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Investing.com - PDS Biotechnology Corp (NASDAQ:PDSB), currently valued at $59.4 million, has completed patient recruitment for Stage 1 of a clinical trial evaluating its PDS01ADC therapeutic in metastatic colorectal cancer (mCRC), meeting criteria to expand into Stage 2. According to InvestingPro data, the company maintains a strong liquidity position with cash reserves exceeding debt levels.
The trial is testing PDS01ADC, an IL-12 fused antibody drug conjugate, administered systemically in combination with floxuridine (FUDR) delivered by hepatic artery infusion pump for mCRC patients. The study met pre-set RECIST v1.1 criteria for expansion, with at least 6 of 9 participants experiencing an objective response.
PDS01ADC was designed to enhance T cell proliferation, potency and longevity in the tumor microenvironment while improving upon the safety profile of traditional IL-12 based therapies. The therapy is currently being evaluated in three ongoing Phase 2 studies led by the National Cancer Institute as part of a collaborative research agreement.
The open-label, single-center, non-randomized Phase 2 study includes three cohorts: mCRC, cholangiocarcinoma, and adrenocortical cancer. While the mCRC cohort advances to Stage 2, the other two cohorts continue to enroll in Stage 1.
H.C. Wainwright reiterated a Buy rating and $13.00 price target on PDS Biotechnology, with the company anticipating enrollment completion for the mCRC cohort by 4Q25. The stock currently trades at $1.30, with analyst targets ranging from $4.50 to $13.00, suggesting significant potential upside according to Wall Street consensus. The company’s next earnings report is scheduled for August 13, 2025.
In other recent news, PDS Biotechnology Corporation has announced significant advancements in its clinical trials. The company reported that its trial for metastatic colorectal cancer treatment met the criteria for expansion into Stage 2, with patient recruitment completed for Stage 1. Concurrently, PDS Biotech has expanded its 2014 Equity Incentive Plan, allowing for an additional 3,144,049 shares, following approval at the company’s annual meeting. Additionally, the firm disclosed new data from its Phase 3 VERSATILE-003 trial, revealing a median overall survival of 30.0 months for patients with HPV16-positive head and neck squamous cell carcinoma. H.C. Wainwright analysts maintained a Buy rating for PDS Biotechnology, citing encouraging results from the Phase 2 VERSATILE-002 trial. The trial demonstrated improved survival outcomes when combining PDS Biotech’s immunotherapy with pembrolizumab, compared to pembrolizumab alone. Furthermore, PDS Biotech’s recent 8-K filing confirmed the election of two Class A directors and the ratification of KPMG US LLP as the independent accounting firm. The company’s strategic developments and trial results highlight its ongoing efforts in advancing cancer treatments.
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