PDS Biotech Announces Presentation of Preliminary Results from Phase 2 Study of IL-12 Tumor Targeted Immunocytokine (PDS01ADC) in 3rd Line Metastatic Castration Resistant Prostate Cancer by the NCI
Rhea-AI Summary
PDS Biotech (Nasdaq: PDSB) reported NCI-led Phase 2 results for its IL-12 tumor-targeted immunocytokine PDS01ADC combined with docetaxel in 3rd-line metastatic castration-resistant prostate cancer (mCRPC).
Results presented Jan 20–22, 2026 at AACR showed median PFS 9.6 months (range 4.3–32.2) and a median PSA decline of 40%, with 6 of 16 patients achieving >50% PSA decline.
Positive
- Median PFS 9.6 months in treated mCRPC patients
- Median PSA decline 40%, signaling tumor activity
- 6 of 16 patients achieved >50% PSA decline
Negative
- Small effective sample size indicated by 16 patients
- Wide PFS range (4.3–32.2 months) shows high variability
- Preliminary, non‑regulatory data presented at a conference, not definitive
News Market Reaction
On the day this news was published, PDSB gained 1.03%, reflecting a mild positive market reaction. Argus tracked a peak move of +9.8% during that session. Argus tracked a trough of -13.3% from its starting point during tracking. Our momentum scanner triggered 11 alerts that day, indicating notable trading interest and price volatility. This price movement added approximately $560K to the company's valuation, bringing the market cap to $55M at that time.
Data tracked by StockTitan Argus on the day of publication.
Key Figures
Market Reality Check
Peers on Argus
PDSB showed a -0.33% move while only one close peer (MAIA) appeared on momentum scanners, up about 5.08%. Other biotech peers had mixed single‑stock moves, suggesting today’s setup is more company-specific than part of a broad sector swing.
Previous Clinical trial Reports
| Date | Event | Sentiment | Move | Catalyst |
|---|---|---|---|---|
| Jan 09 | PFS endpoint alignment | Positive | +7.7% | FDA alignment on using PFS as primary endpoint for VERSATILE-003. |
| Aug 25 | Phase 2 survival data | Positive | +9.2% | Final VERSATILE-002 data showed strong median overall survival vs standard. |
| Jul 10 | PDS01ADC colorectal data | Positive | -1.5% | PDS01ADC colorectal cohort met criteria to expand Phase 2 trial to Stage 2. |
| Apr 08 | AACR data presentation | Positive | -2.9% | Announcement of upcoming AACR presentation on PDS01ADC immune response data. |
| Mar 07 | Phase 3 trial start | Positive | -8.2% | Initiation of VERSATILE-003 Phase 3 trial in HPV16-positive head and neck cancer. |
Clinical updates often move the stock, but reactions have been mixed, with several positive trial headlines followed by negative price moves.
Over the past year, PDS Biotech has issued multiple clinical trial updates across PDS0101 and PDS01ADC. Events such as the VERSATILE‑002 Phase 2 survival data on Aug 25, 2025 and FDA alignment on PFS as a primary endpoint on Jan 9, 2026 produced generally positive price reactions. Other PDS01ADC-focused updates, including AACR presentations and cohort expansion, sometimes coincided with declines, underscoring inconsistent trading responses to otherwise constructive data.
Historical Comparison
Across 5 prior clinical trial headlines, PDSB’s average one-day move was about 5.92%, with both strong gains and notable selloffs, indicating volatile but inconsistent reactions to trial news.
Clinical updates trace a path from initiating the VERSATILE-003 Phase 3 trial through positive VERSATILE-002 survival data, while NCI-led PDS01ADC programs advance across multiple solid tumor settings.
Regulatory & Risk Context
On Aug 29, 2025, PDSB filed a Form S-3 shelf to offer up to $200.0 million in securities, including a separate prospectus for up to $20.0 million of common stock and an additional at-the-market program of up to $50.0 million, of which $5.7 million has been sold. The shelf is active but not yet effective and has been used once via a Nov 12, 2025 prospectus supplement.
