This section highlights FDA-related milestones and regulatory updates for drugs developed by PDS Biotechnology (PDSB).
Over the past two years, PDS Biotechnology has reported clinical trial outcomes, regulatory submissions, approvals, and other FDA events for drugs and therapies such as
PDS01ADC, VERSATILE-003, PDS0101, VERSATILE-002, Infectimune, and Versamune. For definitions of regulatory abbreviations such as NDA, BLA, or PDUFA, see the event status legend.
Select a button below to view the list of FDA events for that drug.
PDS01ADC FDA Regulatory Timeline and Events
PDS01ADC is a drug developed by PDS Biotechnology for the following indication: For the treatment of recurrent prostate cancer.
This drug is under review by the U.S. Food and Drug Administration (FDA).
Below is a timeline of key regulatory milestones for this therapy.
- Drug:
- PDS01ADC
- Announced Date:
- April 15, 2026
- Indication:
- For the treatment of recurrent prostate cancer
Announcement
PDS Biotechnology 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.
AI Summary
PDS Biotechnology announced publication (Journal of Clinical Oncology Oncology Advances, March 10, 2026) of clinical and immunological biomarker data from Stage 1 of a Phase 2 trial of PDS01ADC, a tumor‑targeted IL‑12 immunocytokine. In the metastatic colorectal cancer cohort (unresectable, MSS/pMMR colorectal liver metastases), Stage 1 (N=9 of a planned 22) reported a 78% objective response rate (ORR) when PDS01ADC was added to hepatic arterial infusion pump (HAIP) therapy, versus a 35% ORR in a parallel trial without PDS01ADC. Two‑year survival exceeded 80% with PDS01ADC compared with roughly 35% in the comparator trial.
The open‑label, single‑center, non‑randomized Phase 2 uses a Simon two‑stage design and includes three disease cohorts; the paper focuses on the colorectal cohort. Investigators observed enhanced immune responses and clinical benefit in patients who had failed at least one prior chemotherapy line. No head‑to‑head randomized comparisons have been done, and further study is needed to confirm these findings.
Read Announcement- Drug:
- PDS01ADC
- Announced Date:
- January 28, 2026
- Indication:
- For the treatment of recurrent prostate cancer
Announcement
PDS Biotechnology 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.
AI Summary
PDS Biotechnology announced that results from a National Cancer Institute (NCI)-led study of its investigational IL-12 tumor-targeted immunocytokine, PDS01ADC, were presented at the American Association for Cancer Research (AACR) special conference on prostate cancer in Boston on January 20–22, 2026. The study reported a median progression-free survival (PFS) of 9.6 months, signaling clinical activity in the treated population. The company highlighted these findings as part of the conference program.
PDS01ADC is a fused IL-12 antibody drug conjugate built on an antibody that binds necrotic DNA inside tumors. That targeting aims to deliver IL-12 directly into the tumor microenvironment, reduce the tumor’s ability to evade the immune system, and boost T cell and natural killer (NK) cell infiltration and activation. PDS said the results support further development; more information is available at www.pdsbiotech.com.
Read Announcement- Drug:
- PDS01ADC
- Announced Date:
- October 30, 2025
- Indication:
- For the treatment of recurrent prostate cancer
Announcement
PDS Biotechnology Corporation announced that the National Cancer Institute (NCI) will present new clinical data at the 2025 Society for Immunotherapy of Cancer (SITC) Annual Meeting, taking place in National Harbor, Maryland.
AI Summary
PDS Biotechnology Corp. announced that the National Cancer Institute will share new clinical data at the Society for Immunotherapy of Cancer’s 2025 Annual Meeting in National Harbor, Maryland. The presentations will highlight emerging findings from PDS’s novel immunotherapy platforms.
The NCI will deliver three abstracts on PDS01ADC, a tumor-targeting IL-12 antibody drug conjugate, and PDS0101, the company’s Phase 3 HPV-targeted immunotherapy. These studies explore how these agents engage the immune system to fight cancer.
