PDS Biotechnology Announces Preclinical Data for PDS0203

NetScientific plc

(“NetScientific” or the “Company”)

PDS Biotechnology Announces Preclinical Data for PDS0203, a T-Cell Activating Recombinant Protein Vaccine Against COVID-19

Versamune-CoV-2 (PDS0203) generated high levels of robust, long-lasting CD8 (killer) T-cell responses and potent neutralizing antibody responses within 14 days of vaccination

NetScientific plc (AIM:NSCI), the transatlantic healthcare IP commercialisation group, announces that its portfolio company PDS Biotechnology Corporation (“PDS”) (Nasdaq: PDSB) today announced preclinical data for its COVID-19 vaccine candidate, Versamune-CoV-2 (PDS0203).  PDS0203 pairs the Versamune® platform with a recombinant protein recognized by the human immune system that is derived from the Severe Acute Respiratory Syndrome Coronavirus 2 (SARS-CoV-2) virus that causes COVID-19.  The protein included in PDS0203 encompasses SARS-CoV-2 sections that induce an antibody response, as well as sections that are recognized by CD8 and CD4 T-cells.

PDS Biotech has generated robust preclinical data confirming that PDS0203 elicits induction of highly active and potent virus-specific CD8 killer and CD4 helper T-cells within 14 days of treatment.  Importantly, the study also demonstrated induction of the long-lasting virus-specific memory T-cells necessary for longer term protection.  PDS0203 demonstrated a 30-45 fold increase in COVID-19 specific T-cells by Day 14 when compared to the vaccine without Versamune®.  These preclinical studies also confirmed induction of strong anti-SARS-CoV-2 neutralizing antibodies within 14 days, with a 20-25-fold increase when compared to the vaccine without Versamune®.  Lastly, these preclinical studies showed a further substantial increase in neutralizing antibody levels continuing more than 30 days after vaccination.  PDS Biotech plans to submit details of the preclinical studies to a peer reviewed scientific journal.

As previously announced, the Company has also initiated preclinical development of Versamune®-CoV-2FC (PDS0204), a COVID-19 vaccine candidate being developed in partnership with Brazil-based Farmacore Biotechnology, which combines the immune-activating Versamune® platform with a Farmacore-developed SARS-CoV-2 recombinant fusion protein.

NetScientific holds 7.18% of PDS’ undiluted share capital.

Dr. Ilian Iliev, Chief Executive Office of the Company said: “We are delighted with the excellent progress made by PDS Biotechnology since the investment anchored by NetScientific earlier this year, and that it is contributing to the global efforts towards the COVID-19 pandemic.”

The full details of the announcement are set out below and can be found here: https://www.pdsbiotech.com/investors/news-center/press-releases/press-releases1/56-2020-news/406-iotechnnouncesreclinicalatafor0203ael20200727

# # #

PDS Biotech Announces Preclinical Data for PDS0203, a T-Cell Activating Recombinant Protein Vaccine Against COVID-19

Versamune-CoV-2 (PDS0203) generated high levels of robust, long-lasting CD8 (killer) T-cell responses and potent neutralizing antibody responses within 14 days of vaccination

FLORHAM PARK, N.J., July 27, 2020 (GLOBE NEWSWIRE) — PDS Biotechnology Corporation (Nasdaq: PDSB), a clinical-stage immunotherapy company developing novel cancer therapies and infectious disease vaccines based on the Company’s proprietary Versamune® T-cell activating technology, today announced preclinical data for its COVID-19 vaccine candidate, Versamune-CoV-2 (PDS0203).  PDS0203 pairs the Versamune® platform with a recombinant protein recognized by the human immune system that is derived from the Severe Acute Respiratory Syndrome Coronavirus 2 (SARS-CoV-2) virus that causes COVID-19.  The protein included in PDS0203 encompasses SARS-CoV-2 sections that induce an antibody response, as well as sections that are recognized by CD8 and CD4 T-cells.

PDS Biotech has generated robust preclinical data confirming that PDS0203 elicits induction of highly active and potent virus-specific CD8 killer and CD4 helper T-cells within 14 days of treatment.  Importantly, the study also demonstrated induction of the long-lasting virus-specific memory T-cells necessary for longer term protection.  PDS0203 demonstrated a 30-45 fold increase in COVID-19 specific T-cells by Day 14 when compared to the vaccine without Versamune®.  These preclinical studies also confirmed induction of strong anti-SARS-CoV-2 neutralizing antibodies within 14 days, with a 20-25-fold increase when compared to the vaccine without Versamune®.  Lastly, these preclinical studies showed a further substantial increase in neutralizing antibody levels continuing more than 30 days after vaccination.  PDS Biotech plans to submit details of the preclinical studies to a peer reviewed scientific journal.

