PDS Biotechnology cancer combo shows 39.3-month OS
Rhea-AI Filing Summary
PDS Biotechnology Corporation (PDSB) reported that results from its VERSATILE-002 Phase 2 trial of PDS0101, an HPV16-targeted immunotherapy, in combination with pembrolizumab for HPV16-positive recurrent/metastatic head and neck cancer were published in JAMA Oncology. In the immune checkpoint inhibitor-naïve modified intention-to-treat population with PD-L1 CPS ≥ 1, median overall survival was 39.3 months, compared with a published 17.9 months for standard-of-care pembrolizumab regimens. Objective response rate for CPS ≥ 1 was 36%, versus a published 19% for standard-of-care pembrolizumab. The combination was reported as well-tolerated, with 13.8% Grade ≥3 treatment-related adverse events compared with a published 17% for pembrolizumab alone. PDS Biotechnology stated it continues to prioritize its PDS0301 program in metastatic colorectal cancer while pursuing a partnership strategy for PDS0101 and noted a recently announced PIPE financing of up to $22.3 million that includes a one-year exclusive right for NantWorks to negotiate an exclusive license to PDS0101.
Positive
- None.
Negative
- None.
Filing Explained
The filing’s efficacy comparisons are cross-study references, not a head-to-head trial: PDS0101 plus pembrolizumab was evaluated in an open-label, nonrandomized Phase 2 study, while the 17.9-month survival and 19% response figures came from published standard-of-care studies.
8-K Event Classification
2 items: 8.01, 9.01
2 items
Item 8.01
Other Events
Other
Voluntary disclosure of events the company deems important to shareholders but not covered by other items.
Item 9.01
Financial Statements and Exhibits
Exhibits
Financial statements, pro forma financial information, or exhibit attachments filed with this report.
Key Figures
Median overall survival (CPS ≥ 1, ICI-naïve, PDS0101 + pembrolizumab): 39.3 months
Median overall survival benchmark (standard-of-care pembrolizumab regimens): 17.9 months
Objective response rate (CPS ≥ 1, PDS0101 + pembrolizumab): 36%
+5 more
8 metrics
Median overall survival (CPS ≥ 1, ICI-naïve, PDS0101 + pembrolizumab)
39.3 months
Modified intention-to-treat cohort with PD-L1 CPS ≥ 1 in VERSATILE-002
Median overall survival benchmark (standard-of-care pembrolizumab regimens)
17.9 months
Published result cited as comparator for CPS ≥ 1 population
Objective response rate (CPS ≥ 1, PDS0101 + pembrolizumab)
36%
CPS ≥ 1 population in VERSATILE-002 Phase 2 trial
Objective response rate benchmark (CPS ≥ 1, pembrolizumab)
19%
Published ORR for CPS ≥ 1 population treated with pembrolizumab
Grade ≥3 treatment-related adverse events (PDS0101 + pembrolizumab)
13.8%
Safety population in VERSATILE-002
Grade ≥3 treatment-related adverse events benchmark (pembrolizumab)
17%
Published safety profile for CPS ≥ 1 pembrolizumab population
Patients enrolled in VERSATILE-002
88 patients
Histologically confirmed HPV16-positive R/M diseases; 87 treated, 75 in mITT
PIPE financing size
$22.3 million
PIPE financing of up to $22.3 million led by Nant Capital
Key Terms
modified Intention-to-Treat, overall survival, objective response rate, treatment-related adverse events, +2 more
6 terms
modified Intention-to-Treat medical
"75 were in the modified Intention-to-Treat (mITT) population used for efficacy"
Modified intention-to-treat is a way of analysing clinical trial results that starts from the original randomized groups but excludes some participants according to rules set before the trial (for example people who never received any study treatment or lack key baseline data). It sits between a strict 'count everyone' approach and a 'only perfect participants' analysis. Investors pay attention because these choices can change reported effectiveness and safety, which can affect regulatory views and market reactions—like judging a recipe after removing certain ingredients.
