Versamune HPV / PDS Biotech - LARVOL DELTA

A Vaccine (PDS0101) Alone or in Combination With Pembrolizumab for the Treatment of Locally Advanced Human Papillomavirus-Associated Oropharynx Cancer (clinicaltrials.gov) - P1/2 | N=20 | Completed | Sponsor: Mayo Clinic | Active, not recruiting ➔ Completed | Trial completion date: Oct 2026 ➔ Apr 2025 | Trial primary completion date: Oct 2026 ➔ Apr 2025

Trial completion • Trial completion date • Trial primary completion date • Head and Neck Cancer • Oncology • Oropharyngeal Cancer • Solid Tumor • Squamous Cell Carcinoma • Squamous Cell Carcinoma of Head and Neck

Phase I/II Evaluation of the Combination of Entinostat, M9241 and Bintrafusp Alfa in Patients with Advanced HPV Related Malignancies (SITC 2022) - P1/2 | "Background More than 630,000 cases of HPV related cancer (e.g. cervical, oropharyngeal, anal) occur worldwide annually. To date the triple combination appears to have a manageable safety profile along with encouraging clinical activity in patients with advanced checkpoint refractory HPV related cancers including in pts who have previously progressed on PD(L)1 inhibitor then on PDS0101, M9241 and bintrafusp alfa. Trial Registration NCT04708470"

Clinical • P1/2 data • Cervical Cancer • Oncology • Oropharyngeal Cancer • IL12A • STAT3 • TGFB1

Novel Combination Immunotherapy and Clinical Activity in Patients With HPV-Associated Cancers: A Nonrandomized Clinical Trial. (PubMed, JAMA Oncol) - P1/2 | "In this trial, the combination of PDS0101, PDS01ADC, and bintrafusp alfa showed an acceptable safety profile and promising antitumor activity and improved OS in patients with HPV-16-positive cancers, in both ICB-naive and ICB-resistant patients, warranting further evaluation of the combination of PDS0101 and PDS01ADC with simultaneous PD-L1/TGF-β inhibition in these populations."

Clinical • Journal • Oncology • Solid Tumor • IL12A • TGFB1

IMMUNOCERV Phase II Trial Combining the HPV-Specific T Cell Immunotherapy PDS0101 with Chemoradiation for Treatment of Locally Advanced Cervical Cancer (ASTRO 2024) - P2 | "In this final report of the IMMUNOCERV clinical trial, PDS0101 was safe and well-tolerated, and receipt of all prescribed doses of PDS0101 was associated with improved PFS. Further investigation of PDS0101 in cervical cancer in combination with pembrolizumab is warranted."

IO biomarker • Metastases • P2 data • Cervical Cancer • Dermatology • Immunology • Oncology • Pain • Solid Tumor • Squamous Cell Carcinoma • Urticaria

PDS Biotech Announces New U.S. Patent Covering Technology Underlying PDS0101 (GlobeNewswire) - "Once issued, the new patent (U.S. Application No. 16/210,750), titled 'Methods and Compositions Comprising Cationic Lipids for Stimulating Type I Interferon Genes', will grant broad composition of method of use claims. It enhances the Company’s robust intellectual property estate, which includes previously granted patents in the U.S., Europe, Japan, China, Australia, Canada, Israel, Mexico, and Hong Kong....The new patent, combined with anticipated U.S. biologics exclusivity, should provide approximately twenty years of market protections for PDS0101..."

Patent • Squamous Cell Carcinoma of Head and Neck

PDS Biotechnology Corporation…announced that the Company has submitted a protocol amendment to the U.S. Food & Drug Administration ('FDA') for its Phase 3 VERSATILE-003 clinical trial (GlobeNewswire) - "The proposed amendment to the VERSATILE-003 Phase 3 trial changes the PFS endpoint to a primary endpoint that can be evaluated earlier with significant statistical power, potentially providing the basis for accelerated approval of PDS0101. Median overall survival (mOS) remains the primary endpoint for full approval as originally recommended by FDA. The submission follows a constructive Type C meeting held with the FDA in December 2025 to discuss the proposed accelerated approval pathway for PDS0101 in HPV16-positive recurrent and/or metastatic Head and Neck Cancer."

Clinical protocol • Squamous Cell Carcinoma of Head and Neck

PDS Biotechnology Corporation…announced that the Japan Patent Office has issued Patent No. 7783866 for PDS0101 granting broad composition of matter and methods of use claims (GlobeNewswire) - "The new patent expands previously granted patents in Japan, and adds to the Company’s robust intellectual property estate, which includes previously granted patents in the United States, China, Australia, and Hong Kong. The Company has additional patent applications pending in several other countries. Together with anticipated biologics exclusivity in the United States, the Company has patent and market protections for PDS0101 into the 2040s."

