Orbus Therapeutics Enters Exclusive License Agreement for Intellectual Property Related to Treatment of Rare Pediatric Syndrome with Eflornithine

Eflornithine method for use patent from Michigan State University/Corewell Health® relates to treating patients with rare Bachmann-Bupp Syndrome

PALO ALTO, Calif., Jan. 10, 2023 (GLOBE NEWSWIRE) — Orbus Therapeutics Inc., a private, late-stage biopharmaceutical company focused on the development and commercialization of therapies that treat rare diseases, announced an exclusive license agreement with Michigan State University (MSU) and Helen DeVos Children’s Hospital (HDVCH), part of Corewell Health^® (formerly Spectrum Health), that grants Orbus exclusive rights to intellectual property related to the method of use of eflornithine in the treatment of a novel pediatric condition known as Bachmann-Bupp Syndrome (BABS).

“We are delighted to enter into this agreement with Orbus Therapeutics,” said Anupam Jhingran, Technology Manager with MSU Technologies, the technology transfer office of MSU. “We believe that Orbus Therapeutics’ unique strength in developing new treatment options in the rare disease space and their current clinical development of eflornithine makes them the ideal partner to move this effort forward.”

Orbus Therapeutics is currently conducting a Phase 3 clinical trial, referred to as the STELLAR study, to evaluate its eflornithine oral solution in patients with anaplastic astrocytoma whose cancer has recurred following radiation and adjuvant temozolomide chemotherapy. The company plans to expand its activities to include development and future commercialization of its eflornithine oral solution in BABS in parallel with its ongoing efforts in malignant glioma.

“These children face significant neurological and development hurdles as a result of this gain-of-function mutation,” said Bob Myers, Chief Executive Officer of Orbus. “We have been very impressed by the results of the ongoing work at MSU and HDVCH, and the positive impact that has been seen in the development of these children following treatment with eflornithine.”

About BABS

BABS is a newly recognized autosomal dominant genetic disorder caused by a heterozygous de novo variant in the ornithine decarboxylase 1 (ODC1) gene identified by Drs. André Bachmann, Caleb Bupp and Surender Rajasekaran. ODC1 produces an enzyme that is integral in putrescine biosynthesis, which is involved in cell division. BABS is a rare condition, where a gain-of-function mutation in ODC1 causes an increase in ODC expression and levels of putrescine in patients, that leads to disabling neurodevelopmental deficits. Researchers at MSU and HDVCH have shown that oral delivery of eflornithine improves physical coordination, attention and interaction in patients with BABS.

About Eflornithine
Eflornithine is a novel cytostatic agent that irreversibly inhibits ornithine decarboxylase, a key enzyme in mammalian polyamine biosynthesis that is up-regulated in certain types of cancer.

Eflornithine has been granted Orphan Drug Designation and Breakthrough Therapy Designation for the treatment of patients with anaplastic glioma by the U.S. Food and Drug Administration (FDA), and has also been granted Orphan Medicinal Product status for the treatment of glioma by the Committee for Medicinal Products for Human Use (CHMP) at the European Medicines Agency (EMA).

About Orbus Therapeutics
Orbus Therapeutics Inc. is a late-stage, private biopharmaceutical company that is dedicated to developing products that treat rare diseases for which there are few, if any, effective therapies. The Company’s lead product candidate, eflornithine, is being evaluated in a pivotal Phase 3 clinical trial in patients with recurrent anaplastic astrocytoma, a rare form of central nervous system cancer. For more information, please visit the Company’s website at http://www.orbustherapeutics.com

Source: Orbus Therapeutics, Inc.