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PDS Biotech Announces Expanded Interim Data in PDS0101 Triple Combination Phase 2 Trial Targeting Advanced HPV-Positive Cancers
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NetScientific PLC
(“NetScientific”, the “Group” or the “Company”)
PDS Update
PDS Biotech Announces Expanded Interim Data in PDS0101 Triple Combination Phase 2 Trial Targeting Advanced HPV-Positive Cancers
NetScientific plc (AIM: NSCI), the international life sciences and sustainability technology investment and commercialisation Group, announces that its portfolio company, PDS Biotechnology Corporation (Nasdaq: PDSB), announced expanded interim data in the Phase 2 clinical trial investigating the PDS0101-based triple combination therapy in advanced human papillomavirus (HPV)-positive cancers.
This Phase 2 study is being conducted at the Center for Cancer Research (CCR) at the National Cancer Institute (NCI), one of the Institutes of the National Institutes of Health. The interim efficacy data from 37 HPV16-positive evaluable patients, including 29 patients in the checkpoint inhibitor (CPI) refractory arm, are consistent with the results presented at ASCO 2022 and affirm the selection of CPI refractory patients as the initial patient population for ongoing clinical development of the triple combination.
The NCI-led Phase 2 clinical trial (NCT04287868) 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) – in recurrent or metastatic HPV-positive cancers in patients who have failed prior therapy. The triple combination is being studied in CPI-naïve and -refractory patients with advanced HPV-positive anal, cervical, head and neck, vaginal, and vulvar cancers. Both M9241 and bintrafusp alfa are owned by Merck KGaA, Darmstadt, Germany.
Highlights of the expanded interim data are as follows:
- Survival data: 66% (19/29) of HPV 16-positive CPI refractory patients in the cohort were alive at a median follow up of 16 months. Historically, this group has a median overall survival of only 3-4 months. i
- Safety profile: 48% (24/50) of patients experienced Grade 3 treatment-related adverse events (AEs), and 4% (2/50) patients experienced Grade 4 AEs. There were no grade 5 treatment-related AEs
Results for HPV 16-positive checkpoint inhibitor naïve patients also continue to appear to be encouraging: 75% (6/8) of CPI naïve patients were alive at a median of 25 months of follow up. 38% (3/8) of responders had a complete response.
Dr. Frank Bedu-Addo, Chief Executive Officer of PDS Biotech commented: “The expanded interim data investigating the PDS0101-based triple combination therapy in advanced HPV-positive cancers continue to appear to show clinical signs of efficacy, durability and safety in an extremely challenging patient population with very few available treatment options.
“Importantly, these results affirm the decision to explore this novel combination for the treatment of CPI refractory patients, who have no approved standard of care, and support development of a combination therapy to address the significant unmet need.”
Dr. Ilian Iliev, CEO of NetScientific, commented: “In a really challenging biotech public market, PDS stands out for its consistent and steady delivery on its objectives. We are delighted with the results and continue to monitor progress.”
The full text of the announcement from PDS Biotechnology is available online here: PDS Biotech – PDS Biotech Announces Expanded Interim Data in PDS0101 Triple Combination Phase 2 Trial Targeting Advanced HPV-Positive Cancers
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
About NetScientific
NetScientific plc (AIM: NSCI) is a holding company, that invests in, develops, commercialises and realises shareholder value in life sciences/healthcare, sustainability and technology companies, which offer significant growth potential predominately in the UK, EU and USA.
With the acquisition of EMV Capital in August 2020 and further investment activities, the Group more than doubled its portfolio from 8 to 22 companies. These are held as direct subsidiary and minority stakes, through balance sheet investment or capital under advisory, varying from start-up private companies to publicly listed equities.
NetScientific delivers shareholder returns through a proactive and hands-on management approach to their 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 transatlantic and growing international presence, providing attractive expansion prospects.
NSCI can deploy a capital-light investment structure; utilising the power of the PLC Brand, and the NetScientific balance sheet to anchor future investments and achieve a multiplier effect by attracting 3rd party investment for the portfolio companies.
NetScientific is headquartered in London, United Kingdom, and was admitted to trading on AIM, a market operated by the London Stock Exchange, in 2013.