Mr. Fahar Merchant reports

MEDICENNA ANNOUNCES EMA APPROVAL OF ITS CLINICAL TRIAL APPLICATION TO EXPAND ITS PHASE 1/2 ABILITY-1 STUDY TO EUROPE

The European Medicines Agency (EMA) has approved Medicenna Therapeutics Corp.'s clinical trial application (CTA) for the conduct of the phase 1/2 Ability-1 (a beta-only IL-2 immunotherapy) study with MDNA11 either alone or in combination with pembrolizumab (KEYTRUDA), thereby expanding the clinical trial in the European Union (EU). MDNA11 is the Company's long-acting, "beta-enhanced not-alpha" IL-2 super-agonist and is currently enrolling patients with advanced solid tumors in the ABILITY-1 trial at clinical trial sites in U.S.A., Canada, Australia, and Korea.

"We are excited to build on the early success and promising efficacy and safety of our ongoing ABILITY-1 study that is demonstrating MDNA11's best-in-class potential," said Fahar Merchant, PhD, President & CEO of Medicenna. "Expanding the clinical trial to various centers in the EU is an important milestone and adds to the positive momentum behind our MDNA11 program. We anticipate that the expansion to Europe will expedite enrolment in the trial and advance the study towards key updates in the monotherapy expansion and combination escalation portions of the ABILITY-1 study which will be presented at medical conferences during H2 2024."

The ABILITY-1 study is designed to assess the safety, pharmacokinetics, pharmacodynamics, and anti-tumor activity of various doses of intravenously administered MDNA11 in patients with advanced, relapsed, or refractory solid tumors and includes an MDNA11 monotherapy arm, as well as a combination arm designed to evaluate MDNA11 in combination with pembrolizumab (KEYTRUDA(TM)).

About MDNA11

MDNA11 is a long-acting 'beta-enhanced not-alpha' interleukin-2 (IL-2) Superkine specifically engineered to overcome the shortcomings of aldesleukin and other next generation IL-2 variants by preferentially activating immune effector cells (CD4+ T, CD8+ T and NK cells) responsible for killing cancer cells, with minimal or no stimulation of immunosuppressive Tregs. These unique proprietary features of the IL-2 Superkine have been achieved by incorporating seven specific mutations and genetically fusing it to a recombinant human albumin scaffold to improve the pharmacokinetic (PK) profile and pharmacological activity of MDNA11 due to albumin's natural propensity to accumulate in highly vascularized sites, in particular tumor and tumor draining lymph nodes. MDNA11 is currently being evaluated in the Phase 1/2 ABILITY-1 study as both a monotherapy and in combination with pembrolizumab (KEYTRUDA(TM)).

About the ABILITY-1 Study

The ABILITY-1 study (NCT05086692) is a global, multi-center, open-label study that assesses the safety, tolerability, pharmacokinetics, pharmacodynamics and anti-tumor activity of MDNA11 as monotherapy or in combination with pembrolizumab (KEYTRUDA(TM)). In the combination dose escalation of the Phase 2 study, approximately 12 patients are expected to be enrolled and administered ascending doses of MDNA11 intravenously once every two weeks in combination with pembrolizumab. This portion of the study includes patients with a wide range of solid tumors with the potential for susceptibility to immune modulating therapeutics. Upon identification of an appropriate dose regimen for combination, the study will proceed to a combination dose expansion cohort.

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 and first-in-class Empowered Superkines. Medicenna's long-acting IL-2 Superkine, MDNA11, is a next-generation IL-2 with superior affinity toward CD122 (IL-2 receptor beta) and no CD25 (IL-2 receptor alpha) binding, thereby preferentially stimulating cancer-killing effector T cells and NK cells. Medicenna's IL-4 Empowered Superkine, bizaxofusp (formerly MDNA55), has been studied in 5 clinical trials enrolling over 130 patients, including a Phase 2b trial for recurrent GBM, the most common and uniformly fatal form of brain cancer. Bizaxofusp has obtained FastTrack and Orphan Drug status from the FDA and FDA/EMA, respectively. Medicenna's early-stage BiSKITs(TM) (Bifunctional SuperKine ImmunoTherapies) and the T-MASK(TM) (Targeted Metalloprotease Activated SuperKine) programs are designed to enhance the ability of Superkines to treat immunologically "cold" tumors.

We seek Safe Harbor.