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.
Overview
PDS Biotechnology Corporation (symbol: PDSB) is a clinical-stage biopharmaceutical company dedicated to developing advanced immunotherapies for treatment of various cancers and infectious diseases. Utilizing a state-of-the-art proprietary platform, Versamune, the Company focuses on creating simpler, safer, and more effective therapeutic interventions that harness the power of the immune system. With its cutting-edge approach involving synthetic, biodegradable lipids that form specialized nanoparticles, PDS Biotechnology is transforming traditional treatment paradigms in immuno-oncology and vaccine development.
Proprietary Technology and Core Platform
The foundation of the Company\s innovative approach is the Versamune platform. This technology is based on uniquely engineered lipid nanoparticles that are designed with a precise structure and positive charge. These characteristics allow the nanoparticles to efficiently activate and be taken up by the immune system. When formulated with a specific antigen – whether a protein uniquely expressed in cancerous cells or a viral protein associated with an infectious agent – the platform stimulates a targeted immune response. This mechanism not only differentiates PDS Biotechnology from traditional therapies but also paves the way for a more personalized form of immunotherapy.
Clinical Development and Product Pipeline
The Company is engaged in extensive clinical research across multiple disease areas. Key initiatives include:
- Targeted Immunotherapy for Cancer: PDS Biotechnology has developed investigational products that are designed to trigger a focused T-cell response against cancer cells. Their lead candidate, formulated using the Versamune platform, is being evaluated in clinical trials for various cancers, including head and neck squamous cell carcinoma, cervical cancer, and other HPV16-positive malignancies.
- Combination Approaches: Recognizing the complexity of tumor biology, the Company is exploring combined regimens. These include pairing their Versamune-based immunotherapy with standard-of-care immune checkpoint inhibitors and innovative antibody-drug conjugates (ADCs). Such combinations aim to create a powerful dual mechanism that disrupts cancer defenses from multiple angles.
- Infectious Disease Vaccines: Beyond oncology, PDS Biotechnology is also leveraging its platform to develop novel vaccines against infectious diseases. The tailored delivery of antigens using Versamune technology offers a promising strategy for inducing robust immune protection.
This diverse pipeline demonstrates the Company\s commitment to transforming the clinical landscape by addressing unmet medical needs across several therapeutic areas.
Strategic Clinical Trial Design and Regulatory Approach
PDS Biotechnology employs a rigorous clinical trial strategy to validate the safety, tolerability, and efficacy of its innovative therapies. The design of its clinical programs is informed by a clear scientific rationale and statistical robustness, ensuring the collection of meaningful data on patient survival, disease control, and immune response. Each clinical trial is structured with a focus on evidence-based outcomes, reflecting the Company\s experience in navigating complex regulatory frameworks.
Market Position and Competitive Landscape
Positioned within the competitive sphere of immuno-oncology, PDS Biotechnology distinguishes itself through its proprietary Versamune technology and the strategic integration of combination therapy approaches. The Company is recognized for its commitment to precision medicine; by targeting specific antigens such as those found in HPV16-positive cancers, its treatments are tailored to individual tumor profiles. This focused strategy, combined with ongoing collaboration with clinical research organizations, underpins the Company\s reputation as an innovator in the field of targeted cancer therapy.
Scientific and Clinical Expertise
The depth of expertise at PDS Biotechnology is reflected in its scientific research and clinical trial execution. The Company partners with leading oncologists, research institutions, and regulatory bodies to ensure that its development programs are grounded in cutting-edge science and clinical rigor. This multidisciplinary approach facilitates the optimization of treatment protocols and supports the advancement of its therapeutic candidates through complex clinical pathways.
Operational Excellence and Future-readiness
While maintaining a focus on current clinical programs, the Company continues to enhance its operational capabilities to deliver on its mission of transforming cancer treatment. Its strategic planning and adaptive clinical trial designs enable a robust evaluation of investigational therapies, ensuring that key scientific insights are rapidly incorporated into development programs. PDS Biotechnology\s use of innovative diagnostic companion tools further supports the effective identification and treatment of patients who are most likely to benefit from their therapies.
Conclusion
PDS Biotechnology Corporation is at the forefront of immunotherapy innovation. Its integrated approach—combining a proprietary nanoparticle technology with strategic clinical trial design—establishes a unique value proposition in the field of biopharmaceutical development. Through its focus on targeted immunotherapy and infectious disease vaccines, the Company is reshaping treatment paradigms. With a strong commitment to scientific excellence, clinical rigor, and operational precision, PDS Biotechnology continues to provide comprehensive, evidence-based information for investors and stakeholders seeking to understand its position within the dynamic landscape of modern medicine.
PDS Biotechnology (Nasdaq: PDSB), a late-stage immunotherapy company specializing in cancer treatment, has announced its participation in the B. Riley Securities Precision Oncology & Radiopharma Conference 2025. The company's President and CEO, Frank Bedu-Addo, PhD, will engage in a fireside chat session on Friday, February 28, 2025.
The presentation is scheduled for 11:30-12:00 PM ET in the Holmes II – Precision Oncology Track at the Lotte New York Palace Hotel. Company leadership will also conduct one-on-one meetings during the conference. Interested parties can register through B. Riley Securities representatives, and a transcript of the fireside chat will be available on PDS Biotech's website one week after the event.
PDS Biotechnology (NASDAQ: PDSB) has confirmed its plans to initiate the VERSATILE-003 Phase 3 clinical trial in Q1 2025. The trial will evaluate Versamune® HPV plus pembrolizumab as a first-line treatment for recurrent and/or metastatic HPV16-positive head and neck squamous cell cancer (HNSCC).
The company submitted its updated clinical protocol on November 15, 2024, amending the IND application. The FDA's comment period has concluded, and the company has received Fast Track designation for the combination therapy. The trial will utilize a newly validated companion diagnostic to confirm HPV16-positive HNSCC during patient screening, marking the first investigational use of this type of diagnostic in a Phase 3 HNSCC trial.
HPV16-positive patients represent a growing subgroup requiring targeted therapies, with HPV16-positive HNSCC expected to become the dominant type in the US and EU.
PDS Biotechnology (Nasdaq: PDSB) announced the granting of nonstatutory stock options to a new clinical department employee. The grant includes options to purchase 7,000 shares of common stock at an exercise price of $2.25 per share, matching the closing price on December 3, 2024. The stock options vest over four years, with 25% vesting after the first year and the remaining shares vesting monthly over the following 36 months, contingent on continued employment. This grant was made under Nasdaq Listing Rule 5635(c)(4) and PDS Biotech's 2019 Inducement Plan.
PDS Biotech (Nasdaq: PDSB) announced a Key Opinion Leader (KOL) event scheduled for December 17, 2024, at 12 p.m. ET. The event will focus on HPV16-positive head and neck squamous cell carcinoma (HNSCC) and the company's upcoming VERSATILE-003 Phase 3 clinical trial of Versamune® HPV combined with pembrolizumab for first-line treatment of recurrent/metastatic HPV16-positive HNSCC.
The panel will feature experts Dr. Francis Worden from Rogel Cancer Center and Dr. Kevin Harrington from The Institute of Cancer Research, UK, with moderation by PDS Biotech's Chief Medical Officer, Dr. Kirk Shepard. The 90-minute webcast will discuss disease pathology, prevalence, and trial design.
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.
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