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Medicenna Therapeutics Announces Key Program Updates and 2026 Outlook
Globenewswire· 2026-01-15 12:30
Core Insights - Medicenna Therapeutics is advancing its clinical programs, particularly focusing on MDNA11 and MDNA113, with promising data indicating their potential as best-in-class therapies for cancer treatment [2][3] MDNA11 Developments - In monotherapy expansion cohorts (n=21), the overall response rate (ORR) was 50% for patients treated with MDNA11 in the 2L/3L setting and 42% when MDNA11 was the next treatment post-ICI failure, indicating its best-in-class potential [5][10] - Among all efficacy-evaluable monotherapy patients (n=55) across 18 different cancers, the ORR was 19% for MDNA11 as a 2L/3L treatment and 24% when used post-ICI failure [10] - The ABILITY-1 Phase 1/2 trial has enrolled over 110 safety-evaluable patients, establishing a biologically effective dose range (BEDR) of 60-120 g/kg without dose-limiting toxicities [4][5] MDNA113 Insights - MDNA113, a bifunctional anti-PD1-IL2 superkine, has shown a favorable safety profile in non-human primates at doses up to 30 mg/kg, supporting its potential for human trials [9][16] - The IND submission and initiation of the first-in-human trial for MDNA113 are expected in H2 2026 [9][17] NEO-CYT Study - The NEO-CYT study, in collaboration with Fondazione Melanoma Onlus, will evaluate MDNA11 in front-line therapy for resectable advanced cutaneous melanoma, with patient enrollment planned for H1 2026 and interim data expected in H2 2026 [8][17] Strategic Priorities for 2026 - Medicenna aims to maximize the potential of MDNA11 in earlier-line and neoadjuvant settings, advance MDNA113 as a targeted bifunctional therapy, and progress bizaxofusp through partnerships for recurrent GBM and other brain cancers [14][17] - Key milestones include completing patient enrollment in the ABILITY-1 study, reporting updated clinical data, and securing FDA guidance for registrational trials [17][18]
Medicenna Therapeutics to Host a Live Webinar with Q&A to Discuss Updated MDNA11 Clinical Data
Globenewswire· 2025-12-09 22:04
Core Insights - Medicenna Therapeutics Corp. is hosting a live webinar on December 10, 2025, at 08:30 AM Eastern Time to discuss updated clinical data from the ABILITY-1 Phase 1/2 Study evaluating MDNA11 [1][2] Company Overview - Medicenna is a clinical-stage immunotherapy company focused on developing Superkines for cancer and autoimmune diseases, with a particular emphasis on long-acting IL-2 Superkine, MDNA11, which has superior affinity toward CD122 and preferentially stimulates cancer-killing T cells and NK cells [5] - The company is also developing MDNA113, a bispecific targeting PD-1 and IL-2 for solid tumors, utilizing proprietary BiSKITs™ and T-MASK™ platforms [5] - Bizaxofusp, an IL-4 Empowered Superkine, has been studied in five clinical trials with over 130 patients and has received FastTrack and Orphan Drug status from the FDA and EMA [5] Webinar Details - The webinar will feature presentations from Medicenna's executive and scientific advisory team, including Dr. Fahar Merchant, Dr. Arash Yavari, and Dr. André Mansinho, along with commentary from key opinion leaders and a live Q&A session [4][9]
Updated MDNA11 Clinical Data from the ABILITY-1 Study to be Presented at the European Society for Medical Oncology (ESMO) Immuno-Oncology Congress 2025
Globenewswire· 2025-10-23 21:12
Core Insights - Medicenna Therapeutics Corp. is set to present updated clinical data for MDNA11 at the ESMO Immuno-Oncology Congress 2025 in London from December 10-12, 2025 [1][2] - The presentation will focus on the Phase 1/2 ABILITY-1 Study, evaluating MDNA11 as a monotherapy and in combination with pembrolizumab for advanced solid tumors [2] Company Overview - Medicenna is a clinical-stage immunotherapy company specializing in the development of Superkines targeting cancer and autoimmune diseases [1][3] - The company’s lead product, MDNA11, is a long-acting IL-2 Superkine designed to preferentially stimulate cancer-killing effector T cells and NK cells [3] - Medicenna is also developing MDNA113, a bispecific targeting PD-1 and IL-2 for solid tumors, utilizing proprietary platforms BiSKITs™ and T-MASK™ [3] - Bizaxofusp, an IL-4 Empowered Superkine, has been studied in five clinical trials with over 130 patients and has received FastTrack and Orphan Drug status from the FDA and EMA [3]
Medicenna Therapeutics (OTCPK:MDNA.F) 2025 Conference Transcript
2025-10-22 18:32
