Genelux Corporation

San Diego, CA, United States

Genelux Corporation

San Diego, CA, United States
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Patent
Genelux Corporation | Date: 2016-10-21

Therapeutic methods and vaccinia virus therefor are provided. The viruses are designed so that they accumulate in immunoprivileged tissues and cells, such as in tumors and other proliferating tissue and in inflamed tissues, compared to other tissues, cells and organs, so that they exhibit relatively low toxicity to host organisms. Combinations of the viruses and anti-cancer agents and uses thereof for treating cancer also are provided.


News Article | December 21, 2016
Site: www.businesswire.com

SAN DIEGO--(BUSINESS WIRE)--Batu Biologics, a San Diego based immuno-oncology company focused on the development of its tumor angiogenesis targeting immune therapy, ValloVax™, announced today the formation of a Clinical Advisory Board to guide the company in the development of its lead program. “Members of the Batu Biologics Clinical Advisory Board have aligned their vision to assess the clinical feasibility of targeting the tumor vasculature as an effective treatment for solid tumors,” said Samuel C. Wagner, President and CEO of Batu Biologics. “Our goal is to streamline and optimize the clinical development plan for the ValloVax™ program in order to ensure the highest likelihood of patient response in the clinical setting.” “Making advances in a challenging and competitive environment requires a team of experts who can share experiences, information and innovative ideas,” said Dr. Santosh Kesari, Chairman of Batu’s Clinical Advisory Board and Professor at the Pacific Neuroscience Institute and John Wayne Cancer Institute at Providence Saint John’s Health Center. “We are excited to explore various strategies in the areas of predictive biomarkers, personalized therapy, and combination approaches with FDA-approved cancer therapeutics in an effort to ensure the best patient response to the ValloVax™ therapy.” The newly appointed members of the Batu Biologics Clinical Advisory Board are: Dr. Santosh Kesari is a Professor and Chair of Translational Neurosciences and Neurotherapeutics at Pacific Neuroscience Institute and John Wayne Cancer Institute at Providence Saint John’s Health Center. His research investigates the biology of gliomas and brain metastases with the aim of developing new therapeutics. He has a long-standing interest in neural development, cancer stem cells, and neuroimmunology and translational research in these areas to accelerate drug development; Mai is a strategic advisor for biotechnology companies with a focus in oncology and immunotherapy. Dr. Le has over 8 years of oncology drug development experience that includes small molecules, biologics, medical devices and companion diagnostics strategy. She previously served as a medical director at Calithera Biosciences, Plexxikon Inc., Onyx Pharmaceuticals and Proteolix, Inc (acquired by Onyx Pharmaceuticals), and most recently, as the Chief Medical Officer at OncoSec Medical, Inc. Dr. Le obtained a medical degree from the University of Rochester School of Medicine and Dentistry and trained in Laboratory Medicine at University of California, San Francisco; and Boris is currently the President of Clinical and Scientific Affairs at StemImmune Inc. and Adjunct Professor at the Moores UCSD Cancer Center. Dr. Minev previously worked as Director of Immunotherapy and Translational Oncology at Genelux Corporation and was heading the Laboratory of Tumor Immunology and Immunotherapy at the Moores UCSD Cancer Center. Dr. Minev has an extensive experience in Immuno-Oncology and cancer vaccine development, having worked closely on the development of the first tumor vaccine to be approved by a regulatory body (Melacine). Batu Biologics is an immuno-oncology company developing novel gene and cellular based therapies for the treatment of cancer. The Company has filed an IND application for its lead therapeutic, ValloVax™, a multivalent therapeutic vaccine for Non Small Cell Lung Cancer targeting several tumor-angiogenesis associated antigens. ValloVax™ has demonstrated strong inhibition of tumor growth in several histologically distinct tumor models, and the company is currently raising funds that will enable the completion of a Phase I clinical study.