One rapid oral abstract will cover early serum proteomic changes predicting anti-tumor activity in HPV-associated cancers. Two additional poster presentations will report increases in natural killer cells and peripheral memory T cells after treatment with the IL-12 immunocytokine therapy.
These data reinforce PDS Biotechnology’s goal to develop immunotherapies that activate both adaptive and innate responses, potentially improving outcomes for patients with hard-to-treat cancers.
Read Announcement- Drug:
- PDS01ADC
- Announced Date:
- July 10, 2025
- Indication:
- For the treatment of recurrent prostate cancer
Announcement
PDS Biotechnology announced patient recruitment has been completed in Stage 1 of a clinical trial of the Company's PDS01ADC therapeutic administered systemically in combination with floxuridine (FUDR) administered by hepatic artery infusion pump (HAIP) for patients with metastatic colorectal cancer (NCT05286814), led by the National Cancer Institute (NCI), a component of the National Institutes of Health (NIH).
AI Summary
PDS Biotechnology announced that patient recruitment for Stage 1 of its clinical trial has been completed. This trial tests the company’s PDS01ADC therapeutic, given systemically in combination with floxuridine (FUDR) delivered by a hepatic artery infusion pump for patients with metastatic colorectal cancer (NCT05286814). The study, led by the National Cancer Institute (NCI) under the NIH, met the pre-set RECIST v1.1 criteria, allowing the trial to advance into Stage 2. The colorectal cancer cohort demonstrated sufficient objective responses, which is a promising milestone in the trial. This approach uses a fused antibody drug conjugate that targets tumor necrosis areas, potentially offering new benefits for patients with a difficult-to-treat cancer. The advancement into Stage 2 is a hopeful development in PDS Biotechnology’s ongoing effort to create more effective cancer treatments.
Read Announcement
VERSATILE-003 FDA Regulatory Timeline and Events
VERSATILE-003 is a drug developed by PDS Biotechnology for the following indication: Evaluating the safety and efficacy of PDS0101 in combination with Merck's anti-PD-1 therapy, KEYTRUDA® (pembrolizumab) versus KEYTRUDA® monotherapy.
This drug is under review by the U.S. Food and Drug Administration (FDA).
Below is a timeline of key regulatory milestones for this therapy.
- Drug:
- VERSATILE-003
- Announced Date:
- February 20, 2026
- Indication:
- Evaluating the safety and efficacy of PDS0101 in combination with Merck's anti-PD-1 therapy, KEYTRUDA® (pembrolizumab) versus KEYTRUDA® monotherapy.
Announcement
PDS Biotechnology Corporation announced the adoption of a protocol amendment to its Phase 3 VERSATILE-003 clinical trial.
AI Summary
PDS Biotechnology Corporation announced it has adopted a protocol amendment to its Phase 3 VERSATILE-003 clinical trial. The company said the change updates trial design and procedures to improve how safety and efficacy data are collected and analyzed for its Versamune-based candidate.
According to PDS, the amendment clarifies participant eligibility, adjusts follow-up timing, and refines statistical plans to reduce variability and support a clearer final readout. It also includes operational adjustments for study sites to streamline enrollment, monitoring, and data collection while maintaining participant safety and oversight.
Next steps include implementing the revised protocol at active sites, continuing patient enrollment and follow-up under the new plan, and using the improved data to support future regulatory interactions and decision making. Versamune® is a registered trademark of PDS Biotechnology Corporation.
Read Announcement- Drug:
- VERSATILE-003
- Announced Date:
- March 27, 2025
- Indication:
- Evaluating the safety and efficacy of PDS0101 in combination with Merck's anti-PD-1 therapy, KEYTRUDA® (pembrolizumab) versus KEYTRUDA® monotherapy.
