ABL Bio (298380.KQ) announced Wednesday that its partner Compass Therapeutics has received orphan drug designation from the U.S. Food and Drug Administration for tobesimig (ABL001), a bispecific antibody drug for bile duct cancer currently under development.
Orphan drug designation typically grants seven years of market exclusivity. The designation also provides benefits including tax credits, partial exemption from FDA review fees, clinical trial grants, and regulatory development support, creating a favorable environment for commercialization and approval processes.
ABL Bio developed tobesimig and licensed global rights to Compass Therapeutics in 2018. The drug is currently in Phase 2/3 clinical trials for second-line treatment of bile duct cancer patients. Upon commercialization, ABL Bio will receive milestone payments and royalties from sales.