BMX-001 / BioMimetix - LARVOL DELTA

A SUPEROXIDE DISMUTASE-MIMETIC (BMX-001) MITIGATES LIPID PEROXIDATION IN A MOUSE MODEL OF ALCOHOL-ASSOCIATED LIVER DISEASE. (AASLD 2025) - "Our data suggests that LDs may serve as central organelles for the storage and trafficking of lipid peroxides in ALD, and that BMX-001 therapy mitigates lipid peroxidation in hepatocytes. Furthermore, sex-specific differences exist with respect to EtOH-induced lipid peroxidation in male and female mice."

Preclinical • Addiction (Opioid and Alcohol) • Hepatology • PLIN2

Results of a Randomized Phase 2 Study of a Novel Superoxide Dismutase Mimetic in Patients with Multiple Brain Metastases undergoing Whole-Brain Radiotherapy (ASTRO 2025) - "BMX-001 was well-tolerated in combination with WBRT. While lack of accrual – in part due to the negative perception of WBRT versus other techniques – limited our ability to judge the efficacy of BMX-001 in this setting, future trials of this agent in appropriate brain metastases populations should be considered, particularly where SRS and HA-WBRT are not indicated."

Clinical • P2 data • Breast Cancer • Lung Cancer • Non Small Cell Lung Cancer • Small Cell Lung Cancer • Solid Tumor

Patient-Reported Outcomes from a Phase 1-2 Trial of Concurrent Chemoradiation and BMX-001 for Locally Advanced Head and Neck Cancer (ASTRO 2025) - "Most patients (89.7%) had definitive CRT to 70 Gy, and 79.3% received >200 mg/m2 cisplatin. Patients treated with BMX-001 and CRT for HNSCC experienced the greatest symptom burden in physical, functional, and head and neck cancer-specific domains. On this trial, PRO signals improved as early as 1 month and returned to baseline by 6 months post-CRT, comparing favorably to historical controls and supporting further investigation of BMX-001 in HNSCC."

Clinical • Metastases • P1/2 data • Patient reported outcomes • Head and Neck Cancer • Oncology • Solid Tumor • Squamous Cell Carcinoma • Squamous Cell Carcinoma of Head and Neck

Therapeutic Potential of BMX-001 for Preventing Chemotherapy-Induced Peripheral Neuropathic Pain. (PubMed, Pharmaceuticals (Basel)) - "Background/Objectives: Chemotherapy-induced neuropathic pain (CINP) represents a critical challenge in oncology, emerging as a common and debilitating side effect of widely used chemotherapeutic agents, such as paclitaxel (PTX). Overall, our study highlights the therapeutic potential of BMX-001 to mitigate CINP and enhance anticancer efficiency. Its dual-selective mechanism supports the future clinical investigation of BMX-001 as a novel adjunct to chemotherapeutic regimens."

Journal • Neuralgia • Oncology • Pain • Peripheral Neuropathic Pain

Suppression of Paclitaxel-Induced Neuropathy and Ovarian Tumor Growth by Mn Porphyrin, MnTnBuOE-2-PyP5+ (BMX-001). (PubMed, Oxid Med Cell Longev) - "The combined neuropathy protection and anticancer efficacy demonstrate, therefore, strong therapeutic potential of BMX-001 for gynecological cancers. Moreover, the ability of BMX-001 to suppress neuropathy may be relevant for all types of cancer where chemotherapeutics that induce neuropathy are used as a standard-of-care."

Journal • Gynecologic Cancers • High Grade Serous Ovarian Cancer • Oncology • Ovarian Cancer • Pain • Solid Tumor

NRG-CC013: Testing the Addition of the Drug BMX-001, a Radioprotector, or a Placebo to the Usual Chemoradiation Therapy for Patients With Head and Neck Cancer (clinicaltrials.gov) - P2 | N=98 | Recruiting | Sponsor: NRG Oncology | Not yet recruiting ➔ Recruiting

