RARE Daily

Orbus Raises $38.5 Million to Advance Rare Brain Cancer Therapy

October 23, 2020

Rare Daily Staff

Orbus Therapeutics said it has closed an expansion of its series A financing at $71 million to advance its late stage therapy for a rare brain cancer.

Abingworth joined existing series A investors led by Longitude Capital, H.I.G. BioVentures and Adams Street Partners. The expanded $71 million series A includes an initial financing of $32.5 million in 2015.

Proceeds will support the ongoing STELLAR study, a phase 3 clinical trial studying eflornithine in patients with anaplastic astrocytoma whose cancer has recurred following radiation and adjuvant chemotherapy. Orbus is also planning to initiate additional clinical studies to study eflornithine in patients suffering from other forms of malignant gliomas.

Several brain tumor types are grouped together under the name glioma which originates in the glial cells that surround and support neurons in the brain. In the United States, greater than 3,600 new cases of anaplastic glioma, one of two categories of malignant glioma, are diagnosed each year with a median survival of just more than three years despite treatment with surgery, radiation and chemotherapy. Anaplastic astrocytoma is the largest subset of anaplastic glioma, and represents approximately 75 percent of anaplastic glioma patients. Anaplastic astrocytomas typically require aggressive treatment and, due to tentacle-like projections that grow into surrounding tissue, are difficult to completely remove during surgery.

“Despite treatment with surgery, radiation and chemotherapy, patients with recurrent anaplastic astrocytoma are still in need of therapies that lead to longer survival,” said Bob Myers, co-founder and CEO of Orbus, “and we are hopeful that the STELLAR study will demonstrate a clinically meaningful improvement over existing therapy.”

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. In controlled, randomized and single arm clinical studies, eflornithine has shown an increase in overall survival of patients with newly diagnosed or recurrent anaplastic astrocytoma. It has been granted Orphan Drug and Breakthrough Therapy designations for the treatment of patients with anaplastic glioma in the United States, and Orphan Medicinal Product status in the for the treatment of glioma in the European Union.

The STELLAR study, a phase 3, randomized, open-label study is designed to evaluate the efficacy and safety profile of eflornithine in combination with lomustine compared to lomustine alone in patients with anaplastic astrocytoma that recurs after surgery, irradiation and adjuvant temozolomide chemotherapy.

Orbus plans to enroll approximately 340 patients into the STELLAR study. The primary efficacy endpoint in the STELLAR study is the duration of overall survival (OS). Secondary pre-specified efficacy endpoints include OS in isocitrate dehydrogenase (IDH) mutant and wild type sub-populations, progression free survival (PFS) and objective response rate (ORR).

The company plans to conduct prespecified interim analysis for superiority in the STELLAR study in late 2021, as well as initiate new clinical studies with eflornithine

Photo: Bob Myers, co-founder and CEO of Orbus

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