Acral Lentiginous Malignant Melanoma

MDNA11 continues to demonstrate encouraging single-agent activity from the dose escalation and evaluation portion of the ABILITY-1 Study including deep ongoing partial responses with 100% reduction of target lesions in one pancreatic and 70% reduction of target lesion in one melanoma cancer patientMDNA11 also showed durable stable disease in 3 melanoma patients for at least 5 months to 18 months with concomitant shrinkage of tumor size following failure with check-point inhibitor therapiesMDNA11 is generally well tolerated with no dose-limiting toxicities or vascular leak syndrome reported in any of the dose escalation cohortsMedicenna believes that these data reaffirm the differentiated and promising therapeutic activity, safety, PD and PK profile of the ‘beta-enhanced not-alpha’ albumin-fused IL-2 superkine in patients with advanced solid tumors who have failed current standard of care TORONTO and HOUSTON, Nov. 06, 2023 (GLOBE NEWSWIRE) -- Medicenna Therapeutics Corp. (“Medicenna” or the “Company”) (TSX: MDNA), a clinical-stage immunotherapy company focused on the development of Superkines, today announced that new clinical data from the Phase 1 monotherapy dose escalation/evaluation portion of the Phase 1/2 ABILITY-1 (A Beta-only IL-2 ImmunoTherapY) study evaluating MDNA11, the only long-acting, ‘beta-enhanced not-alpha’ interleukin-2 (IL-2) super-agonist in clinical development, in patients with advanced solid tumors, were presented at the 38th Annual Meeting of the Society for Immunotherapy of Cancer (SITC) held in San Diego, CA, on November 4th, 2023. “We are very encouraged by two partial responses and three durable stable diseases in patients with advanced cancer who had progressed on multiple prior therapies, reinforcing MDNA11’s promising single-agent activity,” said Fahar Merchant, Ph.D., President and Chief Executive Officer of Medicenna. “These data add to the growing body of evidence demonstrating the clinical effectiveness of MDNA11 with highly favorable underlying immune response characterized by robust expansion and activation of CD8+ T cells with minimal impact on immune-suppressive Tregs. MDNA11 with uniquely differentiating ‘beta-enhanced not-alpha’ features, continues to be a potential best-in-class next-generation IL-2 super-agonist for treatment of advanced solid tumors. We look forward to reporting results from the monotherapy expansion and combination escalation arms of the Phase 2 study in the first half of 2024.” Key findings from the Phase 1 monotherapy dose escalation portion of the ABILITY-1 study at time of data cut-off (26-Oct-2023) include: Favorable safety profile: No dose limiting toxicity (DLT) reported and no evidence of vascular leak syndrome (VLS). Vast majority (95.6%) of treatment-related adverse events (TRAEs) were of grade 1-2 severity and resolved within 48 hours; grade 3 TRAEs mainly constituted transient LFT elevations; no grade 4 or 5 events were reported. Encouraging single-agent anti-tumor activity at doses of 60 ug/kg (N = 15): Partial response reported in 2 patients with aggressive tumor types A patient with metastatic pancreatic ductal adenocarcinoma (PDAC; MSI-H), who had previously failed on multiple systemic therapies and exhibited primary resistance to immune checkpoint inhibitors, experienced remarkable response to MDNA11 (60 ug/kg) with baseline target lesions and non-target lesions showing deepening shrinkage on successive imaging scans. Following return from a 7 week vacation, a single new lesion was observed and MDNA11 treatment was resumed. Prior to receiving one cycle of radiotherapy for the new lesion, complete resolution of initial 2 target and 1 non-target lesions was achieved. Patient continues on MDNA11 post radiotherapy.A patient with cutaneous melanoma, who progressed on prior line of dual checkpoint inhibitors, treated with MDNA11 (90 ug/kg dose), showed a 70% reduction of the target lymph node lesion at week 12. Durable stable disease in 3 metastatic melanoma patients with concomitant reduction in tumor burden: Two patients with SD of >20 (acral melanoma) and >24 weeks (cutaneous melanoma) are continuing MDNA11 treatment in the 120 ug/kg cohort. One patient with cutaneous melanoma had SD for > 1.5 years having started MDNA11 at the 10 ug/kg dose with subsequent intra-patient dose escalations of 30, 60 and 90 ug/kg. Potent proliferation of effector immune populations: Pharmacodynamic data showed robust and durable activation of effector immune cells, particularly CD8+ T cells (CD25+, OX40+), with minimal impact on the immunosuppressive Treg population. Recommended Dose for Expansion (RDE): Target dose of 90 ug/kg (following two step-up doses of 30 and 60 ug/kg) Q2W IV infusion was chosen for monotherapy expansion portion of the ABILITY-1 study. Monotherapy expansion part of ABILITY-1 is enrolling patients with metastatic melanoma, non-melanoma skin cancers (CSCC, MCC, and BCC) and MSI-H/dMMR tumors. The main objectives of the monotherapy dose escalation part of the Phase 1/2 ABILITY-1 study (Clinicaltrials.gov ID: NCT05086692) were to assess MDNA11’s safety, tolerability, PK, PD, and anti-tumor activity to inform on the RDE in an all-comer solid tumor population with advanced cancers refractory to prior systemic therapies. A total of six dose escalation cohorts (MDNA11 dose ranging from 3 ug/kg to 120 ug/kg) were evaluated, with the majority of patients (73%) having also received at least one prior line of immunotherapy with or without primary resistance to immune checkpoint inhibitors. A copy of the poster and a related slide deck have been posted to the “Events and Presentations” page of Medicenna’s website. About MDNA11 MDNA11 is an intravenously administered, long-acting ‘beta-enhanced not-alpha’ interleukin-2 (rIL-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 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®). 