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Medicenna Reports Confirm Clinical Update on Pancreatic Cancer Partial Response and MDNA11 Monotherapy Dose Escalation Portion of the Ongoing Phase 1/2 ABILITY Study, Canadian Business Journal

  • A confirmed partial response in a patient with fourth-line metastatic pancreatic cancer who had previously failed chemotherapy and checkpoint inhibitor therapy suggests the potential of MDNA11 as a single agent in advanced solid tumors unresponsive to established therapies. backs up
  • The 36% tumor control rate observed in low- and intermediate-dose cohorts (n=14) of patients with advanced metastatic cancer further strengthens confidence in the monotherapeutic activity of MDNA11 to selectively enhance cancer-fighting immunity. It is consistent with our belief that it has the potential to enhance.cell
  • A fifth dose escalation cohort is currently enrolling patients for whom no dose-limiting toxicities have been observed in previous trials.

TORONTO & HOUSTON, Sept. 28, 2022 (GLOBE NEWSWIRE) — Medicenna Therapeutics Corp. (“Medicenna” or the “Company”) (NASDAQ: MDNA TSX: MDNA), a clinical-stage immuno-oncology company, today announced Presented new clinical data. Anti-tumor activity from the Phase 1/2 ABILITY trial of his MDNA11, the company’s ‘beta-only’ long-acting IL-2 superagonist. These data include a confirmed partial response (PR) in patients with fourth-line metastatic pancreatic ductal adenocarcinoma (PDAC) who had previously failed chemotherapy and checkpoint inhibitor therapy. Confirmatory scans of this patient continue to show further tumor shrinkage compared to previous scans, suggesting sustained anticancer activity after MDNA11 monotherapy. Overall, 5 of 14 evaluable patients in the low- and mid-stage dose escalation cohorts of the ABILITY study achieved tumor control (PR or stable disease (SD)) with MDNA11 monotherapy.

Dr. Fahar Merchant, President and CEO of Medicenna, said: “Furthermore, in all patients enrolled in the dose escalation cohort of ABILITY, an additional four patients experienced tumor control despite advanced stage cancer. It provides early evidence to support our belief in activity and underscores its therapeutic potential as a best-in-class IL-2 agonist.The dose escalation portion of the trial primarily assessed safety and pharmacokinetics. , given that it is designed to determine the dose for Phase 2, these early indications of potential clinical benefit continue with dose escalation and progress towards the dose expansion phase of the trial. It’s particularly impressive because we’re in early next year.”

The dose escalation cohort of the ABILITY trial was designed with the primary objectives of evaluating safety and pharmacokinetics and determining the recommended phase 2 dose (RP2D) in patients with advanced solid tumors intravenously administered once every two weeks. We are evaluating MDNA11 monotherapy administered intraperitoneally. Once RP2D is established, an important secondary objective of the trial is to assess the anti-tumor activity of MDNA11 alone and in combination with the checkpoint inhibitor KEYTRUDA.® (pembrolizumab) in the dose expansion phase of the trial.

In the first three dose escalation cohorts of the ABILITY study, MDNA11 was evaluated at doses of 3, 10 and 30 µg/kg. Patients in the fourth and her fifth dose escalation cohorts receive two ‘priming’ doses of 30 μg/kg of MDNA11 followed by fixed doses of 60 and 90 μg/kg, respectively. The trial is currently enrolling patients in its fifth dose escalation cohort and has not, to date, allowed dose-limiting toxicities, dose interruptions, dose reductions or treatment discontinuations due to safety issues. A summary of demographic and treatment activity data from all evaluable patients in the first four dose escalation cohorts is provided below.

patient demographics

Prior to enrollment in the ABILITY study, patients in cohorts 1-4 (n=14) had failed up to 4 systemic therapies.

Prior to enrollment in the ABILITY study, 11 of 14 patients (89%) in cohorts 1–4 relapsed, were not tolerated, or did not respond to at least one immunotherapy with a checkpoint inhibitor. did.

therapeutic activity

Five of 14 evaluable patients (36%) achieved study-defined tumor control.

  • One fourth-line (4L) metastatic PDAC patient who had previously failed chemotherapy and checkpoint inhibitor therapy achieved a confirmed PR at a dose of 60 μg/kg
  • One patient with 3L non-clear cell renal cell carcinoma who achieved SD achieved at a dose of 60 μg/kg
  • One patient with 4L sarcoma who received a dose of 30 μg/kg achieved SD
  • Two patients (3L sarcoma and 3L metastatic melanoma) achieved SD at the 10 μg/kg dose, and the metastatic melanoma patient maintained SD for >1 year while escalating to the 60 μg/kg dose Did.