Summary of Medicenna Therapeutics Conference Call Company Overview - Medicenna Therapeutics is a publicly listed company on the TSX main board and OTCQX under the symbol MDNA, focused on developing immunotherapies for late-stage diseases, particularly cancer [1][2] - The company specializes in a class of molecules known as cytokines, aiming to develop enhanced versions called Superkines [1][2] Core Points and Arguments Development and Collaborations - Medicenna licensed the Superkines platform from Stanford University in 2016 and has exclusive worldwide rights [2] - The company has a clinical collaboration with Merck, utilizing Keytruda, the world's best-selling drug, in combination with its own therapies [2][3] Clinical Trials and Data - Medicenna is preparing to provide updates on its Superkine MDNA11, with over 100 patient data points collected [3][6] - The company has received FDA agreement on a phase 3 design for its brain cancer drug, indicating significant progress in its development pipeline [3][5] - MDNA11 has shown promising results, with tumor shrinkage observed in 30% to 50% of patients who have previously failed other therapies [12][14] Market Opportunity - Keytruda, which is set to go off patent in 2028, currently generates nearly $30 billion in annual sales, highlighting a significant market opportunity for alternatives like MDNA11 [11][12] - Medicenna's valuation is approximately $60 million USD, with potential for substantial growth given the response rates observed in clinical trials compared to competitors [18][19] Competitive Landscape - The company is positioned against competitors like Replimune and Iovance, which have higher valuations despite similar response rates [19][20] - Recent multibillion-dollar transactions in the bispecific molecule space, such as the $11.2 billion deal between Takeda and Innovent, indicate a growing interest in this area [21][22] Pipeline and Future Developments - Medicenna is advancing multiple drugs, including MDNA113, a bispecific molecule combining anti-PD-1 and IL-2, with data expected soon [21][23] - The brain cancer program shows potential for significant market impact, with an estimated $4 billion opportunity across various brain cancer types [25][26] Important but Overlooked Content - The company has a strong advisory team, including leading experts in brain cancer and skin cancer, which enhances its credibility and potential for success [4] - Medicenna's approach to IL-2 therapy addresses previous challenges with safety and efficacy, aiming to provide a safer treatment option that effectively shrinks tumors [10][11][13] - The company has a cash runway into Q3 of the following year, allowing it to continue its development efforts without immediate financial pressure [26][40] Upcoming Milestones - Key data readouts are expected by the end of the year, particularly at a major cancer conference in the UK [27][40] - The company plans to meet with regulators to discuss pathways for accelerated approval based on upcoming clinical trial results [28][40]
Medicenna Therapeutics Announces Participation in Upcoming Conferences
Globenewswire· 2025-10-20 11:00
Core Insights - Medicenna Therapeutics Corp. is a clinical-stage immunotherapy company focused on developing Superkines for cancer and autoimmune diseases, participating in several upcoming conferences to showcase its innovative therapies and engage with the investment community [1][5]. Upcoming Conference Participation - Medicenna will participate in the Planet MicroCap Showcase in Toronto in 2025, BIO-Europe 2025 in Vienna, and the Oppenheimer Miami Oncology Summit [2][3][4]. - The BIO-Europe event is one of the largest life sciences partnering events, providing Medicenna a platform to engage with potential partners and investors [7]. - The Oppenheimer Miami Oncology Summit will focus on oncology advancements, allowing Medicenna to discuss its immunotherapy innovations [7]. Company Overview - Medicenna is developing novel, highly selective versions of IL-2, IL-4, and IL-13 Superkines, including the long-acting IL-2 Superkine, MDNA11, which preferentially stimulates cancer-killing effector T cells and NK cells [5]. - The IL-4 Empowered Superkine, bizaxofusp, has been studied in five clinical trials with over 130 patients, including a Phase 2b trial for recurrent GBM, and has received FastTrack and Orphan Drug status from the FDA and EMA [5]. - Medicenna's early-stage BiSKITs™ and T-MASK™ programs aim to enhance the effectiveness of Superkines in treating immunologically "cold" tumors [5].