Enrollment open • Dental Disorders • Head and Neck Cancer • Hypopharyngeal Cancer • Laryngeal Cancer • Nasopharyngeal Carcinoma • Oncology • Oral Cancer • Oropharyngeal Cancer • Solid Tumor • Squamous Cell Carcinoma • Squamous Cell Carcinoma of Head and Neck • Squamous Cell Skin Cancer • Stomatitis

BMX-HGG: Trial of Newly Diagnosed High Grade Glioma Treated With Concurrent Radiation Therapy, Temozolomide and BMX-001 (clinicaltrials.gov) - P1/2 | N=177 | Completed | Sponsor: BioMimetix JV, LLC | Active, not recruiting ➔ Completed | Phase classification: P2 ➔ P1/2

Phase classification • Trial completion • Anaplastic Astrocytoma • Astrocytoma • Brain Cancer • Glioblastoma • Glioma • High Grade Glioma • Oncology • Solid Tumor

Safety Study of BMX-001 (Radio-protector) in Patients With Newly Diagnosed Anal Cancer (clinicaltrials.gov) - P1/2 | N=24 | Active, not recruiting | Sponsor: University of Nebraska | Recruiting ➔ Active, not recruiting

Enrollment closed • Anal Carcinoma • Oncology • Solid Tumor • Squamous Cell Carcinoma

Treatment with Manganese Porphyrin, MnTnBuOE-2-PyP5+, Suppressed the Activation of Macrophages in a Mouse Intracerebral Hemorrhage. (PubMed, Pharmaceuticals (Basel)) - "However, BMX-001 reduced the number of macrophages in the hemorrhagic area (48 ± 10 in vehicle, 33 ± 8 in BMX-001, p = 0.008) and the number of cells stained with Prussian blue-an indicator of iron released during hemorrhage (65 ± 22 in vehicle and 41 ± 15 in BMX-001, p = 0.027). The results support the safe use of BMX-001 in stroke patients in combination with thrombolysis or thrombectomy and, moreover, indicate the beneficial anti-inflammatory effect of BMX-001, alike to that previously reported in stroke studies of analogous, similarly redox-active, Mn porphyrins."

Journal • Preclinical • Cardiovascular • Cerebral Hemorrhage • Hematological Disorders • Ischemic stroke

Testing the Addition of the Drug BMX-001, a Radioprotector, or a Placebo to the Usual Chemoradiation Therapy for Patients With Head and Neck Cancer (clinicaltrials.gov) - P2 | N=98 | Not yet recruiting | Sponsor: NRG Oncology | Trial completion date: Sep 2026 ➔ Jan 2027 | Initiation date: Oct 2024 ➔ Apr 2025 | Trial primary completion date: Sep 2026 ➔ Jan 2027

Trial completion date • Trial initiation date • Trial primary completion date • Dental Disorders • Head and Neck Cancer • Hypopharyngeal Cancer • Laryngeal Cancer • Nasopharyngeal Carcinoma • Oncology • Oral Cancer • Oropharyngeal Cancer • Solid Tumor • Squamous Cell Carcinoma • Squamous Cell Carcinoma of Head and Neck • Squamous Cell Skin Cancer • Stomatitis

BMX-001 + Paclitaxel in Adult Patients With Advanced, Recurrent, Metastatic Ovarian or Endometrial Cancer (clinicaltrials.gov) - P1/2 | N=27 | Not yet recruiting | Sponsor: BioMimetix JV, LLC

New P1/2 trial • Endometrial Cancer • Oncology • Ovarian Cancer • Solid Tumor • BCL2 • TNFA

Testing the Addition of the Drug BMX-001, a Radioprotector, or a Placebo to the Usual Chemoradiation Therapy for Patients With Head and Neck Cancer (clinicaltrials.gov) - P2 | N=98 | Not yet recruiting | Sponsor: NRG Oncology

New P2 trial • Head and Neck Cancer • Hypopharyngeal Cancer • Laryngeal Cancer • Nasopharyngeal Carcinoma • Oncology • Oral Cancer • Oropharyngeal Cancer • Solid Tumor • Squamous Cell Carcinoma • Squamous Cell Carcinoma of Head and Neck • Squamous Cell Skin Cancer

Single-Cell Profiling Reveals Immune-Based Mechanisms Underlying Tumor Radiosensitization by a Novel Mn Porphyrin Clinical Candidate, MnTnBuOE-2-PyP5+ (BMX-001). (PubMed, Antioxidants (Basel)) - "CellChat analysis showed that the number of cell-cell communications was the lowest in the MnBuOE/RT group. Our study is the first to provide evidence for the combined radiotherapy with a novel Mn porphyrin clinical candidate, BMX-001, from the perspective of each cell type within the tumor microenvironment."

