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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 (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.
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.