Phase II year
2009
(last award dollars: 2013)
Phase II Amount
$3,375,529
Recent advances in cellular immunology have revolutionized our understanding of antigen processing and presentation. UBIVAC, LLC, has an exclusive option on technology (patent pending) that exploits these developments that was developed by Dr. Hong-Ming Hu. Further, the founders of UBIVAC (Drs. Hu and Fox) and their collaborators have investigated additional treatment combinations that can significantly augment the therapeutic efficacy of vaccines. The combination of these strategies with this vaccine technology (DRibbles) in preclinical animal models further increased priming/expansion of tumor-specific T cells and provided a significant survival advantage for the DRibble vaccine strategy. Based on the data generated in UBIVAC's Phase I SBIR, a pilot Clinical Trial of Autologous NSCLC DRibbles was initiated (R21-CA123864). This Investigator-initiated trial just opened and autologous DRibble vaccine has been successfully made for the first eligible patient. UBIVAC, LLC, has one candidate NSCLC cell line (adenocarcinoma) that over expresses a large number of genes in common with seven other NSCLC cell lines screened, grows well and is a good producer of supernatant DRibbles. Before this SBIR Phase II award is initiated, UBIVAC will use the same criteria listed above to identify a second cell line (of squamous origin) for production of DRibbles. In Aim 1 UBIVAC will generate a master cell bank (MCB) for each cell line, test the MCBs for sterility, generate WCBs and optimize DRibble production using CMC specifications from the FDA-approved autologous NSCLC DRibble IND and produce sufficient vaccine to complete the 48 patient trial. Aim 2 will conduct a randomized phase II trial of docetaxel and allogeneic NSCLC DRibble vaccine combined with either GM-CSF or imiquimod (DRibble Plus) Aim 3 will evaluate the humoral immune response induced by Universal NSCLC DRibble Plus vaccine. It will also investigate whether vaccination reduces the number of circulating tumor cells (CTC), a biomarker that has the potential to be a surrogate for clinical response. UBIVAC, LLC has a letter of intent that could provide 2 to 50 million dollars to support the commercial development of DRibble technology if the proposed phase II SBIR study is successful. To help guide this transition UBIVAC has assembled an advisory board that includes a successful president/CEO with more than 40 years Pharma experience; a physician- scientist with large Pharma oncology experience who served as Global Head Vaccines & Immunomodulatory Agents; and the managing Director of Northwest Technology Ventures. Taken together, UBIVAC has the critical elements, compelling preclinical data, Individuals with substantial clinical, translational research, business and venture experience, a well designed randomized phase II study and cutting edge monitoring strategies that hold great promise to make a difference in the lives of patients with NSCLC, and the experience to get this agent to market.
Public Health Relevance: Successful completion of the randomized Phase II clinical trial of UBIVAC's two promising NSCLC Dribble Plus vaccines (DPV-1 + GM-CSF or imiquimod) will allow UBIVAC to ""pick-the-winner"", arrange funding and/or a strategic partner and provide a compelling argument to move the lead product forward into a randomized Phase III clinical trial for advanced NSCLC.
Thesaurus Terms: 1-Isobutyl-1h-Imidazo(4,5-C)Quinolin-4-Amine; 1h-Imidazo(4,5-C)Quinolin-4-Amine, 1-(2-Methylpropyl)-; 20s Catalytic Proteasome; 20s Core Proteasome; 20s Proteasome; 20s Proteosome; 3m Brand Of Imiquimod; Apc; Atgn; Accounting; Adenocarcinoma; Adenoma, Malignant; Agonist; Aldara; Allogenic; Animal Model; Animal Models And Related Studies; Animals; Antibody Formation; Antibody Production; Antibody Response; Antigen Presentation Pathway; Antigen Processing And Presentation; Antigen-Presenting Cells; Antigens; Antineoplastic Vaccine; Antitumor Response; Assay; Autologous; Award; Binding; Binding (Molecular