NEOK Bio's Dual-Target ADCs Enter Human Trials for Advanced Cancers

BURLINGAME, CA – May 27, 2026 – In a significant step forward for oncology, clinical-stage therapeutics company NEOK Bio announced today that it has begun dosing patients in Phase 1 clinical trials for two of its lead drug candidates. The studies will evaluate NEOK001 and NEOK002, a new class of cancer drugs known as bispecific antibody-drug conjugates (ADCs), for the treatment of advanced solid tumors.

The initiation of these first-in-human trials marks a critical milestone for the company and a moment of potential new hope for patients battling cancers that have exhausted conventional treatment options. Both candidates are built on a novel therapeutic platform designed to attack cancer cells with greater precision and power than existing targeted therapies.

A New Generation of "Smart Bombs"

At the heart of NEOK Bio's strategy is the advancement of antibody-drug conjugates, a class of therapies often described as biological "smart bombs" or "Trojan Horses." Traditional ADCs link a potent cytotoxic drug (the payload) to a monoclonal antibody that is engineered to seek out a specific protein, or antigen, found on the surface of cancer cells. This allows for the direct delivery of a powerful toxin to the tumor while minimizing damage to healthy surrounding tissue.

However, NEOK Bio is pushing this concept into its next generation with bispecific ADCs. While conventional ADCs recognize a single target, NEOK's candidates are designed to bind to two distinct antigens simultaneously. This dual-targeting approach aims to overcome key limitations that have challenged first-generation ADCs.

One of the most significant challenges in cancer treatment is tumor heterogeneity—the reality that not all cells within a single tumor are identical. Some cells may have high levels of a target antigen, while others have low or no expression. A single-target ADC might successfully kill one subpopulation of cells but leave others untouched, allowing the cancer to survive and regrow, often in a more resistant form. By requiring the presence of two different targets, bispecific ADCs can achieve greater tumor coverage and reduce the chance of such "antigen escape." Furthermore, this dual engagement can trigger more efficient internalization of the ADC into the cancer cell, ensuring the cytotoxic payload reaches its destination more effectively. This enhanced selectivity could also improve the therapy's safety profile by reducing uptake in healthy tissues that may express only one of the two target antigens.

Targeting Cancer's Key Vulnerabilities

The specific targets chosen for NEOK Bio's two candidates are well-known drivers of tumor growth and are associated with poor prognoses across a range of hard-to-treat solid tumors.

NEOK001 is a first-in-class bispecific ADC that targets B7-H3 and ROR1. B7-H3 is an immune checkpoint protein highly expressed in numerous cancers—including lung, breast, and prostate—but has limited presence in normal tissues, making it an ideal therapeutic target. High B7-H3 levels are often linked to metastasis and resistance to other therapies. ROR1 is an oncofetal antigen, meaning it is present during fetal development, disappears in adults, but reappears in many cancers. Its expression is correlated with tumor proliferation and shorter survival rates in cancers like triple-negative breast cancer and lung adenocarcinoma. By targeting both, NEOK001 aims to cast a wider net to capture and destroy tumor cells that might evade a single-target therapy.

The company's second candidate, NEOK002, targets EGFR and MUC1. The Epidermal Growth Factor Receptor (EGFR) is one of the most well-established oncogenic drivers, and its overexpression fuels the growth of many solid tumors, including colorectal and head and neck cancers. While numerous EGFR inhibitors exist, resistance is a common and significant clinical problem. MUC1 is a protein that is abnormally expressed and overproduced in a wide array of epithelial cancers, where it plays a role in tumor invasion and metastasis. By combining an attack on the well-known EGFR pathway with a second attack on MUC1, NEOK002 is designed to create a potent synergistic effect and potentially overcome established resistance mechanisms.

Strategic Execution in a Competitive Market

The advancement of two candidates into the clinic simultaneously is a bold and strategic move, positioning NEOK Bio as a serious contender in the rapidly expanding ADC market. The global market for antibody-drug conjugates was valued at over $12 billion in 2024 and is projected by some analysts to exceed $36 billion by the end of the decade, fueled by major acquisitions and intense research and development.

This rapid progress is largely enabled by NEOK Bio's relationship with its parent company, ABL Bio, a South Korean leader in bispecific antibody engineering. NEOK Bio was established as a U.S. subsidiary to spearhead global clinical development and commercialization, emerging with $75 million in Series A financing led by ABL Bio. This backing provides not only substantial capital but also the core technological foundation for its drug candidates. Both NEOK001 and NEOK002 utilize ABL Bio’s proprietary "Grabody" bispecific antibody platform and a potent topoisomerase I inhibitor payload, a combination designed for enhanced tumor selectivity and stability.

While the ADC field is competitive, with many companies developing drugs against these same targets, NEOK's bispecific approach remains a key differentiator. Most competing programs are monospecific, leaving them potentially vulnerable to the challenges of tumor heterogeneity and antigen escape that NEOK's platform was specifically designed to address.

The Path Forward: From Lab to Clinic

The ongoing Phase 1 trials for NEOK001 and NEOK002 are designed to primarily assess the safety, tolerability, and appropriate dosage of the new drugs in patients with advanced solid tumors that co-express the target antigens. These studies will also gather preliminary data on efficacy. The company's move into human trials is supported by a foundation of robust preclinical studies, which demonstrated superior tumor-killing efficacy in animal models compared to traditional single-target 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, in a statement. “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.”

While the journey through clinical development is long and uncertain, the initiation of these trials represents a tangible advancement. NEOK Bio anticipates releasing initial clinical data from both Phase 1 studies in 2027. For patients and clinicians grappling with the complexities of advanced cancer, the arrival of this dual-targeting strategy in the clinic offers a new and scientifically compelling avenue of investigation in the ongoing fight against the disease.