Versamune MUC1 / PDS Biotech, National Cancer Institute - Bethesda - LARVOL DELTA

PDS Biotech Announces FDA Clearance of IND Application for Combination of Versamune MUC1 and PDS01ADC to Treat Metastatic Colorectal Cancer (GlobeNewswire) - "PDS Biotechnology Corporation...announced that the U.S. Food and Drug Administration has cleared its Investigational New Drug ('IND') application filed in January 2025 to evaluate a combination of Versamune MUC1 (formerly PDS0103), its novel investigational MUC1-targeted immunotherapy candidate + PDS01ADC to treat MUC1-positive unresectable, metastatic colorectal carcinoma ('mCRC') in patients who failed previous treatment....The National Cancer Institute ('NCI'), under its Cooperative Research and Development Agreement ('CRADA') with PDS Biotech, will lead the Phase 1/2 clinical trial evaluating the combination of Versamune MUC1 + PDS01ADC in recurrent/metastatic colorectal cancer."

IND • New P1/2 trial • Colorectal Cancer

"Can you elaborate on the Mayo study? Are they using PDS0101 and PDS0103 in it?" (@LSteelback)

PDS Biotech Announces Abstract Demonstrating Versatility of the Versamune Platform in Oncology Accepted for Presentation at AACR Special Conference on Tumor Immunology and Immunotherapy (GlobeNewswire) - "PDS Biotechnology Corporation...announced that an abstract reporting on preclinical studies of two the company’s oncology pipeline products targeting multiple types of cancer has been accepted for presentation at...AACR Special Conference on Tumor Immunology and Immunotherapy 2022....The abstract accepted for presentation at the AACR Tumor Immunology and Immunotherapy Conference highlights the development of Versamune® based drug formulations containing multi-epitope peptide antigen sequences of the tumor-associated protein TARP (T cell receptor gamma chain Alternate Reading frame Protein) and modified sequences of novel Mucin 1 oncoprotein (MUC1). This research provided the foundation for the development of PDS0102 as a potential treatment for TARP-associated acute myeloid leukemia (AML), prostate, and breast cancers, and PDS0103 as a potential treatment for MUC1-associated breast, colon, lung, ovarian, and other cancers."

Preclinical • Acute Myelogenous Leukemia • Breast Cancer • Colorectal Cancer • Genito-urinary Cancer • Gynecologic Cancers • Hematological Malignancies • Leukemia • Lung Cancer • Oncology • Ovarian Cancer • Prostate Cancer • Solid Tumor • MUC1

PDS Biotechnology Nets $1.2M Through NJ Economic Development Program to Advance Oncology Candidates (Precision Oncology News) - "PDS said it will put the $1.2 million raised toward advancing its lead candidate PDS0101 into four Phase II trials and moving another candidate, PDS0103, into the clinic. PDS0101, which the firm is currently evaluating in single-agent and combination trials for several HPV16-related cancers, is designed to target HPV16 antigens on cancer cells and induce CD8 cytotoxic T-cell responses."

Commercial • Gastrointestinal Cancer • Head and Neck Cancer • Oncology • Oropharyngeal Cancer

PDS Biotech Provides Business Update and Reports Fourth-Quarter and Full-Year 2021 Financial Results (PDS Biotech Press Release) - "We look forward to an equally productive 2022, during which we expect to announce additional data from our ongoing Phase 2 oncology trials for PDS0101, as well as plan to progress at least one of our preclinical programs, PDS0103 into the clinic.'”"

Clinical • P2 data • Oncology

PDS Biotechnology to Present at B. Riley Securities Virtual Oncology Conference (GlobeNewswire) - "The presentation will provide an update on three ongoing PDS0101 phase 2 clinical trials. In the Versatile-002 phase 2 clinical trial, PDS Biotech is collaborating with MERCK & Co., to evaluate a combination of PDS0101 and KEYTRUDA....The presentation will also provide updates on the progression of two other investigational pipeline immune-oncology products. PDS0102 (Versamune^® + TARP) addresses prostate cancer, breast cancer and AML, and PDS0103 (Versamune^® + MUC1) addresses multiple cancers including breast, colon, lung, and ovarian cancers."

