Welcome to our dedicated page for Pds Biotechnology Corporation news (Ticker: PDSB), a resource for investors and traders seeking the latest updates and insights on Pds Biotechnology Corporation stock.
PDS Biotechnology Corporation (Nasdaq: PDSB) is a late-stage immunotherapy company developing investigational cancer therapies based on its Versamune® platform and IL-12 immunocytokine technology. News about PDS Biotech centers on the clinical and regulatory progress of its lead HPV16-targeted immunotherapy PDS0101 and its tumor-targeting IL-12 fused antibody drug conjugate PDS01ADC.
On this page, readers can follow company announcements on pivotal and mid-stage trials, including the VERSATILE-002 Phase 2 study and the VERSATILE-003 Phase 3 trial in HPV16-positive recurrent and/or metastatic head and neck squamous cell cancers. Updates often cover final survival and progression-free survival data, sub-analyses in specific patient subgroups such as low PD-L1 (CPS 1–19) cohorts, and efforts to align with the U.S. Food and Drug Administration on potential accelerated approval pathways.
PDS Biotech news also highlights translational research presented at scientific meetings like the Society for Immunotherapy of Cancer, where investigators have reported immune biomarker signatures, natural killer cell reprogramming, and expansion of stem-like memory T cells associated with PDS0101 and PDS01ADC. Additional coverage includes National Cancer Institute-led Phase 2 trials in metastatic colorectal and other advanced solid tumors, intellectual property developments such as new composition of matter patents for PDS0101, and capital markets events including registered direct offerings disclosed in Form 8-K filings.
Investors and observers who want to track PDSB can use this news feed to monitor clinical milestones, regulatory interactions, scientific data presentations, and financing activities that may influence the company’s development programs and overall outlook.
PDS Biotechnology (Nasdaq: PDSB), a late-stage immunotherapy company, has announced that it will release its second quarter 2024 financial results on Tuesday, August 13, 2024, before the market opens. The company, which focuses on developing innovative cancer immunotherapies and infectious disease vaccines, will also provide a business update along with the financial report.
Investors and interested parties can access the press release containing the financial results and business update in the Investor Relations section of PDS Biotech's official website at www.pdsbiotech.com. This announcement signals the company's commitment to transparency and regular communication with its shareholders and the broader investment community.
PDS Biotechnology (Nasdaq: PDSB) has announced that an abstract presenting updated data from their VERSATILE-002 trial has been accepted for presentation at the European Society for Medical Oncology (ESMO) Congress 2024. The trial evaluates the first-line treatment with Versamune® HPV (formerly PDS0101) in combination with KEYTRUDA® (pembrolizumab) for patients with HPV16-positive recurrent/metastatic head and neck squamous cell carcinoma (HNSCC).
The poster presentation, titled 'VERSATILE-002: Survival with First-Line Treatment with PDS0101 Therapeutic Vaccine and Pembrolizumab in HPV16-positive Recurrent/Metastatic Head and Neck Squamous Cell Carcinoma (HNSCC)', will be presented by Dr. Jared Weiss, Principal Investigator of the VERSATILE-002 clinical trial. The ESMO Congress 2024 is scheduled for September 13-17, 2024, in Barcelona, Spain.
PDS Biotechnology (Nasdaq: PDSB) has aligned with the FDA on the Phase 3 VERSATILE-003 trial for its Versamune® HPV immunotherapy in HPV16-positive first-line recurrent or metastatic head and neck cancer. The trial, set to begin in Q4 2024, will focus on the combination of Versamune® HPV and pembrolizumab, which has received Fast Track designation. The company presented data from VERSATILE-002 and proposed a triple combination therapy, which the FDA supported. However, to avoid delays, the FDA agreed to proceed with the 2-arm double combination trial. The updated VERSATILE-003 study will have overall survival as the primary endpoint, with revised statistical endpoints based on mature survival data.
PDS Biotechnology (Nasdaq: PDSB), a late-stage immunotherapy company, has announced a conference call scheduled for August 1, 2024, at 8:00 a.m. ET to provide a clinical program update. The company, which focuses on enhancing immune system targeting of cancers and developing infectious disease vaccines, will offer multiple ways for interested parties to join the call:
1. Dial-in options: 1-877-704-4453 or 1-201-389-0920
2. Webcast registration available via provided link
3. Call Me™ feature available 15 minutes before the call
This update presents an opportunity for investors and stakeholders to gain insights into PDS Biotech's latest developments in immunotherapy and vaccine research.
PDS Biotechnology (Nasdaq: PDSB), a late-stage immunotherapy company, has announced its participation in the BTIG Virtual Biotechnology Conference. The company's President and CEO, Frank Bedu-Addo, PhD, will engage in a fireside chat on Monday, August 5, 2024, at 10:00 a.m. ET.
PDS Biotech focuses on revolutionizing how the immune system targets and eliminates cancers, as well as developing vaccines for infectious diseases. Interested parties can arrange meetings with the PDS Biotech team through their BTIG representatives. After the event, a replay of the fireside chat will be accessible in the Investor Relations section of the company's website at www.pdsbiotech.com.
PDS Biotechnology provided a data update from its VERSATILE-002 Phase 2 clinical trial in head and neck cancer as of May 17, 2024. The trial focuses on the combination of Versamune® HPV and KEYTRUDA® in HPV16-positive HNSCC patients. Median Overall Survival (mOS) remains at 30 months, consistent with previous data. Out of 53 enrolled patients, 27 remain alive, 6 withdrew consent, 2 were lost to follow-up, and 18 have died. The lower limit of the 95% confidence interval is 19.7 months, while the upper limit is not yet estimable. Full data are expected in Q3 2024. PDS Biotech plans a three-arm Phase 3 trial to further evaluate treatment efficacy.
PDS Biotech (Nasdaq: PDSB) has released its Q1 2024 financial results and business updates. Key highlights include positive data from the Phase 2 VERSATILE-002 trial for HPV16-positive head and neck cancer, showing improved survival rates with Versamune® HPV and KEYTRUDA®. The company also announced a new two-part clinical trial strategy for Versamune® in combination with PDS01ADC and pembrolizumab. Financials show a net loss of $10.6 million, up from $9.7 million in Q1 2023, mainly due to increased R&D and interest expenses. Cash reserves stand at $66.6 million.
PDS Biotech's VERSATILE-002 Phase 2 clinical trial for first-line recurrent/metastatic HPV16-positive head and neck cancer met primary study endpoints with a 30-month median overall survival, impressive response rates, and a planned Phase 3 trial in 2024. The trial evaluated the combination of Versamune® HPV + KEYTRUDA® (pembrolizumab) and showed promising results. The Company also announced a two-part registrational trial focusing on a triple combination therapy.
PDS Biotechnology (Nasdaq: PDSB) will participate in two investor conferences in May 2024. The first is the Citizens JMP Life Sciences Conference on May 13 in New York, where the company will present and hold 1:1 meetings. The second event is the A.G.P.'s Virtual Healthcare Company Showcase on May 21, featuring a fireside chat with A.G.P.’s Jim Molloy and Scott Henry.
PDS Biotech, a late-stage immunotherapy company, will announce its first quarter 2024 financial results on May 15, 2024. They will also discuss positive data from their VERSATILE-002 Phase 2 clinical trial during a Key Opinion Leader Event on May 8, 2024.
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