Drugs / IL-4(38-37)-PE38KDEL
Trials 3
| Phase | Registry id | Dates | Indication | Sponsor | Status | Outcome |
|---|---|---|---|---|---|---|
| Phase 12 trials | ||||||
| Phase 1 | NCT00039052 | Jan 2002 → May 2003 | breast cancer, kidney cancer, lung cancer | Neurocrine Biosciences | Completed | No outcome recorded |
| Phase 1 | NCT00003842 | Mar 1999 → ? | brain cancer | Barrett Cancer Center | Unknown | No outcome recorded |
| Phase 21 trial | ||||||
| Phase 2 | NCT02858895 | Apr 2017 → Sep 2019 | astrocytoma (excluding glioblastoma), glioblastoma | Medicenna Therapeutics, Inc. | Completed | No outcome recorded |
News releases announcing trial results or a regulatory action · 23
| Date | Issuer | Release |
|---|---|---|
| 2024-06-03 | Medicenna Therapeutics, Inc. | Results 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 medicenna.com ↗
Bizaxofusp increased median overall survival (mOS) by 88% (p = 0.009) and improved overall survival at 1 and 2 years by 180% and 290%, respectively |
| 2023-11-17 | Medicenna Therapeutics, Inc. | Results Medicenna Announces Compelling Survival Benefit from Phase 2b Study of Bizaxofusp in Recurrent Glioblastoma at the 28th Annual Meeting of the Society for NeuroOncology medicenna.com ↗
Single treatment of bizaxofusp doubled mOS (14.5 months vs. 7.2 months) irrespective of IL4R expression (high or low) compared to patients treated in the external control arm |
| 2021-05-07 | Medicenna Therapeutics, Inc. | Results Medicenna Announces the Peer-Reviewed Publication of Clinical Data from Phase 2b Trial Evaluating MDNA55 in Recurrent Glioblastoma medicenna.com ↗ |
| 2020-10-26 | Medicenna Therapeutics, Inc. | Results Medicenna Presents Late Breaking Abstract Updating Results from Phase 2b Recurrent GBM Trial at the 36th EORTC-NCI-AACR Meeting medicenna.com ↗
The poster presentation updated long-term survival results from the Phase 2b trial evaluating MDNA55, an interleukin-4 (IL-4)-guided toxin, as a treatment for rGBM, the most common and uniformly fatal form of brain cancer. |
| 2020-05-29 | Medicenna Therapeutics, Inc. | Results Medicenna Updates Efficacy Results from Phase 2b Recurrent GBM Trial at ASCO 2020 medicenna.com ↗
Currently there are no approved therapies for rGBM that can extend survival by 50%, let alone by 70 - 100% as seen with MDNA55 after just one treatment, |
| 2020-01-13 | Medicenna Therapeutics, Inc. | Results Medicenna Reports Compelling Results from Recurrent Glioblastoma Trial When Compared to an Eligibility-Matched Control Arm medicenna.com ↗ |
| 2019-12-12 | Medicenna Therapeutics, Inc. | Results Medicenna Presents Additional Encouraging Phase 2b Clinical Data at the Inaugural Glioblastoma Drug Development Annual Summit medicenna.com ↗ |
| 2019-11-25 | Medicenna Therapeutics, Inc. | Results Medicenna Reports Promising Efficacy in Phase 2b MDNA55 Clinical Trial at the Society for Neuro-Oncology Annual Meeting medicenna.com ↗ |
| 2019-11-21 | Medicenna Therapeutics, Inc. | Results Medicenna Reports Improved Drug Distribution of MDNA55 with Novel Delivery Technology in Phase 2b Recurrent Glioblastoma Clinical Trial medicenna.com ↗ |
| 2019-09-25 | Medicenna Therapeutics, Inc. | Results Medicenna Presents Promising Update from its MDNA55 Clinical Trial in Recurrent Glioblastoma at the Targeting Innate Immunity Congress medicenna.com ↗ |
| 2019-06-26 | Medicenna Therapeutics, Inc. | Results MDNA55 Shows Promising Results in Models of Ovarian Cancer medicenna.com ↗
In the published pre-clinical data, MDNA55 (IL-4 fused to Pseudomonas exotoxin) was shown to effectively target and kill ovarian cancer cells overexpressing the IL-4 receptor (IL4R), consistent with previous data showing the antitumor effect of MDNA55. |
| 2019-06-18 | Medicenna Therapeutics, Inc. | Results Medicenna Presents Preliminary Top-Line Clinical Results from their Phase 2b Trial of MDNA55 in Recurrent Glioblastoma medicenna.com ↗ |
| 2019-06-03 | Medicenna Therapeutics, Inc. | Results Medicenna Presents Clinical Validation of the IL4 Receptor as a Biomarker for MDNA55 in Recurrent Glioblastoma medicenna.com ↗
75% (6 of 8) of subjects with moderate to high IL4R ( IL4R +ve ) expression show disease control (tumor shrinkage or tumor stabilization from baseline) without clinical decline on assessment of imaging data within 90 days following a single treatment with MDNA55. |
| 2019-02-07 | Medicenna Therapeutics, Inc. | Results Medicenna Presents Promising Clinical Data from Phase 2b Recurrent Glioblastoma Trial of MDNA55 medicenna.com ↗
Results being presented today demonstrate promising signs of clinical benefit, particularly in recurrent patients with an aggressive form of GBM. |
