PDS Biotech Announces Updated Survival Data

NetScientific PLC

09 November 2023

 

RNS: For immediate release

NetScientific plc

PDS Biotech Announces Updated Survival Data from NCI-Led Phase 2 Clinical Trial of PDS0101-Based Triple Combination Therapy in Advanced HPV16-Positive Cancer Patients which Show 75% Survival of ICI Naïve Patients at 36 Months

75% of immune checkpoint inhibitor (ICI) naïve patients remain alive at 36 months; published median overall survival (OS) in similar patients is 7-11 months

12-month survival rate in ICI resistant patients is 72%

Median OS in ICI resistant patients is approximately 20 months; published median OS is 3.4 months

NetScientific Plc (AIM: NSCI), the deep tech and life sciences VC investment group, reports that its portfolio company, PDS Biotechnology Corporation (Nasdaq: PDSB), 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, has announced updated survival data from the Phase 2 clinical trial investigating the triple combination of PDS0101, PDS0301 (IL-12 antibody-drug conjugate) and an investigational immune checkpoint inhibitor (ICI) in two groups of advanced cancer patients with various types of human papillomavirus (HPV) 16-positive cancers.

The ICI naïve group had not responded to standard-of-care treatments but had not yet been treated with an ICI. The ICI resistant group included patients who had not responded to multiple prior treatments, including ICI therapy. Investigators at the National Cancer Institute (NCI), part of the National Institutes of Health, have completed the primary endpoint analysis of the Phase 2 trial.

In the ICI naïve group, final survival data from the trial indicated that 75% (6/8) of these patients were still alive at 36 months, and the median overall survival (OS) has not yet been reached. Published data on standard-of-care ICIs report 30-50% of these patients typically remain alive at 12 months, and less than 30% of the patients remain alive at 24 months.

In the ICI resistant group, the 12-month OS rate was 72% and the triple combination achieved a median OS of approximately 20 months. In addition:

·      For PDS0101 plus high doses of ICI and PDS0301, the overall response rate (ORR) was 63% (5/8).

·      For PDS0101 plus low doses of ICI and/or PDS0301, the ORR was 5% (1/21).

·    The historical median survival for ICI therapy in HPV-positive cancer ICI resistant patients is reported to be 3.4 months.

Frank Bedu-Addo, PhD, Chief Executive Officer of PDS Biotech said:

"We are encouraged by the survival rates for both ICI naïve and ICI resistant patients with HPV16-positive cancers who were treated with the triple combination therapy.  The ICI resistant data from the VERSATILE-002 trial evaluating PDS0101 in combination with KEYTRUDA^® (pembrolizumab) that were reported 3 October 2023, further clarify the path forward for a potential registrational clinical trial of PDS0101 and PDS0301 in combination with a commercial ICI. With this exciting information, we will be finalising the regulatory and clinical pathway for the triple combination with OS as the primary endpoint."

PDS0101, PDS Biotech's lead candidate, is a Versamune^® based investigational immunotherapy designed to stimulate a potent targeted T cell attack against HPV16-positive cancers. PDS0301 is a novel, proprietary investigational tumour-targeting IL-12 antibody-drug conjugate that enhances the proliferation, potency, and longevity of T cells in the tumour microenvironment formulated to overcome tumour immune suppression utilizing a different mechanism from checkpoint inhibitors. PDS Biotech has patented the combination of Versamune^® and IL-12.   The investigational ICI used in the triple combination therapy is Bintrafusp alfa, a bifunctional fusion protein targeting two independent immunosuppressive pathways (PD-L1 and TGF-β).

About PDS0101

PDS0101, PDS Biotech's lead candidate, is a novel investigational human papillomavirus (HPV)-targeted immunotherapy that stimulates a potent targeted T cell attack against HPV-positive cancers. PDS0101 is given by subcutaneous injection alone or in combination with other immunotherapies and cancer treatments. In a Phase 1 study of PDS0101 in monotherapy, the treatment demonstrated the ability to generate multifunctional HPV16-targeted CD8 and CD4 T cells with minimal toxicity. Interim data suggests PDS0101 generates clinically active immune responses, and the combination of PDS0101 with other treatments can demonstrate significant disease control by reducing or shrinking tumours, delaying disease progression and/or prolonging survival. The combination of PDS0101 with other treatments does not appear to compound the toxicity of other agents.

About PDS0301

PDS0301 is a novel investigational tumour-targeting IL-12 antibody-drug conjugate IL-12 that enhances the proliferation, potency and longevity of T cells in the tumour microenvironment. PDS0301 is given by a subcutaneous injection. PDS0301 is designed to improve the safety profile of IL-12 and to enhance the anti-tumour response.

References:

Strauss J et al. Journal for Immuno Therapy of Cancer 2020;8:e001395
Burtness B et al., Lancet. 2019; 394:1915-1928
Ferris RL, et al. NEJM. 2016;375:1856-67

A full version of PDS Biotech's announcement can be accessed here:  https://pdsbiotech.com/index.php/investors/news-center/press-releases/press-releases1/125-2023-news/885-iotechnnouncespdatedurvivalatafromedh20231109

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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 tumors 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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