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Medicenna Reports Confirmed Partial Response in Pancreatic Cancer and Clinical Update on MDNA11's Monotherapy Dose Escalation Portion of the Ongoing Phase 1/2 ABILITY Study
TORONTO and 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 new clinical data on anti-tumor activity from the Phase 1/2 ABILITY study of MDNA11, the Company’s “beta-only” long-acting IL-2 super-agonist. These data include a confirmed partial response (PR) in a fourth-line metastatic pancreatic ductal adenocarcinoma (PDAC) patient that had previously failed chemo and checkpoint inhibitor therapies. The confirmatory scan for this patient continues to show further tumor reduction compared to prior scans, suggesting durable anti-cancer activity following MDNA11 monotherapy. Overall, five of fourteen evaluable patients in the ABILITY study’s low and mid-stage dose escalation cohorts have achieved tumor control (PR or stable disease (SD)) with MDNA11 monotherapy. “We are excited to report confirmation of a partial response in a patient with late-stage pancreatic cancer, one of the most aggressive tumors that rarely responds to single agent immunotherapy,” said Fahar Merchant, PhD, President and CEO of Medicenna. “Furthermore, four additional patients have experienced tumor control despite the advanced stage of cancer in all patients enrolled in ABILITY’s dose escalation cohorts. This outcome provides early evidence supporting our belief in MDNA11’s single-agent anti-tumor activity and underscores its therapeutic potential as a best-in-class IL-2 agonist. Given that the dose-escalation portion of the trial is designed primarily to evaluate the safety and pharmacokinetics and determine the phase 2 dose, these early signs of potential clinical benefit are particularly impressive as we continue to dose escalate and advance towards the trial’s dose expansion phases early next year.” The ABILITY study’s dose escalation cohorts are evaluating MDNA11 monotherapy administered intravenously once every two weeks to patients with advanced solid tumors, with the primary objective of evaluating the safety and pharmacokinetics and determining the recommended Phase 2 dose (RP2D). Once the RP2D has been established, a key secondary objective of the trial will be to evaluate the anti-tumor activity of MDNA11 alone and in combination with the checkpoint inhibitor KEYTRUDA® (pembrolizumab) in the trial’s dose expansion phases. The ABILITY study’s first three dose escalation cohorts evaluated MDNA11 at doses of 3,10 and 30 µg/kg. Patients in the fourth and fifth dose escalation cohorts receive two 30 µg/kg “priming” doses of MDNA11 before stepping up to receive fixed doses of 60 and 90 µg/kg, respectively. The trial is currently enrolling patients in the fifth dose-escalation cohort, with no dose-limiting toxicities, dose interruptions, dose de-escalations, or treatment discontinuations due to safety issues observed to-date. A summary of demographic and therapeutic activity data from all evaluable patients in the first four dose escalation cohorts is provided below. Patient Demographics Prior to enrolment in the ABILITY Study, patients in Cohorts 1 to 4 (n=14) had failed up to four lines of systemic therapy. Prior to enrolment in the ABILITY Study, eleven of fourteen patients (89%) in Cohorts 1 to 4 had relapsed on, could not tolerate, or did not respond to at least one immunotherapy with a checkpoint inhibitor. Therapeutic Activity Five of fourteen evaluable patients (36%) have achieved tumor control as defined in the study
To date, MDNA11 has demonstrated a favorable tolerability profile in the monotherapy dose escalation segment of the ABILITY study. New data on MDNA11’s safety, pharmacokinetic and pharmacodynamic profiles are expected to be presented at a major medical meeting in the fourth quarter of the calendar year. About the Phase 1/2 ABILITY Study KEYTRUDA® is a registered trademark of Merck Sharp & Dohme LLC, a subsidiary of Merck & Co., Inc., Rahway, NJ, USA. About Medicenna Forward-Looking Statements 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. 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] |