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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 Biotech (PDSB) reported Q3 2024 financial results and provided clinical program updates. The company reported a net loss of $10.7 million ($0.29 per share) compared to $10.8 million ($0.35 per share) in Q3 2023. Research and development expenses increased to $6.8 million from $6.4 million, while general and administrative expenses decreased to $3.4 million from $4.1 million. Cash position stood at $49.8 million as of September 30, 2024.
The company announced modifications to its VERSATILE-003 Phase 3 trial design, reducing costs and time to interim data readout. The updated design will include approximately 350 patients and maintains 2:1 randomization with median overall survival as the primary endpoint.
PDS Biotechnology (Nasdaq: PDSB), a late-stage immunotherapy company focused on cancer treatment and infectious disease vaccines, has scheduled its Q3 2024 financial results conference call for November 14, 2024, at 8:30 AM ET. The company will present financial results for the quarter ended September 30, 2024, along with a clinical program update. Participants can join via phone (1-877-704-4453 or 1-201-389-0920) or through the webcast registration link.
PDS Biotechnology (Nasdaq: PDSB) announced that the rationale and trial design for a study evaluating PDS01ADC in recurrent prostate cancer treatment will be presented at the 12th Annual Meeting of the International Cytokine & Interferon Society (Cytokines 2024) in Seoul, South Korea. The presentation, titled 'A Clinical Trial Combining a Tumor Targeting Immunocytokine (PDS01ADC) and Enzalutamide without Testosterone Lowering Therapy in Biochemically Recurrent Prostate Cancer,' will be given by Dr. Ravi A. Madan from the National Cancer Institute on October 23, 2024. The study will evaluate the combination of PDS01ADC and Xtandi® (Enzalutamide) versus Xtandi® alone in recurrent prostate cancer patients.
PDS Biotechnology (PDSB) announced updated data from the IMMUNOCERV Phase 2 clinical trial evaluating Versamune® HPV with chemoradiation for locally advanced cervical cancer. Key highlights include:
- 36-month overall survival (OS) rate of 84.4% for all patients, and 100% for patients receiving all five doses
- 36-month progression-free survival (PFS) rate of 74.9% for all patients, and 100% for patients receiving all five doses
- Complete metabolic response achieved in 88% of patients
- Versamune® HPV appeared safe and well-tolerated
The trial enrolled 17 high-risk patients with large tumors. Historical data show 36-month OS and PFS rates of approximately 64% and 61%, respectively, with chemoradiation alone. The results suggest potential efficacy of Versamune® HPV in combination with standard-of-care for locally advanced cervical cancer treatment.
PDS Biotechnology (Nasdaq: PDSB) announced updated results from the VERSATILE-002 Phase 2 clinical trial evaluating Versamune® HPV in combination with KEYTRUDA® for first-line treatment of HPV16-positive recurrent/metastatic head and neck squamous cell carcinoma (HNSCC). Key findings include:
- Median Overall Survival of 30 months
- Objective Response Rate of 36% (19/53 patients)
- Disease Control Rate of 77% (41/53 patients)
- 21% of patients (11/53) experienced 90-100% tumor shrinkage
- 9% of patients (5/53) had a complete response
The combination therapy showed promising tolerability and efficacy compared to published data for pembrolizumab alone. PDS Biotech plans to initiate the VERSATILE-003 Phase 3 clinical trial this year to further evaluate the combination therapy.
PDS Biotechnology (PDSB) will present updated data from the VERSATILE-002 trial at the ESMO Congress 2024 on September 14, 2024, in Barcelona, Spain. The trial evaluates Versamune® HPV (formerly PDS0101) combined with KEYTRUDA® (pembrolizumab) as a first-line treatment for 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 HNSCC', will be presented by Dr. Jared Weiss, Principal Investigator of the trial. The poster will be available on the company's website after the presentation.
PDS Biotechnology (Nasdaq: PDSB), a late-stage immunotherapy company, has announced its participation in the H.C. Wainwright 26th Annual Global Investment Conference. The event is scheduled for September 9-11, 2024, in New York City. Frank Bedu-Addo, PhD, President and CEO of PDS Biotech, will deliver a presentation on Tuesday, September 10, 2024, from 2:00-2:30 PM ET.
The presentation will be available for on-demand viewing starting at the same time. Interested parties can register for the in-person event or access the archived replay in the Investor Relations section of the company's website at www.pdsbiotech.com after the conference.
PDS Biotechnology (PDSB) has provided a business update and reported financial results for Q2 2024. Key highlights include:
Clinical Progress: Alignment with FDA on Phase 3 VERSATILE-003 trial design for HPV16-positive HNSCC, set to start in Q4 2024. Updated VERSATILE-002 trial data to be presented at ESMO 2024.
Financial Results: Net loss of $8.3 million ($0.23 per share) in Q2 2024, compared to $11.5 million ($0.37 per share) in Q2 2023. R&D expenses decreased to $4.5 million from $8.0 million, while G&A expenses reduced to $4.2 million from $4.7 million. Cash and cash equivalents stood at $57.7 million as of June 30, 2024.
The company is progressing with its Versamune® HPV immunotherapy platform, showing potential in various cancer indications.
PDS Biotechnology (Nasdaq: PDSB) has announced that updated data from their IMMUNOCERV Phase 2 clinical trial will be presented at the 2024 ASTRO Annual Meeting. The trial evaluates Versamune® HPV (formerly PDS0101) in combination with chemoradiation for treating locally advanced cervical cancer. The presentation, titled '298 - IMMUNOCERV Phase II Trial Combining the HPV-Specific T Cell Immunotherapy PDS0101 with Chemoradiation for Treatment of Locally Advanced Cervical Cancer,' will be given by Dr. Adam Grippin from The University of Texas MD Anderson Cancer Center on October 1, 2024. This presentation is part of the session 'SS 34 - GYN 2: Strategies and Innovations of Clinical Trials in Gynecologic Cancers.'
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.
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