PDS prioritise PDS0101 in high risk HPV to Phase 2
("NetScientific" or the "Company")
Portfolio Company PDS Biotechnology to prioritise lead immunotherapy treatment in high-risk human papillomavirus (HPV) into Phase 2 studies
London, UK - 1 October 2019 - NetScientific plc (AIM: NSCI), the transatlantic healthcare IP commercialisation Group, is pleased to note today's announcement by portfolio company, PDS Biotechnology ("PDS") (Nasdaq: PDSB) to prioritise clinical development of PDS0101 in combination therapies targeting advanced cancers. This follows PDS' recent reporting of promising PDS0101 Phase 1 clinical trial outcome data, in which regression of lesions was demonstrated in 60% of patients.
Ian Postlethwaite, CEO of NetScientific, said:
"It is great to see the growing momentum at PDS following the positive Phase I data for their lead immunotherapy treatment for high-risk HPV. They are set to advance their combination studies with PDS0101 in various advanced HPV-associated cancers into Phase 2 clinical studies which are partnered with top leaders in the field. As a shareholder in PDS, we continue to provide our support and look forward to hearing updates on the progress of PDS0101 in the future."
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Below is the full announcement made today by PDS Biotechnology:
PDS Biotechnology Prioritizes Development of PDS0101 in Advanced Cancers Following Promising Phase 1 Clinical Outcome Data
Data demonstrated regression of lesions in 60% of patients
Berkeley Heights, NJ, October 1, 2019 - PDS Biotechnology Corporation ("PDS Biotechnology") (Nasdaq: PDSB), a clinical-stage immuno-oncology company pioneering the development of multi-functional immunotherapeutic products, today announced it will prioritize clinical development of PDS0101 in advanced cancers following its recent reporting of promising PDS0101 Phase 1 clinical trial outcome data.
On September 19, 2019, PDS reported clinical outcome data from a Phase 1 clinical trial of PDS0101 in patients with cervical intraepithelial neoplasia (CIN) infected with multiple high-risk, cancer-causing types of human papillomavirus (HPV). The study demonstrated robust treatment-induced HPV16-specific killer T-cell (CD8+) responses as well as clearance of the disease and regression of lesions in 60% of patients. These in-vivo PDS0101-induced T-cells were demonstrated to induce granzyme-b thus confirming their cytolytic/killing potency. This clinical data supports the superior CD8+ T-cell induction and anti-tumor efficacy of the Company's Versamune® platform, as published based on the results of preceding preclinical studies in the June 2019 Issue of the Journal of Immunology.
"Our intent is to continue to advance our previously announced combination studies with PDS0101 in various advanced HPV-associated cancers. These phase 2 clinical studies are partnered with top leaders in the field. We also intend to rapidly progress PDS0102 (targeting prostate and breast cancers), PDS0103 (targeting colon, lung, ovarian cancers) and PDS0104 (targeting melanoma) into human clinical trials in combination with checkpoint inhibitors. This approach has been recently supported by promising Phase 1 clinical outcome data," said Dr. Frank Bedu-Addo, CEO of PDS. "The unique ability of PDS0101 to promote in-vivo induction of high levels of CD8+ T-cells overcomes a significant limitation of many current immunotherapy approaches such as checkpoint inhibitors. Checkpoint inhibitors have a proven ability to induce effective anti-tumor responses in approximately 20% of patients by "releasing the brakes" of the immune system that have been activated by cancer. It has been reported that there is a strong correlation between the presence of tumor-targeting CD8+ T-cells and the efficacy of checkpoint inhibitors. We believe that the Versamune® platform, by promoting induction of these tumor-specific cytolytic CD8+ killer T cells, could be critical to substantially expanding clinical efficacy of checkpoint inhibitors into a larger percentage of the population, which could address unmet patient needs for improved treatment options across a range of advanced cancer indications."
As a result of the recent data showing strong CD8+ T-cell induction and the subsequent decision to prioritize the platform's application in combination therapies addressing advanced cancer, the Company no longer anticipates starting a Phase 2 study to evaluate PDS0101 monotherapy in CIN2/3 as previously reported.
About the Versamune® Platform Technology Versamune® is a proprietary, synthetic lipid-based T-cell activating platform. PDS Biotechnology's pipeline of Versamune®-based products, which are administered by subcutaneous injection, provides strong activation of type I interferon genes. The Versamune® mechanism of action also involves effective presentation of tumor antigens via the MHC Class I and Class II pathways. These mechanisms together promote strong in-vivo induction of polyfunctional tumor-targeting CD8+ T-cells. Versamune®-based immunotherapies have been demonstrated to alter the tumor micro-environment in preclinical mechanism of action studies, thus further enhancing the ability of Versamune®-induced T-cells to effectively kill tumor cells. Preclinical data demonstrating the novel multi-functional mechanism of action of the Versamune® platform technology and the resulting superior T-cell induction and unique regression of advanced tumors were published in the Journal of Immunology (Journal of Immunology, Vol. 202, Issue 1215 June 2019).
About PDS Biotechnology and PDS0101 PDS Biotechnology is a clinical stage immuno-oncology company with a growing pipeline of clinical-stage immunotherapies to treat various HPV-associated cancers, including head and neck cancer, cervical and anal cancers. PDS0101 includes the Versamune® immune-activating platform and a mixture of HPV16 E6 and E7 peptide antigens designed to induce cytolytic T-cell responses against HPV expressed in patients with HPV-associated cancers. Clinical outcome findings from the PDS0101 Phase 1 clinical study demonstrated unique in-vivo systemic induction of high levels of granzyme-b inducing HPV-specific killer T-cells associated with observed clinical responses (regression and elimination of pre-cancerous lesions) in the majority of evaluable patients treated with PDS0101 monotherapy, and a lack of dose limiting toxicities at all tested doses. Versamune® is a registered trademark of PDS Biotechnology Corporation, Berkeley Heights, NJ, USA.
For full release and additional information about PDS, please visit www.pdsbiotech.com.
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This announcement contains inside information for the purposes of Article 7 of the Market Abuse Regulation (EU) No. 596/2014.
For more information, please contact:
Ian Postlethwaite, CEO / CFO
Tel: +44 (0)20 3514 1800
WHIreland (NOMAD, Financial Adviser and Broker)
Chris Fielding / Darshan Patel
Tel: +44 (0)20 7220 1666
MO PR ADVISORY (Press Contact)
Tel: +44 (0)78 7644 4977
NetScientific PLC is a transatlantic healthcare IP commercialisation Group focused on technologies and companies that have the potential to treat chronic disease and significantly improve the health and well-being of people.
For more information, please visit the website at www.NetScientific.net
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