Interim PDS01ADC data lift responses in tough mCRC for PDS Biotech (PDSB)
Filing Impact
Filing Sentiment
Form Type
8-K
Rhea-AI Filing Summary
PDS Biotechnology Corporation reported positive interim results from Stage 1 of an NCI-led Phase 2 trial of its tumor-targeted IL‑12 immunocytokine PDS01ADC in metastatic colorectal cancer with liver metastases. In nine patients who had failed at least one prior chemotherapy line, adding PDS01ADC to hepatic artery infusion pump therapy produced a 78% objective response rate, compared with 35% in a parallel trial without PDS01ADC. The two-year survival rate exceeded 80%, versus about 35% in the parallel trial, in this largely immunotherapy‑resistant microsatellite stable or mismatch repair‑proficient population.
Positive
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Negative
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Insights
Early Phase 2 data show notably higher responses and survival but in a very small cohort.
The interim analysis covers Stage 1 of a non‑randomized Phase 2 trial in metastatic colorectal cancer with liver metastases. Nine patients received PDS01ADC plus hepatic artery infusion pump floxuridine after failing at least one prior treatment. This design targets a difficult microsatellite stable or mismatch repair‑proficient population where immune checkpoint inhibitors have been ineffective for about 95% of patients.
The reported 78% objective response rate and more than 80% two‑year survival compare favorably to a parallel trial without PDS01ADC, which showed 35% response and roughly 35% two‑year survival. However, the company notes no head‑to‑head trials have been performed, and the data come from a small, single‑center, open‑label Simon two‑stage study.
The publication in JCO Oncology Advances highlights interest in this tumor‑targeted IL‑12 approach, which aims to concentrate activity at sites of tumor cell death and reduce systemic exposure. Future stages of this 22‑patient design and additional Phase 2 trials across multiple indications, as described, will be important to clarify robustness and durability of these early findings.
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, and exhibit attachments filed with this report.
Key Figures
Objective response rate with PDS01ADC: 78% ORR
Objective response rate without PDS01ADC: 35% ORR
Two-year survival with PDS01ADC: >80%
+4 more
7 metrics
Objective response rate with PDS01ADC
78% ORR
Stage 1 of Phase 2 metastatic colorectal cancer cohort (N=9)
Objective response rate without PDS01ADC
35% ORR
Parallel trial without PDS01ADC
Two-year survival with PDS01ADC
>80%
Stage 1 PDS01ADC plus HAIP arm
Two-year survival without PDS01ADC
~35%
Parallel trial without PDS01ADC
Stage 1 sample size
9 patients
Stage 1 of a 22-patient metastatic colorectal cancer cohort
Planned colorectal cancer cohort size
22 patients
Metastatic colorectal cancer cohort in Simon two-stage Phase 2 trial
Share of mCRC that is MSS or pMMR
about 95%
Metastatic colorectal cancer patients where immune checkpoint inhibitors have been ineffective
Key Terms
Simon two-stage design, hepatic artery infusion pump (HAIP), immunocytokine, microsatellite stable (MSS), +2 more
6 terms
Simon two-stage design financial
"The open-label, single-center, non-randomized Phase 2 trial utilizes a Simon two-stage design"
A Simon two-stage design is a clinical trial plan used early in drug development to test whether a treatment shows enough promise to continue. It works like a two-step audition: a small first group is tested and if results are poor the trial stops early to save time and money, while acceptable early results trigger a second, larger group; investors care because it limits wasted capital and reduces risk by quickly filtering out ineffective therapies.
hepatic artery infusion pump (HAIP) medical
"combined subcutaneous injection of PDS01ADC with floxuridine (FUDR), delivered via hepatic artery infusion pump (HAIP)"
immunocytokine medical
"evaluating its tumor-targeted IL-12 immunocytokine, PDS01ADC"
An immunocytokine is a lab-designed medicine that fuses a targeting antibody with an immune signaling protein so the immune response is directed to specific cells or tissue. Think of it as a guided package that brings a signal to rally the body's defenses where needed; investors pay attention because this targeted approach can improve effectiveness, reduce side effects, and strongly influence clinical results, approvals, and commercial value.
microsatellite stable (MSS) medical
"unresectable microsatellite stable (MSS) or mismatch repair-proficient p(MMR) colorectal liver metastases"
Microsatellite stable (MSS) describes a tumor whose short, repeating DNA sequences remain unchanged during cell division, meaning the cancer’s DNA repair system is functioning normally. For investors this matters because MSS status is a common biological test result used to predict how well certain therapies—especially some immunotherapies—will work, influence clinical trial design and enrollment, and affect regulatory decisions and commercial prospects for new cancer treatments.
immune checkpoint inhibitors medical
"in which immune checkpoint inhibitors have been unsuccessful"
Drugs that release the immune system’s natural “brakes,” allowing immune cells to recognize and attack cancer cells; imagine taking the safety off a guard dog so it can chase intruders. They matter to investors because they can become high-value treatments with large sales potential, but their commercial success depends on clinical trial results, regulatory approval, competition and side-effect management, which all affect a company’s valuation.
