Welcome to our dedicated page for Pds Biotechnology news (Ticker: PDSB), a resource for investors and traders seeking the latest updates and insights on Pds Biotechnology stock.
PDS Biotechnology Corporation reports developments in targeted cancer immunotherapies based on its Versamune platform. Company news centers on PDS0101, also called Versamune HPV, in HPV16-positive head and neck cancer, and on PDS01ADC, an IL-12 fused antibody drug conjugate and tumor-targeted immunocytokine evaluated across multiple solid tumor indications.
Recurring updates include clinical-trial data, National Cancer Institute-led study presentations, FDA and IND protocol communications, scientific publications, patent coverage for core technology, quarterly financial results, and broader corporate-program updates.
PDS Biotechnology Corporation (PDSB) has completed Phase 3 manufacturing of PDS0101 for a registrational trial in recurrent/metastatic HPV16-positive head and neck cancer. The VERSATILE-003 trial will compare PDS0101 in combination with KEYTRUDA® against KEYTRUDA® alone, aiming to start in Q4 2023. An amended IND application will be submitted to the FDA in Q3 2023. Phase 2 data showed a 41% objective response rate and an 87% overall survival rate at nine months for the combination, with no severe adverse events reported. The trial represents a significant milestone, addressing the critical need for new treatments in head and neck cancer.
PDS Biotechnology Corporation (Nasdaq: PDSB) announced participation in Cantor’s Future of Oncology Virtual Symposium from April 3-5, 2023. Dr. Frank Bedu-Addo, President and CEO, will present on April 4 at 3:00 PM ET. The company focuses on developing targeted immunotherapies for cancer and infectious diseases through innovative platforms like Versamune® and Infectimune™. Their lead candidate, PDS0101, has shown promise in treating HPV16-associated cancers, demonstrating tumor reduction and disease stabilization. PDS Biotech aims to enhance immunotherapy effectiveness by optimizing T cell responses.
PDS Biotechnology Corporation (NASDAQ: PDSB) announced a successful meeting with the FDA, discussing the registrational pathway for a triple combination treatment involving PDS0101, PDS0301, and a commercial immune checkpoint inhibitor. Preliminary results from the IMMUNOCERV trial showed 100% clinical response in high-risk cervical cancer patients.
In 2022, the company reported a net loss of $40.9 million, a significant increase from $16.9 million in 2021, primarily due to R&D investments. The cash balance as of December 31, 2022, was $73.8 million, expected to fund operations through Q3 2024.
PDS Biotechnology Corporation (Nasdaq: PDSB) is set to release its financial results for Q4 2022 on March 28, 2023, before market opening. A conference call will follow to discuss these results and provide a business update. The company is developing targeted immunotherapies for cancer and infectious diseases, utilizing its proprietary platforms, Versamune® and Infectimune™. Their lead candidate, PDS0101, has shown promise in reducing tumors in HPV16-related cancers. The conference call will be accessible via domestic and international numbers and a webcast will be archived for six months.
PDS Biotechnology Corporation (Nasdaq: PDSB), an innovative clinical-stage immunotherapy company, announced that its CEO, Dr. Frank Bedu-Addo, will present at the 33rd Annual Oppenheimer Healthcare Conference on March 14, 2023, at 8:00 AM ET. The event will be held virtually, and investors can register for the webcast here. PDS Biotech focuses on targeted immunotherapies for cancer and infections, leveraging proprietary platforms like Versamune® and Infectimune™. Their lead candidate, PDS0101, has shown promise in Phase 2 trials for HPV16-associated cancers.
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.