PDS Biotech: Clinical trial meets study endpoints

PDS Biotech VERSATILE-002 Phase 2 Clinical Trial Meets Primary Study Endpoints in First Line Recurrent/Metastatic HPV16-Positive Head and Neck Cancer

30 month median overall survival (OS); median OS independent of patient CPS score

ORR 34% (CPS≥1); 48% (CPS≥20)

Phase 3 registrational trial planned to initiate in 2024

NetScientific Plc (AIM: NSCI), the deep tech and life sciences VC investment group, reports that its portfolio company, PDS Biotechnology Corporation (Nasdaq: PDSB), in which it holds a 3.5% direct holding, hosted a Key Opinion Leader event on May 8, 2024. PDS Biotech is a late-stage immunotherapy company focused on transforming how the immune system targets and kills cancers and the development of infectious disease vaccines. During the event, prominent experts in head and neck squamous cell cancer ("HNSCC") discussed positive, updated VERSATILE-002 data and the unmet need in HPV16-positive HNSCC. A replay of the event can be found here.

• The VERSATILE-002 trial is evaluating Versamune® HPV + KEYTRUDA® (pembrolizumab) in patients with HPV16-positive HNSCC.
• Median overall survival ("mOS") is 30 months (n=53) in first line recurrent metastatic HNSCC; Published results for immune checkpoint inhibitors are 7-18 months.
• The immune checkpoint inhibitor (ICI) naïve cohort (n=53) met its primary endpoint of best overall response (BOR).

o BOR by investigator assessment is 34% (Combined Positive Score (CPS) ≥1; n=18/53); 48% (CPS≥20; n=10/21); Published results for ICIs are <20% (CPS>1) and <25% (CPS≥20).

o Progression free survival ("PFS") is 6.3 months (CPS≥1); 14.1 months (CPS≥20); Published results for immune checkpoint inhibitors 2-3 months.

o VERSATILE-002 data to date indicate a durable response in first line recurrent and / or metastatic HNSCC patients with CPS≥1.

o The combination of Versamune® HPV + pembrolizumab was well tolerated.

• The Company announced an updated clinical strategy with a two-part registrational trial focused on the triple combination of Versamune® HPV + PDS01ADC + pembrolizumab as a first line treatment in HPV16-positive recurrent/metastatic HNSCC.

o PDS01ADC is the Company's novel, investigational tumour-targeting IL-12-fused antibody-drug conjugate (ADC), which has shown promise in a clinical trial of Versamune® HPV + PDS01ADC + an investigational ICI conducted by the National Cancer Institute.

o Part one of the clinical trial will focus on dose optimisation with a data readout based on safety and objective response rate.

o The randomised second part of the trial will include an interim data readout with OS as its primary endpoint.

A full version of PDS Biotech's announcement can be accessed here:

About PDS Biotechnology

PDS Biotechnology is a late-stage immunotherapy company focused on transforming how the immune system targets and kills cancers and the development of infectious disease vaccines. The Company plans to initiate a pivotal clinical trial in 2024 to advance its lead program in advanced head and neck squamous cell cancers (HNSCC). PDS Biotech's lead program is a proprietary dual-acting combination of IL-12 fused antibody drug conjugate (ADC) PDS01ADC and T-cell activator Versamune® HPV in regimen with a standard-of-care immune checkpoint inhibitor. We believe that proof-of-concept long-term data have shown positive survival results and tumour shrinkage with this combination and indicate favourable tolerability.

We believe that with a novel investigational "inside-outside" mechanism, the PDS01ADC and Versamune® HPV immunotherapy has shown compelling results with potential to successfully disrupt a tumour inside defences, while also generating potent, targeted killer T-cells to attack the tumour from the outside. We believe that data from more than 350 patients, as well as ongoing clinical trials across multiple tumour types and standard treatment regimens, have validated the potential for both platforms and point to potential broad utility.

Our Infectimune® based vaccines have demonstrated the potential to induce not only robust and durable neutralising antibody responses, but also powerful T-cell responses, including long-lasting memory T-cell responses in pre-clinical studies to date. For more information, please visit www.pdsbiotech.com.