Medicenna Announces That Initiation of MDNA11 Phase 1/2 Study is on Track; Update to be Provided at the PropThink Digital Conference
- Phase 1/2 ABILITY Study is designed to evaluate MDNA11, a potentially best-in-class IL-2 Superkine, in patients with advanced solid tumors
- Study to start enrollment in the third quarter of 2021 in
- Presentation by management team to take place today,
Medicenna’s Phase 1/2 ABILITY Study (A Beta-only IL-2 ImmunoTherapY Study) of MDNA11, the Company’s selective, long-acting and novel IL-2 super-agonist, is designed to assess safety, pharmacokinetics (PK), pharmacodynamics (PD), and anti-tumor activity of various doses of intravenously administered MDNA11 in patients with advanced solid tumors. The study, MDNA11-01, includes a monotherapy dose escalation phase followed by expansion phase for both the MDNA11 monotherapy arm at the recommended phase 2 dose (RP2D), and a combination arm designed to evaluate MDNA11 with a checkpoint inhibitor. As previously announced, in addition to enrolling patients in
Medicenna recently submitted a clinical trial application to a Human Research Ethics Committee (HREC) in
Following discussions with Australian clinicians, investigators, contract research organizations, and clinical trial sites participating in the study regarding the status of oncology clinical trials amid COVID-19-related government restrictions in
- Treatment of medical conditions is exempt from COVID-19-related travel restrictions;
- Prior government-mandated lockdowns have had minimal impact on enrollment in Phase 1 oncology trials;
- Enrollment in Phase 1 oncology trials at sites participating in Medicenna’s MDNA11-01 Study has continued with no effect on enrollment amid the COVID-19-related restrictions currently in place in some Australian states.
A preliminary update on safety, PK/PD, and biomarker data, from patients enrolled in the dose escalation phase this year, is expected by the end of calendar 2021, and preliminary efficacy updates are expected at various times during calendar 2022.
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 IL-2 Superkine asset, MDNA11, is a next-generation IL-2 with potentially superior CD122 binding without CD25 affinity thereby preferentially stimulating cancer killing effector T cells and NK cells unlike competing IL-2 programs. Medicenna’s early-stage BiSKITs™ program, (Bifunctional SuperKine ImmunoTherapies) is designed to further enhance the ability of Superkines to treat immunologically “cold” tumors. 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.
This news release contains forward-looking statements within the meaning of applicable securities laws and relate to the future operations of the Company and other statements that are not historical facts including statements related to the Phase 1/2 ABILITY Study and its timeline, design and expansion, regulatory submissions and approvals, the clinical potential of MDNA11 and the impact of COVID-19 pandemic on the Company’s business and operations. Forward-looking statements are often identified by terms such as "will", "may", "should", "anticipate", "plan", "expects", "believes" and similar expressions. All statements other than statements of historical fact, included in this release, including 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 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
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. 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.
Further Information For further information about the Company please contact:
Elizabeth Williams, Chief Financial Officer, 416-648-5555, firstname.lastname@example.org Investor Contact For more investor information, please contact: Dan Ferry, Managing Director, LifeSci Advisors, 617-430-7576, email@example.com
Source: Medicenna Therapeutics Corp.