Patent • Head and Neck Cancer

PDS Biotech Announces Scheduling of Type C Meeting with U.S. Food and Drug Administration ('FDA') (GlobeNewswire) - "The meeting was requested to discuss the proposed accelerated approval pathway for PDS0101 in HPV16-positive recurrent and/or metastatic Head and Neck Cancer....Company to discuss proposed amendment to phase 3 VERSATILE-003 trial enabling potential accelerated approval pathway....The proposed amendment to the VERSATILE-003 Phase 3 trial would change the PFS endpoint to become a surrogate primary endpoint that can be evaluated earlier....'We will provide further updates once we receive the FDA’s meeting minutes in January 2026'."

Clinical protocol • FDA event • Squamous Cell Carcinoma of Head and Neck

Company announced completion of VERSATILE-002 phase 2 trial of PDS0101 + pembrolizumab in HPV16-positive recurrent/metastatic head and neck cancer (GlobeNewswire) - "Announced plan to seek accelerated approval pathway in the VERSATILE-003 Phase 3 randomized trial for PDS0101 in combination with pembrolizumab versus pembrolizumab monotherapy...Due to positive final PFS result, the proposed amendment would change PFS endpoint to become a surrogate primary endpoint that can be evaluated earlier with high statistical power and potentially form the basis for potential accelerated approval...mOS will remain as the primary endpoint for full approval as originally recommended by FDA."

Clinical protocol • Trial completion • Squamous Cell Carcinoma of Head and Neck

PDS Biotechnology Announces up to $11.1 Million Registered Direct Offering (GlobeNewswire) - "$5.3 million upfront with up to an additional $5.8 million of aggregate gross proceeds upon the cash exercise in full of warrants....The Company currently intends to use the net proceeds from the offering for the continuation of its ongoing VERSATILE-003 Phase 3 clinical trial following planned discussions with the Food and Drug Administration (FDA) regarding an amendment to the trial’s protocol, that would allow for an expedited approval pathway for PDS0101 and for other research and development expenses and general corporate purposes."

Financing • Squamous Cell Carcinoma of Head and Neck

Early changes in serum proteomic profiles predict anti-tumor activity in patients with advanced HPV-associated malignancies treated with novel combination immunotherapy (SITC 2025) - P1/2 | "Background We previously reported on the clinical activity of an HPV16 cancer vaccine (PDS0101), a tumor-targeting IL-12 immunocytokine (NHS-IL12, PDS01ADC), and a bifunctional agent targeting PD-L1 and TGF-β (bintrafusp alfa, BA) for the treatment of advanced HPV-associated malignancies, which demonstrated promising clinical activity (NCT04287868).1 Here, we perform a comprehensive survey of the peripheral immunome from patients treated with this novel immunotherapeutic combination to query systemic immunological changes and build models predicting clinical response.Methods Peripheral blood was serially collected from patients (n=50) for HPV16 circulating tumor DNA (ctDNA) detection, qualitative serum proteome profiling with the Olink ImmunoOncology platform, and immunophenotyping by flow cytometry. These data pave the way for outcome prediction in patients with HPV-associated malignancies using readily quantifiable molecular correlates from peripheral blood and..."

Clinical • Metastases • Oncology • GZMB • HMOX1 • IFNG • IL12A • IL6 • TGFB1

VERSATILE-002: Study of PDS0101 and Pembrolizumab Combination I/O in Subjects With HPV16 + Recurrent and/or Metastatic HNSCC (clinicaltrials.gov) - P2 | N=95 | Completed | Sponsor: PDS Biotechnology Corp. | Active, not recruiting ➔ Completed

Trial completion • Head and Neck Cancer • Infectious Disease • Oncology • Oropharyngeal Cancer • Solid Tumor • Squamous Cell Carcinoma • Squamous Cell Carcinoma of Head and Neck • PD-L1

VERSATILE-003: Phase 3 Study of PDS0101 and Pembrolizumab in HPV16+ Recurrent/Metastatic Head and Neck Squamous Cell Carcinoma (clinicaltrials.gov) - P3 | N=351 | Active, not recruiting | Sponsor: PDS Biotechnology Corp. | Recruiting ➔ Active, not recruiting

