 17, 2019, Medicenna
completed a public offering raising total gross proceeds of
$6,900,000. The Company issued
5,307,693 units at a price of $1.30,
each such unit consisting of one common share and one-half common
share purchase warrant. Each such whole warrant is exercisable at a
price of $1.75 until October 17, 2022.
- On March 17, 2020, the Company
closed a public offering of 11,290,323 common shares at a price of
$3.10 per share for gross proceeds of
approximately $35 million (the "2020
Public Offering") and subsequent to the year end, On April 15, 2020, Medicenna announced the closing
of the full over-allotment option to purchase an additional
1,693,548 common shares of Medicenna at a price of $3.10 per share, in connection with the 2020
Public Offering for total gross proceeds of $40.25 million.
Upcoming Milestones
Medicenna will focus on achieving the following milestones in
the upcoming quarters:
- Meeting with the US FDA to discuss the development path forward
for MDNA55. It is currently anticipated this meeting will be held
in Q3 calendar 2020.
- Initiation of IND enabling studies for MDNA109 Superkine
Platform (MDNA19 or MDNA11) in Q4 of calendar 2020.
- Completion of a US listing in Q4 calendar 2020.
- Initiation of Phase 1 clinical study for MDNA109 Superkine
Platform (MDNA19 or MDNA11) in mid-2021.
Annual Financial Results
Net loss for the year ended March 31,
2020 was $8,277,069, or
$0.26 per share, compared to a loss
of $4,708,031, or $0.18 per share, for the year ended March 31, 2019. The increase in net loss for the
year ended March 31, 2020 compared
with the year ended March 31, 2019
was primarily a result of a lower amount of costs reimbursed under
the Cancer Prevention and Research Institute of Texas ("CPRIT") grant in the current year of
$1,076,538 compared with $5,646,227 in the prior year and an increase in
spending on discovery and preclinical expenses associated with the
development of the MDNA109 platform (MDNA11 and MDNA19).
Research and development expenses of $5,869,588 were incurred during the year ended
March 31, 2020, compared with
$3,017,997 incurred in the year ended
March 31, 2019. The increase in
expenses in the current year is primarily attributable to:
increased regulatory costs associated with preparation for the EOP2
meeting, higher discovery and preclinical expenses associated with
the development of the MDNA109 platform (MDNA11 and MDNA19) as we
advance it towards the clinic, increased travel and administrative
costs associated with closing clinical sites, program symposium and
the EOP2 meeting. In addition a lower reimbursement of
expenses with respect to the CPRIT grant of $951,166 in the year ended March 31, 2020, compared with $5,140,039 in the year ended March 31, 2019 contributed to the increase.
These increases were partially offset by no amortization related to
the research & development warrant which was fully amortized in
the prior year as well as lower clinical trial costs due to
completion of enrolment in the Phase 2b rGBM clinical study and the wind down of the
study.
General and administrative expenses of $2,375,211 were incurred during the year ended
March 31, 2020, compared with
$1,709,286 during the year ended
March 31, 2019. The increase in
expenditures year over year is primarily attributed to lower
amounts of expenses eligible for reimbursement from CPRIT in the
current year as well as higher facilities and operations expenses
associated with office rent and relocation costs as well as higher
corporate communications expenses in the current year due to higher
levels of activity. Stock based compensation expense increased in
the year ended March 31, 2020
compared with the prior year due to the timing of grants as well as
higher Black Scholes values of current year grants.
Medicenna had cash, cash equivalents and marketable securities
of $37,700,202 at March 31, 2020. Subsequent to the fiscal year-end
additional gross proceeds of $5,249,998 was raised through the exercise of
overallotment noted above. These funds provide the Company with
sufficient capital to late 2022 based on its current plans and
projections.
Medicenna's audited annual consolidated financial statements for
the year ended March 31, 2020 and the related
management's discussion and analysis (MD&A) will be available
on SEDAR at www.sedar.com
About Medicenna Therapeutics Corp.
Medicenna is a
clinical stage immunotherapy company focused on the development 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 lead IL4-EC, MDNA55, has
completed a Phase 2b clinical trial for rGBM, the most
common and uniformly fatal form of brain cancer. 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. Medicenna's long-acting IL2 Superkine assets,
MDNA19 and MDNA11, are best-in-class next-generation IL-2's in
development with superior CD122 binding without CD25 affinity and
therefore preferentially stimulating cancer killing effector T
cells and NK cells when compared to competing IL-2 programs.
It is anticipated that MDNA19 or MDNA11 will be ready for the
clinic in 2021. 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", "believes" and similar
expressions. All statements other than statements of historical
fact, included in this release, including, without limitation,
statements related to Medicenna being well-positioned
for continued success in calendar 2020 and 2021, that Medicenna
will submit an end of phase 2 meeting package to the FDA in Q2
calendar 2020, that a Nasdaq listing will be completed
in calendar Q4, that IND enabling studies for the MDNA109 Superkine
Platform will be initiated in Q4 of calendar 2020 and completed by
Q1 of calendar year 2021, that the best is yet to come, that
the Initiation of a Phase 1 clinical study for MDNA109 Superkine
Platform (MDNA19 or MDNA11) will occur in mid-2021 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
May 14, 2020 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 and that study results could change over time
as the study is continuing to follow up all patients and new data
are continually being received which could materially change study
results. 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.