Medicenna Therapeutics to Participate in the ROTH 4th Annual Healthcare Opportunities Conference
Globenewswire· 2025-10-01 11:00
Core Insights - Medicenna Therapeutics Corp. is a clinical-stage immunotherapy company focused on developing Superkines for cancer and autoimmune diseases [1][3] - Dr. Fahar Merchant, President and CEO, will participate in the ROTH 4 Annual Healthcare Opportunities Conference on October 8-9, 2025 [1][5] Company Overview - Medicenna specializes in novel, highly selective versions of IL-2, IL-4, and IL-13 Superkines, including first-in-class Empowered Superkines [3] - The company's long-acting IL-2 Superkine, MDNA11, has superior affinity toward CD122 and preferentially stimulates cancer-killing effector T cells and NK cells [3] - Bizaxofusp, an IL-4 Empowered Superkine, has been studied in five clinical trials with over 130 patients, including a Phase 2b trial for recurrent GBM [3] - Bizaxofusp has received FastTrack and Orphan Drug status from the FDA and FDA/EMA, respectively [3] - Medicenna is also developing early-stage BiSKITs™ and T-MASK™ programs aimed at treating immunologically "cold" tumors [3] Event Details - The ROTH 4 Annual Healthcare Opportunities Conference will feature 1-on-1 and small group meetings for institutional investors to interact with executive management [2][5] - The conference will take place at the Metropolitan Club in New York City [5]
Medicenna Announces Results of Annual Meeting of Shareholders
Globenewswire· 2025-09-25 21:00
Core Points - Medicenna Therapeutics Corp. held its annual meeting of shareholders on September 25, 2025, where all nominees listed in the management information circular were elected as directors [1][2] - A total of 55.75% of the issued and outstanding common shares were represented at the meeting [2] Election Results - Dr. Fahar Merchant received 35,539,547 votes (99.25% for, 0.75% against) - Mr. Albert Beraldo received 35,572,009 votes (99.35% for, 0.65% against) - Dr. John (Jack) Geltosky received 35,432,573 votes (98.96% for, 1.04% against) - Ms. Karen Dawes received 35,574,263 votes (99.35% for, 0.65% against) - Mr. Karim Lalji received 35,401,699 votes (98.87% for, 1.13% against) [2] Board Changes - Dr. John H. Sampson did not stand for re-election but will continue to support the company as a clinical advisor [3] - Mr. Albert Beraldo expressed gratitude for Dr. Sampson's service and ongoing support [3] Company Overview - Medicenna is focused on developing Superkines, including long-acting IL-2 Superkine MDNA11, which preferentially stimulates cancer-killing effector T cells and NK cells [4] - The company’s IL-4 Empowered Superkine, bizaxofusp, has been studied in five clinical trials with over 130 patients, including a Phase 2b trial for recurrent GBM [4] - Bizaxofusp has received FastTrack and Orphan Drug status from the FDA and FDA/EMA, respectively [4] - Medicenna is also developing early-stage BiSKITs™ and T-MASK™ programs aimed at treating immunologically "cold" tumors [4]
Medicenna to Participate at the H.C. Wainwright 27th Annual Global Investment Conference
Globenewswire· 2025-09-05 11:00
Core Insights - Medicenna Therapeutics Corp. is a clinical-stage cancer immunotherapy company focused on developing Superkines [1][4] - Dr. Fahar Merchant, President and CEO, will present at the H.C. Wainwright 27th Annual Global Investment Conference from September 8-10, 2025 [1][2] - The company is developing novel versions of IL-2, IL-4, and IL-13 Superkines, with a focus on enhancing cancer treatment [4] Presentation Details - The presentation is scheduled for September 9, 2025, from 2:30 PM to 3:00 PM (Eastern Standard Time) at the Lotte New York Palace Hotel [2] - A webcast of the presentation will be