Journal • Immunology • Oncology • CAFs • CD8 • TNFA

BMX-HGG: Trial of Newly Diagnosed High Grade Glioma Treated With Concurrent Radiation Therapy, Temozolomide and BMX-001 (clinicaltrials.gov) - P2 | N=160 | Active, not recruiting | Sponsor: BioMimetix JV, LLC | Trial completion date: Jul 2024 ➔ Dec 2024 | Trial primary completion date: Jan 2024 ➔ Aug 2023

Trial completion date • Trial primary completion date • Anaplastic Astrocytoma • Astrocytoma • Brain Cancer • CNS Tumor • Glioblastoma • Glioma • Oncology • Solid Tumor

A Trial for Treatment of Cancer Patients With Multiple Brain Metastases Undergoing Whole-Brain Radiotherapy (clinicaltrials.gov) - P1/2 | N=35 | Terminated | Sponsor: BioMimetix JV, LLC | N=69 ➔ 35 | Trial completion date: Sep 2025 ➔ Apr 2024 | Recruiting ➔ Terminated | Trial primary completion date: Aug 2024 ➔ Dec 2023; Cessation of grant funding

Enrollment change • Trial completion date • Trial primary completion date • Trial termination • Oncology • Solid Tumor

Trial of the Efficacy and Safety of Short and Long Course Radiation Therapy With/Without BMX-001 (clinicaltrials.gov) - P2 | N=118 | Recruiting | Sponsor: University of Nebraska | Trial completion date: Feb 2028 ➔ Jun 2029 | Trial primary completion date: Jan 2028 ➔ May 2027

Metastases • Trial completion date • Trial primary completion date • Colorectal Adenocarcinoma • Colorectal Cancer • Gastrointestinal Cancer • Oncology • Rectal Cancer • Solid Tumor

Trial of the Efficacy and Safety of Short and Long Course Radiation Therapy With/Without BMX-001 (clinicaltrials.gov) - P2 | N=118 | Recruiting | Sponsor: University of Nebraska | Trial completion date: Dec 2033 ➔ Feb 2028 | Trial primary completion date: May 2028 ➔ Jan 2028

Metastases • Trial completion date • Trial primary completion date • Colorectal Adenocarcinoma • Colorectal Cancer • Gastrointestinal Cancer • Oncology • Rectal Cancer • Solid Tumor

Trial of the Efficacy and Safety of Short and Long Course Radiation Therapy With/Without BMX-001 (clinicaltrials.gov) - P2 | N=118 | Recruiting | Sponsor: University of Nebraska | Trial completion date: Dec 2032 ➔ Dec 2033 | Trial primary completion date: May 2027 ➔ May 2028

Metastases • Trial completion date • Trial primary completion date • Colorectal Adenocarcinoma • Colorectal Cancer • Gastrointestinal Cancer • Oncology • Rectal Cancer • Solid Tumor

Trial of the Efficacy and Safety of Short and Long Course Radiation Therapy With/Without BMX-001 (clinicaltrials.gov) - P2 | N=118 | Recruiting | Sponsor: University of Nebraska | Trial completion date: Jun 2029 ➔ Dec 2032

Metastases • Trial completion date • Colorectal Adenocarcinoma • Colorectal Cancer • Gastrointestinal Cancer • Oncology • Rectal Cancer • Solid Tumor

