PDSB

PDS Biotech Announces the Publication of PDS0301 Study Linking Induced Changes in Immune Responses with Clinical Outcomes in International Immunopharmacology Journal

Retrieved on: 
Wednesday, March 1, 2023
Safety, Immunotherapy, Neck, Vulvar cancer, Cancer, Patient, Survival, PDS, NK, PDSB, CD8, Research, NKT, Interleukin, Trial of the century, Serum, Interleukin 12, Head, Bangladesh Technical Education Board, Neoplasm, IL-12, Biotechnology, Infection, NCI, Vaccine

The clinical study assessed immune changes in relation to the dose level and dosing schedule of PDS0301 (NHS-IL12), a novel investigational fusion protein consisting of a tumor-targeting antibody conjugated to Interleukin 12 (IL-12).

Key Points: 
  • The clinical study assessed immune changes in relation to the dose level and dosing schedule of PDS0301 (NHS-IL12), a novel investigational fusion protein consisting of a tumor-targeting antibody conjugated to Interleukin 12 (IL-12).
  • The study also evaluated the correlation of several treatment-related immunological changes with clinical responses.
  • “Importantly, this study appears to demonstrate the safety and tolerability of biologically active doses of PDS0301 and reports increases in specific immune cells that were associated with PDS0301 administration and improved clinical outcomes."
  • The publication also summarizes clinical results from a study combining PDS0301, with a checkpoint inhibitor and PDS0101, PDS Biotech’s HPV-targeted immunotherapy that has been shown to promote induction of multifunctional, tumor-infiltrating killer T-cells.

PDS Biotech Completes Successful Meeting with FDA for Triple Combination of PDS0101, PDS0301 and a Commercial Immune Checkpoint Inhibitor

Retrieved on: 
Monday, February 27, 2023
Clinical trial, ICI, Cancer, Survival, PDS, Longevity, PDSB, National Cancer Institute, FDA, Patient, Interleukin, Regulation of food and dietary supplements by the U.S. Food and Drug Administration, Head, Neoplasm, NIH, ICIS, Tumor microenvironment, Interleukin 12, HPV, Bangladesh Technical Education Board, IL-12, Biotechnology, Food, Infection, NCI, Pharmaceutical industry

There remains a critical unmet medical need to develop new treatment options for patients who have failed treatment with ICIs.

Key Points: 
  • There remains a critical unmet medical need to develop new treatment options for patients who have failed treatment with ICIs.
  • In recent interactions with the FDA, PDS Biotech has confirmed the required contents of the study design for a potential registrational trial of the combination of PDS0101, PDS0301 and a commercial immune checkpoint inhibitor.
  • 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.
  • “We are pleased with the guidance from the FDA on key elements of a study design to progress the development of our assets, PDS0101 and PDS0301, in combination with a commercial immune checkpoint inhibitor,” said Dr. Frank Bedu-Addo, Chief Executive Officer of PDS Biotech.

PDS Biotech Announces Preclinical Publication in Peer Reviewed Viruses Journal Showing Superior CD4 T Cell Induction by Infectimune™

Retrieved on: 
Thursday, February 16, 2023
Vaccine, Viral, SARS-CoV-2, PDS, Vaccination, CD4, CpG, Biotechnology, University, Research, Immunology, PDSB, Civics, Infection, National Institute of Allergy and Infectious Diseases, Interferon, CD8, Cancer, Doctor of Philosophy, Virus

The preclinical research studied Infectimune™, PDS Biotech’s novel investigational infectious disease immune activating platform, and demonstrated the technology’s potency in eliciting CD4 T cells.

Key Points: 
  • The preclinical research studied Infectimune™, PDS Biotech’s novel investigational infectious disease immune activating platform, and demonstrated the technology’s potency in eliciting CD4 T cells.
  • The studies focused on comparing Infectimune™ induced immune responses following primary vaccination against influenza with immune responses induced by leading vaccine adjuvants.
  • This publication follows a recent article in Viruses highlighting the ability of Infectimune™ to generate a broad immune response against viruses, including SARS-CoV-2 and multiple strains of influenza.
  • Results from the study concluded that Infectimune™ dramatically enhanced CD4 T cell responses to recombinant HA-B proteins relative to AddaVax™ and AddaVax™ plus CpG.

