Medicenna Therapeutics Corp. (“Medicenna” or the “Company”) (TSX:
MDNA; OTC: MDNAF), a clinical-stage company focused on the design
and development of novel evolutionary superkines to create
revolutionary immunotherapies, today announced financial results
and corporate highlights for the second quarter of fiscal 2024,
ended September 30, 2023.
“We are pleased that our cash runway now extends
through multiple data readouts in mid-2024 and into the first
quarter of 2025, which provides potential opportunities for
additional milestones across our programs.” said Fahar Merchant,
Ph.D., President, and Chief Executive Officer of Medicenna. “At
SITC 2023, we shared positive clinical data readouts for MDNA11.
The Phase 1 dose escalation data from the ABILITY-1 study
demonstrated that MDNA11 is generally well tolerated and results in
durable single-agent activity, including deep ongoing responses
with 100% reduction of target lesions in a pancreatic cancer
patient and 70% reduction of target lesion in a melanoma cancer
patient. This week at SNO 2023, we will be reporting 4-year
follow-up survival data from the Phase 2b bizaxofusp study in
patients with recurrent glioblastoma, a uniformly fatal form of
brain cancer.”
“Another key achievement from the period was
dosing the first patient in the Phase 2 dose expansion monotherapy
arm of the ABILITY-1 study. In addition, we expect to commence the
combination portion of the ABILITY-1 study before the end of this
year evaluating MDNA11 with pembrolizumab (Keytruda®). We look
forward to reporting initial Phase 2 dose expansion data from both
the monotherapy and combination arms during the first half of
2024,” concluded Dr. Merchant.
Pipeline Highlights
MDNA11
- Reported updated Phase 1
MDNA11 dose escalation data at SITC 2023. In early
November 2023, Medicenna reported encouraging single-agent activity
from the dose escalation and evaluation portion of the ABILITY-1
study in advanced cancer patients receiving doses ≥60 μg/kg of
MDNA11 (N=15) and who had previously failed immune check-point
inhibitor therapies. The results included ongoing partial responses
with 100% and 70% reduction of target lesions in pancreatic and
melanoma cancer patients, respectively, in addition to durable
stable disease in 3 melanoma patients (>20 to 80 weeks).
- Dosed first patient in
Phase 2 monotherapy arm. In October 2023, Medicenna dosed
the first patient in the Phase 2 monotherapy dose expansion portion
of the Phase 1/2 ABILITY study evaluating MDNA11 in patients with
advanced melanoma, non-melanoma skin cancer or microsatellite
instability (MSI)-high or mismatch repair (MMR) deficient cancers.
Up to 40 patients are expected to be enrolled and administered
MDNA11 (90 µg/kg intravenously [IV] Q2W). The Company expects to
report initial data from the monotherapy arm in the first half of
2024.
Bizaxofusp (MDNA55)
- Presenting 4-Year Follow-up
overall survival data from Phase 2b bizaxofusp study. A
poster presentation and an oral summary highlighting long-term
follow up from the Phase 2b clinical trial of bizaxofusp (formerly
known as MDNA55) in patients with recurrent glioblastoma (rGBM),
the Company’s first-in-class IL-4R targeted therapy, will be
presented at the Society for Neuro-Oncology (SNO) 2023 Annual
Meeting, to be held from November 15-19, 2023, in Vancouver,
Canada.
- Exploring partnerships to
fund pivotal study. Following the print publication of the
Phase 2b clinical results in the June 2023 issue of the journal
Neuro-Oncology, where bizaxofusp demonstrated a doubling of
survival versus standard of care in patients with rGBM, Medicenna
has embarked on a comprehensive effort to explore partnership
opportunities for a Phase 3 registration trial.
Other Pipeline Programs
- Presented preclinical data
for MDNA113 at SITC 2023. Medicenna presented preclinical
data for MDNA113, a first-in-class IL-13R⍺2 targeted therapy that
delivers a masked bi-specific IL-2-anti-PD1 Superkine to the tumor
micro-environment. The data demonstrated proof-of-concept for the
Company’s novel T-MASK (Targeted
Metalloprotease Activated
SuperKine) platform technology.
The data showed reduced IL-2R agonism with no change to PD1/PDL-1
blockade and reduced systemic lymphocyte expansion providing
evidence of dampening of systemic activity. In addition, the
preclinical data showed that cleavage of MDNA113 by tumor
associated metalloproteases restores IL-2R signaling and that
MDNA113 is as effective as non-masked MDNA223 (a bispecific
antiPD1-IL-2 superkine) in tumor models.
- Presented preclinical data
for MDNA223 at AACR’s Special Conference in Cancer Research: Tumor
Immunology and Immunotherapy. Medicenna presented new
preclinical data on MDNA223, a fusion of MDNA11 combined with an
anti-PD1 antibody, that is designed to maximize anti-tumor response
by concurrently facilitating IL-2R pathway stimulation and PD1
checkpoint blockade on the same effector immune cell. The data
support the potential of Medicenna’s superkine-focused platform to
create novel therapies for challenging-to-treat ‘cold’ tumors.
