ADDED
In March 2025, we announced the initiation of our VERSATILE-003 Phase 3 clinical trial evaluating PDS0101 (PDS0101) in HPV16-positive first-line treatment of recurrent/metastatic head and neck squamous cell carcinoma.
In July 2025, we announced that the colorectal cancer cohort of a phase 2 clinical trial with PDS01ADC met the pre-defined criteria for expansion to stage 2 following positive stage 1 results.
In August 2025, we announced final topline survival data from our VERSATILE-002 Phase 2 trial evaluating PDS0101 in HPV16-positive first-line treatment of recurrent/metastatic head and neck squamous cell carcinoma.
In September 2025, we announced final topline survival data for the low-CPS patient population from our VERSATILE-002 Phase 2 trial evaluating PDS0101 in HPV16-positive first-line treatment of recurrent/metastatic head and neck squamous cell carcinoma.
In October 2025, we announced our request for a Type C meeting with the FDA to discuss a proposed expedited pathway for our VERSATILE-003 Phase 3 clinical trial, based on a proposed amendment to the trial s design to include progression-free survival as an interim primary endpoint, in addition to median overall survival.
An important function of the body s immune system is to identify and respond to proteins not normally expressed in healthy tissue (antigens).
Processed antigen is turned into peptides that go on to present in both the MHC class I and class II pathways.
As noted, Versamune is injected subcutaneously, and its mechanisms of action are localized primarily in the lymph nodes.
Similarly, in our ongoing Phase 2 trials in combination with other treatments, no dose-limiting toxicities or long-term safety concerns were attributed to PDS0101 since the studies were initiated in 2020.
All the antigens currently being evaluated in combination with Versamune , such as antigens specific to Human Papilloma Virus, are present primarily in cancer cells which should therefore result in tumor-specific T cell attack, thereby minimizing off-target toxicity and potential destruction of healthy cells and tissue.
REMOVED
In December 2022, we executed an exclusive global license agreement with Merck KGaA, Darmstadt, Germany for the tumor targeting IL-12 fused antibody drug conjugate, M9241, which joined our pipeline as PDS01ADC.
PDS01ADC is a novel investigational tumor-targeting fusion protein of IL-12 that enhances the proliferation, potency, infiltration and longevity of T cells in the tumor microenvironment and is therefore designed to overcome the limitations of cytokine therapy which today have resulted in high toxicity and limited therapeutic potential.
The proprietary combination of Versamune HPV and PDS01ADC is designed to overcome tumor immune suppression utilizing a different mechanism from immune checkpoint inhibitors (ICI).
The combination of Versamune and PDS01ADC to overcome immune suppression is patented by us, and we believe our ownership of both assets will streamline the clinical development, registrational process and their potential therapeutic use.
In a Phase 2 National Cancer Institute (NCI)-led clinical trial in ICI-resistant patients, the combination of Versamune HPV and PDS01ADC administered with an investigational bi-functional ICI resulted in a median overall survival of approximately 20 months.
The historical median survival reported in ICI-resistant HPV-positive cancers when treated with ICIs is 3-4 months and best reported median survival to date with systemic therapy is 8.2 months in ICI-resistant head and neck cancer.
In February 2023, we announced completion of a Type B meeting with the FDA for the triple combination of Versamune HPV and PDS01ADC with an FDA-approved immune checkpoint inhibitor for the treatment of recurrent/metastatic, ICI-resistant head and neck cancer that is positive for the human papilloma virus (HPV) type 16.
In recent interactions with the FDA, we confirmed the required contents of a clinical protocol for the potential registrational trial.
In June 2023, an abstract was presented at the 2023 American Society of Clinical Oncology: Abstract number 6012, Safety and Efficacy of Immune Checkpoint Inhibitor Na ve Cohort from Study of Versamune HPV and Pembrolizumab in HPV16-positive Head and Neck Squamous Cell Carcinoma (HNSCC) .
In September 2023, data on our investigational universal flu vaccine, PDS0202, was presented at the 9 th European Scientific Working Group on Influenza (ESWI) conference.