overall survival medical
"In the overall CPS ≥ 1 population, the mOS was 39.3 months"
Overall survival is the average or median length of time patients remain alive after starting a treatment or entering a clinical study, measured regardless of cause of death. Investors care because it is a clear, hard measure of a therapy’s real-world benefit — like timing how long a new battery actually runs — and strong improvements in overall survival can drive regulatory approval, market adoption and revenue potential.
objective response rate medical
"Objective response rate (ORR) for CPS ≥ 1 was 36%"
The objective response rate (ORR) is the percentage of patients in a clinical trial whose tumors measurably shrink or disappear according to preset rules. Investors use it as a quick, objective signal of a drug’s ability to produce a clear treatment effect—like counting how many plants visibly respond after applying a new fertilizer—and higher ORR can improve odds of regulatory approval, commercial success, and company valuation.
immune checkpoint inhibitor medical
"separate evaluation of immune checkpoint inhibitor (ICI)-naïve and -resistant cohorts"
An immune checkpoint inhibitor is a type of medicine that helps the body's immune system recognize and attack cancer cells more effectively. It works by blocking certain signals that cancer uses to hide from immune defenses, allowing the immune system to target tumors. This breakthrough has led to new cancer treatments, making immune checkpoint inhibitors an important area of growth and innovation in the healthcare industry.
nonrandomized clinical trial medical
"A Nonrandomized Clinical Trial."
FAQ
AI-generated questions and answers. How Rhea-AI works. Not financial advice.
What did PDSB announce in this 8-K about the VERSATILE-002 trial?
PDS Biotechnology announced JAMA Oncology publication of Phase 2 VERSATILE-002 results for PDS0101 plus pembrolizumab in HPV16-positive recurrent/metastatic head and neck cancer, including data on overall survival, objective response rate, and safety in immune checkpoint inhibitor-naïve and -resistant patients.
What was the median overall survival reported for PDSB’s PDS0101 combination in VERSATILE-002?
In the immune checkpoint inhibitor-naïve modified intention-to-treat population with PD-L1 CPS ≥ 1, median overall survival was 39.3 months (95% CI, 23.9 to NE). The company notes that a published benchmark for standard-of-care pembrolizumab regimens reports 17.9 months median overall survival.
What objective response rate did PDSB report for PDS0101 plus pembrolizumab?
For patients with PD-L1 CPS ≥ 1, the combination produced a reported 36% objective response rate, with complete responders in both investigator and central reviews. A published comparator for standard-of-care pembrolizumab in a CPS ≥ 1 population shows an objective response rate of 19%.
How did the safety profile of PDS0101 plus pembrolizumab compare to published pembrolizumab data?
The combination had 13.8% Grade ≥3 treatment-related adverse events, one Grade 4 event one year after PDS0101 therapy, and no Grade 5 events. A published dataset for pembrolizumab alone in CPS ≥ 1 patients reports 17% Grade ≥3 treatment-related adverse events.
What strategic plans did PDSB disclose for PDS0101 and PDS0301?
PDS Biotechnology stated it will prioritize PDS0301 in metastatic colorectal cancer and seek strategic partnerships or externally funded opportunities for Phase 3 development of PDS0101, reflecting a focus on advancing its tumor-targeted IL-12 immunocytokine while leveraging partners for the HPV16 program.
AI-generated analysis. How Rhea-AI works. Not financial advice.
