BMX-001

P1/2, N=27, Not yet recruiting, BioMimetix JV, LLC

P2, N=98, Not yet recruiting, NRG Oncology

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.

P2, N=160, Active, not recruiting, BioMimetix JV, LLC | Trial completion date: Jul 2024 --> Dec 2024 | Trial primary completion date: Jan 2024 --> Aug 2023

P1/2, N=35, Terminated, 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

P2, N=118, Recruiting, University of Nebraska | Trial completion date: Feb 2028 --> Jun 2029 | Trial primary completion date: Jan 2028 --> May 2027

P2, N=118, Recruiting, University of Nebraska | Trial completion date: Dec 2033 --> Feb 2028 | Trial primary completion date: May 2028 --> Jan 2028

P2, N=118, Recruiting, University of Nebraska | Trial completion date: Dec 2032 --> Dec 2033 | Trial primary completion date: May 2027 --> May 2028

P2, N=118, Recruiting, University of Nebraska | Trial completion date: Jun 2029 --> Dec 2032

P1/2, N=24, Recruiting, University of Nebraska | Trial completion date: Dec 2026 --> Dec 2029 | Trial primary completion date: Dec 2024 --> Dec 2025

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.

We have employed a redox-active MnP (MnTnBuOE-2-PyP, Mn(III) meso-tetrakis (N-n-butoxyethylpyridinium-2-yl) porphyrin) frequently identified as superoxide dismutase mimic or BMX-001, to explore the redox status of normal ovarian cell in relation to two ovarian cancer cell lines: OV90 human serous ovarian cancer cell and chemotherapy-resistant OV90 cell (OVCD). It is significant to emphasize that MnP protects normal ovarian cell line, hTER7, against carboplatin toxicity. Our data demonstrate that the addition of MnP-based redox-active drugs may be used (via increasing excessively the oxidative stress of serous ovarian cancer cells) to improve cancer patients' chemotherapy outcomes, which develop resistance to platinum-based drugs.

The lead Mn porphyrins, namely, MnTE-2-PyP (BMX-010, AEOL10113), MnTnBuOE-2-PyP (BMX-001), and MnTnHex-2-PyP, were tested in numerous injuries of normal tissue and cellular and animal cancer models. The wealth of the data led to the progression of MnTnBuOE-2-PyP into four Phase II clinical trials on glioma, head and neck cancer, anal cancer, and multiple brain metastases, while MnTE-2-PyP is in Phase II clinical trial on atopic dermatitis and itch.