bizaxofusp (MDNA55) / Medicenna - LARVOL DELTA

Medicenna Presents Preclinical Data on MDNA11 and Bizaxofusp at the 2024 Annual Meeting of the Society for Neuro-Oncology (SNO) (GlobeNewswire) - "MDNA11 shows significant survival benefits in preclinical glioblastoma models, expanding CD8+ T and NK cells; Bizaxofusp selectively targets human tumor cells and immune-suppressive cells, enhancing anti-tumor immunity; Combination therapy with MDNA11 and Bizaxofusp demonstrates synergistic tumor-killing in human GBM tumoroids."

Preclinical • Glioblastoma • Oncology

Phase 2 study of bizaxofusp, an IL-4R targeted toxin payload, in nonresectable recurrent GBM: Comparison of overall survival with contemporaneous eligibility-matched and propensity score balanced external control arm. (ASCO 2024) - P2 | "Bizaxofusp achieved significant OS benefit in patients with nonresectable rGBM compared to contemporaneous emECA. Patients who experienced tumor control, including those with PsP, showed significantly longer survival than patients with tumor progression. Phase 3 ready registrational trial will comprise a high dose bizaxofusp arm and a hybrid control arm with 1/3 randomized subjects and 2/3 pmECA."

Clinical • P2 data • Glioblastoma • IL4R

Medicenna Reports Significant Survival Benefit in Patients with Recurrent Glioblastoma Following Treatment with Bizaxofusp When Compared to a Matched External Control Arm at the 2024 ASCO Annual Meeting (GlobeNewswire) - P2b | N=47 | NCT02858895 | Sponsor: Medicenna Therapeutics, Inc. | "The updated analysis, presented at ASCO 2024, builds upon the prior Phase 2b data by excluding IL-4R expression as a prognostic factor in propensity score balancing, thereby increasing the number of bizaxofusp and EC arm patients eligible for analysis. Earlier studies had excluded these patients due to lack of tumor tissue available for IL-4R expression analysis. These expanded data demonstrate that a single treatment of bizaxofusp significantly increased mOS by 88% (13.5 vs. 7.2 months, p=0.009), reduced risk of death by approximately half (HR: 0.54, 95% confidence interval: 0.34-0.83), and improved OS by 180% at Year 1 and 290% at Year 2."

P2b data • Glioblastoma

Medicenna Announces Oral Presentation of MDNA11 Data from the Phase 1/2 ABILITY-1 Study at the 2024 ASCO Annual Meeting (GlobeNewswire) - "The oral podium presentation will include new clinical data from the ongoing Phase 1/2 ABILITY-1 Study evaluating MDNA11, a long-acting ‘beta-enhanced not-alpha’ interleukin-2 (IL-2) super-agonist, as both a monotherapy and in combination with pembrolizumab (KEYTRUDA) in patients with advanced or metastatic solid tumors....The second abstract will provide new data analyses for bizaxofusp (formerly known as MDNA55) survival outcomes compared to a propensity matched external control arm (ECA) in nonresectable recurrent glioblastoma (rGBM)."

P1/2 data • P2 data • Glioblastoma • Solid Tumor

Medicenna Announces Compelling Survival Benefit from Phase 2b Study of Bizaxofusp in Recurrent Glioblastoma at the 28th Annual Meeting of the Society for NeuroOncology (GlobeNewswire) - P2b | N=47 | NCT02858895 | Sponsor: Medicenna Therapeutics, Inc. | "Medicenna Therapeutics...announced that a poster presentation and an oral summary highlighting longer term follow up results from the Phase 2b clinical trial of bizaxofusp (formerly known as MDNA55)...at the Society for Neuro-Oncology (SNO) 2023 Annual Meeting....The data demonstrated that a single treatment with bizaxofusp increased median overall survival (mOS) by 72% compared to the ECA (12.4 months vs. 7.2 months). Overall survival (OS) for bizaxofusp-treated patients increased 370% at Year 1 and increased more than 50% at Year 2. Importantly, bizaxofusp doubled mOS (14.5 months vs. 7.2 months) irrespective of IL4R expression (high or low) compared to ECA. No systemic or clinically significant laboratory abnormalities were reported."

P2b data • Glioblastoma

Survival Outcomes in Recurrent Glioblastoma (rGBM) Patients Treated with a Single Intra-tumoral Administration of Bizaxofusp, an IL-4R-targeting Toxin, in a Phase IIb Trial (SNO 2023) - "In patients with rGBM, a single treatment of Bizaxofusp resulted in significantly improved OS compared to eligibility-matched ECA. High-dose Bizaxofusp was equally effective irrespective of IL4R expression. A Phase 3 registration trial will use a novel hybrid design with a propensity-matched ECA comprising two-thirds of the control arm, setting a new precedent for GBM clinical trials."