To date, MDNA11 has shown a favorable tolerability profile in the monotherapy dose escalation segment of the ABILITY trial. New data on the safety, pharmacokinetic and pharmacodynamic profiles of MDNA11 are expected to be presented at a major medical conference in the fourth calendar quarter.

About the Phase 1/2 ABILITY Study
Ability (a B.eta only Illinois-2 MeimmunityT.Herupworld) The study was designed to evaluate the safety, pharmacokinetics, pharmacodynamics, and antitumor activity of various doses of intravenously administered MDNA11 in patients with advanced, recurrent, or refractory solid tumors. It has been. The trial includes an MDNA11 monotherapy arm and a combination arm designed to evaluate MDNA11 with his KEYTRUDA.® (pembrolizumab). The ABILITY trial is expected to enroll approximately 80 patients. Following establishment of the recommended Phase 2 dose (RP2D) and optimal treatment schedule in the dose escalation phase of the study, Medicenna is available in monotherapy and combination therapy for the treatment of renal cell carcinoma, melanoma, and other solid tumors. A dose escalation phase to enroll patients is planned. For more information, see ClinicalTrials.gov Identifier: NCT05086692.

Keytruda® is a registered trademark of Merck Sharp & Dohme LLC, a subsidiary of Merck & Co., Inc., Rahway, NJ, USA.

About Medicenna
Medicenna is a clinical-stage immunotherapy company focused on developing novel, highly selective versions of IL-2, IL-4 and IL-13 superkines, as well as first-in-class empowered superkines. Medicenna’s long-acting IL-2 superkine, MDNA11, is the next generation IL-2 with excellent CD122 (IL-2 receptor beta) binding without CD25 (IL-2 receptor alpha) affinity and thereby preferentially stimulate cancer-killing effector T cells and NK. cell. Medicenna early-stage BiSKITs™ program (byfunctional S.upperK.rice MeimmunityT.Herapys) are designed to enhance the ability of superkines to treat immunologically “cold” tumors. Medicenna’s IL-4 Empowered Superkine, MDNA55, is being studied in five clinical trials, including a Phase 2b trial in recurrent GBM, the most common and uniformly fatal form of brain cancer. MDNA55 has received Fast-Track and Orphan Drug status from the FDA and FDA/EMA, respectively.

Forward-Looking Statements
This news release contains, but is not limited to, forward-looking statements within the meaning of applicable securities laws that relate to our future business, and statements related to clinical potential, development and tolerability profiles. It contains other statements that are not factual. Anticipated timing of publication of MDNA11 and related new data. Forward-looking statements often use words such as “will,” “may,” “should,” “anticipate,” “expect,” “believe,” “seek,” identified by terms such as ‘as gender’, and similar expressions. All statements other than statements of historical fact contained in this release, including but not limited to statements regarding the potential for eventual treatment of MDNA11 and the Company’s future plans and objectives, are subject to risks and uncertainties. Affected forward-looking statements. There can be no assurance that such statements will prove to be accurate, and actual results and future events could differ materially from those projected by such statements. Significant factors that may cause it to differ materially include our most recent Annual Information Form and Annual Report on Form 20-F and other documents that we file with applicable securities regulators from time to time. includes the risks detailed in Ticking time in Canada and the United States.

Readers are cautioned that the assumptions used in preparing forward-looking information may prove to be incorrect. Actual results may differ materially from projections due to events and circumstances. It is the result of a number of known and unknown risks, uncertainties and other factors, many of which are beyond the Company’s control. Readers are cautioned not to place undue reliance on forward-looking information. Such information, even if deemed reasonable by management, could prove to be inaccurate and actual results could differ materially from those projected. The forward-looking statements contained in 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 publicly update any forward-looking statements contained herein. We have no intention or obligation to revise or revise it.

Further information

For more information about the company, please contact:

Elizabeth Williams, Chief Financial Officer, 416-648-5555, [email protected]

investor contact

For investor details, please contact:

Dan Ferry, Managing Director, LifeSci Advisors, 617-430-7576, [email protected]

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Medicenna Reports Confirm Clinical Update on Pancreatic Cancer Partial Response and MDNA11 Monotherapy Dose Escalation Portion of the Ongoing Phase 1/2 ABILITY Study, Canadian Business Journal

Source link Medicenna Reports Confirm Clinical Update on Pancreatic Cancer Partial Response and MDNA11 Monotherapy Dose Escalation Portion of the Ongoing Phase 1/2 ABILITY Study, Canadian Business Journal

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