US WorldMeds Ventures has acquired Orbus Therapeutics, adding a late-stage investigational therapy for recurrent Grade 3 astrocytoma to its rare-disease pharmaceutical portfolio. Orbus is now a wholly owned subsidiary of US WorldMeds.
The transaction includes an upfront payment to Orbus as well as potential development, regulatory, and sales milestone payments and tiered royalties on future U.S. net sales.
Orbus has been developing oral eflornithine, also known as DFMO, for rare and serious malignant brain tumors.
Eflornithine inhibits ornithine decarboxylase, an enzyme involved in cellular proliferation that can be elevated in certain cancers.
Orbus advanced the drug through the Phase 3 STELLAR clinical study in recurrent Grade 3 astrocytoma. The FDA previously granted Breakthrough Therapy designation to the program for anaplastic astrocytoma.
The STELLAR trial enrolled 343 patients and compared eflornithine plus lomustine with lomustine alone.
The study did not show an overall survival benefit in the full intent-to-treat population, which was its primary endpoint.
However, a prespecified subset analysis based on updated 2021 World Health Organization tumor classifications evaluated 196 patients with IDH-mutant Grade 3 astrocytoma.
Within that subgroup, median overall survival reached 34.9 months for patients receiving eflornithine plus lomustine compared with 23.5 months for lomustine alone.
Median progression-free survival was 15.8 months compared with 7.2 months.
US WorldMeds already markets eflornithine tablets under the IWILFIN brand for a separate rare oncology indication, giving the company existing development and commercialization experience with the molecule.
US WorldMeds plans to evaluate potential regulatory and development pathways for eflornithine in recurrent IDH-mutant Grade 3 astrocytoma and other adult malignant gliomas.
KEY QUOTES:
“Orbus has built a strong scientific and clinical foundation for eflornithine. US WorldMeds brings the development expertise, commercial infrastructure and commitment to patients needed to advance the program.”
Jason Levin, Former President And CEO Of Orbus Therapeutics
“The science and clinical results supporting eflornithine make this an especially exciting opportunity for US WorldMeds. We have built our company around bringing meaningful therapies to patients affected by difficult-to-treat and underserved diseases.”
“This transaction is an opportunity to build on Orbus’ work and responsibly evaluate eflornithine’s potential in adult malignant glioma.”
P. Breckinridge Jones, CEO Of US WorldMeds
