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 (Nasdaq: PDSB), a late-stage immunotherapy company specializing in cancer treatment, has scheduled its full year 2024 financial results conference call and webcast for March 27, 2025, at 8:00 AM ET. The presentation will include both financial performance review and clinical programs updates.
Investors can access the call through domestic (1-877-704-4453) or international (1-201-389-0920) dial-in numbers. A webcast option is also available, and the presentation will be archived on the company's website for six months following the live event.
PDS Biotechnology (PDSB) has received FDA clearance for its IND application to evaluate the combination of Versamune® MUC1 and PDS01ADC in treating metastatic colorectal cancer (mCRC). The Phase 1/2 trial will be conducted under a Cooperative Research and Development Agreement with the National Cancer Institute.
The treatment targets MUC1-positive tumors in Proficient Mismatch Repair/Microsatellite Stable mCRC, which represents 95% of mCRC patients. These tumors typically show resistance to current immunotherapies and second-line chemotherapy. The company recently received U.S. Patent #12,201,685 for methods using combinations of the Versamune® platform and various immunocytokines.
While this marks progress for the Versamune® platform's expansion beyond HPV-related cancers, PDS Biotech maintains its primary focus on the ongoing VERSATILE-003 Phase 3 clinical trial in HPV16-positive head and neck squamous cell carcinoma.
PDS Biotechnology (Nasdaq: PDSB), a late-stage immunotherapy company specializing in cancer treatment, has announced two significant upcoming presentations by CEO Frank Bedu-Addo, PhD.
The presentations are scheduled for:
- Zacks SCR Life Sciences Virtual Investor Forum on March 13, 2025, at 2:30 PM ET, featuring an investor presentation
- 2025 CAGLA NeauxCancer Conference in New Orleans at The Roosevelt Hotel, scheduled for March 28, 2025, at 4:00 PM ET, where a scientific presentation will be delivered as part of the Innovation Track
Both events offer virtual attendance options through their respective registration platforms, providing accessibility to investors and stakeholders interested in PDS Biotech's developments in cancer immunotherapy.
PDS Biotech (PDSB) has initiated VERSATILE-003, a groundbreaking Phase 3 clinical trial evaluating Versamune® HPV in combination with pembrolizumab for HPV16-positive head and neck cancer treatment. This global, multi-center study represents the first-ever Phase 3 trial for this specific cancer type.
The trial will enroll approximately 350 patients in a 2:1 ratio, comparing the combination therapy against pembrolizumab alone as a first-line treatment for recurrent/metastatic HPV16-positive head and neck squamous cell carcinoma (HNSCC). The study's primary endpoint is overall survival, with secondary endpoints including objective response rate and progression-free survival.
Following promising results from the VERSATILE-002 Phase 2 trial, Versamune® HPV received Fast Track designation from the FDA, making it eligible for Priority Review upon Biologics License Application submission. Dr. Katharine Price from Mayo Clinic Comprehensive Cancer Center will serve as the Principal Investigator.
PDS Biotechnology (PDSB), a late-stage immunotherapy company, has announced a registered direct offering priced at-the-market under Nasdaq rules. The offering includes 7,330,121 shares of common stock and warrants at a combined purchase price of $1.50 for institutional investors and $1.66 for company directors.
The deal structure includes $11 million in immediate funding upon closing, expected around February 28, 2025, with potential for an additional $11 million through warrant exercises. The warrants, exercisable at $1.50 per share, will be immediately available upon issuance with a 5-year expiration term.
The offering, managed by A.G.P./Alliance Global Partners as sole placement agent, will provide funds for research and development expenses and general corporate purposes. Both new and existing healthcare-focused institutional investors, along with company directors, are participating in this capital raise.
PDS Biotech (PDSB) has published promising clinical results in JAMA Oncology for its triple combination therapy treating recurrent/metastatic HPV-associated cancers. The therapy combines Versamune® HPV, PDS01ADC, and a PD-L1 immune checkpoint inhibitor.
Key findings include:
- 42.4 months median Overall Survival in checkpoint inhibitor naïve patients (vs. 7-12 months historical)
- 75% confirmed objective response rate in HPV16-positive checkpoint inhibitor naïve patients (vs. 11-24% historical)
- 17 months median survival in HPV16-positive checkpoint inhibitor resistant patients (vs. 3-4 months historical)
The trial included 50 patients with various HPV-associated cancers. Grade 3 and 4 treatment-related adverse events occurred in 52% of patients, with no treatment-related deaths. The company plans to begin VERSATILE-003 Phase 3 trial of Versamune® HPV + pembrolizumab in HPV16-positive head and neck cancer.
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.