Safety Study of BMX-001 (Radio-protector) in Patients With Newly Diagnosed Anal Cancer (clinicaltrials.gov) - P1/2 | N=24 | Recruiting | Sponsor: University of Nebraska | Trial completion date: Dec 2026 ➔ Dec 2029 | Trial primary completion date: Dec 2024 ➔ Dec 2025

Trial completion date • Trial primary completion date • Anal Carcinoma • Gastrointestinal Cancer • Oncology • Solid Tumor • Squamous Cell Carcinoma

BioMimetix Presents Data from Phase 2 Study of BMX-001 Demonstrating Increased Survival of 6.6 Months in High Grade Glioma Patients at the 2023 Society for Neuro-Oncology Annual Meeting (Businesswire) - P2 | N=160 | BMX-HGG (NCT02655601) | Sponsor: BioMimetix JV, LLC | "BioMimetix JV...announced the presentation of encouraging data from its Phase 2 study of lead candidate, BMX-001, for the treatment of high-grade glioma (HGG) at the 2023 Society for Neuro-Oncology (SNO) Annual Meeting....The Phase 2 clinical trial included 160 subjects with newly diagnosed high grade glioma of which 145 completed protocol treatment. Patients on concurrent RT/TMZ who also received BMX-001 were found to have an increased median survival of 6.6 months. BMX-001 also mitigated radiation-induced cognitive issues - demonstrated by an increase in Hopkins Verbal Learning Test scores at 6-months post-baseline versus the control group, and an improvement in Brief Assessment of Cognition (BAC) scores."

P2 data • Glioblastoma

Results of BMX-HGG study: a multi-institutional, randomized phase 2 clinical trial of concurrent chemoradiation with or without BMX-001 in patients with newly diagnosed high grade glioma (SNO 2023) - No abstract available

Clinical • Late-breaking abstract • P2 data • Brain Cancer • CNS Tumor • Glioma • Oncology • Solid Tumor

Intracarotid Infusion of Redox-Active Manganese Porphyrin, MnTnBuOE-2-PyP, following Reperfusion Improves Long-Term, 28-Day Post-Stroke Outcomes in Rats. (PubMed, Antioxidants (Basel)) - "These findings indicate that BMX-001 is a candidate drug as an adjunct treatment for thrombectomy procedure to further improve the neurologic outcomes of thrombectomy patients. This study warrants further clinical investigation of BMX-001 as a new stroke therapy."

Journal • Preclinical • Cardiovascular • Hypertension • Inflammation • Ischemic stroke

BioMimetix Announces Acceptance of Late-Breaking Abstract and Oral Presentation of BMX-001 Clinical Data at the 2023 Society for Neuro-Oncology Annual Meeting (Businesswire) - "BioMimetix JV, LLC...announced that data from its Phase 2 study of lead candidate, BMX-001, for the treatment of high-grade glioma (HGG), has been selected as a late breaking oral presentation at the 2023 Society for Neuro-Oncology (SNO) Annual Meeting taking place on November 15-19, 2023 in Vancouver, Canada."

P2 data • CNS Tumor • Glioma • Oncology • Solid Tumor

The Redox-Active Manganese(III) Porphyrin, MnTnBuOE-2-PyP, Impairs the Migration and Invasion of Non-Small Cell Lung Cancer Cells, Either Alone or Combined with Cisplatin. (PubMed, Cancers (Basel)) - "Manganese(III) porphyrin MnTnBuOE-2-PyP (MnBuOE, BMX-001) is a third-generation redox-active cationic substituted pyridylporphyrin-based drug with a good safety/toxicity profile that has been studied in several types of cancer. MnBuOE alone or combined with cisplatin downregulated MMP2, MMP9, VIM, EGFR and VEGFA and upregulated CDH1 in both cell lines. Overall, our data demonstrate the anti-metastatic potential of MnBuOE for the treatment of NSCLC."

Journal • Anal Carcinoma • Brain Cancer • CNS Tumor • Gastrointestinal Cancer • Glioma • Head and Neck Cancer • Lung Cancer • Non Small Cell Lung Cancer • Oncology • Solid Tumor • Squamous Cell Carcinoma • CDH1 • EGFR • MMP2 • MMP9