Interleukin-12 (IL-12) medical
"designed to deliver Interleukin-12 (IL-12), a potent immune-activating agent, directly to the tumor"
A naturally occurring protein that acts like an alarm and conductor for the immune system, telling key immune cells to activate and coordinate an attack. Investors care because drugs that increase, mimic, or block interleukin-12 can change how well therapies fight infections, cancer, or control inflammation, and so influence clinical trial results, regulatory review, safety profiles, and a biotech company's commercial potential.
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): April 15, 2026
(Exact Name of Registrant as Specified in Charter)
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(State or Other Jurisdiction of Incorporation)
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(Commission File Number)
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(I.R.S. Employer Identification No.)
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(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):
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Written communication pursuant to Rule 425 under the Securities Act (17 CFR 230.425)
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Soliciting material pursuant to Rule 14a-12 under the Exchange Act (17 CFR 240.14a-12)
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Pre-commencement communication pursuant to Rule 14d-2(b) under the Exchange Act (17 CFR 240.14d-2(b))
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Pre-commencement communication pursuant to Rule 13e-4(c) under the Exchange Act (17 CFR 240.13e-4(c))
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Securities registered pursuant to Section 12(b) of the Act:
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Title of each class
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Trading Symbol(s)
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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.
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On April 15, 2026, PDS Biotechnology Corporation (the “Company”) issued a press release announcing the publication of
clinical and immunological biomarker data from Stage 1 of a Phase 2 trial evaluating its tumor-targeted IL-12 immunocytokine, PDS01ADC, in the March 10, 2026 issue of Journal of
Clinical Oncology (JCO) Oncology Advances.
A copy of the press release is filed herewith as Exhibit 99.1 and incorporated by reference herein.
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Financial Statements and Exhibits.
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(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 April 15, 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.
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PDS BIOTECHNOLOGY CORPORATION
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Date: April 15, 2026
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By:
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/s/ Frank Bedu-Addo, Ph.D.
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Name: Frank Bedu-Addo, Ph.D.
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Title: President and Chief Executive Officer
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Exhibit 99.1
PDS Biotech Announces Publication of Positive PDS01ADC Interim Phase 2 Clinical Trial Data from Stage 1 of NCI-led
Metastatic Colorectal Cancer (mCRC) Trial
78% Objective Response Rate (ORR) with PDS01ADC; Parallel trial without PDS01ADC had 35% ORR
2-year survival rate of >80%; Parallel trial without PDS01ADC resulted in 2-year survival rate of ~35%
Trials performed in unresectable microsatellite stable (MSS) or mismatch repair-proficient p(MMR) colorectal liver metastases, which
constitute the majority of mCRC, and in which immune checkpoint inhibitors have been unsuccessful
PRINCETON, N.J., April 15, 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 clinical and immunological biomarker data from Stage 1 of a Phase 2 trial evaluating its tumor-targeted IL-12 immunocytokine, PDS01ADC, in the March 10,
2026 issue of Journal of Clinical Oncology (JCO) Oncology Advances.
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 hepatic artery infusion pump (HAIP), in patients with MSS or pMMR metastatic
colorectal cancer with liver metastases who had failed at least one round of prior treatment (NCT05286814). Immune checkpoint inhibitors have been ineffective to date in about 95% of mCRC
patients with MSS or pMMR disease1. Patients interested in enrolling in this study may contact NCI’s toll-free number 1-800-4-Cancer (1-800-422-6237) (TTY: 1-800-332-8615) and/or visit the web site: https://trials.cancer.gov and/or email NCIMO referrals@mail.nih.gov.
The open-label, single-center, non-randomized Phase 2 trial utilizes a Simon two-stage design and includes three disease cohorts: metastatic colorectal cancer,
cholangiocarcinoma, and adrenocortical cancer. The publication reports data from the metastatic colorectal cancer cohort of the trial.
Key findings from Stage 1 (N=9) of the 22-patient study*
In colorectal cancer patients with liver metastases previously treated with at least one line of chemotherapy, who had failed prior treatment, the addition of
PDS01ADC to HAIP therapy appears to enhance the immune response and clinical responses.:
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Objective response rate by RECIST v1.1: 77.8% (7/9)
at six months; in the parallel trial without PDS01ADC, the ORR was 35% (7/20)
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24-month survival rate: Approximately 85%; in the
parallel study without PDS01ADC, the 2-year survival rate was approximately 40%
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Extrahepatic progression-free survival (PFS): median
not reached at minimum follow-up of 13.1 months; in the parallel trial without PDS01ADC, the PFS was 8.1 months
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*No head-to-head trials have been performed.