PDS Biotech Announces Publication of Preclinical Infectimune™ Based Vaccine Studies Demonstrating Effective Protection Against Viral Infection in Peer-Reviewed Journal, Viruses

Retrieved on: 
Wednesday, February 8, 2023
Biotechnology, Cancer, Infection, Vaccine, Animal, COBRA, CD4, Immune system, University, National Institute of Allergy and Infectious Diseases, Influenza and Other Respiratory Viruses, Severe acute respiratory syndrome coronavirus 2, CD8, PDS, Research, PDSB, Mouse, Virus

The paper, titled, “Recombinant Protein Vaccines Formulated with Enantio-Specific Cationic Lipid R-DOTAP Induce Protective Cellular and Antibody-Mediated Immune Responses in Mice,” highlighted results from preclinical studies.

Key Points: 
  • The paper, titled, “Recombinant Protein Vaccines Formulated with Enantio-Specific Cationic Lipid R-DOTAP Induce Protective Cellular and Antibody-Mediated Immune Responses in Mice,” highlighted results from preclinical studies.
  • It was found that Infectimune™ (R-DOTAP) promoted strong T cell and antibody immune responses in both single- and multi-viral antigen (protein) containing vaccines.
  • The vaccines induced antigen-specific and multi-cytokine-inducing CD8 and CD4 T cells associated with antigen-specific killing and immune memory, respectively.
  • Importantly, these Infectimune™ induced neutralizing antibody and T cell responses completely protected animals from lethal challenges with live SARS-CoV-2 and influenza viruses.

PDS Biotech Announces Abstract Accepted for Presentation at ESMO Targeted Anticancer Therapies Congress

Retrieved on: 
Monday, February 6, 2023
Biotechnology, Immunity, ESMO, Immunotherapy, Cancer, Infection, Patient, Pembrolizumab, CD8, PDSB, Vaccine

FLORHAM PARK, N.J., Feb. 06, 2023 (GLOBE NEWSWIRE) -- PDS Biotechnology Corporation (Nasdaq: PDSB), a clinical-stage immunotherapy company developing a growing pipeline of targeted immunotherapies for cancer and infectious disease, today announced that an abstract investigating the ability of PDS0101 in combination with KEYTRUDA® (pembrolizumab) to induce HPV16-specific CD4 and CD8 T cell activation and functionality has been accepted for presentation at the ESMO Targeted Anticancer Therapies Congress 2023 (ESMO TAT) in Paris, March 6-8, 2023.

Key Points: 
  • FLORHAM PARK, N.J., Feb. 06, 2023 (GLOBE NEWSWIRE) -- PDS Biotechnology Corporation (Nasdaq: PDSB), a clinical-stage immunotherapy company developing a growing pipeline of targeted immunotherapies for cancer and infectious disease, today announced that an abstract investigating the ability of PDS0101 in combination with KEYTRUDA® (pembrolizumab) to induce HPV16-specific CD4 and CD8 T cell activation and functionality has been accepted for presentation at the ESMO Targeted Anticancer Therapies Congress 2023 (ESMO TAT) in Paris, March 6-8, 2023.
  • PDS Biotech’s HPV-targeted immunotherapy, PDS0101, is being studied in combination with KEYTRUDA, Merck’s anti-PD-1 therapy, in the Phase 2, VERSATILE-002 clinical trial ( NCT04260126 ) in patients with advanced recurrent or metastatic HPV16-positive head and neck cancer.
  • Measurement of antigen-specific activation of endogenous T cells is critical to understanding drug-induced, T cell based immunity and its association with observed clinical outcomes.
  • Authors: Dr. Lauren V. Wood, Dr. David Schaaf, Nathalie Riebel, and Sally Jones from PDS Biotech and Stephen McCarthy, Dr. Adam Cotty and Dr. Julie Bick from FlowMetric

PDS Biotech to Participate at the B. Riley Securities 3rd Annual Oncology Conference

Retrieved on: 
Friday, January 13, 2023
Conference, Biotechnology, PDSB, Infection, Cancer, Pharmaceutical industry

FLORHAM PARK, N.J., Jan. 13, 2023 (GLOBE NEWSWIRE) -- PDS Biotechnology Corporation (Nasdaq: PDSB), a clinical-stage immunotherapy company developing a growing pipeline of targeted immunotherapies for cancer and infectious disease, today announced that its management will participate in a fireside chat at the B. Riley Securities 3rd Annual Oncology Conference being held virtually on January 18-19, 2023.