Enrollment closed • Head and Neck Cancer • Oncology • Oropharyngeal Cancer • Solid Tumor • Squamous Cell Carcinoma • Squamous Cell Carcinoma of Head and Neck

New Clinical and Translational Data on PDS Biotechnology’s Novel Investigational Cancer Therapies PDS0101 and PDS01ADC to be Presented at the 2025 Society for Immunotherapy of Cancer (SITC) Annual Meeting (GlobeNewswire)

Clinical data • Solid Tumor

PDS Biotech to Seek Expedited Approval Pathway for PDS0101 in HPV16-Positive Head and Neck Cancer (GlobeNewswire) - "...The Company has requested a meeting with the Food and Drug Administration ('FDA') to explore an expedited approval pathway for PDS0101 in HPV16-positive Head and Neck Cancer. The FDA meeting request is based on the final results from its VERSATILE-002 trial and a proposed amendment to the VERSATILE-003 Phase 3 trial to reduce the number of patients, while maintaining statistical power, and to add progression free survival (PFS) as an earlier primary endpoint in addition to median overall survival (mOS). If the PFS endpoint is met, it would allow for an accelerated approval submission to the FDA. While the Company’s trial amendment is undergoing review by the FDA, the VERSATILE-003 trial will be temporarily paused."

Clinical protocol • FDA event • Trial suspension • Squamous Cell Carcinoma of Head and Neck

Integration of Imaging and Blood-Based Biomarkers for Prognostication in Locally Advanced Cervical Cancer (ASTRO 2025) - "Seventeen patients received an additional therapeutic HPV vaccine as part of a clinical trial (PDS0101; IMMUNOCERV)... Combining imaging and cfDNA may be more informative than single biomarkers alone, necessitating future research with larger, multinational datasets to validate these findings and optimize biomarker combinations. Identifying patients with optimal biomarker and imaging characteristics may help personalize treatment with regards to radiation dose and use of systemic therapies."

Biomarker • Metastases • Cervical Cancer • Oncology • Solid Tumor

PDS Biotech Sets Significant Benchmark in Head and Neck Cancer by Achieving Extended Survival in Low PD-L1 Expression (CPS 1–19) Cohort in VERSATILE-002 Trial, Potentially Eliminating Need for Chemotherapy in the Population (GlobeNewswire) - "Approximately 60% of the patients enrolled (n=53) in the VERSATILE-002 trial had low PD-L1 expression, a difficult to treat subset of the overall HNSCC patient population. The sub-analysis of this patient cohort shows: Median overall survival (mOS) for patients within the CPS 1-19 cohort (n=32) was 29.5 months; Published mOS in this CPS cohort was 10.8 months with Keytruda monotherapy and 12.3 months with Keytruda plus chemotherapy....The Company announced mOS results for the full study population of 39.3 months from the VERSATILE-002 trial on August 25, 2025, and the full data set for the trial is expected to be published later this year."

P2 data • Squamous Cell Carcinoma of Head and Neck

PDS Biotech Announces Final Topline Survival Data from VERSATILE-002 Phase 2 Trial in Head and Neck Cancer (GlobeNewswire) - "53 patients were enrolled in the 1L R/M HNSCC arm of the trial...The 5th and final subcutaneous dose of PDS0101 was administered on cycle 12. On every other cycle where PDS0101 was not administered, pembrolizumab monotherapy was administered. This continued until disease progression, death, or to cycle 35: The median overall survival (mOS) is 39.3 months in patients with CPS ≥ 1. The lower limit of the 95% confidence interval is 23.9 months, and the upper limit is not yet estimable....'We look forward to publishing the full data set for this trial later this year.'"

P2 data • Squamous Cell Carcinoma of Head and Neck

Testing for Safety and Immune Effects of PDS0101, an Anti-HPV Therapy, Among People Living With HIV (clinicaltrials.gov) - P2 | N=27 | Not yet recruiting | Sponsor: Weill Medical College of Cornell University

New P2 trial • Anal Carcinoma • Cervical Cancer • Human Immunodeficiency Virus • Infectious Disease • Oncology • Solid Tumor

A Vaccine (PDS0101) Alone or in Combination With Pembrolizumab for the Treatment of Locally Advanced Human Papillomavirus-Associated Oropharynx Cancer (clinicaltrials.gov) - P1/2 | N=24 | Active, not recruiting | Sponsor: Mayo Clinic | Recruiting ➔ Active, not recruiting | Trial completion date: Jul 2025 ➔ Oct 2026 | Trial primary completion date: Jul 2025 ➔ Oct 2026

