Medicenna Therapeutics Inc. (NASDAQ: (MDNA) stock plunged by 10.67% in the after-hours trading session. Medicenna is a clinical-stage immunotherapy firm dedicated to developing innovative, incredibly selective IL-2, IL-4, and IL-13 Superkines, as well as first-in-class Empowered Superkines.
MDNA stock’ Recent Development
The US Food and Drug Administration (FDA) has approved Medicenna Therapeutics’ investigational new drug (IND) request to let them broaden their MDNA1’s Phase 1/2 ABILITY (A Beta-only IL-2 ImmunoTherapY) research. It’s a long-acting, “beta-only” IL-2 super-agonist that the firm is bringing to clinical testing sites in the United States. Patients are now being enrolled in the ABILITY Study at clinical testing locations in Australia, with regulatory submissions to broaden the trial to sites in Canada and the United Kingdom likely to be finalized this calendar year.
The ABILITY Study will evaluate the security, pharmacokinetics (PK), pharmacodynamics (PD), and anti-tumor efficacy of different dosages of MDNA11 given intravenously. It contains an MDNA11 monotherapy arm as well as a combination arm aimed to investigate MDNA11 with a checkpoint inhibitor in people with severe, relapsed, or resistant solid malignancies.
The ABILITY Study is intended to enroll approximately 80 individuals. After the development of the suggested Phase 2 dose (RP2D) and therapy plan in the study’s dose-escalation phase, Medicenna expects to register patients with renal cell carcinoma, melanoma, and other solid tumors in monotherapy and combination settings.
Dr. Fahar Merchant, President, and CEO of Medicenna stated that,
The approval of our IND application is a significant achievement that contributes to our MDNA11 program’s good momentum. The expansion of the ABILITY Research to the United States is expected to speed up enrolment and move the study closer to crucial findings at the end of 2021 and mid-2022. MDNA11’s distinct “beta-only” strategy to attacking the IL-2 receptor, they believe, has the power to tackle the drawbacks of existing “not-alpha” IL-2 medicines. They also anticipate publishing on the possible benefits of their approach when the trial progresses to the dose-expansion and combination stages.
