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PDS Biotechnology Corporation (NASDAQ: PDSB) delivers innovative immunotherapies through its Versamune® platform, targeting cancers and infectious diseases. This news hub provides investors and researchers with timely updates on clinical advancements, regulatory milestones, and corporate developments.
Access primary-source press releases and curated analysis covering PDSB's clinical trials, partnership announcements, and financial disclosures. Track progress across key areas: Phase II/III oncology studies, FDA communications, and strategic collaborations enhancing their nanoparticle-based therapies.
Our repository ensures you stay informed about critical developments in HPV-associated cancer treatments, combination therapy research, and infectious disease vaccine progress. Bookmark this page for direct access to PDSB's verified updates, eliminating the need to scour multiple sources.
PDS Biotech (NASDAQ: PDSB) has published promising results for its Versamune® HPV immunotherapy in Clinical Cancer Research. The study showed that combining Versamune® HPV with chemoradiation therapy (CRT) led to superior clearance of HPV16-positive cancer cells from patients' bloodstream compared to CRT alone.
Key findings include:
- 100% of patients receiving Versamune® HPV + CRT showed no detectable HPV16 ctDNA at 3-4 months vs. 50% for CRT alone
- Patients with undetectable HPV ctDNA at 3-4 months demonstrated 93% 2-year recurrence-free survival vs. 30% in those with detectable ctDNA
- 36-month overall survival rate was 100% for patients receiving 5 doses of Versamune® HPV + CRT
The company plans to initiate a Phase 3 trial for Versamune® HPV in HPV16-positive head and neck squamous cell carcinoma (HNSCC) in Q1 2025.
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.
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