“HAIP was approved by the FDA in 2024 and is gaining prominence at leading oncology centers. Despite many meaningful advances in oncology, metastatic colorectal
cancer remains an area of significant unmet need. These early results showing strong tumor response rates and promising patient survival are encouraging and support our approach of subcutaneously administering PDS01ADC to activate the immune system
against the cancer,” said Frank Bedu-Addo, PhD, President and Chief Executive Officer of PDS Biotech. “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."
The data were published in an article titled Tumor-Targeted IL-12 (PDS01ADC) With
Hepatic Artery Infusion Pump Therapy for Colorectal Liver Metastases: Interim Analysis of a Nonrandomized Phase II Trial in the March 10, 2026 issue of JCO
Oncology Advances (JCO Oncol Adv 3, e2500173(2026).
About PDS01ADC
PDS01ADC is a tumor-targeted immunocytokine designed to deliver Interleukin-12 (IL-12), a potent immune-activating agent, directly to the
tumor while minimizing exposure to the rest of the body. The therapy uses the NHS76 antibody, which binds to DNA exposed in areas of tumor cell death, concentrating the drug where it is needed most. This targeted approach prevents the presence of
free IL-12 in the body, and is designed to improve tolerability while enhancing anti-tumor potency. In clinical studies, PDS01ADC has been shown to:
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Promote the development of stem-like T cells, including memory T cells with self-renewing properties, which may support durable anti-tumor responses2
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Activate a subtype of natural killer cells associated with potent tumor-killing capability3
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Inhibit immune-suppressive cells, such as regulatory T cells and myeloid-derived suppressor cells, that can otherwise protect tumors from immune attack4
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About Metastatic Colorectal Cancer
Colorectal cancer is the second leading cause of cancer-related deaths in the United States, according to the American Cancer Society. More than 150,000 new
cases are diagnosed in the U.S. each year. Approximately 20% of patients have metastatic disease at the time of diagnosis, and an additional 25% of those with initially localized disease will eventually progress to metastatic cancer (Biller LH, 2021;325;(7):669-685). Globally, colorectal cancer causes nearly 2 million deaths annually, according to the World Health Organization.
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 is being developed in combination with a standard-of-care immune checkpoint inhibitor, and also in a triple combination including PDS01ADC, an IL-12 fused antibody drug conjugate (ADC), and a standard-of-care immune
checkpoint inhibitor. PDS01ADC is being evaluated in multiple phase 2 trials in various cancer indications in combination with standard of
care.
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 did PDS Biotech (PDSB) report about the PDS01ADC Phase 2 colorectal cancer trial?
PDS Biotech reported interim Stage 1 data from a Phase 2 trial of PDS01ADC in metastatic colorectal cancer with liver metastases. Nine previously treated patients receiving PDS01ADC plus hepatic artery infusion pump floxuridine showed higher response and survival rates than a parallel trial without PDS01ADC.
What response rates were seen with PDS01ADC in PDS Biotech’s metastatic colorectal cancer study?
The company reported a 78% objective response rate in Stage 1 among nine metastatic colorectal cancer patients treated with PDS01ADC plus hepatic artery infusion pump therapy. A parallel trial without PDS01ADC showed a 35% objective response rate, highlighting a notably higher tumor response in this early analysis.
How did PDS01ADC affect two-year survival in PDSB’s Phase 2 colorectal cancer trial?
Two‑year survival in the PDS01ADC combination arm exceeded 80%, compared with about 35% in a parallel trial without PDS01ADC. These data come from a small Stage 1 cohort in an open‑label, single‑center, non‑randomized Phase 2 trial using a Simon two‑stage design.
What type of colorectal cancer patients were enrolled in PDS Biotech’s PDS01ADC trial?
The trial enrolled patients with unresectable microsatellite stable or mismatch repair‑proficient metastatic colorectal cancer with liver metastases who had failed at least one prior chemotherapy line. This group represents the majority of metastatic colorectal cancer cases and typically responds poorly to immune checkpoint inhibitors.
How is PDS01ADC designed to work according to PDS Biotech (PDSB)?
PDS01ADC is a tumor‑targeted immunocytokine delivering Interleukin‑12 directly to tumors while limiting systemic exposure. It uses the NHS76 antibody to bind DNA exposed in areas of tumor cell death, aiming to concentrate IL‑12 where needed and improve tolerability while enhancing anti‑tumor potency.
Who is leading the PDS01ADC metastatic colorectal cancer trial reported by PDSB?
The clinical trial is led by Dr. Jonathan Hernandez, an Investigator in the Surgical Oncology Program at the National Cancer Institute, part of the National Institutes of Health. The open‑label, single‑center, non‑randomized Phase 2 study uses a Simon two‑stage design with three disease cohorts.