Enrollment closed • Trial completion date • Trial primary completion date • Head and Neck Cancer • Oncology • Oropharyngeal Cancer • Solid Tumor • Squamous Cell Carcinoma • Squamous Cell Carcinoma of Head and Neck

PDS Biotech to Host Key Opinion Leader Event to Discuss Versamune HPV for the Treatment of HPV16+ HNSCC (The Manila Times) - "The event will review the changing landscape of HNSCC in context with Merck’s KEYNOTE-689 (KN-689) study and the rapidly increasing incidences of HPV16-positive HNSCC in the US and Europe. The event will also include a review of Versamune HPV, which is currently being evaluated in a Phase 3 clinical trial in combination with pembrolizumab as a first-line treatment for R/M HPV16+ HNSCC, as well as in Phase 2 clinical trials for the treatment of various types of HPV16-positive cancers."

Clinical • Squamous Cell Carcinoma of Head and Neck

Versatile-002: Overall survival of HPV16-positive recurrent/metastatic head and neck squamous cell carcinoma patients treated with T cell stimulating immunotherapy PDS0101 and pembrolizumab. (ASCO 2025) - P2 | "These data represent one of the most extended follow-up periods to date of subjects receiving an HPV16-targeted therapy for HPV16-positive R/M HNSCC. The PDS0101 and pembrolizumab combination is well tolerated and has demonstrated deep and durable clinical responses. Median OS is promising in light of historic expectations, both overall and relative to PD-L1 subgroup, and remains durable with continued follow up."

Clinical • Metastases • Dermatology • Fatigue • Head and Neck Cancer • Oncology • Pain • Pruritus • Solid Tumor • Squamous Cell Carcinoma • Squamous Cell Carcinoma of Head and Neck • PD-L1

Initial results of MC200710 investigating therapeutic vaccine (PDS0101) alone or with pembrolizumab prior to surgery or radiation therapy for locally advanced HPV associated oropharyngeal carcinoma, a phase 2 window of opportunity trial. (ASCO 2025) - P1/2 | "The combination of PDS0101 and pembrolizumab met the trial's primary endpoint of ctDNA response and shows promise for further evaluation. ctDNA can be used to assess early response and future studies could use ctDNA to adapt neoadjuvant therapy. Based on these findings, a neoadjuvant dose optimization study in HPV16+ oropharyngeal carcinoma is warranted and evaluation of PDS0101 and pembrolizumab in comparison to pembrolizumab alone."

Metastases • P2 data • Surgery • Hepatology • Oncology • Oropharyngeal Cancer • Pneumonia • Solid Tumor • Squamous Cell Carcinoma • Squamous Cell Carcinoma of Head and Neck

VERSATILE-003: A phase 3, randomized, open-label trial of PDS0101 and pembrolizumab compared with pembrolizumab for first-line treatment of patients with HPV16-positive recurrent/metastatic head and neck squamous cell carcinoma. (ASCO 2025) - P2, P3 | "Exploratory objectives include tumor response assessed by investigator and by irRECIST, PFS2, quality of life as assessed by EQ-5D, QLQ-C30, and QLQ H&N35, and assessment of ctHPVDNA. Updated enrollment data will be provided."

Clinical • IO biomarker • Metastases • P3 data • Cervical Cancer • Head and Neck Cancer • Oncology • Solid Tumor • Squamous Cell Carcinoma • Squamous Cell Carcinoma of Head and Neck • PD-L1

PDS Biotech Unveils Updated Positive Data From VERSATILE-002 Trial…Evaluating Versamune HPV to Treat Head and Neck Cancers at the 2025 American Society of Clinical Oncology (ASCO) Annual Meeting (GlobeNewswire) - P2 | N=95 | VERSATILE-002 (NCT04260126) | Sponsor: PDS Biotechnology Corp. | "Median overall survival (mOS) has remained steady at 30.0 months over the last 1.5 years, suggesting durability of the Versamune HPV-induced clinical responses. The lower limit of the 95% confidence interval for mOS has, however, increased from 18.4 months in 2023 to 23.9 months as the data has matured. All data are reported according to RECISTv1.1 criteria, requiring clinical responses on at least two consecutive tumor scans at least 4 weeks apart. Enrollment in the trial (n=53) is complete; 22 patients (including 3 still on treatment) continue to be followed for survival. No new safety signals have emerged."

P2 data • Head and Neck Cancer • Squamous Cell Carcinoma of Head and Neck