Versamune HPV / PDS Biotechnology - LARVOL DELTA

Cervicovaginal Bacterial Microbiome Remodeling after Brachytherapy in Patients with Locally Advanced Cervical Cancer Patient Treated with Chemoradiation with or without Therapeutic HPV Vaccine (ASTRO 2026) - "Materials/ Patients with locally advanced cervical cancer treated with CCRT in standard of care (SOC group) and IMMUNOCERV trial (PDS group; primary =5 cm and/or imaging-positive nodes) in presence of therapeutic HPV vaccine immunotherapy PDS0101: subcutaneously administered HPV-specific vaccine containing peptide pools encoding E6/E7 antigens were prospectively undergone cervicovaginal swab for microbiome detection at pre-brachytherapy (pre-BT) and post-brachytherapy (post-BT)... Global alpha and beta diversity was stable after brachytherapy but composition remodeling including enrichment of gram-positive mucosa associated cocci including members of Peptostreptococcaceae family. Brachytherapy appears to induce restructuring and not broad depletion of microbiome. Future studies will investigate the clinical and immunologic implications of these changes."

Clinical • Metastases • Cervical Cancer • Oncology • Solid Tumor • Vaginal Cancer

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

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

VERSATILE-003: Phase 3 Study of PDS0101 and Pembrolizumab in HPV16+ Recurrent/Metastatic Head and Neck Squamous Cell Carcinoma (clinicaltrials.gov) - P3 | N=12 | Terminated | Sponsor: PDS Biotechnology Corp. | N=252 ➔ 12 | Trial completion date: Feb 2029 ➔ Aug 2026 | Active, not recruiting ➔ Terminated | Trial primary completion date: Feb 2029 ➔ Aug 2026; The study is being discontinued solely based on financial constraints and is not related to the safety of study participants, the investigational product, PDS0101, nor the conduct of the study.

Enrollment change • Trial completion date • Trial primary completion date • Trial termination • Head and Neck Cancer • Oncology • Oropharyngeal Cancer • Solid Tumor • Squamous Cell Carcinoma • Squamous Cell Carcinoma of Head and Neck • PD-L1

PDS0101 With Pembrolizumab in HPV16-Positive Recurrent/Metastatic Head and Neck Squamous Cell Carcinoma: A Phase 2 Nonrandomized Clinical Trial. (PubMed, JAMA Oncol) - P2 | "The findings support further evaluation in a first-line setting. ClinicalTrials.gov Identifier: NCT04260126."

Clinical • Journal • P2 data • Head and Neck Cancer • Oncology • Solid Tumor • Squamous Cell Carcinoma • Squamous Cell Carcinoma of Head and Neck • PD-L1

The Company recently announced the initial closing of a PIPE financing of up to $22.3 million led by Nant Capital, alongside an agreement granting NantWorks, LLC, an affiliate of Nant Capital, a one-year exclusive right to negotiate an exclusive license to PDS0101 (GlobeNewswire)

Financing • Squamous Cell Carcinoma of Head and Neck

PDS Biotech Announces Publication of VERSATILE-002 Phase 2 Clinical Trial Results of PDS0101 with pembrolizumab in HPV16-Positive Recurrent and/or Metastatic (R/M) Head and Neck Cancer in JAMA Oncology (GlobeNewswire) - "62.3% of the ICI-naïve participants in the mITT cohort (n = 53) had low CPS of 1-19, and 37.7% had high CPS ≥ 20. In the overall CPS ≥ 1 population, the mOS was 39.3 months (95% CI, 23.9 to NE); The best published result with standard of care pembrolizumab or pembrolizumab + chemotherapy is 17.9 months. Objective response rate (ORR) for CPS ≥ 1 was 36% of which 5/53 were complete responders by investigator review and 34% of which 6/53 were complete responders by central review. The published ORR for the overall population with CPS ≥ 1 when treated with standard of care pembrolizumab is 19%."

