SECURITIES AND EXCHANGE COMMISSION
Washington, D.C. 20549
REPORT OF FOREIGN PRIVATE ISSUER PURSUANT TO RULE 13a-16 OR 15d-16 UNDER THE SECURITIES EXCHANGE ACT OF 1934
For the month of May 2022
Commission File Number: 001-39458
Medicenna Therapeutics Corp.
(Translation of registrant's name into English)
2 Bloor St. W., 7th Floor
Toronto, Ontario M4W 3E2, Canada
(Address of principal executive office)
Indicate by check mark whether the registrant files or will file annual reports under cover of Form 20-F or Form 40-F.
Form 20-F [ ] Form 40-F [ X ]
Indicate by check mark if the registrant is submitting the Form 6-K in paper as permitted by Regulation S-T Rule 101(b)(1): [ ]
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Pursuant to the requirements of the Securities Exchange Act of 1934, the registrant has duly caused this report to be signed on its behalf by the undersigned, thereunto duly authorized.
|Medicenna Therapeutics Corp.|
|Date: May 11, 2022||By:||/s/ Elizabeth Williams|
|Name: Elizabeth Williams|
|Title: Chief Financial Officer|
|99.1||Press Release dated May 11, 2022|
Medicenna Presents Phase 1/2 ABILITY Study Data Highlighting MDNA11’s Favorable Clinical Profile at the 2022 Frontiers in Cancer Immunotherapy Meeting
-- New data show that MDNA11 boosted the lymphocyte population by 2-fold without inducing significant increases in eosinophils (associated with toxicity)
-- MDNA11 selectively increased a sub-population of anti-tumor ICOS+ CD8 T cells without enhancing proliferation of highly immune-suppressive pro-tumor ICOS+ Treg cells
-- Dose-dependent and 3-fold increase in immune cells expressing Granulysin, a peptide known to target tumor cell killing.
TORONTO and HOUSTON, May 11, 2022 (GLOBE NEWSWIRE) -- Medicenna Therapeutics Corp. (“Medicenna” or “the Company”) (NASDAQ: MDNA TSX: MDNA), a clinical stage immuno-oncology company, today announced that clinical data from the Phase 1/2 ABILITY (A Beta-only IL-2 ImmunoTherapY) study of MDNA11, the Company’s long-acting IL-2 super-agonist, have been featured in a poster presentation at the 9th Annual Frontiers in Cancer Immunotherapy Meeting. The meeting, organized by the New York Academy of Sciences, is taking place both virtually and in-person from May 9 – 11, 2022.
“Developing a best-in-class IL-2 Superkine is our top priority and we are pleased to disclose additional promising clinical data which are consistent with our expectations based on the novel “beta-only” mechanism of MDNA11,” said Dr. Fahar Merchant, President and CEO of Medicenna. “The cadence of our early clinical data demonstrates that MDNA11 is a unique long-acting IL-2 with favorable pharmacokinetic and pharmacodynamic effects boosting cancer-fighting CD8+T cells and natural killer cells without stimulating immunosuppressive regulatory T cells or eosinophils known to cause toxicity”.
The presentation featured both, previously announced data from the ABILITY study’s initial dose escalation cohorts showing dose-dependent stimulation of anti-cancer immune cells with MDNA11 treatment (doses ranging from 3 µg/kg to 30 µg/kg administered every 2 weeks), as well as new pharmacokinetic (PK) and pharmacodynamic (PD) analyses from the first 8 patients with treatment refractory solid tumors. Key findings from the new analyses include:
Enrollment into the study’s fourth dose escalation cohort is ongoing. An initial update on efficacy data from the ABILITY study is expected in mid-2022.
A copy of the presentation, entitled, “MDNA11 is a Long-Acting ‘Beta-Only’ IL-2 Agonist Exhibiting Potent Tumor Growth Control in Preclinical Models and Preferential Expansion of NK and CD8+ T Cells in Patients with Advanced Solid Tumors,” will be posted to the “Events and Presentations” page of Medicenna’s website.
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.
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.
This news release contains forward-looking statements under applicable securities laws and relate 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", "seeks" and similar expressions. All statements other than statements of historical fact, included in this release, including statements related to the clinical potential and development of MDNA11 and the timing of updates on the ABILITY study 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 annual information form and Form 40-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.
For further information about the Company please contact:
Elizabeth Williams, Chief Financial Officer, 416-648-5555, email@example.com
For more investor information, please contact:
Dan Ferry, Managing Director, LifeSci Advisors, 617-430-7576, firstname.lastname@example.org