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 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™ program (Bifunctional SuperKine ImmunoTherapies) is designed to enhance the ability of Superkines to treat immunologically “cold” tumors. Forward-Looking Statements This news release contains forward-looking statements within the meaning of applicable securities laws that relate to the future operations of the Company, plans and projections and other statements that are not historical facts, including, without limitation, statements on the clinical development and potential and safety profile of MDNA11, additional data and reporting thereof. Forward-looking statements are often identified by terms such as “will”, “may”, “should”, “anticipate”, “expect”, “believe”, “seek”, “potentially” and similar expressions and are subject to risks and uncertainties. There can be no assurance that such statements will prove to be accurate and actual results and future events could differ materially from those anticipated in such statements. Important factors that could cause actual results to differ materially from the Company’s expectations include the risks detailed in the latest Annual Report on Form 20-F of the Company and in other filings made by the Company with the applicable securities regulators from time to time in Canada and the United States. 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. Investor Contact Christina Cameron Investor Relations, Medicenna Therapeutics ir@medicenna.com Argot PartnersPhone: 212-600-1902medicenna@argotpartners.com

WEDNESDAY, July 12, 2023 -- Black men are more likely to die of melanoma, new research shows, and one reason why may be the unusual places where the deadly skin cancer is likely to show up on their bodies. Even though the disease is more common in white men, the new report shows that Black men are 26% more likely to die from it, the Washington Post reported. “The purpose of our study was to dive deeper into why we are seeing these differences in survival rates and the factors that may be driving this,” study co-author Ashley Wysong , chair of dermatology at the University of Nebraska Medical Center, told the Post . The researchers analyzed more than 205,000 cases and discovered that melanoma in Black men is often found in areas that have not had a lot of sun exposure, including the soles of the feet, toes, toenails, fingernails, fingernail beds and palms, the Post reported. About 51% of Black men with melanoma have it on their lower extremities. In white men, only about 10% of those with melanoma have it on their lower extremities, while 35.5% have it on their trunk and nearly 26% have it on their head and neck, the study found. Only about 13% of cases in Black men were on the trunk and just under 10% were on the head. “I think this is significant,” Ali Hendi , a specialist in skin cancer surgery in Chevy Chase, Md., told the Post . “This study doesn’t give us the answer as to why, but it sheds light on the numbers.” Black men also tended to be diagnosed later, with nearly 49% diagnosed at late stages of the disease. Just over 21% of white men are diagnosed with late-stage disease, as are about 40% of Hispanic men, 38% of Asian men and 29% of Native American men, the study found. The findings were published July 11 in the Journal of the American Academy of Dermatology . The five-year survival rate of melanoma is 99% when the cancer is found early, but it’s only 32% after it has spread, the Post reported. That plays out in outcomes, with more than 75% of white men living for five years after diagnosis compared to about 52% of Black men, the study found. The researchers found that about 20% of Black melanoma patients had a deadlier subtype found on the sole of the foot or palm of the hand that is called Acral lentiginous melanoma . Fewer than 1% of white men had this subtype. “It’s not related to sun exposure,” Robert Brodell , a professor of pathology and dermatology at the University of Mississippi Medical Center, told the Post . “It seems to have a different natural history, and a poorer prognosis, though late diagnosis is a component of that.” Wysong noted that melanomas on places like fingers, toes, palms and soles of feet can be mistaken for warts and fungus. “Most people don’t think of skin cancers in their nails or on their hands and feet,” Wysong said. “So we see delays in diagnosis because of the location. It’s hard to see. Most people don’t know what a nail melanoma looks like.” These cancers can look like a black dot under a fingernail, Brodell said. Overall, invasive melanoma cases are up by 27% in 10 years, the Post reported. In 2023, there were over 97,000 cases in the United States, more than 58,000 in men. Nearly 8,000 people are expected to die of melanoma this year. More education is needed for doctors and patients, including in Black patients where it rarely occurs, Jeremy Brauer , a clinical associate professor of dermatology at NYU Langone Health, told the Post . Doctors may not be aware of the differences, Brauer said. “This disproportionate and unfortunate rate of death means we have to try to be much more preventative,” Brauer said. Sources Journal of the American Academy of Dermatology, July 11, 2023 Washington Post Posted July 2023

