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PDS Halts Phase 3 Head and Neck Therapy to Focus on Colorectal Program

on August 13, 2026

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PDS Biotechnology has halted its Phase 3 head and neck cancer therapy (PDS0101, VERSATILE-003 trial) to redirect resources toward its colorectal cancer program, PDS0301/PDS01ADC, citing strong Phase 2 data in metastatic colorectal cancer with liver metastases.

Stage 1 of the NCI-led Phase 2 trial for PDS01ADC in metastatic, microsatellite stable, mismatch repair–proficient colorectal cancer showed a 77.8% objective response rate at 6 months and an ~85% 24‑month survival rate, significantly outperforming the control arm without PDS01ADC.

The company is now prioritizing PDS0301 as its lead asset in colorectal cancer, designing a randomized Phase 2b trial with FDA input and aiming to generate meaningful data over the next 18–24 months, while seeking strategic partnerships or external funding to continue PDS0101 development.

Sources:

PDS halts ph. 3 cancer therapy to focus on colorectal contender

PDS Biotechnology Refocuses on PDS0301, Ends Internal ...

PDS Biotechnology Halts PDS0101 Trial, Pivots to PDS0301 in ...

Strategiewechsel bei PDS Biotechnology: Phase-3-Studie gestoppt, Fokus auf PDS0301 Von Investing.com

PDS Biotechnology (PDSB) halts PDS0101 Phase 3, pivots ...

PDS Biotechnology prioritizes PDS0301 after Phase 2 mCRC data, halts internal PDS0101 Phase 3 spend

PDS Biotech Announces Publication of Positive PDS01ADC Interim ...

PDS Biotech Announces Interim 24-Month Survival Rate of 74% in ...

PDS Biotech Announces FDA Clearance of IND Application for ...

FDA Clears PDS Biotech's Novel Immunotherapy Combination for ...

PDS Biotech trial reports 77.8% response in colorectal cancer

PDS Biotech Reports First Quarter 2026 Financial Results

PDS Biotech Announces Colorectal Cancer Cohort of Phase 2 Clinical Trial with PDS01ADC Met Criteria for Expansion to Stage 2 Following Positive Stage 1 Results

On Our Radar: August 2026 Clinical Trials Roundup

PDS Biotech Reports Promising Metastatic Colorectal Cancer Trial ...

Biotechnology Clinical Trials colorectal contender immunocytokine interleukin-12 Metastasis from malignant neoplasm of colon and/or rectum PDS0101 PDS01ADC PDS0301 Pendred's syndrome

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