UNITED STATES
SECURITIES AND EXCHANGE COMMISSION
WASHINGTON, DC 20549
FORM 8-K
CURRENT REPORT
Pursuant to Section 13 or 15(d) of the
Securities Exchange Act of 1934
Date of Report (Date of earliest event reported): September 22, 2026
(Exact Name of Registrant as Specified in Charter)
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| (State or Other Jurisdiction of Incorporation) | (Commission File Number) | (I.R.S. Employer Identification No.) |
(Address of Principal Executive Offices, and Zip Code)
(800 ) 208-3343
Registrant’s Telephone Number, Including Area Code
(Former Name or Former Address, if Changed Since Last Report)
Check the appropriate box below if the Form 8-K filing is intended to simultaneously satisfy the filing obligation of the registrant under any of the following provisions (see General Instruction A.2. below):
Written communication pursuant to Rule 425 under the Securities Act (17 CFR 230.425)
Soliciting material pursuant to Rule 14a-12 under the Exchange Act (17 CFR 240.14a-12)
Pre-commencement communication pursuant to Rule 14d-2(b) under the Exchange Act (17 CFR 240.14d-2(b))
Pre-commencement communication pursuant to Rule 13e-4(c) under the Exchange Act (17 CFR 240.13e-4(c))
Securities registered pursuant to Section 12(b) of the Act:
| Title of each class | Trading Symbol(s) | Name of each exchange on which registered |
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Indicate by check mark whether the registrant is an emerging growth company as defined in Rule 405 of the Securities Act of 1933 (17 CFR §230.405 of this chapter) or Rule 12b-2 of the Securities Exchange Act of 1934 (17 CFR §240.12b-2 of this chapter).
Emerging growth company ☐
If an emerging growth company, indicate by check mark if the registrant has elected not to use the extended transition period for complying with any new or revised financial accounting standards provided pursuant to Section 13(a) of the Exchange Act. Yes ☐ No ☐
Item 8.01
Other Events.
On September 22, 2026, PDS Biotechnology Corporation issued a press release announcing the publication of results from a Phase 2 trial evaluating PDS0101, its HPV16-targeted immunotherapy, in combination with pembrolizumab in the September 17, 2026, issue of JAMA Oncology, a peer reviewed journal of the American Medical Association. The data were published in an article titled “VERSATILE-002 – A Phase 2 Study of PDS0101 HPV16-targeted T Cell Immunotherapy and Pembrolizumab Combination in HPV16-Positive Recurrent/Metastatic Head and Neck Squamous Cell Carcinoma: A Nonrandomized Clinical Trial.”
A copy of the press release is filed herewith as Exhibit 99.1 and incorporated by reference herein.
Item 9.01
Financial Statements and Exhibits.
(d) Exhibits.
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Exhibit
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Description
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99.1
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Press Release Dated September 22, 2026.
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104
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Cover Page Interactive Data File (embedded within the Inline XBRL Document).
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Signature
Pursuant to the requirements of the Securities Exchange Act of 1934, the registrant has duly caused this report to be signed on its behalf by the undersigned hereunto duly authorized.
| PDS BIOTECHNOLOGY CORPORATION | ||
| Date: September 22, 2026 | By: | /s/ Frank Bedu-Addo, Ph.D. |
| Name: Frank Bedu-Addo, Ph.D. | ||
| Title: President and Chief Executive Officer | ||
Exhibit 99.1
PDS Biotech Announces Publication of VERSATILE-002 Phase 2 Clinical Trial Results of PDS0101 with pembrolizumab in HPV16-Positive Recurrent and/or Metastatic (R/M) Head and Neck Cancer in JAMA Oncology
39.3 months median overall survival in first-line (1L) R/M immune checkpoint inhibitor naïve patients
Company
continues to prioritize PDS0301 in metastatic colorectal cancer (mCRC) while pursuing
partnership strategy for PDS0101
PRINCETON, N.J., September 22, 2026 -- 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 the publication of results from a Phase 2 trial evaluating PDS0101, its HPV16-targeted immunotherapy, in combination with pembrolizumab in the September 17, 2026, issue of JAMA Oncology, a peer reviewed journal of the American Medical Association. The data were published in an article titled “VERSATILE-002 – A Phase 2 Study of PDS0101 HPV16-targeted T Cell Immunotherapy and Pembrolizumab Combination in HPV16-Positive Recurrent/Metastatic Head and Neck Squamous Cell Carcinoma: A Nonrandomized Clinical Trial.”
Key findings
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62.3% of the ICI-naïve participants in the mITT cohort (n = 53) had low CPS of 1-19, and 37.7% had high CPS ≥ 20. In the overall CPS ≥ 1 population, the mOS was 39.3 months (95% CI, 23.9 to NE); The best published result with standard of care pembrolizumab or pembrolizumab + chemotherapy is 17.9 months 1.
