PDS Preliminary Biomarker Study Results

NetScientific PLC

23 October 2023

 

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Biotech Announces Preliminary Biomarker Study Results in Subset of Advanced HPV-Positive Head and Neck Cancer Patients at ESMO

Combination of PDS0101 and KEYTRUDA^® appears to lead to changes towards a TH1 predominant cytokine profile reported to be associated with improved killer T cell activity

Lowered CD8 T cells in peripheral blood after treatment align with previously reported CD8 T cell targeting and accumulation in tumors¹

NetScientific Plc (AIM: NSCI), the deep tech and life sciences VC investment group, reports that its portfolio company, PDS Biotechnology Corporation (Nasdaq: PDSB) ("PDS Biotech" or "the Company"), a clinical-stage immunotherapy company developing a growing pipeline of targeted cancer immunotherapies and infectious disease vaccines based on the Company's proprietary T cell activating platforms, announced immune response data from a preliminary analysis of a subset of patients in VERSATILE-002, the Phase 2 clinical trial evaluating the safety and efficacy of PDS0101 in combination with Merck's anti-PD-1 therapy KEYTRUDA^® (pembrolizumab) in patients with human papillomavirus (HPV)16-positive recurrent or metastatic head and neck squamous cell carcinoma (HNSCC). The data presented during the European Society for Medical Oncology Congress 2023 (ESMO Congress 2023) provided preliminary insight to the pre-existing immune responses in advanced HPV-positive HNSCC patients and potential changes to the immune profile after treatment.

Kevin Harrington, PhD, Professor of Biological Cancer Therapies, The Royal Marsden

"Generation of multifunctional, anti-tumour T cells with the relevant cytokine and chemokine profiles are necessary for effective long-term control of tumour growth and clinical outcomes. This initial study focused on understanding the immunological profile of advanced head and cancer patients in the blood. This preliminary study suggests that PDS0101 may promote a TH1 predominant cytokine profile as well as induction of important T cell activating chemokines. Such studies could be helpful in providing further insight into how PDS0101 in combination with KEYTRUDA® alters T cell cytokine and chemokine profiles to promote improved clinical outcomes."

The data presented at ESMO 2023 included 18 patients with a median age of 63 years (range 46-83) and all had confirmed HPV16-positive tumours. The immunological profiles were assessed at three timepoints: pre-treatment,12 (cycle 5), and 36 weeks (cycle 13) following four and five cycles of combination therapy, respectively.

Highlights of the analysis include:

·     Combination of PDS0101 and KEYTRUDA® appears to lead to changes towards a TH1 predominant cytokine profile reported to be associated with improved killer T cell activity

·     Combination of PDS0101 and KEYTRUDA® resulted in increased polyfunctionality reflected in T cells expressing 5 or more cytokines. Increased polyfunctionality is typically associated with enhanced killing function and anti-tumour activity

Lauren V. Wood, MD, Chief Medical Officer of PDS Biotech said:

"This analysis provides preliminary insights into how PDS0101 in combination with KEYTRUDA® may be impacting specific cytokines and chemokines in CD8 and CD4 T cell populations. The investigational combination appears to be promoting a predominant TH1 immunologic profile that is associated with decreases in CD8 T cells in peripheral blood. We are encouraged that these observations align with other Phase 2 studies reporting PDS0101-induced polyfunctional CD8 T cells traffic to tumours and we look forward to continued investigation in our VERSATILE-003 Phase 3 study."

1 Klopp A, et al. 2022. IMMUNOCERV, an ongoing Phase II trial combining PDS0101, an HPV-specific T cell immunotherapy, with chemotherapy and radiation for treatment of locally advanced cervical cancers. Presented at: Society for Immunotherapy of Cancer; November 8-12, 2022. Boston, MA. Abstract: 674.

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

PDS Biotech - PDS Biotech Announces Preliminary Biomarker Study Results in Subset of Advanced HPV-Positive Head and Neck Cancer Patients at ESMO

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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.

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About PDS Biotechnology

PDS Biotech is a clinical-stage immunotherapy company developing a growing pipeline of targeted cancer and infectious disease immunotherapies based on our proprietary Versamune^®, Versamune^® plus PDS0301, and Infectimune^® T cell-activating platforms. We believe our targeted immunotherapies have the potential to overcome the limitations of current immunotherapy approaches through the activation of the right type, quantity and potency of T cells. To date, our lead Versamune® clinical candidate, PDS0101, has demonstrated the ability to reduce and shrink tumours and stabilize disease in combination with approved and investigational therapeutics in patients with a broad range of HPV16-associated cancers in multiple Phase 2 clinical trials and will be advancing into a Phase 3 clinical trial in combination with KEYTRUDA^® for the treatment of recurrent/metastatic HPV16-positive head and neck cancer in 2023. Our Infectimune^® based vaccines have also demonstrated the potential to induce not only robust and durable neutralizing antibody responses, but also powerful T cell responses, including long-lasting memory T cell responses in pre-clinical studies to date. To learn more, please visit www.pdsbiotech.com or follow us on Twitter at @PDSBiotech.

 

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