On March 2, 2026 NEOK Bio, Inc., an oncology therapeutics company focused on the development of novel antibody drug conjugates (ADCs) for improving outcomes for cancer patients, reported that the U.S. Food and Drug Administration (FDA) approved the Investigational New Drug (IND) application for NEOK002, a bispecific ADC targeting epidermal growth factor receptor (EGFR) and Mucin 1 (MUC)-expressing solid tumors.

Schedule your 30 min Free 1stOncology Demo!
Discover why more than 1,500 members use 1stOncology™ to excel in:

Early/Late Stage Pipeline Development - Target Scouting - Clinical Biomarkers - Indication Selection & Expansion - BD&L Contacts - Conference Reports - Combinatorial Drug Settings - Companion Diagnostics - Drug Repositioning - First-in-class Analysis - Competitive Analysis - Deals & Licensing

                  Schedule Your 30 min Free Demo!

NEOK002 is the company’s second ADC to enter clinical development this year, closely following the FDA IND clearance of NEOK001, a first-in-class B7-H3/ROR1 bispecific ADC for the treatment of solid tumors.

As a bispecific ADC targeting EGFR and MUC1, NEOK002 offers potential for enhanced efficacy and safety against competitive, monovalent ADCs that only target EGFR or MUC1 singularly. The Phase 1 study will focus on evaluating its potential to address significant unmet needs for patients with cancers that co-express these targets.

"Securing our second IND clearance in just six weeks highlights the team’s productivity and dedication, and positions NEOK with strong momentum as we advance toward our clinical milestones," said Mayank Gandhi, CEO of NEOK Bio. "Our bispecific ADCs are designed to improve the therapeutic window of ADCs and have the potential to target a wider range of tumors, overcome drug resistance, increase internalization rates, and improve the safety profile by increasing selectivity and reducing off-tumor toxicity."

(Press release, Neok Bio, MAR 2, 2026, View Source [SID1234663195])