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Objective response rate (ORR) for CPS ≥ 1 was 36% of which 5/53 were complete responders by investigator review and 34% of which 6/53 were complete responders by central review.
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The published ORR for the overall population with CPS ≥ 1 when treated with standard of care pembrolizumab is 19%2.
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The treatment was well-tolerated with 13.8% Grade ≥3 treatment-related adverse events (TRAEs), 1 Grade 4 event one year after PDS0101 therapy, and no Grade 5 TRAEs.
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The published safety profile for the overall population with CPS ≥ 1 when treated with standard of care pembrolizumab reports 17% Grade ≥ 3 TRAEs 2.
VERSATILE-002 was an open-label, non-randomized phase 2 trial performed at twenty-six oncology centers across the US, UK and Ireland. Eighty-eight patients with histologically confirmed R/M HPV16-positive diseases were enrolled in the study; 87 received treatment and comprised the safety population; 75 were in the modified Intention-to-Treat (mITT) population used for efficacy analyses: 53 ICI-naïve with PD-L1 CPS ≥1, 22 ICI-resistant (Mean age = 64.5 years, 94.7% male, 92.0% White).
The trial was led by Dr. Jared Weiss, MD, of the Lineberger Comprehensive Cancer Center, University of North Carolina, Chapel Hill, NC, and was performed to determine the efficacy and safety of PDS0101, in combination with pembrolizumab in participants with HPV16-positive recurrent or metastatic head and neck squamous cell carcinoma (R/M HNSCC), with separate evaluation of immune checkpoint inhibitor (ICI)-naïve and -resistant cohorts.
“We’re very pleased with the publication of the Phase 2 clinical results of the VERSATILE-002 clinical trial in a leading peer reviewed oncology journal,” said Dr. Kirk Shepard, M.D., Chief Medical Officer of PDS Biotech. “These results support the durable clinical effect of PDS0101, consistent with promising survival outcomes reported in two other recently published studies, the IMMUNOCERV study, and the NCI-led study in HPV16-positive recurrent and/or metastatic cancers. We believe PDS0101 has the potential to bring new hope to the rapidly growing population of HPV16-positive head and neck cancer patients.”
The Company recently announced the initial closing of a PIPE financing of up to $22.3 million led by Nant Capital, alongside an agreement granting NantWorks, LLC, an affiliate of Nant Capital, a one-year exclusive right to negotiate an exclusive license to PDS0101.
*No head-to-head trials have been performed.
1Licitra L et al, J Clin Oncol; 2026 Apr 20;44(12):1098-1107.doi: 10.1200/JCO-25-00570. Epub 2026 Mar 12
2Harrington, KJ et al. J Clin Oncol. 2022;41:790-802. https://doi.org/10.1200/JCO.21.02508.
About PDS Biotechnology
PDS Biotechnology is a clinical-stage biotechnology company focused on developing targeted immunotherapies for cancer. PDS Biotechnology owns the Versamune® cancer vaccine platform, including PDS0101, which has been evaluated in HPV16-positive cancers. The Company intends to pursue strategic partnerships or other externally funded opportunities for the Phase 3 development of PDS0101.
The Company’s lead development program, PDS0301 (also referred to as PDS01ADC & NHS-IL12), is an investigational tumor-targeted interleukin-12 (IL-12) immunocytokine designed to deliver IL-12 preferentially to the tumor microenvironment, with the goal of enhancing anti-tumor immune activity while limiting systemic exposure. PDS0301 has been clinically evaluated across multiple solid tumors, including metastatic colorectal cancer and prostate cancer. The Company is focused on advancing PDS0301 in indications where its tumor-targeted mechanism may help address and overcome mechanisms of resistance to immunotherapy.
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 PDS0301, PDS0101 (Versamune® HPV), 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 PDS0301, PDS0101 (Versamune® HPV), 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; compliance with the rules and regulations of Nasdaq; 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