Medicenna Reports First Quarter Fiscal 2023 Financial Results and Operational Highlights
-- Extended Cash Runway Into 2024 With
-- New MDNA11 Data From Dose Escalation in ABILITY Study Shows Tumor Control In Four Of Ten Evaluable Patients Including Unconfirmed Partial Response In Pancreatic Cancer Patient
-- ABILITY Study Commences Enrolling In Its Fifth Dose Escalation Cohort With No Dose-Limiting Toxicities Reported To Date
-- Additional Clinical Results Including Tumor Control Data From Fourth And Fifth Dose Escalation Cohorts Expected During The Second Half Of Calendar 2022
-- Management Hosting Conference Call And Webcast Today At
“We are off to a solid start in fiscal 2023 with a stronger balance sheet and promising anti-tumor activity of MDNA11 monotherapy in the ABILITY study,” said Dr. Fahar Merchant, President and CEO of Medicenna. “Whereas single agent activity with next-generation IL-2s has been elusive, we are encouraged with early signs of tumor control in patients with “immunologically cold” tumors including an unconfirmed partial response in a patient with advanced pancreatic cancer. These findings have accompanied desirable pharmacokinetic and pharmacodynamic characteristics, suggesting that MDNA11’s rational design and ‘beta-only’ binding profile are facilitating selective stimulation of anti-cancer immune cells while avoiding the liabilities associated with native IL-2 and competing IL-2 programs. We look forward to building on these preliminary data as we continue to evaluate higher doses of MDNA11 as a single agent and plan to report new data from the ABILITY study during the coming weeks and months.”
Recent Clinical Highlights
In
Following the presentation at the Cytokine Summit, a patient with pancreatic cancer had further tumor shrinkage consistent with an unconfirmed partial response (uPR). The uPR is preliminary and subject to further review. As per protocol and RECIST 1.1, a second scan at 28 days after the most recent scan is required to confirm a partial response in this patient. As a result, the preliminary data from this scan are subject to change and not predictive of the final results. There can be no assurance that, upon completion of the confirmatory scan, that the patient will have a partial response.
Pharmacodynamic data from the ABIILTY study show MDNA11 treatment leading to the preferential activation and expansion of anti-cancer immune cells (CD8+ T cells and natural killer cells) with limited proliferation of regulatory T cells (cause of immunosuppression) and eosinophils (cause of toxicity) typically associated with native IL-2 and “alpha-binding” IL-2 variants. In addition, MDNA11 continues to exhibit an acceptable safety profile, with no dose-limiting toxicities reported in the ABILITY study to date. The trial is currently enrolling into its fifth dose escalation cohort, which evaluates patients receiving two 30 µg/kg priming doses of MDNA11 followed by step up to a fixed dose of 90 µg/kg with each dose administered at 2 week intervals.
Expected Upcoming Milestones
Additional anti-tumor activity data from the ABILITY study’s fourth dose escalation cohort are expected in late
Initial safety, PK, PD and anti-tumor activity data from the ABILITY study’s fifth dose escalation cohort are expected in the fourth quarter of calendar 2022.
Anti-tumor activity data from the ABILITY study’s single agent expansion phase are expected in the middle of calendar 2023.
Top-line anti-tumor activity data from the ABILITY study’s combination arm are expected in the second half of calendar 2023.
Financial Results
“We are pleased to start fiscal 2023 with a newly strengthened balance sheet from our raise of
Medicenna had cash, cash equivalents, and marketable securities of
Net loss for the quarter ended
Research and development (R&D) expenses of
General and administrative (G&A) expenses of
Medicenna’s condensed consolidated interim financial statements for the quarter ended June 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 a checkpoint inhibitor. Approximately 80 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.
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 under applicable securities laws. Forward-looking statements are often identified by terms such as "will", "may", "should", "anticipate", "expects", "believes", "seeks", “plan” and similar expressions. All statements other than statements of historical fact, included in this release, including statements related to cash runway, the clinical potential and development and safety profile of MDNA11 and the Superkine and BISKITs platform, the ability to enroll patients in clinical trials or complete clinical trials on a timely basis, including for the ABILITY study, upcoming milestones and the sharing of additional data and out-licensing efforts for MDNA55 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 may differ materially from those contemplated 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 and Form 20-F of the Company and in other filings (including the prospectus supplement dated
Readers are 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. Readers are cautioned not to place undue reliance on any forward-looking statements. 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 undertake no obligation to update or revise any forward-looking statements.
Contacts: For information about the Company please contact:Elizabeth Williams , Chief Financial Officer, 416-648-5555, ewilliams@medicenna.com Investor Contact For investor information, please contact:Dan Ferry , Managing Director,LifeSci Advisors , 617-430-7576, daniel@lifesciadvisors.com
Source: Medicenna Therapeutics Corp.