available for 90 days on Medicenna's investor relations website [2] Company Overview - Medicenna's long-acting IL-2 Superkine, MDNA11, has superior affinity toward CD122 and preferentially stimulates cancer-killing effector T cells and NK cells [4] - The IL-4 Empowered Superkine, bizaxofusp, has been studied in five clinical trials with over 130 patients, including a Phase 2b trial for recurrent GBM [4] - Bizaxofusp has received FastTrack and Orphan Drug status from the FDA and EMA [4] - Medicenna is also developing early-stage BiSKITs™ and T-MASK™ programs aimed at treating immunologically "cold" tumors [4]
Medicenna Therapeutics Reports First Quarter Fiscal 2026 Financial Results and Operational Highlights
Globenewswire· 2025-08-01 11:00
Core Insights - Medicenna Therapeutics is encouraged by positive clinical results from the MDNA11 program, demonstrating best-in-class potential in treating checkpoint-resistant tumors [1][2] - The company is on track to complete enrollment in the Phase 1/2 ABILITY-1 trial and expects to provide top-line clinical data in the second half of 2025 [1][5] - Recent patent grants strengthen Medicenna's intellectual property position, with a total of 86 granted or allowed patents [6][7] Clinical Development - MDNA11 has shown durable efficacy with complete responses in pancreatic and melanoma cancer patients, remaining cancer-free for 18 and 6 months, respectively [1] - The company is advancing its MDNA113 candidate, a bispecific anti-PD1-IL2 Superkine, which has shown promising preclinical data [2][5] - Bizaxofusp, the IL-4 Superkine program, is seeking partnership opportunities for recurrent glioblastoma [4] Financial Overview - Medicenna reported cash and cash equivalents of $20.5 million as of June 30, 2025, providing a runway through mid-2026 [8] - Total operating costs for the quarter were $5.5 million, an increase from $4.0 million in the same quarter of the previous year, primarily due to higher R&D spending [9] - The net loss for the quarter was $4.9 million, compared to a net loss of $3.6 million in the prior year, attributed to increased R&D expenses and foreign exchange losses [10][11]
Medicenna Strengthens Intellectual Property Portfolio with Five Patents Granted for its IL-2 and IL-4 Superkines
Globenewswire· 2025-07-31 11:00
Core Insights - Medicenna Therapeutics Corp. has been granted five patents that enhance its intellectual property position for IL-2 and IL-4 Superkine platforms, which are crucial for its clinical and preclinical programs [1][2]. Patent Details - The newly granted patents cover various aspects including composition, formulation, combination, use, and therapeutic applications of IL-2 and IL-4 Superkines, with expiration dates ranging from 2033 to 2040 [2]. - Notable patents include coverage for IL-2 superagonists in combination with anti-PD-1 antibodies, which is significant for the ongoing Phase 1/2 ABILITY-1 study of MDNA11 [2][4]. - A novel formulation of bizaxofusp (MDNA55) has also received patent protection, which is used in a Phase 2b clinical trial for recurrent glioblastoma, enhancing its commercial exclusivity [2][3]. Company Overview - Medicenna is focused on developing novel immunotherapies, particularly Superkines, for oncology and autoimmune diseases [3]. - The company’s lead asset, MDNA11, is a long-acting IL-2 Superkine designed to preferentially stimulate cancer-fighting T cells and NK cells [3]. - Bizaxofusp has been involved in five clinical trials with over 130 patients and has received FastTrack and Orphan Drug status from the FDA and EMA [3]. Intellectual Property Portfolio - Medicenna's global intellectual property portfolio now includes 86 granted or allowed patents, supporting a diverse clinical pipeline [2].