Medicenna Reports Second Quarter Fiscal 2023 Financial Results and Operational Highlights
- Results from low and mid-dose escalation cohorts in Phase 1/2 ABILITY study show tumor control in 5 of 14 evaluable patients, including a confirmed partial response in pancreatic cancer
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- Management hosting conference call and webcast today at 8:30 am ET
“Achievements this quarter have substantively bolstered our clinical dataset and balance sheet, providing support for MDNA11’s best-in-class potential and runway through completion of the ABILITY study,” said
Program highlights for the quarter ended
MDNA11: IL-2 Superkine Program
In
Patients in the ABILITY study’s first four dose-escalation cohorts (n=14) failed up to four lines of systemic therapy prior to enrolling in the trial, including eleven (79%) who relapsed on, could not tolerate, or did not respond to at least one prior immunotherapy with a checkpoint inhibitor. All patients in the trial’s dose escalation phase are treated with MDNA11 monotherapy via intravenous infusion every two weeks. With no dose-limiting toxicities, dose interruptions, dose de-escalations, or treatment discontinuations due to safety issues observed to-date, the trial is currently enrolling patients in its fifth dose-escalation cohort (two 30 µg/kg “priming” doses of MDNA11 followed by fixed doses of 90 µg/kg).
Clinical Trial Collaboration and Supply Agreement with Merck
In
Preclinical IL-4/IL-13 Super-Antagonists and BiSKITs™ Programs
Medicenna continues to conduct preclinical studies exploring the potential of its novel Superkines and BiSKITs (Bifunctional SuperKine ImmunoTherapies) as part of its ongoing efforts to build a diverse pipeline. In
Intellectual Property
The
Financing
In
Expected Upcoming Milestones
New safety, pharmacokinetic (PK), and pharmacodynamic (PD) data from the ABILITY study’s first four dose escalation cohorts will be presented next week at the
Updated anti-tumor activity data from the ABILITY study’s escalation cohorts are expected in calendar Q1-2023.
Early anti-tumor activity data from the ABILITY study’s single agent expansion phase are expected in mid-2023.
Early anti-tumor activity data from the ABILITY study’s combination arm are expected in Q4-2023.
Though these milestones represent a brief delay compared to prior guidance, we believe that taking the extra time necessary to recruit an optimized patient population in the current and future cohorts will allow us to potentially increase the impact of the data from these dose cohorts from a scientific and value-creation perspective.
Financial Results
Medicenna had cash, cash equivalents, and marketable securities of
Net loss for the quarter ended
Research and development expenses of
General and administrative expenses of
Medicenna’s condensed consolidated interim financial statements for the quarter ended September 30, 2022 and the related management’s discussion and analysis (MD&A) will be available on SEDAR at www.sedar.com and EDGAR at www.sec.gov.
Conference Call and Webcast
Medicenna will host a conference call and webcast today at
About the Phase 1/2 ABILITY Study
The ABILITY (A Beta-only IL-2 ImmunoTherapY) study is designed to assess the safety, pharmacokinetics, pharmacodynamics, and anti-tumor activity of various doses of intravenously administered MDNA11 in patients with advanced, relapsed, or refractory solid tumors. The trial includes an MDNA11 monotherapy arm, as well as a combination arm designed to evaluate MDNA11 with KEYTRUDA® (pembrolizumab). Approximately 100 patients are expected to be enrolled into the ABILITY Study. Following establishment of the recommended Phase 2 dose (RP2D) and optimal treatment schedule in the study’s dose escalation phase, Medicenna plans to conduct a dose expansion phase that will enroll patients with renal cell carcinoma, melanoma, and other solid tumors in monotherapy and combination settings. For more information, see ClinicalTrials.gov Identifier: NCT05086692.
KEYTRUDA® is a registered trademark of Merck Sharp & Dohme LLC, a subsidiary of Merck & Co., Inc., Rahway, NJ, USA.
About Medicenna
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 Superkines. Medicenna’s long-acting IL-2 Superkine, MDNA11, is a next-generation IL-2 with superior CD122 (IL-2 receptor beta) binding without CD25 (IL-2 receptor alpha) affinity thereby preferentially stimulating cancer killing effector T cells and NK cells. Medicenna’s early-stage BiSKITs™ program, (Bifunctional SuperKine ImmunoTherapies) is designed to enhance the ability of Superkines to treat immunologically “cold” tumors. Medicenna’s IL-4 Empowered Superkine, MDNA55, has been studied in 5 clinical trials including a Phase 2b trial for recurrent GBM, the most common and uniformly fatal form of brain cancer. MDNA55 has obtained Fast-Track and Orphan Drug status from the FDA and FDA/EMA, respectively.
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, but not limited to, statements related to the clinical potential, development of MDNA11 and the expected timing and milestones for the presentation of new data related thereto, cash runway, the clinical trial collaboration and supply agreement with Merck (known as MSD outside the United States and Canada) to evaluate MDNA11 in combination with KEYTRUDA® (pembrolizumab), the potential of the Superkines and BiSKITs (Bifunctional SuperKine ImmunoTherapies), the diversification of the pipeline and planned expenditures. Forward-looking statements are often identified by terms such as “will”, “may”, “should”, “anticipate”, “expect”, “believe”, “seek”, “potentially” and similar expressions. All statements other than statements of historical fact, included in this release, including, but not limited to, MDNA11’s ultimate treatment potential and statements on the future plans and objectives of the Company, are forward-looking statements that 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.
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Source: Medicenna Therapeutics Corp.