Announcement
PDS Biotechnology Provides Clinical Programs Update
AI Summary
PDS Biotechnology provided an update on its clinical programs, highlighting the launch of the VERSATILE-003 Phase 3 trial. This study will evaluate the effectiveness of Versamune® HPV when combined with standard treatments for patients with recurrent or metastatic HPV16-positive head and neck squamous cell carcinoma. The trial is designed as a two-arm study with 2:1 randomization and will include around 350 patients. The primary goal is to assess median overall survival, a decision based on the strong, lasting responses observed in the earlier VERSATILE-002 trial.
The company is working closely with the FDA to ensure that the trial meets all regulatory endpoints. PDS Biotechnology is confident that this innovative combination therapy could significantly improve patient outcomes and set a new standard of care, with plans to activate additional clinical sites in the near future.
Read Announcement- Drug:
- VERSATILE-003
- Announced Date:
- March 7, 2025
- Indication:
- Evaluating the safety and efficacy of PDS0101 in combination with Merck's anti-PD-1 therapy, KEYTRUDA® (pembrolizumab) versus KEYTRUDA® monotherapy.
Announcement
PDS Biotechnology announced the initiation of the VERSATILE-003 Phase 3 clinical trial. The trial is now open to patient enrollment.
AI Summary
PDS Biotechnology Corporation has begun the VERSATILE-003 Phase 3 clinical trial, now open to patient enrollment. The study is a global, multi-center trial aimed at assessing the safety and effectiveness of the experimental Versamune HPV treatment combined with pembrolizumab for patients with recurrent or metastatic HPV16-positive head and neck squamous cell carcinoma. Researchers plan to enroll around 350 participants who will be divided between a group receiving the combination therapy and a control group receiving pembrolizumab alone. The trial will measure overall survival as its primary outcome and evaluate additional factors such as response rate and progression-free survival.
PDS Biotechnology is hopeful that encouraging results from earlier studies will lead to meaningful improvements in patient care. This trial shows a major step forward in advancing treatment for those battling head and neck cancers.
Read Announcement- Drug:
- VERSATILE-003
- Announced Date:
- February 5, 2025
- Indication:
- Evaluating the safety and efficacy of PDS0101 in combination with Merck's anti-PD-1 therapy, KEYTRUDA® (pembrolizumab) versus KEYTRUDA® monotherapy.
Announcement
PDS Biotechnology today reaffirmed the Company's guidance of initiating its VERSATILE-003 Phase 3 clinical trial of Versamune® HPV plus pembrolizumab for first-line treatment of recurrent and/or metastatic (R/M) HPV16-positive head and neck squamous cell cancer (HNSCC) in the first quarter of this year.
AI Summary
PDS Biotechnology has reaffirmed its plan to initiate the VERSATILE-003 Phase 3 clinical trial in the first quarter of this year. The trial will test the combination of Versamune® HPV with pembrolizumab as a first-line treatment for patients with recurrent and/or metastatic HPV16-positive head and neck squamous cell cancer (HNSCC). The company submitted an updated clinical protocol on November 15, 2024, amending its Investigational New Drug application. With the window for FDA comments now closed and Fast Track designation granted by the FDA for this treatment combination, site activation is set to begin as planned. The trial also plans to use a newly validated companion diagnostic test to accurately identify eligible patients, aiming to potentially enhance treatment outcomes for this growing patient subgroup.
Read Announcement- Drug:
- VERSATILE-003
- Announced Date:
- August 1, 2024
- Target Action Date:
- Q4 2024
- Estimated Target Date Range:
- October 1, 2024 - December 31, 2024
- Indication:
- Evaluating the safety and efficacy of PDS0101 in combination with Merck's anti-PD-1 therapy, KEYTRUDA® (pembrolizumab) versus KEYTRUDA® monotherapy.
