On August 13, 2026 Baylink Biosciences, Inc. ("Baylink"), a biotechnology company focused on developing next-generation antibody-drug conjugates (ADCs) for the treatment of solid tumors, reported that the U.S. Food and Drug Administration (FDA) has cleared the Investigational New Drug (IND) application for BLB101, a novel CLDN6/CLDN9 dual-targeting ADC for the treatment of patients with advanced solid tumors.
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BLB101 is Baylink’s lead ADC program and is designed to selectively deliver the highly potent topoisomerase I inhibitor Exatecan to tumor cells expressing CLDN6 and/or CLDN9. The molecule incorporates Baylink’s proprietary BL001 hydrophilic cleavable linker. It uses cysteine-maleimide conjugation approach with a drug-to-antibody ratio (DAR) of 8.
"FDA clearance of the BLB101 IND is an important milestone for Baylink and validates the progress of our ADC development platform," said Alice Chen, CSO of Baylink Biosciences. "BLB101 represents our differentiated approach to ADC development, combining dual CLDN6/CLDN9 targeting, a TOP1 inhibitor payload that is insensitive to efflux pump, and our proprietary hydrophilic linker technology. We look forward to advancing BLB101 into clinical development and evaluating its potential to provide a new treatment option for patients with advanced solid tumors."
Designed for Broader Tumor Targeting
CLDN6 is a tight-junction protein with highly restricted expression in most normal adult tissues and aberrant expression in some solid tumors. CLDN9, a closely related Claudin family member, is also expressed in a range of solid tumors and may provide complementary tumor coverage.
BLB101 incorporates Baylink’s proprietary 2D5S antibody, which binds both CLDN6 and CLDN9. This dual-targeting strategy is designed to expand the potential patient population and address tumor heterogeneity associated with expression of individual tumor antigens.
Preclinical studies have demonstrated specific binding to CLDN6 and CLDN9, internalization of BLB101 into target-positive tumor cells, and potent cytotoxic activity in relevant tumor models.
Exatecan Payload and Proprietary BL001 Linker
BLB101 uses Exatecan, a highly potent Topoisomerase I inhibitor that is insensitive to efflux pump, as its cytotoxic payload. Following internalization and intracellular processing of the ADC, Exatecan is released and induces DNA damage through stabilization of the TOP1-DNA cleavage complex, ultimately leading to tumor cell death.
Baylink’s proprietary BL001 linker was designed to improve the overall physicochemical properties and stability of high-DAR ADCs while supporting efficient intracellular payload release. BL001 incorporates hydrophilic structural elements and a cleavable Val-Ala sequence and supports a high drug-to-antibody ratio of 8. BL001 linker was also designed to reduce non-specific internalization by non-cancer cells which is expected to further reduce side effects.
Advancing Toward Clinical Proof of Concept
Baylink has completed key preclinical, CMC, and IND-enabling activities for BLB101, including GLP toxicology studies, pharmacokinetic and toxicokinetic characterization, analytical development, drug substance and drug product manufacturing, formulation development, and stability studies.
The FDA clearance of the BLB101 IND enables Baylink to initiate clinical development of BLB101 in patients with advanced solid tumors.
"The IND clearance is the result of the tremendous effort of the Baylink team," said Patrick Zweider-McKay, MD/PhD, Baylink’s Clinical Advisor. "We are excited to bring this program into the clinic and generate clinical data that will help determine the therapeutic potential of CLDN6/CLDN9 dual targeting."
(Press release, Baylink Biosciences, AUG 13, 2026, View Source [SID1234670159])