| 2018-10-31 | Medicenna Therapeutics, Inc. | Results Medicenna Provides Positive Interim Update From Phase 2b Trial of MDNA55 in Recurrent Glioblastoma medicenna.com ↗
Results from the low dose cohorts showed promising median overall survival of 9.8 months following a single treatment with an overall survival rate of 89% at 6 months, 58% at 9 months and 47% at 12 months. |
| 2018-08-22 | Medicenna Therapeutics, Inc. | Results Medicenna Presented Insights from the Phase 2b Clinical Trial of MDNA55 at the European Society for Medical Oncology 2018 Congress medicenna.com ↗
Dr. Martin Bexon, Head of Clinical Development at Medicenna, presented results outlining the patterns of responses seen in the MDNA55 Phase 2b clinical trial in patients treated at low doses implemented during the first half of the study. |
| 2018-03-02 | Medicenna Therapeutics, Inc. | Results Medicenna Amends Protocol of Phase 2b Recurrent Glioblastoma Study of MDNA55 in Response to Strong Safety Data and Early Efficacy Read-outs medicenna.com ↗ |
| 2017-11-16 | Medicenna Therapeutics, Inc. | Results Medicenna Presents Updates on Phase 2b Clinical Trial of MDNA55 at the Annual Meeting of the Society of Neuro-Oncology medicenna.com ↗
The early results also demonstrate that higher infusion volumes, which were only recently implemented in the protocol, are associated with superior target coverage. |
| 2017-11-14 | Medicenna Therapeutics, Inc. | Results Medicenna Presents Clinical Data From Previous Phase 1 and 2 Clinical Trials of MDNA55 medicenna.com ↗
In the MDNA55 Phase 1 multicenter study, an overall response rate (ORR) of 56% was achieved, with a complete response rate of 20%. |
| 2017-10-10 | Medicenna Therapeutics, Inc. | Results Medicenna Presents Clinical Data on Initial Experience from Ongoing Phase 2b Study of MDNA55 medicenna.com ↗ |
| 1999-10-14 | Neurocrine Biosciences | Regulatory FDA Approves Fast Track Designation for NBI-3001 in Malignant Brain Tumors gcs-web.com ↗
Neurocrine Biosciences, Inc. (Nasdaq: NBIX) today announced that the U.S. Food and Drug Administration (FDA) has granted fast track designation to the Company's IL-4 Fusion Toxin compound (NBI-3001). |
| 1999-06-29 | Neurocrine Biosciences | Results Nature Medicine Publication Demonstrates IL-4 Fusion Toxin is Effective In Treating Systemic Form of Cancer in Preclinical Models gcs-web.com ↗
The publication reports that in preclinical models of Kaposi's sarcoma (KS), treatment with IL-4 Fusion Toxin resulted in eradication of KS tumors and prevented disease-related symptoms, such as cachexia (weight loss) and lymphophenia. |
| 1998-11-25 | Neurocrine Biosciences | Results Neurocrine Announces Advancement of NBI-3001 for Malignant Brain Tumors: Phase I Results Presented/Initiation of Multi-Center, International Phase I/II Clinical Trial gcs-web.com ↗
The abstract also stated that of nine patients treated, five patients showed evidence of necrosis (tumor cell death) in major sections of tumor by MRI, PET and MR-SPEC scanning. |
All press releases naming this drug 38 releases
Evidence & citations 9 cited values
Every value below carries the sentence it was read from. 3 sources stand behind the page.
| Field | Value | Cited text |
|---|---|---|
| Known as | IL-4(38-37)-PE38KDEL | “A Phase I Study of a Recombinant Chimeric Protein Composed of Circularly Permuted IL-4 and a Mutated Form of the Pseudomonas Exotoxin Termed IL-4(38-37)-PE38KDEL (IL-4 Toxin)...” NCT00003842 ↗ |
| Known as | IL-4 Toxin | “A Phase I Study of a Recombinant Chimeric Protein Composed of Circularly Permuted IL-4 and a Mutated Form of the Pseudomonas Exotoxin Termed IL-4(38-37)-PE38KDEL (IL-4 Toxin)...” NCT00003842 ↗ |
| Known as | interleukin-4 PE38KDEL cytotoxin | “Patients receive interleukin-4 PE38KDEL cytotoxin (NBI-3001) IV over 10 minutes once daily on days 1-5.” NCT00039052 ↗ |
| Known as | MDNA55 | ClinicalTrials.gov intervention name — accepted as the source's own label NCT02858895 ↗ |
| Known as | NBI-3001 | “Patients receive interleukin-4 PE38KDEL cytotoxin (NBI-3001) IV over 10 minutes once daily on days 1-5.” NCT00039052 ↗ |
| Action | Deplete | “IL-4(38-37)-PE38KDEL immunotoxin may locate tumor cells and kill them without harming normal cells.” NCT00003842 ↗ |
| Modality | Protein / enzyme biologic | “a Recombinant Chimeric Protein Composed of Circularly Permuted IL-4 and a Mutated Form of the Pseudomonas Exotoxin” NCT00003842 ↗ |
| Route | Other | “intratumorally infused IL-4(38-37)-PE38KDEL immunotoxin” NCT00003842 ↗ |
| Target | IL4R | “MDNA55 binds to the IL-4 receptor (IL4R), over-expressed by cancer cells and non-malignant immunosuppressive cells of the tumor microenvironment (TME)” NCT02858895 ↗ |