Market Pulse Summary
This announcement highlights preliminary Phase 2 results for PDS01ADC in 3rd line metastatic castration-resistant prostate cancer, with median PFS of 9.6 months and a median PSA decline of 40%. It extends an ongoing pattern of clinical progress alongside earlier VERSATILE-002 and VERSATILE-003 updates. At the same time, prior filings detail substantial financing needs and an active $200.0 million shelf, making future capital-raising and program execution key metrics to monitor.
Key Terms
progression-free survival medical
metastatic castration-resistant prostate cancer medical
interleukin-12 medical
antibody drug conjugate medical
tumor microenvironment medical
natural killer (NK) cell medical
AI-generated analysis. Not financial advice.
NCI-Led Study Shows Median PFS of 9.6 Months
Results Presented at AACR Special Conference on Innovations in Prostate Cancer
PRINCETON, N.J., Jan. 28, 2026 (GLOBE NEWSWIRE) -- PDS Biotechnology Corporation (Nasdaq: PDSB) (“PDS Biotech” or the “Company”), a late-stage immunotherapy company focused on transforming how the immune system targets and kills cancers, today announced that results of a National Cancer Institute (“NCI”)-led study of the Company’s investigational Interleukin-12 (IL-12) tumor targeted immunocytokine, PDS01ADC, were presented at the American Association of Cancer Research (“AACR”) special conference on prostate cancer research, held in Boston, MA on January 20-22, 2026.
The study, titled Docetaxel and the Tumor-Targeting Interleukin-12 (“IL-12”) PDS01ADC in Patients with Metastatic Castration-Resistant Prostate Cancer (“mCRPC”), was presented by Melissa Abel, MD., Assistant Research Physician, Genitourinary Malignancies Branch, Center for Cancer Research, at the NCI, part of the National Institutes of Health (“NIH”). The clinical study is being done to evaluate the ability of PDS01ADC to enhance responses to docetaxel in advanced prostate cancer, based on the potential synergy of PDS01ADC with the necrosis inducing chemotherapeutic agent. The study was performed in advanced cancer patients, the majority of whom had failed 2nd line treatment with androgen deprivation therapy and an androgen pathway inhibitor (ARPI), and therefore had few remaining treatment options (3rd line). Results showed median progression-free survival (“PFS”) of 9.6 months (range: 4.3–32.2 months) for the combination therapy in mCRPC patients. Additionally, a promising median PSA decline of
"These findings reinforce the potential of our tumor-targeting IL-12 immunocytokine to enhance the efficacy of existing therapies across multiple solid tumor types," said Frank Bedu-Addo, PhD, President and Chief Executive Officer of PDS Biotech. "We are encouraged by the progression-free survival and PSA declines observed in this difficult-to-treat population and remain focused on advancing PDS01ADC as a key component of our immuno-oncology pipeline."
PDS01ADC is a fused IL-12 antibody drug conjugate designed using an antibody that binds to necrotic DNA found within tumors. This enables targeted delivery of IL-12 into the tumor microenvironment, suppressing the tumor's ability to evade the immune response while promoting T cell and Natural Killer (NK) cell infiltration and activation within the tumor.
About PDS Biotechnology
PDS Biotechnology is a late-stage immunotherapy company focused on transforming how the immune system targets and kills cancers. The Company has initiated a pivotal clinical trial to advance its lead program in advanced HPV16-positive head and neck squamous cell cancers. PDS Biotech’s lead investigational targeted immunotherapy PDS0101 (Versamune® HPV) is being developed in combination with a standard-of-care immune checkpoint inhibitor, and in a triple combination including PDS01ADC, an IL-12 fused antibody drug conjugate (ADC), and a standard-of-care immune checkpoint inhibitor.