Key Points: 
  • FLORHAM PARK, N.J., Jan. 13, 2023 (GLOBE NEWSWIRE) -- PDS Biotechnology Corporation (Nasdaq: PDSB), a clinical-stage immunotherapy company developing a growing pipeline of targeted immunotherapies for cancer and infectious disease, today announced that its management will participate in a fireside chat at the B. Riley Securities 3rd Annual Oncology Conference being held virtually on January 18-19, 2023.

PDS Biotech Announces Exclusive Global License Agreement for Investigational IL-12 Tumor-Targeted Cytokine from Merck KGaA, Darmstadt, Germany

Retrieved on: 
Tuesday, January 3, 2023
Cancer, Standard of care, OS, International, Head, Food, Infection, Vulvar cancer, Merck, PDS, Platinum, Biotechnology, Neoplasm, Patient, Merck KGaA v. Integra Lifesciences I, Ltd., CPI-0610, PD-L1, FDA, Webcast, IL-12, Food and Drug Administration Amendments Act of 2007, Merck Group, Longevity, PDSB, National Cancer Institute, Neck, TGF, PARK, Palladium, Pharmaceutical industry, CPI

FLORHAM PARK, N.J., Jan. 03, 2023 (GLOBE NEWSWIRE) -- PDS Biotechnology Corporation (Nasdaq: PDSB), a clinical-stage immunotherapy company developing a growing pipeline of targeted immunotherapies for cancer and infectious disease, today announced an exclusive global license agreement with Merck KGaA, Darmstadt, Germany for the tumor-targeting IL-12 fusion protein M9241 (formerly known as NHS-IL12), which will join the pipeline as PDS0301. M9241 appears to enhance the proliferation, potency and longevity of T cells in the tumor. The combination of Versamune® and IL-12 is patented by PDS Biotech and is designed to overcome tumor immune suppression utilizing a different mechanism from checkpoint inhibitors.

Key Points: 
  • Under the terms of the agreement, PDS Biotech will receive from Merck KGaA, Darmstadt, Germany an exclusive license to M9241.
  • PDS Biotech will assume responsibility for future development, commercialization, and manufacturing of M9241.
  • “We are pleased to have partnered with Merck KGaA, Darmstadt, Germany to advance the development of M9241, a highly innovative cytokine therapy,” said Dr. Frank Bedu-Addo, PDS Biotech CEO.
  • “Under the licensing arrangement between Merck KGaA, Darmstadt, Germany and PDS Biotech, assumption of an equity stake by Merck KGaA, Darmstadt, Germany in PDS Biotech further confirms the potential of the Versamune® platform and the data generated to date with this combination therapy.

PDS Biotech Reports Median Overall Survival (OS) of 21 Months in Advanced, Refractory Cancer Patients Having Few Remaining Treatment Options and with Reported Historical Survival of 3-4 months

Retrieved on: 
Wednesday, December 28, 2022
Cancer, OS, Head, NCI, Infection, Vulvar cancer, ORR, Platinum, Biotechnology, ASCO, AES, Patient, CPI-0610, Fourth grade, PD-L1, FDA, IL-12, CCR, Grade 3, Merck Group, PDSB, HPV, Neck, National Cancer Institute, TGF, American Society of Clinical Oncology, Society, Pharmaceutical industry, CPI

All patients in the study had failed prior treatment with chemotherapy and 90% had failed radiation treatment.

