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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.

Pierpaoli E.,Laboratory of Tumor Immunology | Viola V.,Laboratory of Tumor Immunology | Pilolli F.,University of Perugia | Piroddi M.,University of Perugia | And 2 more authors.
Life Sciences | Year: 2010

Aims: Breast cancer is the most common malignancy among women, with an age-specific incidence profile. During the last years much evidence has accumulated demonstrating the anticancer activity of tocotrienols (T3), a subfamily of natural vitamin E (VE). In this study, mouse and human breast cancer cells (with or without HER-2/neu oncogene overexpression) were used to investigate the anticancer effect of α-, γ-, and δ-tocotrienols in comparison with α-tocopheryl succinate (α-TOS), a synthetic derivative with widely recognized anticancer properties. Main methods: Human and mouse breast cancer cell lines were used. The effect of VE compounds on cell viability was investigated using Alamar Blue assay. Apoptosis was assessed by propidium iodide and JC-1 staining. Expression of senescence-associated markers was evaluated by RT-PCR and Western blot analysis was used to examine the changes in the expression levels of HER-2/neu. Key findings: γ- and δ-T3 reduced cell viability with IC50 values of less than half those of α-T3 and α-TOS. δ- and δ-T3, and α-TOS to a lesser extent, induced apoptosis possibly via the mitochondrial pathway, and the expression of senescent-like growth arrest markers as p53, p21, and p16. Both α-TOS and tocotrienols downregulated HER-2/neu in tumor cells overexpressing this oncogene, but this effect did not seem to be essential for the antitumor activity of these compounds. Significance: We demonstrate that in HER-2/neu breast cancer cells, the non-alpha form of T3 shows stronger anticancer activity than the synthetic VE-derivative α-TOS and this effect occurs independently from the inhibition of HER-2/neu oncogene expression. © 2010 Elsevier Inc.

Viola V.,University of Perugia | Ciffolilli S.,University of Perugia | Legnaioli S.,University of Perugia | Piroddi M.,University of Perugia | And 5 more authors.
BioFactors | Year: 2013

Anticancer activity and mitochondrial mechanism of the vitamin E form δ-tocotrienol (δ-T3) was investigated in HER-2/neu-overexpressing human SKBR3 and murine TUBO breast cancer cells. δ-T3 was confirmed to possess high cytotoxic and apoptotic activity in SKBR3 cells as compared with all natural forms of vitamin E and several synthetic forms that included novel derivatives with the same backbone of δ-T3 such as δ-tocotrienyl-succinyl amide (δ-T3AS) and the redox-active analogue δ-tocotrienyl amine (δ-T3NH2). As observed in the case of alpha-TOS, a prototypical anticancer drug derived from α-tocopherol, succinylation of δ-T3 enhanced citotoxicity and apoptotic activity of the vitamer. δ-T3 induced apoptosis of SKBR3 cells was associated with mitochondrial destabilization, energy failure, and unbalanced activity of stress/survival MAPKs, namely p38 and ERK1/2 pathways. An increased generation of ROS followed to such a series of early events. Enhanced activity of δ-T3 in this human carcinoma cell line was characterized by the sustained uptake and oxidative transformation to the quinone derivative δ-T3Q, thereby suggesting redox effects in SKBR3 mitochondria by this vitamer. Viability and uptake data show a different pattern of responses in TUBO cells with higher response to synthetic derivatives of δ-T3 than in SKBR3 cells. In conclusion, synthetic derivatives of δ-T3 with enhanced apoptotic activity in breast carcinoma cells are investigated for the first time in this study also describing mechanistic aspects of mitochondrial effects of δ-T3. Further investigation in preclinical models of HER2/neu-high breast adenocarcinoma is underway to identify other and more effective forms of VE in this type of cancer. © 2013 International Union of Biochemistry and Molecular Biology, Inc.

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