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| Date | 7 Nov 2022 |
| Time | 15:40:57 |
| Category | Corporate updates |
| ID | 5769F |
For immediate release
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.
· 87.5% (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.
-Ends-
For more information, please contact:
NetScientific
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: langus@belvederepr.com
About NetScientific
NetScientific Plc ("NSCI") is an active holding Company that proactively invests in a global portfolio of companies across the healthcare, life science, ESG, and deep technology sectors. NetScientific delivers shareholder returns through a proactive and hands-on management approach to its portfolio companies; identifying, investing in, and helping to build game-changing companies. The Group targets value inflection points and the release of value through partial or full exits from trade sales, public listings, or equity sales. The Company has a strong Trans-Atlantic and growing international presence, providing attractive expansion prospects.
The Company differentiates itself by employing a capital-light investment approach, making use of its wholly owned subsidiary, EMV Capital's network of private, corporate, and institutional investors. By syndicating investment and making minimal use of its balance sheet, the Company is able to secure direct stakes, as well as carried interest stakes, in its portfolio. This ultimately creates a structure that can support a large portfolio with a limited balance sheet.
NetScientific is headquartered in London, United Kingdom, and was admitted to trading on AIM, a market operated by the London Stock Exchange, in 2013.
About PDS Biotech
PDS Biotech is a clinical-stage immunotherapy company developing a growing pipeline of targeted cancer and infectious disease immunotherapies based on our proprietary Versamune® and Infectimune™ T cell-activating technology platforms. We believe our targeted Versamune® based candidates have the potential to overcome the limitations of current immunotherapy by inducing large quantities of high-quality, potent polyfunctional tumor specific CD4+ helper and CD8+ killer T cells. To date, our lead Versamune® clinical candidate, PDS0101, has demonstrated the potential to reduce tumors and stabilize disease in combination with approved and investigational therapeutics in patients with a broad range of HPV-expressing cancers in multiple Phase 2 clinical trials. 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.