“Recent COVID-19 research has highlighted the critical importance of developing vaccines capable of generating high levels of targeted CD8 and CD4 T-cells, in addition to neutralizing antibodies, to achieve durable protection against COVID-19 infection. Our preclinical data shows PDS0203’s ability to rapidly induce both protective antibodies and long-lasting T-cells specific for COVID-19,” commented Dr. Frank Bedu-Addo, CEO of PDS Biotech, “Due to the mechanism by which Versamune® activates a disease-specific immune response, our PDS0101 program demonstrated successful translation of T-cell induction and safety data from preclinical models to humans.  We therefore believe that this encouraging PDS0203 preclinical data may similarly translate to humans.  If so, then it may present unique potential to provide the breadth and level of immune responses necessary for a safe and effective vaccine with long-term protection against COVID-19.”

As previously announced, the Company has also initiated preclinical development of Versamune®-CoV-2FC (PDS0204), a COVID-19 vaccine candidate being developed in partnership with Brazil-based Farmacore Biotechnology, which combines the immune-activating Versamune® platform with a Farmacore-developed SARS-CoV-2 recombinant fusion protein.

About the Versamune® technology platform

The Versamune® technology is based on proprietary immune activating lipids that uniquely activate an important immunological signaling pathway, called the Type 1 interferon signaling pathway, known to be important in the induction of both anti-viral and anti-tumor immune responses.  It also promotes efficient access of the disease-specific immunologically recognized protein (antigen) into two important immunological pathways called the Class I and II MHC pathways, therefore enabling powerful induction and activation if CD8 (Killer) and CD4 (helper) T-cells that can recognize, kill and protect against the specific disease.  The technology is protected by multiple international composition and application patents.

About PDS Biotechnology

PDS Biotech is a clinical-stage immunotherapy company with a growing pipeline of cancer immunotherapies and infectious disease vaccines based on the Company’s proprietary Versamune® T-cell activating technology platform. Versamune® effectively delivers disease-specific antigens for in vivo uptake and processing, while also activating the critical type 1 interferon immunological pathway, resulting in production of potent disease-specific killer T-cells as well as neutralizing antibodies. PDS Biotech has engineered multiple therapies, based on combinations of Versamune® and disease-specific antigens, designed to train the immune system to better recognize disease cells and effectively attack and destroy them. To learn more, please visit www.pdsbiotech.com or follow us on Twitter at @PDSBiotech.

About PDS0203

PDS0203 is a COVID-19 vaccine candidate that combines the utility of the Versamune® platform with a recombinant native Severe Acute Respiratory Syndrome Coronavirus 2 (SARS-CoV-2) protein.  The World Health Organization (WHO) declared the COVID-19 outbreak caused by a novel coronavirus, Severe Acute Respiratory Syndrome Coronavirus 2 (SARS-CoV-2), a global health emergency in January of 2020. Within three months of initial discovery COVID-19 was declared a global pandemic, reflecting alarming levels of spread and severity and resulting in unprecedented action by local and national governments to restrict the movement of citizens to contain the spread.  Building immunity to the disease is the key to stopping its spread. A COVID-19 vaccine would train the immune system to recognize and destroy the virus without the vaccinated person getting sick.

About PDS0204

PDS0204 is a COVID-19 vaccine candidate that combines the utility of the Versamune® platform with a Farmacore-developed recombinant fusion protein of Severe Acute Respiratory Syndrome Coronavirus 2 (SARS-CoV-2).  The World Health Organization (WHO) declared the COVID-19 outbreak caused by a novel coronavirus, Severe Acute Respiratory Syndrome Coronavirus 2 (SARS-CoV-2), a global health emergency in January of 2020. Within three months of initial discovery COVID-19 was declared a global pandemic, reflecting alarming levels of spread and severity and resulting in unprecedented action by local and national governments to restrict the movement of citizens to contain the spread.  Building immunity to the disease is the key to stopping its spread. A COVID-19 vaccine would train the immune system to recognize and destroy the virus without the vaccinated person getting sick.

# # #

The information contained within this announcement is deemed by the Company to constitute inside information as stipulated under the Market Abuse Regulations (EU) No. 596/2014. Following the publication of this announcement, this inside information is now considered to be in the public domain.

For more information, please contact:

About NetScientific

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