For more information, please visit www.pdsbiotech.com
Forward Looking Statements
This communication contains forward-looking statements (including within the meaning of Section 21E of the United States Securities Exchange Act of 1934, as amended, and Section 27A of the United States Securities Act of 1933, as amended) concerning PDS Biotechnology Corporation (the “Company”) and other matters. These statements may discuss goals, intentions and expectations as to future plans, trends, events, results of operations or financial condition, or otherwise, based on current beliefs of the Company’s management, as well as assumptions made by, and information currently available to, management. Forward-looking statements generally include statements that are predictive in nature and depend upon or refer to future events or conditions, and include words such as “may,” “will,” “should,” “would,” “expect,” “anticipate,” “plan,” “likely,” “believe,” “estimate,” “project,” “intend,” “forecast,” “guidance”, “outlook” and other similar expressions among others. Forward-looking statements are based on current beliefs and assumptions that are subject to risks and uncertainties and are not guarantees of future performance. Actual results could differ materially from those contained in any forward-looking statement as a result of various factors, including, without limitation: the Company’s ability to protect its intellectual property rights; the Company’s anticipated capital requirements, including the Company’s anticipated cash runway and the Company’s current expectations regarding its plans for future equity financings; the Company’s dependence on additional financing to fund its operations and complete the development and commercialization of its product candidates, and the risks that raising such additional capital may restrict the Company’s operations or require the Company to relinquish rights to the Company’s technologies or product candidates; the Company’s limited operating history in the Company’s current line of business, which makes it difficult to evaluate the Company’s prospects, the Company’s business plan or the likelihood of the Company’s successful implementation of such business plan; the timing for the Company or its partners to conduct clinical trials for PDS0101 (Versamune® HPV), PDS01ADC, PDS0103 (Versamune® MUC1) and other Versamune® based product candidates; the future success of such trials; the successful implementation of the Company’s research and development programs and collaborations, including any collaboration studies concerning PDS0101 (Versamune® HPV), PDS01ADC, PDS0103 (Versamune® MUC1) and other Versamune® based product candidates and the Company’s interpretation of the results and findings of such programs and collaborations and whether such results are sufficient to support the future success of the Company’s product candidates; the success, timing and cost of the Company’s or its partners’ ongoing clinical trials and anticipated clinical trials for the Company’s current product candidates, including statements regarding response rates, the timing of initiation, pace of enrollment and completion of the trials (including the Company’s ability to fully fund its disclosed clinical trials, which assumes no material changes to the Company’s currently projected expenses), futility analyses, presentations at conferences and data reported in an abstract, and receipt of interim or preliminary results (including, without limitation, any preclinical results or data), which are not necessarily indicative of the final results of the Company’s ongoing clinical trials; any Company statements about its understanding of product candidates mechanisms of action and interpretation of preclinical and early clinical results from its clinical development programs and any collaboration studies; the Company’s ability to continue as a going concern; and other factors, including legislative, regulatory, political and economic developments not within the Company’s control. The foregoing review of important factors that could cause actual events to differ from expectations should not be construed as exhaustive and should be read in conjunction with statements that are included herein and elsewhere, including the other risks, uncertainties, and other factors described under “Risk Factors,” “Management’s Discussion and Analysis of Financial Condition and Results of Operations” and elsewhere in the documents we file with the U.S. Securities and Exchange Commission. The forward-looking statements are made only as of the date of this press release and, except as required by applicable law, the Company undertakes no obligation to revise or update any forward-looking statement, or to make any other forward-looking statements, whether as a result of new information, future events or otherwise.
Versamune® is a registered trademark of PDS Biotechnology Corporation.
Investor Contact:
Mike Moyer
LifeSci Advisors
Phone +1 (617) 308-4306
Email: mmoyer@lifesciadvisors.com
Media Contact:
Jude Gorman / Kiki Torpey
Collected Strategies
PDS-CS@collectedstrategies.com
FAQ
What were the key PDS01ADC results announced by PDSB on January 28, 2026?
How clinically meaningful is the 9.6-month median PFS for PDSB's PDS01ADC in mCRPC?
What does the reported 40% median PSA decline mean for PDSB investors about PDS01ADC?
Was the PDS01ADC data from a randomized trial or regulatory submission for PDSB (PDSB)?
How large was the patient group in the PDSB PDS01ADC study presented at AACR in January 2026?
What are realistic next steps for PDSB after the NCI-led PDS01ADC Phase 2 results?