Announcement
PDS Biotechnology Corporation announced that Company to initiate Phase 3 VERSATILE-003 trial in Q4 2024
AI Summary
PDS Biotechnology Corporation announced that it will initiate the Phase 3 VERSATILE-003 trial in the fourth quarter of 2024. The trial will focus on evaluating the Versamune® HPV immunotherapy in combination with pembrolizumab for patients with recurrent or metastatic HPV16-positive head and neck squamous cell carcinoma. The company received official FDA meeting minutes that reviewed the updated study design. This design now includes revised statistical endpoints based on more mature survival data from earlier trials, adding extra robustness to the planned study. The updated strategy also considers a future arm that will test a triple combination with PDS01ADC. The FDA has shown support by allowing the dose optimization for PDS01ADC to be conducted separately, thereby avoiding delays in the main trial's initiation. These steps are critical for the company as it works to improve targeted immunotherapy for HPV16-positive HNSCC patients.
Read Announcement
PDS0101 FDA Regulatory Timeline and Events
PDS0101 is a drug developed by PDS Biotechnology for the following indication: For the treatment of cervical cancer.
This drug is under review by the U.S. Food and Drug Administration (FDA).
Below is a timeline of key regulatory milestones for this therapy.
- Drug:
- PDS0101
- Announced Date:
- December 9, 2025
- Indication:
- For the treatment of cervical cancer
Announcement
PDS Biotechnology announced that the Japan Patent Office has issued Patent No. 7783866 for PDS0101 granting broad composition of matter and methods of use claims.
AI Summary
PDS Biotechnology announced that the Japan Patent Office has issued Patent No. 7783866 for PDS0101, granting broad composition-of-matter and methods-of-use claims. This new Japanese patent expands the company’s existing local protections and strengthens the overall intellectual property position for PDS0101. The broad claims are intended to cover the core makeup of PDS0101 and how it is used, helping to safeguard the therapy against competitors.
The company said the patent adds to its global IP estate, which includes granted patents in the United States, China, Australia and Hong Kong, with additional applications pending in other countries. Together with anticipated biologics exclusivity in the U.S., PDS Biotechnology expects patent and market protections for PDS0101 into the 2040s, supporting the company’s plans to advance the therapy worldwide.Read Announcement
- Drug:
- PDS0101
- Announced Date:
- December 2, 2025
- Indication:
- For the treatment of cervical cancer
Announcement
PDS Biotechnology announced that its request for a Type C Meeting with the FDA has been accepted by the agency, and the meeting has been scheduled to occur this month.
AI Summary
PDS Biotechnology said the FDA accepted its request for a Type C meeting and scheduled the meeting for this month. The company will discuss a proposed accelerated approval pathway for PDS0101 in HPV16-positive recurrent and/or metastatic head and neck cancer. The meeting request rests on positive final VERSATILE-002 results, which showed promising median overall survival and durable progression-free survival in patients with CPS ≥ 1.
PDS Biotech proposes amending the VERSATILE-003 Phase 3 trial to make progression-free survival a surrogate primary endpoint that can be assessed earlier with strong statistical power and could support accelerated approval. Median overall survival would remain the primary endpoint for full approval. The company says the PFS data could shorten time to a primary endpoint and speed regulatory submission so patients may access the therapy sooner. PDS expects to share FDA meeting minutes in January 2026.
Read Announcement- Drug:
- PDS0101
- Announced Date:
- November 10, 2025
- Indication:
- For the treatment of cervical cancer
Announcement
PDS Biotechnology announced positive clinical and translational data presented at the 2025 Society for Immunotherapy of Cancer (SITC) Annual Meeting.
AI Summary
PDS Biotechnology reported positive clinical and translational data presented at the 2025 Society for Immunotherapy of Cancer (SITC) Annual Meeting. The work, done under a research agreement with the National Cancer Institute, included a rapid oral abstract (selected among the top 150 abstracts) and two poster presentations that link immune changes to clinical activity.
For PDS0101, analysis of 50 patients with advanced HPV16-positive cancers treated with a combination including PDS0101 showed broad immune activation. Multiple blood proteins and cytokine changes predicted clinical benefit with good accuracy, supporting the use of blood-based biomarkers and prospective validation in future trials.
