PDS Biotech’s stock has jumped nearly 25% after its tumour-targeting fused antibody drug conjugate (ADC) elicited a 78% response in patients with colorectal cancer.
In an investigator-led Phase II study (NCT05286814) of PDS01ADC, there was a 77.8% objective response rate (ORR) as per RECIST v1.1 observed after six months in patients with colorectal cancer and liver metastases. In a parallel trial without PDS01ADC, the ORR was 35%.
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The 24-month survival rate was approximately 85% in patients treated with PDS01ADC, compared with 40% in the parallel trial.
A median extrahepatic progression-free survival (PFS) was not reached at the minimum follow-up of 13.1 months. In the parallel trial without PDS01ADC, the PFS was 8.1 months.
The clinical trial, led by Dr Jonathan Hernandez, MD, Investigator in the Surgical Oncology Program at the National Cancer Institute (NCI), part of the National Institutes of Health (NIH), combined subcutaneous injection of PDS01ADC with floxuridine (FUDR), delivered via a hepatic artery infusion pump (HAIP). The trial enrolled patients previously treated with at least one line of chemotherapy, who had failed prior treatment.
The data has caused PDS Biotech’s stock to rise 23.4% from a market open of $1.07 to a high of $1.32 (correct at 11.30am EST) on 15 April.
Dr Frank Bedu-Addo, CEO of PDS Biotech, said: “Despite many meaningful advances in oncology, metastatic colorectal cancer remains an area of significant unmet need. These early results showing strong tumour response rates and promising patient survival are encouraging and support our approach of subcutaneously administering PDS01ADC to activate the immune system against the cancer. We believe these findings represent a meaningful step toward more precise immune-based treatments without the significant side effects that have historically limited traditional recombinant cytokine therapies.”
PDS01ADC is a tumour-targeted immunocytokine designed to deliver Interleukin-12 (IL-12), a potent immune-activating agent, directly to the tumour while minimising exposure to the rest of the body.
At the 2025 European Society of Medical Oncology (ESMO) congress, Merck KGaA’s antibody-drug conjugate (ADC), precemtabart tocentecan (Precem-TcT), showed promising efficacy during an early-stage trial in heavily pre-treated colorectal cancer. In the Phase I PROCEADE-CRC-01 study (NCT05464030), the drug triggered an objective response rate (ORR) of 31% in patients at a dose of 2.8mg/kg.
Earlier in 2025, Pfizer’s metastatic colorectal cancer combination therapy improved PFS in a Phase III trial. The combination includes Pfizer’s Braftovi (encorafenib), Eli Lilly’s Erbitux (cetuximab) and mFOLFOX6 (fluorouracil, leucovorin and oxaliplatin).
Colorectal cancer is the third most common cancer globally, with nearly two million new incident cases being diagnosed and 900,000 deaths associated with the disease every year. Of these global cases, 10% will have a BRAF V600E gene mutation implicated in carcinogenesis pathways and have a poor prognosis compared to other subtypes of CRC, such as KRAS mutations.
