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NEOK Bio Initiates Phase 1 Clinical Trials of Both Lead Bispecific ADCs

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  • First patients dosed in Phase 1 clinical trials of NEOK001 and NEOK002, bispecific ADCs targeting difficult-to-treat solid tumor cancers
  • Initiation of the Phase 1 studies represents NEOK's transition to a clinical stage company
  • Initial clinical data readouts from both trials are anticipated in 2027

NEOK Bio, Inc., a clinical-stage oncology therapeutics company focused on the development of novel antibody drug conjugates (ADCs), today announced that the first patients have been dosed in each of the Phase 1 clinical trials for its lead bispecific ADC candidates, NEOK001 and NEOK002, being developed for the treatment of advanced solid tumors.

NEOK001 is a first-in-class bispecific ADC designed to target B7-H3 and ROR1, two surface proteins highly expressed in cancer cells. NEOK002 is a novel bispecific ADC targeting EGFR epidermal growth factor receptor (EGFR) and MUC1 (Mucin 1)-expressing solid tumors. Each Phase 1 study is evaluating the safety, tolerability, and efficacy of these candidates in patients with cancers that co-express these targets. Both candidates enter the clinic on a foundation of promising preclinical studies in which they have demonstrated superior in vivo efficacy in solid tumors compared to traditional monovalent ADCs.

“Advancing two ADC programs from preclinical development to first-in-human dosing in such a short time underscores the operational efficiency and execution capabilities of our team,” said Mayank Gandhi, MD, CEO of NEOK Bio. “Our novel bispecific ADC approach holds significant promise for unlocking new therapeutic value for patients with hard-to-treat solid tumors who need more effective treatment options.”

Initial clinical data from both Phase 1 studies are expected in 2027.

About NEOK Bio

NEOK Bio is a clinical-stage 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. NEOK Bio is backed by ABL Bio, a proven leader in antibody engineering.

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