PDS01ADC monotherapy reprogrammed natural killer (NK) cells toward killer phenotypes tied to responses and reduced NK subsets linked to poor outcomes. In 28 patients, PDS01ADC also increased stem-like, self-renewing CD8 and CD4 memory T cells associated with disease stabilization, suggesting durable anti-tumor immunity and rationale for combination strategies.
Read Announcement- Drug:
- PDS0101
- Announced Date:
- October 30, 2025
- Indication:
- For the treatment of cervical cancer
Announcement
PDS Biotechnology announced that the National Cancer Institute (NCI) will present new clinical data at the 2025 Society for Immunotherapy of Cancer (SITC) Annual Meeting, taking place in National Harbor, Maryland.
AI Summary
PDS Biotechnology announced that the National Cancer Institute (NCI) will present new clinical data at the 2025 Society for Immunotherapy of Cancer (SITC) Annual Meeting in National Harbor, Maryland. The NCI will share three abstracts highlighting findings from PDS Biotech’s immunotherapy platforms.
One abstract will show early changes in blood proteins that predict immune responses in patients with HPV-linked cancers treated with a new combination therapy. Another will report increases in natural killer cells after treatment with an IL-12 linked antibody. The third will describe memory T cell increases with this IL-12 therapy.
These presentations underscore PDS Biotechnology’s commitment to developing treatments that engage both adaptive and innate immunity against cancer. The data will help researchers understand how these therapies reshape the immune response and may guide future clinical trials to improve outcomes for patients with hard-to-treat tumors.
Read Announcement- Drug:
- PDS0101
- Announced Date:
- October 29, 2025
- Indication:
- For the treatment of cervical cancer
Announcement
PDS Biotechnology announced that after recent review of the final VERSATILE-002 data, the Company has requested a meeting with the Food and Drug Administration ("FDA") to explore an expedited approval pathway for PDS0101 in HPV16-positive Head and Neck Cancer.
AI Summary
PDS Biotechnology announced it has requested a meeting with the Food and Drug Administration to explore an expedited approval pathway for its immunotherapy PDS0101 in HPV16-positive head and neck cancer. This request follows a review of final VERSATILE-002 Phase 2 data showing a median progression-free survival of 6.3 months and a median overall survival of 39.3 months. These results represent a significant improvement for patients with recurrent or metastatic disease.
To accelerate access, PDS Biotech plans to amend its ongoing VERSATILE-003 Phase 3 trial by adding progression-free survival as an earlier primary endpoint alongside overall survival. If this endpoint is met, the company could submit for accelerated approval. While the FDA reviews the amendment, the Phase 3 trial will be temporarily paused, though treatment will continue for already enrolled patients. PDS Biotechnology aims to make PDS0101 available sooner to a cancer type projected to become the most common head and neck cancer in the US by the mid-2030s.
Read Announcement- Drug:
- PDS0101
- Announced Date:
- February 26, 2025
- Indication:
- For the treatment of cervical cancer
Announcement
PDS Biotechnology announced the publication of clinical results in the Journal of the American Medical Association (JAMA) Oncology.
AI Summary
PDS Biotechnology announced the publication of key clinical results in JAMA Oncology. The study focused on patients with recurrent/metastatic HPV-associated cancers treated with a triple combination therapy including Versamune® HPV, an IL-12 fused antibody-drug conjugate (PDS01ADC), and a PD-L1 inhibitor. Notably, among HPV16-positive patients who had not received previous immune checkpoint inhibitors, the median overall survival reached 42.4 months, compared to historical results of 7-12 months. For immune checkpoint inhibitor-resistant patients, the median overall survival was 17 months, a significant improvement over the standard 3-4 months seen historically. The published results also highlighted a high objective response rate, with significant tumor shrinkage in many patients. The compelling findings from this trial support the potential of Versamune® HPV and provide a strong foundation for the company’s future clinical investigations.
Read Announcement
VERSATILE-002 FDA Regulatory Timeline and Events
VERSATILE-002 is a drug developed by PDS Biotechnology for the following indication: Treatment of recurrent or metastatic human papillomavirus (HPV)16-positive head and neck cancer.
