Chemistry and Mechanism of Action

Chemistry and Mechanism of Action BioMimetix is advancing an entirely new class of small molecules, redox-active metalloporphyrins (MnPs), with potent anti-inflammatory effects. Our MnPs are enzymatic and optimized for redox activity at near diffusion limited rates to provide dual action of tumor killing and protecting healthy tissue. BMX-001 modulates cellular signaling such as by inhibiting of NF-𝛋B and HIF-1𝛂 pathways.

Mechanism of Action: Dual Impact on Tumor Cells and Normal Tissues

In Tumor Cells

  • NF-𝛋B supports pro-survival functions
  • HIF-1𝛂 supports angiogenesis
  • Blocking NF-𝛋B and HIF-1𝛂 by BMX-001, enhances tumor killing, inhibits angiogenesis and reduces long-term tumor proliferation
  • This has been demonstrated in animal models (glioblastoma, head and neck, Anal & Rectal) and tumor inhibition confirmed in clinical trial of patients with high-grade glioma

In Normal Cells

  • NF-𝛋B is the primary regulator of inflammatory injury following radiation therapy
  • HIF-1𝛂 is not expressed under normal conditions
  • Blocking NF-𝛋B by BMX-001 markedly reduces inflammatory injury to normal cells by radiation therapy
  • Blocking HIF-1𝛂 by BMX-001 has no significant effect on normal cells
  • These effects have been seen in preclinical and humans:
    • Protects white matter tracks and cognition after brain RT
    • Reduces mucositis and xerostomia after HN RT
    • Reduces GI/GU incontinence, strictures, and skin inflammation after RT
BMX-001 is lipophilic and optimized for greater systemic availability when subcutaneously injected.
The mechanism supporting BMX-001 + RT as a combination therapy targeting tumor suppression is supported by multiple published preclinical studies:

BMX-001: Addressing an Unmet Medical Need

Significant resistance to therapy is found for many forms of tumor.
Radiation therapy and chemotherapy are limited by multiple side effects.
Efficacy of BMX-001 in both tumor inhibition and protection of normal tissues is backed by preclinical and clinical data.
High-Grade Glioma
Aggressive and malignant tumor with poor prognosis
  • Limited treatment options
  • The blood brain barrier protects many drugs from reaching the brain (BMX-001 penetrates the BBB)
  • Cancer cells mutate and adapt, rendering targeted therapies less effective
Head and Neck Cancer
Complex Anatomy
  • Treating cancer in this region while preserving function remains a challenge
  • Current SOC (surgery and chemoradiation) causes significant side effects
Anal & Rectal Cancers
Impaired QoL
  • Despite advances in treatment, these cancers present several unmet medical needs
    Some become resistant to treatment
    Chemoradiation therapy causes significant side effects

BMX-001 is a platform solution for cancer treatment

Killing the Cancer

BMX-001 delivered a  6.6 month survival benefit in a large, randomized, controlled trial.

Preclinical studies support tumor inhibition by BMX-001:

  • Glioblastoma Multiforme
  • Head and Neck cancer
  • Anal & rectal cancer


  • BMX-001 is active at a very low dose.
  • BMX-001 has been chemically optimized for wide distribution and penetration of blood-brain barrier.

Rigorous HGG Trial Design

Problems with most HGG trials: 

  • OS was not a primary endpoint,
  • > 60% were single-arm,
  • relied on historic controls,
  • many were single center.

Our Phase 2 HGG  trial was designed to avoid these mistakes. 

Safety and Protection

BMX-001 has a benign safety profile, with AEs that are minor and manageable.

BMX-001 protects against radiation injury to brain, head and neck tissues, bowel and skin. In HGG patients, cognitive function is preserved.

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