ATL Reniale Lipo Nova AG Hannover Germany

Reniale is an autologous cancer vaccine based on lysates from patient's tumor cells. The cells are purified and after a few hours of incubation with gamma interferon they go through a devitalization process. Liponova completed a phase 3 trial of Reniale, involving 558 patients with nonmetastatic RCC. Although the majority of clinical research indicates greater benefit of cancer vaccines among patients with earlier-stage disease, a subset analysis of the phase 3 trial found a significant...

Outlining the Gap Between Preclinical Models and

Therapeutic and Prophylactic Cancer Vaccines Emerging Perspectives from Allogeneic and Infectious Disease Vaccines 55 4. Personalized Cancer Vaccines 69 Florentina Teofilovici and Kerry Wentworth 5. Dendritic Cell Vaccines for Gliomas 83 Anne Luptrawan, Gentao Liu, Suzane Brian, and John S. Yu 6. Peptide-Based Active Immunotherapy in Cancer 109 7. Multimodality Immunization Approaches to Improve on DNA Vaccines for Cancer 131 8. Bidirectional Bedside Lab Bench Processes...

Using Diagnostic Assays in Pretreatment Screening and Eligibility Criteria

The fact that human cancer cells express antigens has been directly addressed by the identification and cloning of a number of tumor-associated and tumor-specific antigens. MKC has focused on TAA-specific antigens that are highly expressed in many different cancers including prostate, breast, ovarian, pancreatic, renal cell, colorectal carcinomas, and melanoma. MKC has assays in place for determining the patient's MHC1 type for HLA-A2 specificity, assaying the patient's tumor tissue for two or...

Extended Peptide Sequences and Proteins

Because of the high sensitivity of minimal antigenic peptides to inactivation by exopeptidases, it has been proposed that elongated peptide sequences should confer increased resistance to proteolytic inactivation and should therefore be more efficient at producing appropriate MHC class I ligands. Immunization of mice with long synthetic peptides was indeed more potent at eliciting CD8+ T-cell responses than minimal peptides (118). Given the necessity of these long peptides to be processed...

Clinical Data In Personalized Cancer Vaccines That Reached Phase 3 Clinical Trials

One of the shared and clear advantages to cancer vaccines is the excellent safety profile, which makes their use in the adjuvant or earlier-stage disease setting more suitable than more conventional treatments such as chemotherapy. Choudhury et al. note that collectively the data indicate that vaccine therapy is safe, and no significant autoimmune reactions are observed even on long-term follow-up (18). Such a safety profile would indicate the potential for a high quality of life index, which...

Stimuvax Biomira Edmonton AB Canada Merck KGaA Darmstadt Germany

Stimuvax, a non-patient-specific vaccine, consists of a synthetic peptide derived from the tumor-associated antigen MUC-1 encapsulated in a liposome a phos-pholipid shell intended to facilitate and improve treatment delivery . It is designed to neutralize the immunosuppressive effect of MUC-1 to better enable the immune system to target the cancer. A phase 2, randomized, open-label trial evaluated Stimuvax in patients with stage IIIB or IV non-small cell lung cancer NSCLC whose disease was...

GSK 1572932A Glaxo SmithKline Philadelphia PA US

This cancer immunotherapeutic non-patient-specific vaccine consists of a purified recombinant MAGE-A3 protein combined with GSK's proprietary adjuvant system. The agent is designed to trigger an immune response against tumor cells expressing MAGE-A3, a tumor-specific antigen expressed on a variety of cancers including NSCLC and melanoma. GlaxoSmithKline has initiated a phase 3, randomized, double-blind placebo-controlled trial of GSK 1572932A as an adjuvant therapy in patients with stage IB,...

Oncophage Vitespen Antigenics Lexington MA US

Oncophage is an autologous vaccine that consists of complexes of heat shock proteins HSPs and their associated peptides derived from patients' own tumor cells. These complexes HSPPCs comprise a sort of antigenic fingerprint that is unique to each patient's cancer. The vaccine is designed to stimulate a specific immune response against cancer cells bearing this fingerprint. Oncophage was evaluated in a phase 3 study, which randomized 728 patients with nonmetastatic renal cell carcinoma RCC...

OncoVAX Intracel Frederick MD US

OncoVAX is an autologous vaccine prepared individually from each patient's tumor cells. After surgical resection of the tumor, cells from the tumor are irradiated and then mixed with the adjuvant bacille Calmette-Guerin BCG, an attenuated strain of bacteria that can boost immune response to a vaccine . It is designed to stimulate a specific immune response against each patient's own cancer. OncoVAX was evaluated in the adjuvant setting in conjunction with another treatment in this case, surgery...

Biomarkerguided Rd

In support of several components of the development process, the hallmarks of the new molecular targeted therapies are biomarkers. Unfortunately, there is a significant heterogeneity of biomarkers, somewhat hampering the communication in this area. We depicted three general categories of biomarkers in Figure 10, based on the scientific significance, utility, and implication to the drug development process. First, markers of disease, disease relapse, or progression are correlates of the...