BioMimetix is developing a new class of proprietary molecules for cancer therapy. BMX-001 is currently in four Phase 2 (or Phase 1/2) studies: high-grade glioma, head and neck cancer, multiple brain metastases, and anal/rectal cancer. In the HGG study of patients treated with radiation and temozolomide, there is an early indication of a survival benefit (23 months v. 16 months) along with clear evidence for protection against thrombocytopenia and cognitive dysfunction. In head and neck cancer and anal/rectal cancer there is early but striking evidence of protection against mucositis and dermatitis, respectively. The PK properties support dosing by twice weekly subcutaneous injection. The drug is well-tolerated and, to date, adverse reactions are few and manageable, with no events rising to the Grade 3 level.
Preclinical studies show that BMX-001 protects against radiation- and/or chemotherapy-induced inflammation and related injuries in a number of tissues, including bone marrow, GI tract and mucosal surfaces, skin, lung, brain, and peripheral nerves. In xenograft models, the drug enhances the anti-tumor effects of radiation and/or. Insofar as it has been possible to test in humans clinical studies, all protective effects observed in preclinical animal models have translated to a medical benefit for human subjects.
In order to develop fully the medical and commercial potential of BMX-001, BioMimetix is seeking a partner with strong capabilities in late-stage clinical development in Oncology, manufacturing, and commercialization of novel therapeutic entities.
Cancer Trials with BMX-001
o High-grade Glioma. Clinical trial of BMX-001 in subjects with high-grade glioma undergoing radiation therapy and treatment with temozolomide. As of April 2019, a Phase 1 dose escalation/safety trial involving 15 HGG patients subjects was completed. The rclinical dose for Phase 2 was determined to be 28 mg s.c. for loading dose and 14 mg s.c., b.i.w. for subsequent doses. Most common related toxicity was grade 1 injection site reaction, and there was no end-organ or bone marrow toxicity. Early data demonstrate protection of cognitive function, protection against marrow suppression by temozolomide, and suggest a substantial survival benefit. The Phase 2 clinical trial is a randomized and placebo-controlled with enrollment in progress.
o Head and Neck Cancer. Clinical trial of BMX-001 in subjects with head and neck cancer undergoing radiation therapy and treatment with cisplatin was initiated as a Phase 1 dose escalation safety trial at Duke University in the third quarter 2017. This trial is in transition to a Phase 2 clinical trial at the recommended clinical dose of 28 mg for loading dose and 14 mg b.i.w. for subsequent doses.
o Multiple Brain Metastases. Clinical trial of BMX-001 in patients with at least 10 brain metastases all of whom will undergo whole brain radiation therapy was initiated at Duke University in January 2019. After an initial 5 patients treated with BMX-001 as a safety bridge, 64 patients will be randomized 1:1 for treatment with BMX-001 vs. no treatment with BMX-001.
o Anal Squamous Cell Carcinoma. Clinical trial of BMX-001 in patients with anal carcinoma is being conducted at the University of Nebraska. This Phase 1 trial is a dose-escalation trial to confirm safety and tolerability in patients receiving radiation therapy plus 5FU/mitomycin.
History of Federal funding:
• NCI HHSN 261201500002C, Radioprotector for Head and Neck Cancer (Phase I and Phase II), 02/09/15-02/08/20.
• NIH 5R44CA195749-02, BMX-001 as a Therapeutic Agent for Treatment of High-Grade Gliomas, 09/18/15-03/31/19.
• NCI 1 R44 CA228694-01 BMX-001 as a Therapeutic Agent for Treatment of Multiple Brain Metastases.
Corporate Structure for BioMimetix JV, LLC
James D. Crapo, MD, Manager and CEO
David S. Silberstein, PhD, COO
Robert Hellewell, JD, VP-Business Development
Kimberly Stone, MD, Director, Dermatology
Shayne Gad, PhD, VP-Director of Drug Development and Regulatory Affairs
John Wetzel, PhD, Director, Chemistry Manufacturing and Controls
Bob Ogden, CPA, CFO
Sara Penchev, Director of Clinical Operations
David MacLeod, PhD, Director of Information Science & Data Management
Pamela Fullerton, Senior Clinical Research Associate
Research and Development Team
Ines Batinic-Haberle, PhD, Chemistry and New Drug Discovery, Professor Emeritus, Duke University
Mark W Dewhirst, DVM, PhD, Radiation Therapy, Professor, Duke University
Irwin Fridovich, PhD, Senior Advisor, Professor Emeritus, Duke University
John Kirkpatrick, MD, PhD, Radiation Oncology, Associate Professor, Duke University
Rebecca Oberley-Deegan, PhD, Radiation and Cancer Studies, Associate Professor, University of Nebraska, Omaha
Katherine B Peters, MD, PhD, Neurology and Neurosurgery, Associate Professor, Duke University
Jon D Piganelli, PhD, Transplant and Stem Cell Applications, Associate Professor, University of Pittsburgh
Ivan Spasojevic, PhD, Bioassays, Associate Professor, Duke University
David Warner, MD, Neurology Studies, Professor, Duke University
Albany Molecular Research, Inc., GMP Drug Synthesis, Bioassay and Stability