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

BMX-001 has the potential to augment tumor killing by radiation therapy and inhibits tumor regrowth by inhibiting pro-survival and pro-angiogenic transcription factors and HIF-1a

In Phase 2 study, BMX-001 demonstrates increased overall survival and tolerable safety profile

GREENWOOD VILLAGE, Colo.–(BUSINESS WIRE)–BioMimetix JV, LLC, a clinical-stage biotechnology company developing metalloporphyrins, a novel drug class for the treatment of cancer patients, today 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. In the Phase 2 study, BMX-001 in combination with radiotherapy (RT) and temozolomide (TMZ) demonstrated a 6.6 month increase in median survival, mitigation of radiation-induced cognitive issues, and improved white matter integrity with a tolerable safety profile, compared to current standard of care. The abstract will be published in SNO’s official journal, Neuro-Oncology.

“Patients with high grade glioma are challenging to treat because the disease grows quickly, ultimately outcomes are very poor for these patients and often carries an unfavorable prognosis. Current treatments aim to remove the tumor through surgery or slow its growth using chemotherapy and radiation therapy, but they are not curative and are associated with significant toxicities, including radiation-induced cognitive dysfunction that is responsible for negatively impacting the quality of life for our patients. The diversity of cases makes finding a cure difficult, and seeing durable responses in these patients is encouraging,” said Katy Peters, MD PhD FAAN (Lead Principal Investigator). “BMX-001 is a promising first-in-class molecule with clinically meaningful activity and the potential to become a new treatment option for patients diagnosed with high grade glioma.”

“The exciting data presented today at SNO underscore what I have sought to achieve over the past several decades in our scientific research. The primary mechanism of action of a redox active metalloporphyrin is modulation of key pathways of cellular signaling in a pattern that augments radiation therapy in killing tumor cells while protecting normal tissues. This is demonstrated by the promising effects seen in this trial with BMX-001 on patients with high grade glioma receiving concurrent radiation and chemotherapies,” said James Crapo, M.D., Chief Executive Officer at BioMimetix. “High grade glioma is an aggressive brain cancer with a low survival rate that affects 10,000-15,000 people in the US per year. A substantial increase in median survival over the standard of care coupled with improved quality of life represents a significant stride towards bringing patients a transformative treatment. We are motivated to continue developing BMX-001 for this area of high unmet need, while also continuing to explore the utility of BMX-001 in other cancer types.”

Presentation Highlights:

• 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.
• BMX-001 was found to have an excellent safety profile.

Presentation Details:
Title: 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

Abstract Number: LTBK-09

Date and Time: Friday, November 17, 2023, from 9:05 – 9:15 a.m. PT

Session: Plenary I, Exhibit Hall C

Presenter: Katherine Peters, M.D., Duke University Medical Center

About BMX-001

BMX-001 is a metalloporphyrin, a novel class of redox-active, small molecule. The active center is designed to mimic the center of superoxide dismutase. The primary mechanism of action is modulation of cellular signaling pathways. BMX-001 inhibits both NFkB and HIF-1a. By inhibiting these pro-survival and pro-angiogenic transcription factors, BMX-001 augments tumor killing by radiation therapy and inhibits tumor regrowth. The inhibition of NFkB blocks major components of the inflammatory cascade which simultaneously results in protection of normal tissue from radiation induced injury. BMX-001 is also being developed in head and neck cancer, anal cancer, and rectal cancer and has been previously granted Orphan, Fast Track and Breakthrough designations by the FDA.

About BioMimetix JV, LLC

BioMimetix JV, LLC is a clinical-stage biotechnology company developing a novel platform drug class, metalloporphyrins, that enhances the effectiveness and safety of chemoradiation for the treatment of cancer patients. The Company’s robust clinical pipeline spanning multiple oncology indications is supported by demonstrated clinical efficacy in multiple ongoing clinical studies and extensive preclinical data.

Contacts

Courtney Turiano

Stern Investor Relations, Inc.

[email protected]