P2 data • Squamous Cell Carcinoma of Head and Neck

CASCADE: Testing for Safety and Immune Effects of PDS0101, an Anti-HPV Therapy, Among People Living With HIV (clinicaltrials.gov) - P2 | N=0 | Withdrawn | Sponsor: University of California, San Diego | N=27 ➔ 0 | Trial completion date: Jul 2026 ➔ Dec 2026 | Not yet recruiting ➔ Withdrawn | Trial primary completion date: Jul 2026 ➔ Dec 2026

Enrollment change • Trial completion date • Trial primary completion date • Trial withdrawal • Anal Carcinoma • Cervical Cancer • Human Immunodeficiency Virus • Infectious Disease • Oncology • Solid Tumor • CD4

PDS Biotech Announces Strategic Refocus Prioritizing PDS0301 in Metastatic Colorectal Cancer (mCRC) and Partnership Strategy for PDS0101 (GlobeNewswire) - "We have decided that we will cease further internal investment in the PDS0101 Phase 3 VERSATILE-003 trial, including the discontinuation of the VERSATILE-003 Phase 3 trial, and intend to pursue strategic partnerships or other externally funded opportunities for the continued development of PDS0101. This decision follows a comprehensive assessment of the capital, time and resources required to complete the Phase 3 trial and support commercialization of PDS0101....A randomized Phase 2b trial with PDS0301 has been designed taking into account feedback received from the FDA and is intended to generate meaningful clinical data with disciplined capital investment."

Pipeline update • Trial termination • Squamous Cell Carcinoma of Head and Neck

Combination Immunotherapy in Subjects With Advanced HPV Associated Malignancies (clinicaltrials.gov) - P1/2 | N=51 | Completed | Sponsor: National Cancer Institute (NCI) | Active, not recruiting ➔ Completed

Trial completion • Anal Carcinoma • Cervical Cancer • Colorectal Cancer • Gynecologic Cancers • Head and Neck Cancer • Oncology • Oropharyngeal Cancer • Penile Cancer • Rectal Cancer • Solid Tumor • Squamous Cell Carcinoma of Head and Neck • Vaginal Cancer • Vulvar Cancer • CD4 • CDKN2A • PD-L1

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 | Active, not recruiting | Sponsor: Mayo Clinic | Completed ➔ Active, not recruiting | Trial completion date: Apr 2025 ➔ Sep 2026

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

Personalized and HPV cancer vaccines in head and neck squamous cell carcinoma: from concept to clinical implementation. (PubMed, Transl Oncol) - "Compounds such as TG4050, mRNA-4157, and PGV001 have shown early, hypothesis-generating signals of activity (from small early-phase studies), particularly in the adjuvant setting. HPV-targeted vaccines, including PDS0101, BNT113, and CUE-101, are being explored in HPV-positive HNSCC, mainly in combination with ICIs...The greatest clinical potential of therapeutic vaccination may lie in earlier disease stages, where the tumor burden is lower and immune modulation more feasible. Further clinical and translational research is needed to define the optimal integration of vaccine-based therapies into multimodal treatment paradigms for HNSCC."

IO biomarker • Journal • Review • Head and Neck Cancer • Immune Modulation • Immunology • Oncology • Solid Tumor • Squamous Cell Carcinoma • Squamous Cell Carcinoma of Head and Neck

PDS Biotech Announces Adoption of Amended Protocol for Phase 3 VERSATILE-003 Trial Incorporating Progression Free Survival (PFS) as Primary Endpoint for Interim Analysis and Potential Accelerated Approval (The Manila Times) - "Enables Potential Shorter Time to Accelerated Approval of PDS0101 in HPV16-positive Head and Neck Cancer...Following the FDA's standard 30-day wait period since filing of the amended protocol to the Investigational New Drug (IND) Application, without objection, the Company is proceeding with the amended protocol."

Clinical protocol • Head and Neck Cancer • Squamous Cell Carcinoma of Head and Neck

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

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