– The launch of the ABILITY study, a first trial in humans, is scheduled for the third quarter of 2021
– The trial is designed to assess the safety, pharmacokinetics (PK), pharmacodynamics (PD) and anti-tumor activity of MDNA11 in patients with advanced solid tumors
– Preliminary update on safety data, PK / PD and biomarkers expected by the end of the year
TORONTO and HOUSTON, June 23, 2021 (GLOBE NEWSWIRE) – Medicenna Therapeutics Corp. (“Medicenna” or “the Company”) (NASDAQ: MDNA TSX: MDNA), a clinical-stage immuno-oncology company, today announced that it has submitted a clinical trial application to an ethics committee Human Research Center (HREC) in Australia to initiate a Phase 1/2 clinical study of MDNA11, the company’s new, selective, long-acting IL-2 superagonist. Subject to HREC approval and acceptance of the Clinical Trial Notification (CTN) by the Australian Therapeutics Goods Administration (TGA), Medicenna plans to launch this study in the third quarter of 2021. In addition, pending the successful patient recruitment, the Company intends to provide a preliminary update on safety, pharmacokinetics (PK), pharmacodynamics (PD) and biomarker data by the end of the year .
“Submitting this dossier for HREC approval is an important step that keeps us on track to execute our larger clinical and business strategy,” said Fahar Merchant, PhD, president and chief executive officer. direction of Medicenna. “We look forward to the launch of this trial and the publication of results that may support the advanced potential of MDNA11 as an ‘IL-2 only beta’ agent instead of ‘non-alpha IL-2’ agents currently. in clinic. In addition to the first ABILITY study of MDNA11 (A Beta-only HE-2 ImmunoTheraldStudy Y), we are advancing our BiSKITMT program to identify a new lead candidate to add to our pipeline as we advance partnership discussions around MDNA55. We are encouraged by the recent progress we have made on several fronts and also hope that a partnership for MDNA55 will be concluded in the coming months. Collectively, our pipeline of opportunities leaves us well positioned to achieve a steady pace of value-creating milestones as we work to address unmet patient needs. “
The planned phase 1/2 ABILITY study is designed to evaluate the safety, pharmacokinetics, PD and anti-tumor activity of various doses of MDNA11 administered intravenously in patients with advanced solid tumors. It includes both an MDNA11 monotherapy arm as well as a combination arm designed to assess MDNA11 with a checkpoint inhibitor. Following its progress in Australia, Medicenna intends to expand the study to the UK, US and Canada.
Mann Muhsin, MD, Medicenna Medical Director, commented, “MDNA11 has the attributes to overcome the limitations of competing IL-2 therapies and filing this application represents a critical step in exploring the pan-tumor potential of MDNA11 and its ability to treat several types of tumors covering a broad spectrum of immunogenicity. Preclinical data demonstrate the ability of MDNA11 to selectively stimulate the sustained expansion of carcinogenic immune cells without the unwanted side effects typically seen with IL-2. Our Phase 1/2 study is designed to clinically validate these results, as it will include safety and PK / PD evaluations as well as collection of biomarker data from matched tumor biopsies before and during treatment. The preliminary reading of the efficacy of the monotherapy arm is expected in 2022 and will notably assess the anti-tumor activity of MDNA11 in expansion cohorts composed of subjects suffering from metastatic melanoma and advanced renal carcinoma, types of tumors which are known to respond to IL-2 therapy but have not yet shown comparable responses with non-alpha IL-2.
Medicenna is a clinical-stage immunotherapy company focused on the development of new, highly selective versions of the IL-2, IL-4 and IL-13 superkins and the first superkins qualified for the treatment of a wide range of cancers. Medicenna’s active long-acting IL-2 Superkine, MDNA11, is a new generation IL-2 with potentially superior CD122 binding without CD25 affinity and therefore preferentially stimulates effector T cells and cancer killer NK cells. compared to competing IL-2 programs. Medicenna’s early stage BiSKITs ™ program (Bifunctional SupperKiné ImmunoTtherapys) is designed to further enhance the ability of Superkines to treat “cold” tumors immunologically. Medicenna’s Superkine Empowered IL4, MDNA55, has completed a Phase 2b clinical trial for rGBM, the most common and consistently 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 statuses from the FDA and FDA / EMA, respectively.
This press release contains forward-looking statements within the meaning of applicable securities laws and relate to future operations of the Company and other statements which are not historical facts, including statements relating to the clinical trial of phase 1/2 of MDNA11 and its schedule, its design and expansion, the clinical potential of MDNA11, the clinical potential and development of the BiSKITs ™ program and its schedule, the partnership discussions around MDNA55 and the schedule for a potential transaction and growth of the Company. Forward-looking statements are often identified by words such as “will”, “may”, “should”, “anticipate”, “expect”, “believe” and similar expressions. All statements other than statements of historical fact included in this press release, including the future plans and objectives of the Company, are forward-looking statements subject to risks and uncertainties. There can be no assurance that such statements will prove to be accurate and that 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 Company’s Annual Information Form and Form 40-F and in other documents filed by the Company with regulatory bodies. securities regulations applicable from time to time in Canada. and the United States.
The reader is cautioned that the 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 expected, due to many 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 forward-looking information. This information, although considered reasonable by management, may prove to be inaccurate and actual results may differ materially from those anticipated. The forward-looking statements contained in this press release are expressly qualified by this cautionary statement. Except as required by law, we do not intend and assume no obligation to publicly update or revise any forward-looking statements included.
CONTACT: Further Information For further information about the Company please contact: Elizabeth Williams, Chief Financial Officer, 416-648-5555, [email protected] Investor Contact For more investor information, please contact: Dan Ferry, Managing Director, LifeSci Advisors, 617-430-7576, [email protected]