Key Points: 
  • All patients in the study had failed prior treatment with chemotherapy and 90% had failed radiation treatment.
  • The interim efficacy data (n=50) involves 37 HPV16-positive evaluable patients, including 29 patients who have, in addition, failed treatment with CPIs (CPI refractory).
  • The reported historical median OS in patients with CPI refractory disease is 3-4 months.
  • Historically median OS for similar patients with platinum experienced CPI naïve disease is 7-11 months.

PDS Biotech Completes First Stage of Enrollment in Checkpoint Inhibitor Refractory Arm of Phase 2 Clinical Trial in Advanced HPV16 Positive Head and Neck Cancer

Retrieved on: 
Thursday, December 15, 2022
Section, Neoplasm, Fast Track, Partnership, Merck & Co., Lead, Neck, MD Anderson Cancer Center, CPI, Biotechnology, Sharp, Research, Cervical cancer, COVID-19, Head, University, Clinical trial, Trial of the century, HPV16, KOL, Food, Safety, Cancer, Risk, Vaccine, UCI race classifications, PDS, Clinical professor, Therapy, Merck, Mayo Clinic, UNC Lineberger Comprehensive Cancer Center, ASCO, RECIST, Pembrolizumab, Infection, Patient, Immunotherapy, Communication, Nature, PDSB, Journal, National Cancer Institute, Survival, NCI, HNSCC, University of Texas at Austin, Pharmaceutical industry, Thorax, Medicine

VERSATILE-002 is investigating two patient populations of HPV16-positive head and neck cancer patients whose cancer has returned or spread.

Key Points: 
  • VERSATILE-002 is investigating two patient populations of HPV16-positive head and neck cancer patients whose cancer has returned or spread.
  • The first group has not been previously treated with a checkpoint inhibitor (CPI naïve).
  • The second group of patients has failed treatments including checkpoint inhibitor therapy (CPI refractory).
  • Currently, there are no approved therapies for CPI refractory head and neck cancer, with patients typically surviving less than a year.

PDS Biotech Announces 100% Clinical Response in Cervical Cancer Patients in Preliminary Data from IMMUNOCERV Phase 2 Clinical Trial

Retrieved on: 
Monday, November 14, 2022
Trial of the century, Communication, Survival, Neck, Lymph, National Cancer Institute, Type 1, CT scan, Cancer, Mayo Clinic, Disease, Radiation, PDS, Toxicity, Immunotherapy, Treatment, Vaccine, Cervical cancer, Blood, Partnership, PET, University, Neoplasm, Research, Nature, Society, MD Anderson Cancer Center, Biotechnology, COVID-19, Merck & Co., Vulvar cancer, Warfarin necrosis, NCI, Merck, MRI, Human, CD8, Sharp, Nominal interest rate, Clinical professor, Therapy, FIGO, CRT, CPI, Gamma ray, III, Risk, Infection, Merck Sharp & Dohme Federal Credit Union, PDSB, Positron emission tomography, CR, Head, SITC, Pharmaceutical industry, Medical imaging, Patient

FLORHAM PARK, N.J., Nov. 14, 2022 (GLOBE NEWSWIRE) -- PDS Biotechnology Corporation (Nasdaq: PDSB), a clinical-stage immunotherapy company developing a growing pipeline of targeted immunotherapies for cancer and infectious disease, today announced that updated clinical data from the ongoing IMMUNOCERV Phase 2 clinical trial was presented during a poster session on November 11 at the 37th Annual Meeting for the Society for Immunotherapy of Cancer (SITC 2022). These data expand upon results detailed in the abstract submitted to SITC 2022 that was released to the public on November 7.

Key Points: 
  • This includes 78% (7/9) of treated patients with advanced cervical cancer (FIGO stage III or IV).
  • 100% (9/9) of patients treated with the combination of PDS0101 and CRT had a clinical response with tumor shrinkage >60% at mid-point evaluation by MRI.
  • We look forward to the continued advancement of the IMMUNOCERV Phase 2 clinical trial and the opportunity to report updated data during 2023.
  • A third Phase 2 clinical trial in first-line treatment of locally advanced cervical cancer is being led by The University of Texas MD Anderson Cancer Center.