- Strengthened intellectual
property portfolio. Medicenna received a U.S. patent for
the use of Interleukin-2 Superkine fusion proteins in oncology.
This patent strengthens the Company’s intellectual property around
its BiSKIT (Bifunctional SuperKine for ImmunoTherapy)
platform.
Corporate and Financial
Highlights
- Management
changes. Key new leadership team appointments include
Humphrey Gardner, M.D., as Chief Medical Officer and Arash Yavari,
M.D., DPhil, as Chair of the Development Advisory Committee.
- Delisted from Nasdaq
Capital Market. Medicenna’s common stock ceased trading on
Nasdaq on November 2, 2023. The Company anticipates significant
financial savings as a result of this decision. The Company has
applied to have its common shares traded on the OTC Markets.
Medicenna’s common stock continues to trade on the Toronto Stock
Exchange (TSX).
Expected Upcoming
Milestones
- Report 4-year follow-up survival
data from the Phase 2b bizaxofusp study in patients with rGBM at
the SNO conference to be held from 15-19 November, 2023
- Commence the combination arm of the
ABILITY study evaluating MDNA11 with pembrolizumab (KEYTRUDA®)
e.
- Clinical update from the ABILITY
study’s MDNA11 Phase 2 monotherapy arm expected in the first half
of 2024.
- Clinical update from the ABILITY
study’s MDNA11 plus pembrolizumab Phase 2 combination arm expected
in the first half of 2024.
Financial Results
As of September 30, 2023, cash and cash
equivalents were $25.7 million, compared to $29.6 million on June
30, 2023.
Net loss for the quarter ended September 30,
2023, was $3.7 million or $(0.05) per share compared to a net loss
of $0.9 million or ($0.01) per share for the quarter ended
September 30, 2022. The increase in net loss for the quarter ended
September 30, 2023, compared with the quarter ended September 30,
2022, was primarily a result of increased research and development
expenditures related to the clinical costs associated with the
MDNA11 ABILITY-1 study, and increased licensing and patent legal
fees.
Research and development expenses of $3.1
million were incurred during the quarter ended September 30, 2023,
compared with $2.4 million incurred in the quarter ended September
30, 2022. The increase in R&D expenses for the quarter ended
September 30, 2023 was primarily attributable to increased
licensing and patent legal fees related to timing as well as
intellectual property activities in the current year quarter,
higher clinical costs related to the MDNA11 ABILITY study in the
current year period, and increased salaries and benefits due to
increase in headcount to support the MDNA11 ABILITY-1 study.
General and administrative expenses of $2.3
million were incurred during the quarter ended September 30, 2023,
compared with $2.4 million during the quarter ended September 30,
2022. The decrease in G&A expenses was primarily attributable
to an increase in public company expenses, and salaries and
benefits due to increase in headcount, partially offset by the
one-time transaction costs associated with warrant derivative in
the six month period ended September, 30, 2022 only.
About Medicenna
Therapeutics
Medicenna is a clinical-stage immunotherapy
company focused on developing novel, highly selective versions of
IL-2, IL-4 and IL-13 Superkines and first in class class-empowered
superkines. Medicenna’s long-acting IL-2 Superkine, MDNA11, is a
next-generation IL-2 with superior affinity toward CD122 (IL-2
receptor beta) and no CD25 (IL-2 receptor alpha) binding, thereby
preferentially stimulating cancer-killing effector T cells and NK
cells. Medicenna’s IL-4 Empowered Superkine, bizaxofusp (formerly
MDNA55), has been studied in 5 clinical trials enrolling over 130
patients, including a Phase 2b trial for recurrent GBM, the most
common and uniformly fatal form of brain cancer. Bizaxofusp has
obtained FastTrack and Orphan Drug status from the FDA and FDA/EMA,
respectively. Medicenna’s early-stage BiSKITs™ program
(Bifunctional SuperKine ImmunoTherapies)
is designed to enhance the ability of Superkines to treat
immunologically “cold” tumors. For more information, please visit
https://www.medicenna.com/.
Forward-Looking Statements
This news release contains forward-looking
statements within the meaning of applicable securities laws that
relate to the future operations of the Company, plans and
projections and other statements that are not historical facts,
including, without limitation, statements on the Company’s cash
runway, clinical development activities, potential, safety profiles
and upcoming milestones and data reporting, including with respect
to MDNA11, MDNA113, MDNA223, the Superkine platform, notably
MDNA55, partnership opportunities, patent protection and cost
savings related to NASDAQ delisting. Forward-looking statements are
often identified by terms such as “will”, “may”, “should”,
“anticipate”, “expect”, “believe”, “seek”, “potentially” and
similar expressions. and are subject to 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 latest
Annual Information Form and Annual Report on Form 20-F of the
Company and in other filings made by the Company with the
applicable securities regulators from time to time in Canada and
the United States.
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, 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 hereof and except as
required by law, we do not intend and do not assume any obligation
to update or revise publicly any of the included forward-looking
statements.
Investor and Media Contacts
Christina CameronInvestor Relations, Medicenna
Therapeuticsir@medicenna.com
Argot PartnersPhone: 212-600-1902medicenna@argotpartners.com
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