BioInvent International has received further patent protection in China, Japan, and Russia covering the use of BI-505 in cancer patients who have failed to respond to, or relapsed after, prior therapies. These patents add to those previously granted in these countries, as well as in Europe and the United States, covering BI-505’s use in the treatment of cancer.
“We are pleased to have added three more patent approvals to our intellectual property portfolio for BI-505 covering the treatment of relapsed cancer in these important territories,” Michael Oredsson, president and CEO of BioInvent, said in a press release. “BI-505 has the potential to provide a life line to multiple myeloma patients who are no longer responsive to standard of care and who have no other treatments options for this fatal disease.”
BI-505, the company’s lead immuno-oncology product, is being primarily developed to treat multiple myeloma. It is a fully human antibody targeting ICAM-1, an adhesion molecule that is overexpressed in multiple myeloma cells and that has been implicated in disease progression and resistance to chemotherapy. By targeting ICAM-1, BI-505 not only induces the death of the resistant myeloma cells, it also recruits immune cells called macrophages to attack myeloma cells.
Preclinical results have shown that BI-505 significantly enhanced survival and delayed disease onset in experimental models of multiple myeloma, compared to current gold-standard treatments — Velcade (bortezomib), Revlimid (lenalidomide), Alkeran (melphalan), or Decadron (dexametasone). In addition, results from a Phase 1 trial in multiple myeloma patients who were resistant to existing drugs (NCT01025206) showed good safety and signs of a positive effect against the disease.
The agent has been designated an Orphan Drug by both the U.S. Food and Drug Administration (FDA) and the European Medicines Agency (EMA) to advance its evaluation as a treatment for multiple myeloma patients. It is currently being evaluated in combination with high dose Alkeran and autologous stem cell transplantation in a randomized Phase 2 trial (NCT02756728). The trial, taking place in Pennsylvania and currently recruiting patients, started earlier this year and is part of a collaboration between BioInvent and researchers at Penn Medicine. More information is available on the study’s clinical trials.gov webpage, or by clicking on the trial’s identification number above.
In addition to BI-505, BioInvent has two other proprietary antibodies in or close to clinical development: BI-1206, which is currently in Phase 1/2 trial for non-Hodgkin’s lymphoma and chronic lymphocytic leukemia, and TB-403, which will soon enter Phase 1 trials in patients with medulloblastoma or neuroblastoma. These antibodies and respective targets were identified using BioInvent’s platform F.I.R.S.T., designed to allow for simultaneous target and drug discovery.