WASHINGTON, July 10, 2023 /PRNewswire/ -- The Melanoma Research Alliance (MRA), the largest non-profit funder of melanoma research, today announced that the RARE Registry for acral and mucosal melanoma has officially surpassed 100 patients, making it the largest registry of its kind in the world and marking an important milestone in advancing cutting-edge research for these rare and difficult-to-treat melanoma subtypes. The MRA began work in 2020 to launch RARE, a direct-to-patient interactive portal, to advance its mission of accelerating treatment options, supporting cutting-edge research and ultimately finding a cure for all types of melanomas. While roughly 90% of melanomas form on sun-exposed skin, rare melanoma subtypes, such as acral and mucosal, form in parts of the body that are shielded from the sun such as the palms of hands, soles of feet, under fingernails, or in mucosal linings of different tissues. Approximately 5,000 patients are diagnosed with these melanoma subtypes annually, and due to their obscurity, patients often face later detection and poorer prognoses, despite positive advancements for treatments for cutaneous melanoma in the last decade. What's more, people of color are also disproportionately affected by acral melanoma, largely due to the misconception that melanoma only impacts people with lighter skin and lighter colored eyes. The lack of awareness around rare melanomas compounded with misconceptions about the risks of melanoma makes the registry even more vital for these underrepresented populations. "We started the RARE Registry to bridge this divide and address the unmet needs of the rare melanoma community, from patients and caregivers to leading researchers and physicians. There's power and strength in each individual facing a rare melanoma sharing their story, and we're so grateful to the patients so far who are already driving this critical research forward," shared Dr. Joan Levy, Chief Science Officer of the MRA and co-principal investigator of RARE. Through the RARE web portal, patients provide information on their demographics, diagnosis, treatment history, lifestyle and quality of life factors. All information collected is de-identified and made available through an open-access portal so that researchers and clinicians gain key insights into tumor genomics, epidemiology, diagnosis pathways, treatment effectiveness, adverse events, natural history of disease and risk factors. While other registries are focused on a single point in time, RARE encourages patients to continuously update the registry with new information. "Because acral and mucosal melanoma are so rare, every single patient participant and data point they're willing to provide about their melanoma journey has the potential to help researchers better understand the origins of the disease and most promising treatments. This is just the beginning of our fight to ensure rare melanoma patients are no longer left behind in the mission to end suffering due to melanoma," says MRA Chief Executive Officer Marc Hurlbert, PhD. In addition to launching the RARE Registry, MRA has invested more than $18,575,000 through 45 research awards specifically focused on all rare melanoma subtypes to spur the field. MRA has also advanced understanding of rare melanomas by regularly bringing together researchers and patient advocates to share findings and progress, produced a review article highlighting gaps in existing pre-clinical models, and fostered collaboration between cancer centers and academic institutions through innovative partnerships. About Melanoma Research Alliance (MRA) The Melanoma Research Alliance (MRA) stands as the largest non-profit funder of melanoma research. Founded in 2007 by Debra and Leon Black, MRA's mission is to end suffering and death due to melanoma by advancing the world's most promising science and research. MRA provides critical funding for melanoma cancer research that propels advances in prevention, diagnosis, treatment, metastasis, and survivorship. MRA-funded researchers have been behind every major melanoma research breakthrough. Since MRA's inception, more than 15 new therapeutic approaches for melanoma have earned FDA approval. MRA is recognized as one of the most fiscally efficient non-profits in the country. Because the Black Family generously underwrites 100% of MRA's administrative and operating costs, every dollar donated is invested directly into MRA's scientific and research program. For more information, please visit: . Media Contacts: KWT Global [email protected] Cody R. Barnett, MRA Senior Director of Communications [email protected] SOURCE Melanoma Research Alliance