PDS Biotech Reports Breakthrough Phase 2 mCRC Results

Princeton, New Jersey, U.S. | April 15, 2026

PDS Biotechnology has announced the publication of positive interim Phase 2 clinical trial data for its tumor-targeted immunotherapy PDS01ADC, demonstrating significantly improved response rates and survival outcomes in metastatic colorectal cancer (mCRC) patients with liver metastases. The findings, published in JCO Oncology Advances, revealed a remarkable 78% objective response rate (ORR) compared to 35% in a parallel study without the therapy, alongside a 2-year survival rate exceeding 80%, highlighting the potential of PDS01ADC to transform treatment in a patient population with historically poor outcomes. This development underscores the growing role of targeted immunocytokine therapies in overcoming resistance to conventional treatments and advancing precision oncology.

Phase 2 Clinical Results Demonstrate Significant Efficacy

The interim results from Stage 1 of the Phase 2 trial evaluated PDS01ADC in combination with hepatic artery infusion pump (HAIP) therapy using floxuridine (FUDR) in patients with microsatellite stable (MSS) or mismatch repair-proficient (pMMR) metastatic colorectal cancer, which represents approximately 95% of mCRC cases and is typically resistant to immune checkpoint inhibitors. The study reported a 77.8% response rate at six months, significantly outperforming existing treatment benchmarks.

Additionally, the therapy demonstrated durable clinical benefit, with median progression-free survival not reached at over 13 months of follow-up, compared to 8.1 months in the parallel study. These findings highlight the therapy’s ability to enhance immune response and improve clinical outcomes in a challenging oncology setting, where treatment options remain limited.

Tumor-Targeted IL-12 Therapy Drives Immune Activation

PDS01ADC is a novel tumor-targeted immunocytokine designed to deliver interleukin-12 (IL-12) directly to tumor sites, enabling localized immune activation while minimizing systemic exposure. The therapy utilizes the NHS76 antibody to bind DNA in necrotic tumor regions, ensuring targeted drug delivery and improved tolerability. This approach promotes the development of stem-like memory T cells, activates natural killer (NK) cells, and inhibits immunosuppressive cells within the tumor microenvironment, resulting in a more robust and sustained anti-tumor response. By combining immune activation with targeted delivery, PDS01ADC represents a next-generation immunotherapy platform capable of addressing tumor resistance mechanisms and improving long-term outcomes.

Addressing Unmet Needs in Metastatic Colorectal Cancer

Metastatic colorectal cancer remains a leading cause of cancer-related mortality worldwide, with limited treatment options for patients who fail first-line therapies. The combination of PDS01ADC with HAIP therapy offers a novel therapeutic strategy that enhances both local and systemic anti-tumor activity, particularly in liver metastases, which are a common site of disease progression.

The strong response rates and survival outcomes observed in the trial suggest that this approach could significantly improve treatment standards and patient prognosis. The study, led by investigators at the National Cancer Institute (NCI), further emphasizes the importance of collaborative clinical research in advancing innovative cancer therapies.

Strategic Implications for Immunotherapy Development

The success of PDS01ADC highlights broader trends in oncology, including the shift toward targeted cytokine therapies and combination treatment strategies. By integrating immunotherapy with established treatment modalities, PDS Biotech is advancing a multimodal approach to cancer care that addresses both tumor biology and immune evasion. The promising interim results support continued clinical development and potential expansion into additional cancer indications, positioning PDS01ADC as a key asset in the company’s pipeline and a potential breakthrough therapy in immuno-oncology.

The publication of positive Phase 2 data for PDS01ADC marks a significant milestone for PDS Biotech and the broader oncology community. With strong efficacy signals, improved survival outcomes, and a novel mechanism of action, the therapy has the potential to reshape treatment paradigms for metastatic colorectal cancer. As clinical development progresses, PDS01ADC may emerge as a transformative immunotherapy, offering new hope for patients with limited treatment options and reinforcing the importance of precision medicine and targeted immune activation in next-generation cancer care.

Source: PDS Biotech press release