Virotherapy using oncolytic vaccinia virus (VACV) strains is one promising new strategy for canine cancer therapy. In this study we describe the establishment of an in vivo model of canine soft tissue sarcoma (CSTS) using the new isolated cell line STSA-1 and the analysis of the virus-mediated oncolytic and immunological effects of two different Lister VACV LIVP1.1.1 and GLV-1h68 strains against CSTS. Cell culture data demonstrated that both tested VACV strains efficiently infected and destroyed cells of the canine soft tissue sarcoma line STSA-1. In addition, in our new canine sarcoma tumor xenograft mouse model, systemic administration of LIVP1.1.1 or GLV-1h68 viruses led to significant inhibition of tumor growth compared to control mice. Furthermore, LIVP1.1.1 mediated therapy resulted in almost complete tumor regression and resulted in long-term survival of sarcoma-bearing mice. The replication of the tested VACV strains in tumor tissues led to strong oncolytic effects accompanied by an intense intratumoral infiltration of host immune cells, mainly neutrophils. These findings suggest that the direct viral oncolysis of tumor cells and the virus-dependent activation of tumor-associated host immune cells could be crucial parts of anti-tumor mechanism in STSA-1 xenografts. In summary, the data showed that both tested vaccinia virus strains and especially LIVP1.1.1 have great potential for effective treatment of CSTS.


Virotherapy on the basis of oncolytic vaccinia virus (VACV) strains is one novel approach for canine cancer therapy. In this study we described for the first time the characterization and the use of new VACV strain LIVP6.1.1 as an oncolytic agent against canine cancer in a panel of four canine cancer cell lines including: soft tissue sarcoma (STSA-1), melanoma (CHAS), osteosarcoma (D-17) and prostate carcinoma (DT08/40). Cell culture data demonstrated that LIVP6.1.1 efficiently infected and destroyed all four tested canine cancer cell lines. In two different xenograft models on the basis of the canine soft tissue sarcoma STSA-1 and the prostate carcinoma DT08/40 cell lines, a systemic administration of the LIVP6.1.1 virus was found to be safe and led to anti-tumor and immunological effects resulting in the significant reduction of tumor growth in comparison to untreated control mice. In summary, the pre-clinical evaluation has demonstrated the efficacy of LIVP6.1.1 for canine cancer therapy. Furthermore, a clinical trial with canine cancer patients has already been started.


Modified or attenuated viruses and methods for preparing the modified viruses and modulating attenuation are provided. Vaccines that contain the viruses are provided. The viruses can be used in methods of treatment of diseases, such as proliferative and inflammatory disorders, including as anti-tumor agents. The viruses also can be used in diagnostic methods.


Like Gemcitabine, irinotecan, doxorubicin and cisplatin, other chemotherapeutic agents can inhibit the growth of an oncolytic vaccinia virus. As such, they can control viral titer in a subject. Such compounds can be used for the treatment or amelioration of side affects associated with oncolytic virus therapy, or for controlling the oncolytic virus load in a subject.


Provided are adjunct therapies for use in combinations and compositions with an oncolytic virus, such as a vaccinia virus. The adjunct therapies include co-administration and co-formulation of a complement inhibitor and/or a lipid emulsion composition with the oncolytic virus. Also provided herein are therapeutic methods using the adjunct therapies for treatment of disease and conditions employing an oncolytic therapeutic virus, such as for the treatment of hyperproliferative diseases or conditions including tumors or cancers.


Modified or attenuated viruses and methods for preparing the modified viruses and modulating attenuation are provided. Vaccines that contain the viruses are provided. The viruses can be used in methods of treatment of diseases, such as proliferative and inflammatory disorders, including as anti-tumor agents. The viruses also can be used in diagnostic methods.


Modified viruses and methods for preparing the modified viruses are provided. Vaccines that contain the viruses are provided. The viruses can be used in methods of treatment of diseases, such as proliferative and inflammatory disorders, including cancer, and as anti-tumor and/or antiangiogenic agents. The viruses also can be used in diagnostic methods.


ROCHESTER, Minn., Feb. 23, 2017 /PRNewswire/ -- Imanis Life Sciences announced today the launch of a new product line of oncolytic vaccinia viruses for virotherapy research. These viruses are licensed from Genelux Corporation as part of Genelux's proprietary, vaccinia virus-based...

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