Clinical • P2b data • Brain Cancer • CNS Tumor • Glioblastoma • Oncology • Solid Tumor • IL4R • IL4R

Survival Outcomes in Recurrent Glioblastoma (rGBM) Patients Treated with a Single Intra-tumoral Administration of Bizaxofusp, an IL-4R-targeting Toxin, in a Phase IIb Trial (SNO 2023) - "In patients with rGBM, a single treatment of Bizaxofusp resulted in significantly improved OS compared to eligibility-matched ECA. High-dose Bizaxofusp was equally effective irrespective of IL4R expression. A Phase 3 registration trial will use a novel hybrid design with a propensity-matched ECA comprising two-thirds of the control arm, setting a new precedent for GBM clinical trials."

Clinical • P2b data • Brain Cancer • CNS Tumor • Glioblastoma • Oncology • Solid Tumor • IL4R • IL4R

Medicenna to Present 4 Year Follow-up Phase 2b Bizaxofusp Survival Data in Recurrent Glioblastoma at the Society for Neuro-Oncology 2023 Annual Meeting (GlobeNewswire) - "Medicenna Therapeutics Corp...today announced that a poster presentation and an oral summary highlighting long-term follow up from the Phase 2b clinical trial of bizaxofusp (formerly known as MDNA55), the Company’s first-in-class IL-4R targeted therapy, will be presented at the Society for Neuro-Oncology (SNO) 2023 Annual Meeting, taking place from November 15-19, 2023, in Vancouver, Canada."

P2b data • Brain Cancer • CNS Tumor • Glioblastoma • Glioma • Oncology • Solid Tumor

Bizaxofusp Demonstrates Encouraging Survival in Recurrent Glioblastoma (Targeted Oncology) - P2 | N=47 | NCT02858895 | "Convection-enhanced delivery (CED) administration of bizaxofusp (formerly MDNA55) showed favorable overall survival (OS) and tumor control as well as acceptable safety in the phase 2b MDNA55-05 trial...of patients with recurrent glioblastoma (rGBM), according to results published in Neuro-Oncology....The open-label, single-arm phase 2b trial of bizaxofusp at escalating doses resulted in a 46% 12-month OS rate and a median OS of 11.64 months in treated patients, with improved efficacy in patients with high interleukin-4 receptor (IL-4R) expression and patients with low IL4R expression who had a higher dose. The rate of adverse events (AEs) did not appear to be dose dependent."

P2b data • CNS Tumor • Glioblastoma • Glioma • Oncology • Solid Tumor

Targeting the IL4 Receptor with MDNA55 in Patients with Recurrent Glioblastoma: Results of a Phase 2b Trial. (PubMed, Neuro Oncol) - "MDNA55 demonstrated tumor control and promising survival and may benefit rGBM patients when treated at high dose irrespective of IL4R expression level."

Journal • P2b data • Brain Cancer • CNS Tumor • Glioblastoma • Oncology • Solid Tumor • IL4 • IL4R • IL4R

[VIRTUAL] Clinical efficacy of MDNA55, an interleukin-­4 receptor targeted immunotherapy, in recurrent GBM delivered by convection enhanced delivery (CED) (SNO 2020) - "MDNA55 demonstrates improved survival and tumor control in this study design and has potential to benefit all rGBM patients treated at high dose irrespective of IL4R expression. There are no approved therapies for rGBM that can extend survival by 50%; the potential for MDNA55 to extend survival by > 100% is promising for this devastating disease."

Clinical • IO Biomarker • Oncology • IL4R

[VIRTUAL] Validation of modified response assessment in neuro oncology (mRANO) determined PFS as a strong predictor of overall survival in recurrent glioblastoma treated with a targeted immunotoxin (SNO 2020) - P2 | " A total of 47 patients with rGBM were enrolled in a phase II convection-enhanced delivery of an IL4R-targeted immunotoxin (MDNA55-05, NCT02858895)... No correlation between PFS and OS was observed for standard RANO or iRANO, but a strong correlation was identified between both locally-determined and centrally-determined PFS and OS using the mRANO criteria. Also, the iRANO criteria was difficult to implement due to need to confirm progression 3 months after initial progression, censoring more than half the patients."

Clinical • Glioblastoma • Oncology • Solid Tumor • IL4R

Medicenna Reports Fiscal Year 2022 Financial Results and Operational Highlights (Bloomberg) - "...Medicenna announced the formation of a Clinical Advisory Board (CAB) comprised of leading experts in immunotherapy and drug development. Members of the CAB include...Hussein Tawbi."