Function); Bioassay; Biologic Assays; Biological Assay; Bleb; Blister; Bulla; Bullous Lesion; Businesses; Cd8; Cd8b; Cd8b1; Cd8b1 Gene; Cancer Vaccines; Cancer, Oncology; Cancers; Carcinoma, Non-Small-Cell Lung; Cell Count; Cell Line; Cell Lines, Strains; Cell Number; Cellline; Cells; Cellular Immunology; Clinical; Clinical Treatment; Clinical Trials; Clinical Trials Design; Clinical Trials, Phase Ii; Clinical Trials, Phase Iii; Clinical Trials, Unspecified; Combined Vaccines; Cross-Priming; Data; Dendritic Cells; Detection; Development; Elements; Evaluation; Fda Approved; Foxes; Funding; Gm-Csf; Gmcsf; Gene Transcription; Generations; Genes; Genetic Transcription; Granulocyte-Macrophage Colony-Stimulating Factor; Head; Histamine-Producing Cell-Stimulating Factor; Human; Human, General; Itx; Imiquimod; Immune Response; Immunologic Accessory Cells; Immunologic, Immunochemical; Immunologically Directed Therapy; Immunologics; Immunotherapy; In Vitro; Incubated; Individual; Infectious Agent; Investigators; Killings; Lyt3; Lead; Legal Patent; Letters; Licensing; Life; Macropain; Macroxyproteinase; Malignant Neoplasms; Malignant Tumor; Mammals, Mice; Man (Taxonomy); Man, Modern; Marketing; Mediating; Mice; Modeling; Molecular Interaction; Molgramostin; Monitor; Monocytes / Macrophages / Apc; Multicatalytic Proteinase; Murine; Mus; N-Debenzoyl-N-(Tert-Butoxycarbonyl)-10-Deacetyltaxol; Nsclc; Nsclc - Non-Small Cell Lung Cancer; Non-Small Cell Lung Cancer; Non-Small-Cell Lung Carcinoma; Patents; Patients; Pb Element; Peptide Biosynthesis, Ribosomal; Peptides; Phase; Phase 2 Clinical Trials; Phase 3 Clinical Trials; Phase Ii Clinical Trials; Phase Iii Clinical Trials; Physicians; Procedures; Process; Production; Prosome; Proteasome; Proteasome Endopeptidase Complex; Proteasome Inhibitor; Protein Biosynthesis; Protein Biosynthesis, Ribosomal; Protein Degradation, Metabolic; Protein Degradation, Regulatory; Protein Synthesis, Ribosomal; Protein Turnover; Proteins; Proteosome; Quality Control; Rna Expression; Randomized; Research Personnel; Researchers; Sbir; Sbirs (R43/44); Scientist; Small Business Innovation Research; Small Business Innovation Research Grant; Source; Staging; Sterility; T-Cells; T-Lymphocyte; Tc-Gm-Csf; Taxotere; Technology; Testing; Therapeutic; Thymus-Dependent Lymphocytes; Transcription; Transcription, Genetic; Translating; Translatings; Translational Research; Translational Research Enterprise; Translational Science; Translations; Treatment Efficacy; Tumor Antigens; Tumor Cell; Tumor Expansion; Tumor-Associated Antigen; Tumor-Cell Human Gm Colony-Stimulating Factor; Tumor-Derived; Vaccination; Vaccine Production; Vaccines; Vaccines, Combination; Vaccines, Combined; Vaccines, Neoplasm; Vaccines, Tumor; Veiled Cells; Vesication; Waste Products; Aberrant Protein Folding; Abnormal Protein Folding; Accessory Cell; Antibody Biosynthesis; Base; Biomarker; Cell Bank; Clinical Investigation; Cultured Cell Line; Design; Designing; Docetaxel; Docetaxol; Experience; Experiment; Experimental Research; Experimental Study; Gene Product; Granulocyte Macrophage Colony Stimulating Factor; Heavy Metal Pb; Heavy Metal Lead; Host Response; Immune Therapy; Immunogen; Immunoglobulin Biosynthesis; Immunoresponse; In Vivo; Infectious Organism; Language Translation; Malignancy; Model Organism; Multicatalytic Endopeptidase Complex; Neoplasm/Cancer; Neoplastic Cell; Nonsmall Cell Lung Cancer; Novel; Oncology; Pathologic Protein Folding; Phase 2 Study; Phase 2 Trial; Phase 3 Study; Phase 3 Trial; Phase Ii Trial; Phase Iii Trial; Polypeptide; Pre-Clinical; Preclinical; Protein Degradation; Protein Mis-Folding; Protein Misfolding; Protein Synthesis; Protocol, Phase Ii; Protocol, Phase Iii; Public Health Relevance; Randomisation; Randomization; Randomly Assigned; Research Study; Response; Scale Up; Sterile; Study, Phase Ii; Study, Phase Iii; Therapeutic Efficacy; Therapeutically Effective; Thymus Derived Lymphocyte; Translation Research Enterprise; Trial Regimen; Trial Treatment; Tumor; Tumor-Specific Antigen; Vaccine Safety