Medicenna Therapeutics Corp 6-K, filed Nov 18, 2020
Medicenna Therapeutics Corp. (MDNAF)
About this 6-K
Medicenna Therapeutics Corp filed this 6-K on November 18, 2020.
UNITED STATES
SECURITIES AND EXCHANGE COMMISSION
Washington, D.C. 20549
Form 6-K
REPORT OF FOREIGN PRIVATE ISSUER PURSUANT TO RULE 13a-16 OR 15d-16 UNDER THE SECURITIES EXCHANGE ACT OF 1934
For the month of November 2020
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): [ ]
Indicate by check mark if the registrant is submitting the Form 6-K in paper as permitted by Regulation S-T Rule 101(b)(7): [ ]
SIGNATURES
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: November 18, 2020 | By: | /s/ Elizabeth Williams |
| Name: Elizabeth Williams | ||
| Title: Chief Financial Officer | ||
EXHIBIT INDEX
| Exhibit Number | Description | |
| 99.1 | Press Release dated November 18, 2020 |
EXHIBIT 99.1
Medicenna Announces Upcoming Oral Presentations at the 2020 Society for Neuro-Oncology Annual Meeting
TORONTO and HOUSTON, Nov. 18, 2020 (GLOBE NEWSWIRE) -- Medicenna Therapeutics Corp. ("Medicenna" or “the Company") (NASDAQ: MDNA TSX: MDNA), a clinical stage immuno-oncology company, today announced that it will be presenting two on-demand oral presentations as part of the 2020 Society for Neuro-Oncology (SNO) Annual Meeting, which is being held virtually from November 19-21, 2020.
The presentations will include data and analyses from the MDNA55-05 trial, a recently completed Phase 2b trial evaluating MDNA55 in recurrent glioblastoma multiforme (rGBM) patients. Following completion of this trial and an End of Phase 2 Meeting, the United States Food and Drug Administration (FDA) has agreed that Medicenna can conduct an innovative open-label hybrid Phase 3 trial that allows for the use of a substantial number of subjects (two-thirds) from a matched external control arm to support regulatory approval of MDNA55 for rGBM. This trial design should provide the opportunity to accelerate the timelines and reduce the costs when compared with a traditional randomized control arm.
Details of the on-demand oral presentations are below:
Abstract ID: CTIM-13
Title: Clinical efficacy of MDNA55, an interleukin-4 receptor targeted immunotherapy, in recurrent GBM delivered by convection enhanced delivery (CED)
Session Name: Clinical Trials Session II
Speaker: Dr. John Sampson, MD, PhD, MHSc, MBA, Robert H. and Gloria Wilkins Distinguished Professor and Chair of Neurosurgery, Duke University School of Medicine
Abstract ID: NIMG-28
Title: Validation of modified response assessment in neuro oncology (mRANO) determined PFS as a strong predictor of overall survival in recurrent glioblastoma treated with a targeted immunotoxin
Session Name: Surgery, Radiation, Imaging Session I
Speaker: Dr. Benjamin M. Ellingson, PhD, Director of the UCLA Brain Tumor Imaging Laboratory (BTIL), Co-Director of the Center for Computer Vision and Imaging Biomarkers, Member of the UCLA Brain Tumor Program, UCLA Health
The on-demand oral presentations will be available for viewing by conference attendees online here beginning on November 19, 2020 at 9:00 AM ET. Slides from the presentations will be posted to the “Events and Presentations” page of Medicenna’s website following the conference.
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 for the treatment of a broad range of cancers. Medicenna's long-acting IL2 Superkine asset, MDNA11, is a next-generation IL-2 with superior CD122 binding without CD25 affinity and therefore preferentially stimulates cancer killing effector T cells and NK cells when compared to competing IL-2 programs. It is anticipated that MDNA11 will be ready for the clinic in 2021. Medicenna's lead IL4 Empowered Superkine, 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 subjects, including 112 adults with rGBM. MDNA55 has obtained Fast-Track and Orphan Drug status from the FDA and FDA/EMA, respectively. For more information, please visit www.medicenna.com.
Forward-Looking Statement
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" and similar expressions. All statements other than statements of historical fact, included in this release, including the anticipated timing as to when MDNA11 will be ready for the clinic, that an external control arm will reduce the development costs and timelines 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 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 and that study results could change over time as the study is continuing to follow up all subjects 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 and United States securities law.
Further Information
For further information about the Company please contact:
Elizabeth Williams, Chief Financial Officer, 416-648-5555, ewilliams@medicenna.com
Investor Contact
For more investor information, please contact:
Dan Ferry, Managing Director, LifeSci Advisors, 617-430-7576, daniel@lifesciadvisors.com