NEOK Bio Secures FDA IND Clearance for NEOK002, a Novel EGFR/MUC1 Bispecific ADC for Treatment of Solid Tumors

• Second candidate in NEOK’s differentiated ADC pipeline to enter the clinic in 2026
• Company plans to initiate a Phase 1 clinical study for NEOK002 in 2Q2026 and share data in 2027​

BURLINGAME, Calif.--(BUSINESS WIRE)--NEOK Bio, Inc., an oncology therapeutics company focused on the development of novel antibody drug conjugates (ADCs) for improving outcomes for cancer patients, today announced 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.

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.”

About NEOK Bio

NEOK Bio is an oncology therapeutics company focused on developing novel antibody drug conjugates (ADCs) designed to improve outcomes for cancer patients. NEOK is rapidly advancing bispecific ADCs, which represent a cutting-edge advancement, leveraging bispecific antibodies that target two complementary antigens, potentially improving safety while enhancing efficacy of ADCs in a wider range of tumors. Backed by ABL Bio, a proven leader in antibody engineering, NEOK plans to initiate clinical studies for its two lead bispecific ADC candidates in solid tumor indications in the first half of 2026.