PDS Biotech Announces Presentation of Data for PDS0101 at Society for Immunotherapy of Cancer

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PDS Biotechnology

NetScientific plc

(“NetScientific” or the “Company”)

PDS Biotech Update

PDS Biotech announces presentation of data for PDS0101 at Society for Immunotherapy of Cancer

NetScientific Plc (AIM: NSCI), the international life sciences and sustainability technology investment and commercialisation Group, is delighted to report that its portfolio company, PDS Biotechnology Corporation (Nasdaq: PDSB), has announced upcoming presentations of clinical data from two Phase 2 clinical trials of PDS0101.

PDS0101 is PDS Biotech’s lead candidate being developed as a potential treatment for HPV-positive cancers.

The presentations will be made at the 37th Annual Meeting for the Society for Immunotherapy of Cancer being held from 8 to 12 November 2022 in the United States.  The Society for Immunotherapy of Cancer is the world’s leading member society of medical professionals dedicated to advancing cancer immunotherapy and biological therapy.

First Abstract and Highlights 

The first abstract accepted for presentation titled “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,” highlights data from The University of Texas MD Anderson Cancer Center-led IMMUNOCERV Phase 2 clinical trial (NCT04580771).

The study is investigating PDS0101 in combination with standard-of-care chemoradiotherapy (CRT) for the potential treatment of cervical cancer in patients with large tumors over 5cm in size and/or cancer that has spread to the lymph nodes (lymph node metastasis).

Highlights from the study include:

• 17 patients have been enrolled in the trial.
• 8 of the 17 patients had completed a Day 170 post-treatment Positron Emission Tomography, Computed Tomography (PET CT) scan to assess the status of the cancer.
• 5% (7/8) of patients treated with the combination of PDS0101 and CRT demonstrated a complete response (CR) on Day 170 by PET CT. One patient who received 3 of the 5 scheduled doses of PDS0101 showed signs of residual disease.
• In comparison, 74.1% (40/54) of locally advanced patients who received CRT alone and were monitored at The University of Texas MD Anderson Cancer Center on a prospective protocol independent of IMMUNOCERV had a CR on PET CT at Day 170.
• The 1-year overall survival is 100% (8/8) in patients treated with the combination of PDS0101 and CRT.
• The observed 1-year disease-free survival rate for IMMUNOCERV patients is 87.5% (7/8).
• Patients treated with the combination of PDS0101 and CRT had a 71% increase in multi-cytokine-inducing (polyfunctional) killer (CD8+) T cells within the tumors from baseline to end of treatment (38% to 65%). This increase in activated T cells was not seen in patients receiving standard-of-care CRT.
• Toxicity of PDS0101 was limited to low-grade local injection site reactions.

Second Abstract and Highlights 

The second abstract, titled “Immune Correlates Associated with Clinical Benefit in Patients with Checkpoint Refractory HPV-Associated Malignancies Treated with Triple Combination Immunotherapy,” reports data from the Phase 2 triple combination trial (NCT04287868), which is being led by the Center for Cancer Research at the National Cancer Institute (NCI), part of the National Institutes of Health.

The study is investigating PDS0101 in combination with two investigational immune-modulating agents: M9241, a tumor-targeting IL-12 (immunocytokine), and bintrafusp alfa, a bifunctional checkpoint inhibitor (PD-L1/ TGF-β). The triple combination is being studied in checkpoint inhibitor (CPI)-naïve and -refractory patients with advanced HPV-positive anal, cervical, head and neck, vaginal, and vulvar cancers who have failed prior therapy. For most patients who are CPI refractory, there is no effective therapy. The immune correlates before and after treatment in the CPI refractory patient population were studied.

Highlights from the study include:

• A more than two-fold increase in HPV16-specific T cells in the blood of 79% (11/14 tested) of the evaluated patients.
• Immune responses were associated with increases in natural killer cells, soluble granzyme B (associated with active killer T cells), IFN-γ, TNF-α, etc., two weeks after the first treatment cycle thus signaling a pro-inflammatory response.
• These immunogenicity findings highlight the potential role of the combination in altering immune suppressive forces, and support previously announced results documenting promising clinical outcomes in the CPI-refractory population receiving the triple combination.

Dr Ilian Iliev, CEO of NetScientific, said that:

“We are delighted that research describing PDS0101’s therapeutic potential will be highlighted in two presentations at the prestigious and respected Annual Meeting of the Society of Immunotherapy of Cancer in Boston, Massachusetts. 

“These presentations set out remarkable progress in the fight against HPV-positive cancers, and PDS Biotech should be enormously proud of their achievements.  We wish them well at the Annual Meeting, and encourage attendees to engage with the team and their findings as they continue their all-important work to battle various diseases.”

Dr Frank Bedu-Addo, CEO of PDS Biotech, said that:

“Taken together, the data being presented demonstrate the potential ability of PDS0101 to elicit in patients the right type and quality of therapeutic immune response. This seems to allow PDS0101 to work in combination with a variety of therapeutic agents to generate clinical responses that appear to exceed current standards of care and allow for improved outcomes in patients with HPV-positive cancers. We look forward to continued progression of our Phase 2 clinical trials evaluating the efficacy, safety and tolerability of PDS0101 in combination with other therapies.”

A full version of PDS Biotech’s  announcement can be accessed here: PDS Biotech Announces Presentation of Preliminary PDS0101 Efficacy, Safety, and Immunology Data at (campaign-archive.com)

This announcement contains inside information for the purposes of Article 7 of the UK version of Regulation (EU) No 596/2014 which is part of UK law by virtue of the European Union (Withdrawal) Act 2018, as amended (“MAR”). Upon the publication of this announcement via a Regulatory Information Service, this inside information is now considered to be in the public domain.

For more information, please contact:

NetScientific PLC

Ilian Iliev, CEO

Via Belvedere Communications

WH Ireland (NOMAD, Financial Adviser and Broker)

Chris Fielding / Darshan Patel / Enzo Aliaj

+44 (0)20 7220 1666

Belvedere Communications

John West / Llew Angus

+44 (0) 203 008 6867

Email: nsci@belvederepr.com