MDNA55, an interleukin-¬4 receptor targeted immunotherapy, for recurrent GBM delivered by Convection Enhanced Delivery (CED) (SNO 2021) - "Following treatment with high concentrations of MDNA55 (6.0 or 9.0 μg/mL), transient (median of 3 cycles) low dose Avastin (5mg/kg q2w or 7.5mg/kg q3w) was used for symptom control and steroid sparring. In the 1:1 randomized Phase 3 trial, the study will enrol two-thirds of subjects in the SOC arm from a matched external control arm. Unlike conventional RCTs, the hybrid design sets a new precedent for GBM trials, allowing robust OS analysis while significantly reducing the number of subjects randomized to SOC arm."

IO biomarker • Brain Cancer • Glioblastoma • Oncology • Solid Tumor • IL4R

Medicenna Receives Award for Excellence in Clinical Trials in Connection with an Upcoming Presentation at the 26th Annual Meeting of the Society for Neuro-Oncology (GlobeNewswire) - "Medicenna Therapeutics Corp...announced that John H. Sampson, MD, PhD, MHSc, MBA, Robert H. and Gloria Wilkins Distinguished Professor of Neurosurgery at Duke University School of Medicine and member of Medicenna’s Board of Directors, received The Abstract Award for Excellence in Clinical Trials in connection with an upcoming oral presentation on MDNA55. The presentation will be delivered by Dr. Sampson at the 26th Annual Meeting of the Society for Neuro-Oncology (SNO), which is taking place November 18 – 21, 2021 at the Hynes Convention Center in Boston, Massachusetts. The presentation will include previously reported data and analyses from the Phase 2b MDNA55-05 trial...Additionally, design of the novel open-label hybrid Phase 3 trial of MDNA55 in rGBM, accepted by the FDA, will also be discussed."

Clinical protocol • P2 data • Glioblastoma • Oncology

Medicenna Reports Second Quarter Fiscal 2022 Financial Results and Operational Highlights (GlobeNewswire) - "Expected Upcoming Milestones: Complete regulatory submissions to expand the ABILITY study to additional sites in the UK and Canada by the end of calendar 2021; Provide preliminary update on safety, PK/PD, and biomarker data from early cohorts of patients enrolled in the dose escalation portion of the ABILITY study by the end of calendar 2021; Report preliminary safety and efficacy data update from the ABILITY study in mid-calendar 2022; Execute a collaboration or partnership for a registration trial and commercialization of MDNA55 in rGBM. Declare a lead candidate from the BiSKITs program by the end of calendar 2021."

Clinical • P1/2 data • Regulatory

[VIRTUAL] MDNA55, a Locally Administered IL4 Guided Toxin for Targeted Treatment of Recurrent Glioblastoma Shows Long Term Survival Benefit (AACR-NCI-EORTC 2020) - "Use of low-dose bevacizumab (Avastin®), at doses typically used to control radiation induced necrosis (5 mg/kg q2w or 7.5 mg/kg q3w), was allowed for management of symptom control and/or steroid sparing...Among these subjects, 17 had tumors with unmethylated MGMT promoter, a marker associated with resistance to temozolomide... The MDNA55-05 study enrolled rGBM patients with limited treatment options and poor prognostic factors with an expected mOS of only 6-9 months, OS-24 of 0 -10% and PFS-12 of 0 -17%. Findings from the Phase 2b trial demonstrate that by combining precise drug delivery and targeting the IL4R, a single treatment with MDNA55 has the potential to present a superior treatment option for improved survival and tumor control in rGBM patients who otherwise rapidly succumb to this disease."

Late-breaking abstract • Glioblastoma • Oncology • Solid Tumor • IL4 • IL4R

Understanding Biological Activity, Tumor Response and Pseudoprogression in a Phase-2b Study of MDNA55 in Adults with Recurrent or Progressive Glioblastoma (GB) (ESMO 2018) - P2; "Prior treatments included surgery (N = 26), radiation (N = 25) and temozolomide (N = 25). These findings show biologic activity of MDNA55 in recurrent GB with appearances on imaging suggestive of disease control in some subjects. We illustrate how supportive diagnostic modalities are required for accurate response assessments and argue the importance of refining overall response tools according to treatment type."

Clinical • P2b data • Solid Tumor

MDNA55: Alocally administered IL4 guided toxin as a targeted treatment for recurrent glioblastoma. (ASCO 2019) - P2; "Treatment options for patients with recurrent GBM are very limited and positive outcomes remain rare. Targeting therapies such as MDNA55 by IL4R status may improve patient outcomes and help guide patient selection strategies for future clinical studies. Clinical trial information: NCT02858895"

[VIRTUAL] MDNA55 survival in recurrent glioblastoma (rGBM) patients expressing the interleukin-­4 receptor (IL4R) as compared to a matched synthetic control. (ASCO 2020) - P2 | "Subgroup analysis in unmethylated MGMT subjects also show better survival with MDNA55 (n = 23) than the SCA (n = 31); mOS 12.3 vs. 7.7 months (p = 0.0268), indicating that MDNA55 may be beneficial in patients resistant to temozolomide. MDNA55 subjects represent a difficult to treat population (de novo GBM, IDH wild-type, not eligible for surgery at recurrence). Single treatment with MDNA55 prolongs survival by nearly 10 months in a subset of rGBM expressing high levels of IL4R when compared to a matched SCA, providing an unprecedented outcome for this highly lethal disease. Research Funding: Medicenna Therapeutics, Cancer Prevention & Research Institute of Texas"

