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
Infectimune, PDS0101, PDS01ADC, Versamune, VERSATILE-002, and VERSATILE-003. For definitions of regulatory abbreviations such as NDA, BLA, or PDUFA, see the event status legend.
Infectimune - FDA Regulatory Timeline and 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.
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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:
- 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.
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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:
- 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.
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Versamune - FDA Regulatory Timeline and 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.
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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:
- 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.
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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:
- 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
- Estimated Event Date Range:
- October 1, 2024 - December 31, 2024
- Target Action Date:
- Q4 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.
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