ABL Bio (298380.KQ) is drawing heightened investor attention after U.S. biotech firm Denali Therapeutics won FDA approval for the first drug applying blood-brain barrier (BBB) shuttle technology. The approval marks the first time the FDA has cleared a medicine using BBB penetration technology, making it a landmark event for the field.
Mirae Asset Securities noted in a report on Monday the potential for a revaluation of ABL Bio's Grabody-B platform following the commercial validation of BBB shuttle technology. The brokerage rated Grabody-B's target, insulin-like growth factor 1 receptor (IGF1R), as more competitive than Denali's core transferrin receptor (TfR) technology. IGF1R was assessed as superior in terms of brain expression levels, aging stability, anemia and hematotoxicity risk, and diversity of BBB penetration pathways.
ABL Bio has secured technology licensing deals worth more than 9 trillion won ($6.6 billion) related to Grabody-B to date. "This approval is expected to further increase the likelihood of big pharma investment in BBB shuttle platforms," Mirae Asset Securities analyst Kim Seung-min said. "Grabody-B possesses a differentiated safety and brain-specificity profile, which could strengthen its positioning as a next-generation BBB shuttle that addresses the limitations of TfR-based platforms," Kim added.
iM Securities analyst Jeong Jae-won also highlighted the significance of the FDA's first commercial approval for a biologic that crosses the blood-brain barrier in a report published Tuesday. "This approval will boost short-term interest in domestic companies that are developing candidate substances with a BBB-crossing concept or that possess such platforms," Jeong said.
Meanwhile, ABL Bio is set to release Phase 2/3 data for its first biliary tract cancer treatment in April. Kim emphasized that this would serve as a critical juncture to simultaneously demonstrate the value of BBB shuttle technology and the clinical potential of the company's bispecific antibody pipeline.