Clinical • Brain Cancer • Glioblastoma • Oncology • Solid Tumor • IDH1 • IL4R

Medicenna Reports First Quarter Fiscal 2022 Financial Results and Operational Highlights (GlobeNewswire) - “Medicenna seeks to achieve the following milestones in the upcoming quarters: Start enrollment in the Phase 1/2 ABILITY Study of MDNA11 in Australia in the third quarter of calendar 2021; Receive regulatory approval to expand the ABILITY study to additional sites in the US, UK, and Canada by the end of calendar 2021; Provide a preliminary update on any available safety, PK/PD and biomarker results from the monotherapy portion of the ABILITY study late in the fourth quarter of calendar 2021; Report preliminary efficacy data from the ABILITY study in the first half of calendar 2022; Execute a collaboration or partnership for a registration trial and commercialization of MDNA55 in rGBM; Declare a lead candidate from the BiSKITs™ program in late calendar 2021.”

Clinical • Commercial • Enrollment status • P1/2 data • Regulatory • Glioblastoma • Oncology

Medicenna Reports Fiscal Year 2021 Financial Results and Operational Highlights (GlobeNewswire) - “Medicenna seeks to achieve the following milestones in the upcoming quarters: In June 2021, submit a Clinical Trial Notification to the Australian Human Research Ethics Committee to commence a Phase 1/2a trial evaluating MDNA11. Initiate a Phase 1/2a trial with MDNA11 in the third quarter of calendar 2021. Report preliminary update on any available safety, PK/PD and biomarker results from the Phase 1/2a MDNA11 monotherapy study late in Q4 of calendar 2021. Execute a collaboration or partnership for a registration trial and commercialization of MDNA55 for rGBM. Declare a lead candidate from our BiSKITs™ program in late calendar 2021.”

Clinical • Licensing / partnership • New P1/2 trial • Non-US regulatory • P1/2 data • Glioblastoma • Oncology

Medicenna Announces the Peer-Reviewed Publication of Clinical Data from Phase 2b Trial Evaluating MDNA55 in Recurrent Glioblastoma (GlobeNewswire) - P2b, N=46; NCT02858895; Sponsor: Medicenna Therapeutics, Inc; "Medicenna Therapeutics Corp...announced the peer-reviewed publication of clinical data from the Company’s Phase 2b recurrent glioblastoma (rGBM) trial in Clinical Cancer Research. The paper, entitled 'Modified RANO, Immunotherapy RANO, and Standard RANO Response to Convection-enhanced Delivery of IL4R-targeted Immunotoxin MDNA55 in Recurrent Glioblastoma'...the median OS of radiographically evaluable patients in the trial irrespective of dose or IL4R expression was 11.8 months, which is longer than what would be expected from the approved drugs carmustine (OS of 5.1 – 7.5 months), lomustine (OS of 7.1 – 9.8 months), or temozolomide (OS of 5.4 – 9.9 months)...Additional analyses from the publication show that both locally and centrally determined PFS using mRANO criteria strongly correlated with OS..."

P2b data • Glioblastoma • Oncology

Medicenna Announces the Peer-Reviewed Publication of Clinical Data from Phase 2b Trial Evaluating MDNA55 in Recurrent Glioblastoma (GlobeNewswire) - "Medicenna is currently pursuing a partnership strategy to facilitate MDNA55’s further development through the planned Phase 3 clinical trial. Following an End of Phase 2 meeting with the United States Food and Drug Administration (FDA), the agency agreed that Medicenna could conduct an open label hybrid Phase 3 trial that allows use of a substantial number of subjects (two-thirds) from a matched external control arm to support regulatory approval of MDNA55 for rGBM. The FDA also expressed their willingness to consider an interim analysis of the trial if certain criteria are met."

FDA event • Glioblastoma • Oncology

Modified RANO (mRANO), iRANO, and standard RANO response to convection-enhanced delivery of IL4R-targeted immunotoxin MDNA55 in recurrent glioblastoma. (PubMed, Clin Cancer Res) - P2 | "No correlation between radiographic PFS and OS was observed for standard RANO or iRANO, but a correlation was observed between PFS and OS using the mRANO criteria. Also, the iRANO criteria was difficult to implement due to need to confirm progression 3 months after initial progression, censoring more than half the patients."

Journal • Brain Cancer • Glioblastoma • Oncology • Solid Tumor • IL4R