Dr. Nageatte Ibrahim reports

MEDICENNA AND FONDAZIONE MELANOMA ONLUS ANNOUNCE FIRST PATIENT DOSED IN THE NEO-CYT STUDY OF MDNA11 IN NEOADJUVANT MELANOMA

The first patient has been dosed in the NEO-CYT study, a randomized, investigator-initiated neoadjuvant phase 1b trial evaluating MDNA11, Medicenna Therapeutics Corp.'s long-acting, beta-enhanced not-alpha IL-2 superkine, in combination with nivolumab, with or without ipilimumab, in patients with high-risk, surgically resectable Stage III cutaneous melanoma at up to 12 centres in Italy.

"Neoadjuvant therapy has demonstrated that the timing of immunotherapy can be critical," said Prof. Paolo A. Ascierto, lead principal investigator of NEO-CYT. "Treating patients while the tumour is still present may generate deeper and more durable immune responses. NEO-CYT is designed to investigate whether MDNA11, a next-generation IL-2 superkine, may potentiate the immune activity of nivolumab, with or without ipilimumab, leading to improved pathologic responses and potentially higher cure rates in patients with resectable, high-risk melanoma."

The NEO-CYT study is designed to evaluate MDNA11 as neoadjuvant immunotherapy before curative-intent surgery in earlier-stage melanoma patients whose immune systems may be more amenable to immunotherapy and more likely to benefit from treatment. MDNA11 will be evaluated in combination with nivolumab, with or without ipilimumab, with major pathologic response as a primary end point, which is considered predictive of long-term survival outcomes.

NEO-CYT is sponsored by a non-profit melanoma foundation (Fondazione Melanoma Onlus) and is led by Prof. Ascierto of the Istituto Nazionale Tumori IRCCS Fondazione G. Pascale. Under the terms of the clinical trial collaboration, Fondazione Melanoma Onlus is the sponsor and Medicenna is supplying the study medications.

"Dosing the first patient in the NEO-CYT study represents an important milestone in the continued clinical development of MDNA11 and expands our evaluation of this next-generation IL-2 superkine into the neoadjuvant setting," said Dr. Nageatte Ibrahim, chief medical officer of Medicenna. "MDNA11 has already demonstrated encouraging anti-tumour activity and a manageable safety profile in heavily pretreated patients with advanced metastatic cancers in the ongoing Ability-1 study. NEO-CYT allows us to evaluate MDNA11 earlier in the treatment paradigm, where the immune system may be more intact and where pathologic response can provide an early and rigorous signal of clinical activity. We are honoured to collaborate with Fondazione Melanoma Onlus and Prof. Ascierto on this important study."

MDNA11 is currently being evaluated in the phase 1/2 Ability-1 study as both monotherapy and in combination with pembrolizumab in patients with advanced solid tumours. In prior clinical updates, MDNA11 has demonstrated encouraging anti-tumour activity in heavily pretreated patients, including patients whose tumours progressed following immune checkpoint inhibitor therapy, alongside robust immune effector cell expansion and a manageable safety profile. NEO-CYT is intended to build on these findings by evaluating MDNA11 in an earlier-stage, potentially curative treatment setting.

About MDNA11

MDNA11 is a long-acting, beta-enhanced not-alpha IL-2 superkine specifically engineered to overcome the shortcomings of aldesleukin and other next generation IL-2 variants by preferentially activating immune effector cells (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 tumour and tumour-draining lymph nodes. MDNA11 is currently being evaluated in the phase 1/2 Ability-1 study as both monotherapy and in combination with pembrolizumab.

About Medicenna Therapeutics Corp.

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 first-in-class targeted PD-1 x IL-2 bispecific, MDNA113, is in development for solid tumours and was designed using the company's proprietary Biskits (bifunctional superkine immunotherapies) and T-Mask (targeted metalloprotease-activated superkine) platforms. Medicenna's IL-4 empowered superkine, bizaxofusp (formerly MDNA55), has been studied in five clinical trials enrolling over 130 patients, including a phase 2b trial for recurrent GBM (glioblastoma), the most common and uniformly fatal form of brain cancer. Bizaxofusp has obtained fast-track and orphan drug status from the FDA (U.S. Food and Drug Administration) and FDA/EMA (European Medicines Agency), respectively.

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