This drug is under review by the U.S. Food and Drug Administration (FDA).
Below is a timeline of key regulatory milestones for this therapy.
- Drug:
- VERSATILE-002
- Announced Date:
- September 18, 2025
- Indication:
- Treatment of recurrent or metastatic human papillomavirus (HPV)16-positive head and neck cancer.
Announcement
PDS Biotechnology announced details of a sub-analysis of the cohort of patients with low PD-L1 expression (CPS 1-19) from the final data for its recently completed VERSATILE-002 Phase 2 clinical trial.
AI Summary
PDS Biotechnology released a sub-analysis from its Phase 2 VERSATILE-002 trial focusing on patients with low PD-L1 expression (CPS 1-19). In this group of 32 individuals, the combination of PDS0101 (Versamune® HPV) and Keytruda® achieved a median overall survival (mOS) of 29.5 months. This exceeds published mOS of 10.8 months for Keytruda® alone and 12.3 months for Keytruda® plus chemotherapy in similar low PD-L1 populations.
About 60% of the 53 trial participants had CPS 1-19, a subgroup that normally responds poorly to immune checkpoint inhibitors. The open-label, multi-center study enrolled both immune checkpoint inhibitor–naive and refractory patients with recurrent or metastatic HPV16-positive head and neck cancer. Investigators say the robust T-cell immune response from PDS0101 may overcome typical treatment limitations. These encouraging results suggest a new, well-tolerated option for difficult-to-treat patients without added chemotherapy.
Read Announcement- Drug:
- VERSATILE-002
- Announced Date:
- August 25, 2025
- Indication:
- Treatment of recurrent or metastatic human papillomavirus (HPV)16-positive head and neck cancer.
Announcement
PDS Biotechnology announced final topline survival data from its VERSATILE-002 Phase 2 clinical trial. VERSATILE-002 evaluated PDS0101 (Versamune® HPV) + Keytruda® (pembrolizumab) in patients with HPV16-positive first-line recurrent and/or metastatic head and neck squamous cell cancer ("1L R/M HNSCC").
AI Summary
PDS Biotechnology announced final topline survival data from its VERSATILE-002 Phase 2 trial. This study tested PDS0101 (Versamune® HPV) combined with pembrolizumab (Keytruda®) in 53 patients with HPV16-positive, first-line recurrent or metastatic head and neck cancer.
The median overall survival (mOS) was 39.3 months in patients with a combined positive score (CPS) ≥ 1. By comparison, standard pembrolizumab or pembrolizumab + chemotherapy regimens typically show a mOS of about 17.9 months. The 95% confidence interval lower limit was 23.9 months, and the upper limit is still being determined. Durable survival appeared driven by long-lasting, multifunctional HPV16-specific CD8+ T cells induced by PDS0101 across different patient groups.
The treatment was well tolerated, and no patients discontinued due to related adverse events. PDS0101 plus pembrolizumab offers a simple, promising option for HPV-driven head and neck cancer. VERSATILE-003, a Phase 3 trial, is already under way, and full VERSATILE-002 data are expected later this year.
Read Announcement- Drug:
- VERSATILE-002
- Announced Date:
- June 2, 2025
- Indication:
- Treatment of recurrent or metastatic human papillomavirus (HPV)16-positive head and neck cancer.
Announcement
PDS Biotechnology announced publication of three Versamune® HPV abstracts now available on the 2025 American Society of Clinical Oncology (ASCO) Annual Meeting website.
AI Summary
PDS Biotechnology announced that three Versamune® HPV abstracts are now available on the 2025 American Society of Clinical Oncology (ASCO) Annual Meeting website. These abstracts were presented during the Head and Neck Cancer Poster Session held from May 30 to June 3, 2025, in Chicago, Illinois. They highlight studies of PDS0101, a novel immunotherapy designed to target HPV16-positive head and neck cancers. The data presented in the abstracts provide insights into the treatment’s ability to sustain durable clinical responses and encourage further exploration of its potential benefits. Given that over 50% of head and neck squamous cell carcinoma cases in the US are linked to HPV16, these findings come at a crucial time. They underscore the importance of developing effective therapies for HPV16-positive cancers and offer hope for improved outcomes in this growing patient population.
