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PDS Biotechnology Corporation (Nasdaq: PDSB) is a clinical stage biopharmaceutical company focused on developing next-generation immunotherapies for cancer and infectious diseases. The company's proprietary Versamune® platform leverages synthetic and biodegradable lipids to form nanoparticles that are readily taken up by the immune system. These nanoparticles are designed to activate and direct the immune system to target and eliminate disease-causing cells.
PDS Biotech's lead product candidates include PDS0101, targeting HPV-related cancers, and PDS01ADC, an IL-12 fused antibody drug conjugate. These candidates are part of the company's broader strategy to treat a range of cancers, including head and neck, prostate, breast, cervical, and anal cancers.
Recent achievements include the completion of a Phase 1 clinical trial for PDS0101 and ongoing Phase 2 trials demonstrating positive survival results and tumor shrinkage. The company is preparing to initiate a pivotal clinical trial in advanced head and neck cancers in 2024.
Financially, PDS Biotech reported a net loss of $10.8 million for Q3 2023, primarily due to increased R&D and administrative expenses. Despite this, the company remains focused on advancing its pipeline and has several key partnerships to support its research and development efforts.
PDS Biotechnology Corporation (Nasdaq: PDSB) announced promising results from a National Cancer Institute (NCI)-led study on PDS0301, an investigational tumor-targeting IL-12 fusion protein. The peer-reviewed research, published in International Immunopharmacology, involved 23 patients with advanced cancers and highlighted dose-dependent immune responses correlating with better clinical outcomes. Higher doses of PDS0301 led to increased CD8 T cells and other immune markers, suggesting improved immune activation. Additionally, 63% of patients receiving the higher dose in combination therapy showed an objective response.
PDS Biotechnology Corporation (Nasdaq: PDSB) announced the successful conclusion of a Type B meeting with the FDA regarding a combination therapy involving PDS0101, PDS0301, and an FDA-approved immune checkpoint inhibitor for treating recurrent/metastatic HPV-positive head and neck cancer. This critical cancer type is seeing a surge in cases. The FDA validated the study design needed for a potential registrational trial. In a prior NCI-led trial, the combination showed a median overall survival of 21 months, significantly better than the historical median of 3-4 months. The company remains focused on addressing unmet needs in cancer treatment through its proprietary immunotherapies.
PDS Biotechnology Corporation (Nasdaq: PDSB) announced the publication of new research demonstrating the efficacy of its investigational platform, Infectimune™, in enhancing CD4 T cell responses compared to leading commercial vaccine adjuvants. Conducted at the University of Rochester, the study, published in Viruses, indicates that Infectimune™ significantly boosts immune responses against influenza, showing promise for more effective flu vaccines, especially in the elderly. The findings suggest potential for broad protection against viral infections. The research was supported by grants from the NIAID and the National Institute of Allergy and Infectious Diseases.
PDS Biotechnology Corporation (PDSB) announced promising preclinical results of its investigational platform, Infectimune™, which demonstrated robust immune responses to SARS-CoV-2 and influenza viruses. Published in the journal Viruses, the study showed that Infectimune™ induced strong T cell and neutralizing antibody responses, offering complete protection in animal models against lethal viral challenges.
The research indicates potential for developing next-generation universal vaccines, facilitating significant dose sparing of viral proteins. PDS Biotech is advancing its Infectimune™ programs, highlighting long-lasting immune memory and efficacy against infectious diseases.
PDS Biotechnology Corporation (PDSB) announced that an abstract, titled “HPV16-specific CD4 and CD8 T cell activation and functionality in patients receiving combination PDS0101 immunotherapy,” has been accepted for presentation at the ESMO Targeted Anticancer Therapies Congress 2023 in Paris, taking place from March 6-8, 2023. The study investigates PDS0101, an HPV-targeted immunotherapy used in combination with KEYTRUDA (pembrolizumab), focusing on its effects on T cell activation in patients with advanced recurrent or metastatic HPV16-positive head and neck cancer. The findings aim to enhance understanding of drug-induced immune responses and their relationship with clinical outcomes.
PDS Biotechnology Corporation (Nasdaq: PDSB), a clinical-stage immunotherapy company, announced its participation in the Channelchek Takeaway Series during the J.P. Morgan Healthcare Conference on January 26, 2023, at 10:00 a.m. EST. CEO Frank K. Bedu-Addo will discuss the company's business and clinical development strategy in a session followed by Q&A with Noble Capital Markets' Senior Analyst Robert LeBoyer. The Channelchek Takeaway Series aims to connect healthcare executives with investors, offering insights into PDS Biotech's product candidates, including PDS0101, which has shown promising results in HPV16-associated cancers.
PDS Biotechnology Corporation (Nasdaq: PDSB), a clinical-stage immunotherapy firm, announced participation in the B. Riley Securities 3rd Annual Oncology Conference, set for January 18-19, 2023. A fireside chat with management will occur on January 19, 2023, at 1:00 PM EST, accessible via livestream. PDS Biotech focuses on developing targeted immunotherapies for cancer and infectious diseases using its proprietary Versamune® and Infectimune™ platforms, showing promise in clinical trials for HPV-expressing cancers.
PDS Biotech has announced an exclusive global license agreement with Merck KGaA for the IL-12 fusion protein M9241, now referred to as PDS0301. The agreement includes a $5 million upfront payment and potential milestone payments totaling up to $116 million, along with a 10% royalty on future sales. M9241 is designed to enhance T cell effectiveness in tumor environments.
Clinical data shows promising results in treating advanced HPV-positive cancers, with significant improvements in survival rates and tumor response compared to standard therapies. A meeting with the FDA is scheduled to discuss a registrational trial.
PDS Biotechnology Corporation (Nasdaq: PDSB) announced promising interim results from its Phase 2 trial of PDS0101, a triple therapy for HPV16-positive cancers. The data revealed a median overall survival (OS) of 21 months in 29 checkpoint inhibitor (CPI) refractory patients, compared to a historical median of 3-4 months. Among CPI-naive patients, 75% remained alive at a median follow-up of 27 months. The objective response rate was 63% in CPI refractory and 88% in CPI naive patients. The trial demonstrates the therapy's durability and tolerability, with 48% reporting Grade 3 adverse events.
PDS Biotechnology Corporation announced the completion of enrollment in the first stage of its VERSATILE-002 Phase 2 study, investigating PDS0101 in combination with Merck’s KEYTRUDA for recurrent and/or metastatic HPV16-positive head and neck cancer. Positive preliminary data from 17 patients showed a 41% objective response rate and 87% overall survival at nine months. The study targets both checkpoint inhibitor refractory and naïve patients, with potential advancements based on initial efficacy results. This highlights a critical milestone in the company's pursuit to improve treatment options for advanced head and neck cancers.
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