PDS: Updated Results, VERSATILE-002 Phase 2 Trial

NetScientific PLC

16 September 2024

 

Immediate release

NetScientific plc

PDS Biotech Announces Updated Results from VERSATILE-002 Phase 2 Clinical Trial Presented at ESMO 2024

Median Overall Survival remains at 30 months; Objective Response Rate of 36% and Disease Control Rate of 77%

11/53 (21%) of patients experienced 90-100% tumour shrinkage

VERSATILE-003 Phase 3 clinical trial planned to begin this year

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% direct holding, has 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).

PDS 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 data were presented during a poster session on September 14 at the European Society for Medical Oncology (ESMO) Congress 2024 in Barcelona, Spain.

As of the latest data cut of the VERSATILE-002 single-arm, Phase 2 trial on May 17, 2024, Versamune^® HPV plus pembrolizumab continued to be well tolerated in this 1L R/M HPV16-positive HNSCC population. Enrollment in the trial (n=53) is complete, 10 patients remain on study treatment and 27 patients (including the 10 on treatment) continue to be followed for survival. Median patient follow-up is 16 months. The data demonstrated the following:

·    Median Overall Survival (mOS) was 30 months with a lower 95% confidence interval of 19.7 months; Published  mOS for pembrolizumab is 12-18 months^1,2

·      Objective Response Rate (ORR) of 36% (19/53); Published ORR for pembrolizumab is 19-25%^1,2

·      Disease Control Rate (DCR) is 77% (41/53)

·      21% (11/53) of patients had deep tumour responses and shrinkage of 90-100%

·      9% (5/53) of patients had a complete response

·      Treatment-related adverse events of Grade ≥3 were seen in 9 patients (Grade 3, n=8 and Grade 4, n=1)

Jared Weiss, M.D., Section Chief of Thoracic and Head/Neck Oncology, Professor of Medicine at the University of North Carolina, and principal investigator of the VERSATILE-002 clinical trial said:

"The updated response data we presented at ESMO show the strong clinical activity and durability of Versamune^® HPV plus pembrolizumab. Continued evaluation shows the promise of this combination in improving survival for patients with HPV16-positive HNSCC."

A global, randomized, controlled Phase 3 clinical trial, VERSATILE-003, that will evaluate Versamune® HPV plus pembrolizumab vs. pembrolizumab monotherapy as 1L treatment in patients with HPV16-positive R/M HNSCC with CPS ≥1 is planned to start this year.

Dr. Kirk Shepard, MD, Chief Medical Officer of PDS Biotech stated:

"We're encouraged to see that as the data from our VERSATILE-002 clinical trial have matured, responses continue to improve, suggesting durability of the Versamune^® HPV induced anti-tumour immune response.  The encouraging patient survival and clinical responses coupled with promising tolerability as seen in the VERSATILE-002 trial underscore our belief in the potential of the combination to be the first HPV-targeted immunotherapy for HNSCC, and a significant advancement in the treatment of the growing population of patients with HPV16-positive HNSCC. We are working toward initiating the VERSATILE-003 Phase 3 study this year."

Versamune^® HPV has been granted Fast Track designation by the FDA.

1.    Harrington K. et al. J Clin Oncol. 2022 ascopubs.org/journal/jco on October 11, 2022: DOI https://doi.org/10.1200/JCO.21.02508

2.    Licitra L. et al. 2024, International Journal of Radiation Oncology Volume 118, Issue 5e2-e3April 01

No head-to-head studies have been performed comparing Versamune^® HPV with other treatments

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

https://www.pdsbiotech.com/index.php/investors/news-center/press-releases/press-releases1/131-2024-news/945-iotechnnouncespdatedesultsfrom002h20240916

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About NetScientific

NetScientific plc (AIM: NSCI) is a deep tech and life sciences VC investment group with an international portfolio of innovative companies.

NetScientific identifies, invests in, and builds high growth companies in the UK and internationally.

The company adds value through the proactive management of its portfolio, progressing to key value inflection points, and delivering investment returns through partial or full liquidity events.

NetScientific differentiates itself by employing a capital-efficient investment approach, making judicial use of its balance sheet and syndicating investments through its wholly owned VC subsidiary, EMV Capital. The group secures a mixture of direct equity stakes and carried interest stakes in its portfolio of companies, creating a lean structure that can support a large portfolio.

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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 HPV16-positive head and neck squamous cell cancers. PDS Biotech's lead investigational targeted immunotherapy Versamune^® HPV 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.

www.pdsbiotech.com

 

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