Read Announcement- Drug:
- VERSATILE-002
- Announced Date:
- September 16, 2024
- Indication:
- Treatment of recurrent or metastatic human papillomavirus (HPV)16-positive head and neck cancer.
Announcement
PDS Biotechnology Corporation announced updated data from the VERSATILE-002 trial evaluating Versamune® HPV (formerly PDS0101) in combination with KEYTRUDA® (pembrolizumab) as a first-line (1L) treatment for patients with HPV16-positive recurrent/metastatic (R/M) head and neck squamous cell carcinoma (HNSCC).
AI Summary
PDS Biotechnology Corporation recently shared updated results from its VERSATILE-002 trial, which studied the use of Versamune® HPV (formerly PDS0101) combined with KEYTRUDA® (pembrolizumab) as a first-line treatment for patients with HPV16-positive recurrent/metastatic head and neck squamous cell carcinoma. The Phase 2 trial enrolled 53 patients with a median follow-up of 16 months. The updated data showed a median overall survival of 30 months—significantly better than the historical survival for KEYTRUDA alone—and an objective response rate of 36% along with a disease control rate of 77%. Notably, 21% of patients experienced between 90-100% tumor shrinkage, and 9% achieved a complete response. These results indicate strong clinical activity and lasting responses, supporting further evaluation. The company also plans to launch a Phase 3 study later this year to compare the combination to KEYTRUDA monotherapy.
Read Announcement- Drug:
- VERSATILE-002
- Announced Date:
- September 9, 2024
- Indication:
- Treatment of recurrent or metastatic human papillomavirus (HPV)16-positive head and neck cancer.
Announcement
PDS Biotechnology will present updated data from the VERSATILE-002 trial evaluating first-line treatment with Versamune® HPV (formerly PDS0101) in combination with KEYTRUDA® (pembrolizumab) in patients with HPV16-positive recurrent/metastatic head and neck squamous cell carcinoma (HNSCC) during a poster presentation at the upcoming European Society for Medical Oncology (ESMO) Congress 2024 on September 14, 2024, in Barcelona, Spain.
AI Summary
PDS Biotechnology Corporation will present updated data from its VERSATILE-002 trial at the upcoming European Society for Medical Oncology (ESMO) Congress 2024. The poster presentation, scheduled for September 14, 2024, in Barcelona, Spain, will highlight survival outcomes from a first-line treatment study using Versamune® HPV (formerly PDS0101) in combination with KEYTRUDA® (pembrolizumab) for patients with HPV16-positive recurrent/metastatic head and neck squamous cell carcinoma (HNSCC). The poster, numbered 879P and titled "VERSATILE-002: Survival with First-Line Treatment with PDS0101 Therapeutic Vaccine and Pembrolizumab in HPV16-positive Recurrent/Metastatic Head and Neck Squamous Cell Carcinoma (HNSCC)," will be presented by Dr. Jared Weiss, a leading expert in thoracic and head/neck oncology. After the presentation, detailed results will be available in the Investor Relations section of PDS Biotechnology’s website.
Read Announcement
Infectimune FDA Regulatory Events
Infectimune is a drug developed by PDS Biotechnology for the following indication: flu vaccine.
This drug is under review by the U.S. Food and Drug Administration (FDA).
Below is a timeline of key regulatory milestones for this therapy.
- Drug:
- Infectimune
- Announced Date:
- April 16, 2025
- Indication:
- flu vaccine
Announcement
PDS Biotechnology nnounced that preclinical immune response data with a novel Infectimune® based flu vaccine will be featured in a symposium on universal influenza vaccines at the American Association of Immunologists' IMMUNOLOGY2025™ Annual Meeting, taking place May 3-7, 2025, in Honolulu, Hawaii.