Clinical • Acute Myelogenous Leukemia • Breast Cancer • Colorectal Cancer • Genito-urinary Cancer • Gynecologic Cancers • Head and Neck Cancer • Hematological Malignancies • Lung Cancer • Non Small Cell Lung Cancer • Oncology • Ovarian Cancer • Prostate Cancer • Solid Tumor • Squamous Cell Carcinoma of Head and Neck

PDS Biotechnology to Present at H.C. Wainwright Bioconnect Virtual Conference (GlobeNewswire) - "The presentation will provide an update on the three ongoing PDS0101 Phase 2 clinical trials. The talk will also provide updates on the progression of two other investigational pipeline products PDS0102 (Versamune^®-TARP) and PDS0103 (Versamune^®-MUC1) into human clinical trials. The conference is taking place virtually from January 10 - 13, 2022."

Clinical • Cervical Cancer • Gynecologic Cancers • Head and Neck Cancer • Oncology • Solid Tumor • Squamous Cell Carcinoma of Head and Neck

PDS Biotechnology to Present at the Benzinga Healthcare Conference (GlobeNewswire) - "PDS Biotech management will deliver a presentation providing an update on the three ongoing PDS0101 Phase 2 clinical trials. The talk will also provide updates on the progression of two investigational pipeline products PDS0102 (Versamune®-TARP) and PDS0103 (Versamune®-MUC1) into human clinical trials."

Clinical • Head and Neck Cancer • Oncology • Solid Tumor • Squamous Cell Carcinoma of Head and Neck

PDS Biotechnology to Present at the Cantor Fitzgerald Virtual Global Healthcare Conference (GlobeNewswire) - "The presentation will provide an update on the three ongoing PDS0101 Phase 2 clinical trials. The talk will also provide updates on progression of two other investigational pipeline products PDS0102 (Versamune®-TARP) and PDS0103 (Versamune®-MUC1) into human clinical trials."

Clinical • P2 data • Head and Neck Cancer • Oncology • Solid Tumor • Squamous Cell Carcinoma of Head and Neck

PDS Biotechnology to Present at the Oppenheimer Fall Healthcare Life Sciences & MedTech Summit (GlobeNewswire) - “PDS Biotechnology…announced today that its management will present at the Oppenheimer Fall Healthcare Life Sciences & MedTech Summit.The presentation will provide an update on the three ongoing PDS0101 Phase 2 clinical trials. The talk will also provide updates on progression of two other investigational pipeline products PDS0102 (Versamune®-TARP) and PDS0103 (Versamune®-MUC1) into human clinical trials. The conference is taking place virtually from September 21 - 23, 2021.”

P2 data • Oncology

PDS Biotechnology to Present at the HC Wainwright 23rd Annual Global Investment Conference (GlobeNewswire) - "The presentation will provide an update on the three ongoing PDS0101 Phase 2 clinical trials. The talk will also provide updates on progression of two other investigational pipeline products PDS0102 (Versamune®-TARP) and PDS0103 (Versamune®-MUC1) into human clinical trials. The conference is taking place virtually from September 13 - 15, 2021."

Clinical • P2 data • Anal Carcinoma • Cervical Cancer • Gastrointestinal Cancer • Gynecologic Cancers • Head and Neck Cancer • Oncology • Rectal Cancer • Squamous Cell Carcinoma of Head and Neck

PDS Biotechnology to Present Recent Phase 2 Human Clinical Data and On-Going Oncology Programs at Investor Conferences (GlobeNewswire) - “PDS Biotechnology…announced today that its management team will present at several investor conferences listed below during the third quarter of 2021…The upcoming investor conferences will offer leadership the opportunity to provide an update on both ongoing PDS0101 Phase 2 clinical trials, as well as preparations to move two other investigational compounds PDS0102 (Versamune®-TARP) and PDS0103 (Versamune®-MUC1) into human testing.”

Clinical data • P2 data • Oncology