NEOK Bio Receives Approval for NEOK001 Bispecific ADC in Solid Tumours
Thursday, January 22, 2026
NEOK Bio has received approval from the US Food and Drug Administration (FDA) for its Investigational New Drug (IND) application for NEOK001.
Antibody–drug conjugates (ADCs) are targeted cancer therapies that combine a monoclonal antibody with a potent anti-cancer drug. The antibody guides the drug directly to cancer cells by recognising specific proteins on their surface, helping to reduce damage to healthy tissue.
In solid tumours, ADCs are gaining increasing attention due to their ability to deliver treatment more precisely in cancers such as breast, lung, ovarian and gastrointestinal tumours. Advances in linker technology, payload design and multi-target approaches are expanding the potential of ADCs to address tumour resistance and improve treatment outcomes.
NEOK001 is a first-in-class bispecific antibody–drug conjugate (ADC) designed to target the B7-H3 and ROR1 proteins, which are commonly found on the surface of cancer cells. The therapy delivers a topoisomerase I inhibitor payload using a specialised linker. Preclinical studies showed stronger anti-tumour activity in solid tumour models when compared with conventional single-target ADCs.
The clearance allows the company to begin a Phase 1 clinical trial in patients with solid tumours.
NEOK001 is a first-in-class bispecific antibody–drug conjugate (ADC) designed to target the B7-H3 and ROR1 proteins, which are commonly found on the surface of cancer cells. The therapy delivers a topoisomerase I inhibitor payload using a specialised linker. Preclinical studies showed stronger anti-tumour activity in solid tumour models when compared with conventional single-target ADCs.
With IND approval secured, NEOK Bio plans to start dosing patients in the coming months. Initial clinical data from the Phase 1 study are expected to be reported in 2027.
The company was established with the support of ABL Bio, a specialist in antibody engineering. NEOK001 is the first candidate from NEOK Bio’s pipeline to enter clinical development and reflects its focus on advancing next-generation bispecific ADCs for cancer treatment.
Source: neokbio.com