AI Summary
PDS Biotechnology announced that its preclinical immune response data for a novel Infectimune®-based flu vaccine will be featured at a symposium on universal influenza vaccines during the American Association of Immunologists’ IMMUNOLOGY2025™ Annual Meeting. The event is set for May 3–7, 2025, in Honolulu, Hawaii. The presentation, titled “Broadly Protective Immunity against Influenza and Opportunities for Universal Influenza Vaccines,” is scheduled for Sunday, May 4, 2025, from 8:30 to 10:30 a.m. HST in Room 314. Dr. Andrea Sant, a Professor of Microbiology and Immunology at the University of Rochester Medical Center, will lead the discussion. This symposium offers an opportunity to explore the potential of the Infectimune® vaccine in stimulating a strong immune response and contributing to the broader effort to develop universal influenza vaccines.
Read Announcement
Versamune FDA Regulatory Events
Versamune is a drug developed by PDS Biotechnology for the following indication: For head and neck squamous cell carcinoma ("HNSCC").
This drug is under review by the U.S. Food and Drug Administration (FDA).
Below is a timeline of key regulatory milestones for this therapy.
- Drug:
- Versamune
- Announced Date:
- March 13, 2025
- Indication:
- For head and neck squamous cell carcinoma ("HNSCC")
Announcement
PDS Biotechnology announced that the U.S. Food and Drug Administration has cleared its Investigational New Drug ("IND") application filed in January 2025 to evaluate a combination of Versamune® MUC1 (formerly PDS0103), its novel investigational MUC1-targeted immunotherapy candidate + PDS01ADC to treat MUC1-positive unresectable, metastatic colorectal carcinoma ("mCRC") in patients who failed previous treatment.
AI Summary
PDS Biotechnology announced that the U.S. Food and Drug Administration has cleared its Investigational New Drug (IND) application filed in January 2025. This clearance allows the evaluation of a combination treatment for patients with unresectable, metastatic colorectal carcinoma (mCRC) who have previously failed treatment. The new therapy pairs Versamune® MUC1 (formerly PDS0103) with a novel MUC1-targeted immunotherapy candidate and PDS01ADC. MUC1 is a protein over-expressed in several solid tumors and is linked to drug resistance and poor outcomes. By targeting MUC1, the treatment aims to trigger a robust and long-lasting T-cell response against tumors, offering a promising new strategy for patients with difficult-to-treat mCRC. This development represents a significant step toward expanding immunotherapy options and potentially overcoming current treatment limitations for MUC1-positive cancers.
Read Announcement- Drug:
- Versamune
- Announced Date:
- August 1, 2024
- Indication:
- For head and neck squamous cell carcinoma ("HNSCC")
Announcement
PDS Biotechnology Corporation announced that it has received the official minutes from its meeting with the U.S. Food and Drug Administration ("FDA") regarding next steps in its planned Phase 3 clinical trial of its Versamune® based investigational immunotherapy designed to stimulate a targeted T cell attack against HPV16-positive head and neck squamous cell carcinoma ("HNSCC").
AI Summary
PDS Biotechnology Corporation announced that it has received the official minutes from its recent meeting with the U.S. Food and Drug Administration (FDA), which detailed the next steps for its planned Phase 3 clinical trial. The trial will assess its Versamune® based investigational immunotherapy, designed to trigger a targeted T cell attack against HPV16-positive head and neck squamous cell carcinoma (HNSCC), in combination with pembrolizumab. The FDA supported the trial’s design, including the updated statistical endpoints for the VERSATILE-003 study, while also requesting additional safety data during the lead-in dose optimization phase for a potential triple combination that includes PDS01ADC.
To avoid delays in the randomized trial, the FDA agreed that the dose optimization would occur separately. This alignment with the FDA is a key step toward initiating enrollment in the pivotal Phase 3 trial, which focuses on overall survival as the primary endpoint.
Read Announcement
