Portola Valley, CA, United States
Portola Valley, CA, United States

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Papadopoulou A.,University of Basel | Von Felten S.,University of Basel | Traud S.,University of Basel | Rahman A.,Bayhill Therapeutics | And 7 more authors.
Journal of Neurology | Year: 2012

Persistent black holes (PBH) are associated with axonal loss and disability progression in multiple sclerosis (MS). The objective of this work was to determine if BHT-3009, a DNA plasmid-encoding myelin basic protein (MBP), reduces the risk of new lesions becoming PBH, compared to placebo, and to test if pre-treatment serum anti-MBP antibody levels impact on the effect of BHT-3009 treatment. In this retrospective, blinded MRI study, we reviewed MRI scans of 155 MS patients from a doubleblind, randomized, phase II trial with three treatment arms (placebo, 0.5 and 1.5 mg BHT-3009). New lesions at weeks 8 and 16 were tracked at week 48 and those appearing as T1-hypointense were classified as PBH. A subset of 46 patients with available pre-treatment serum anti-MBP IgM levels were analyzed separately. Overall, there was no impact of treatment on the risk for PBH. However, there was a significant interaction between anti-MBP antibodies and treatment effect: patients receiving 0.5 mg BHT-3009 showed a reduced risk of PBH with higher antibody levels compared to placebo (p\0.01). Although we found no overall reduction of the risk for PBH in treated patients, there may be an effect of low-dose BHT-3009, depending on the patients' pre-treatment immune responses. © Springer-Verlag 2011.


Roep B.O.,Leiden University | Solvason N.,Bayhill Therapeutics | Solvason N.,Foothill College | Gottlieb P.A.,Barbara Davis Center for Childhood Diabetes | And 21 more authors.
Science Translational Medicine | Year: 2013

In type 1 diabetes (T1D) an intense inflammatory response destroysβcells in the pancreas, where insulin is produced and released. A therapy for T1D that reduces the specific autoimmune response in this disease while leaving the remainder of the immune system intact has long been sought. Proinsulin is a major target of adaptive immunity in T1D. We hypothesized that an engineered DNA plasmid encoding proinsulin (BHT-3021) would preserveβcell function in T1D patients through reduction of insulin-specific T cells. We studied 80 subjects over 18 years of age who were diagnosed with T1D within 5 years. Subjects were randomized 2:1 to receive intramuscular injections of BHT-3021 or BHT-placebo, weekly for 12 weeks, and then monitored for safety and immune responses in a blinded fashion. Four dose levels of BHT-3021 were evaluated: 0.3, 1.0, 3.0, and 6.0 mg. C-peptide served as an exploratory measure of efficacy and safety. Islet-specific CD8+ T cell frequencies were assessed with multimers of monomeric human leukocyte antigen class I molecules loaded with peptides containing pancreatic or unrelated antigens. No serious adverse events related to BHT-3021 occurred. C-peptide levels improved relative to placebo at all doses, most notably at 1 mg at 15 weeks (+19.5% BHT-3021 versus -8.8% BHT-placebo, P < 0.026). Proinsulin-reactive CD8+ T cells, but not T cells against unrelated islet or foreign molecules, declined in the BHT-3021 arm (P < 0.006). Thus, we demonstrate that a plasmid encoding proinsulin reduces the frequency of CD8+ T cells reactive to proinsulin while preserving C-peptide over the course of dosing. Copyright © 2013 by the American Association for the Advancement of Science; all rights reserved.


Fontoura P.,Roche Holding AG | Fontoura P.,New University of Lisbon | Garren H.,Bayhill Therapeutics
Results and Problems in Cell Differentiation | Year: 2010

The current treatments for multiple sclerosis (MS) are, by many measures, not satisfactory. The original interferon-β therapies were not necessarily based on an extensive knowledge of the pathophysiological mechanisms of the disease. As more and more insight has been acquired about the autoimmune mechanisms of MS and, in particular, the molecular targets involved, several treatment approaches have emerged. In this chapter, we highlight both promising preclinical approaches and therapies in late stage clinical trials that have been developed as a result of the improved understanding of the molecular pathophysiology of MS. These clinical stage therapies include oral agents, monoclonal antibodies, and antigen-specific therapies. Particular emphasis is given to the molecular targets when known and any safety concerns that have arisen because, despite the need for improved efficacy, MS remains a disease in which the safety of any agent remains of paramount importance. © 2010 Springer-Verlag Berlin Heidelberg.


Patent
Bayhill Therapeutics and Stanford University | Date: 2011-03-23

This invention relates to methods and compositions for treating or preventing disease comprising the administration of immune modulatory nucleic acids having one or more immune modulatory sequences (IMSs). The invention further relates to the means and methods for the identification of the IMSs for preventing or treating disease, more particularly the treatment and prevention of autoimmune or inflammatory diseases. The invention also relates to the treatment or prevention of disease comprising the administration of the immune modulatory nucleic acids alone or in combination with a polynucleotide encoding self-protein(s), -polypeptide(s) or -peptide(s). The present invention also relates to methods and compositions for treating diseases in a subject associated with one or more self-protein(s), - polypeptide(s) or -peptide(s) that are present in the subject and involved in a non-physiological state.


Patent
Bayhill Therapeutics and Stanford University | Date: 2011-05-18

This invention relates to methods and compositions for treating or preventing disease comprising the administration of immune modulatory nucleic adds having one or more immune modulatory sequences (IMSs). The invention further relates to the means and methods for the identification of the IMSs for preventing or treating disease, more particularly the treatment and prevention of auloimmune or Inflammatory diseases. The invention also relates to the treatment or prevention of disease comprising the administration of the Immune modulatory nucleic acids alone or in combination with a polynucleotide encoding self-proteln(s), -polypeptida(s) or -peptide(s), The present invention also relates to methods and compositions for treating diseases in a subject associated with one or more self-protein(s), - polypeptide(s) or -peptide(s) that are present in the subject and involved In a non-physiological state.


Patent
Bayhill Therapeutics and Stanford University | Date: 2011-06-08

This invention relates to methods and compositions for treating or preventing disease comprising the administration of immune modulatory nucleic acids having one or more immune modulatory sequences (IMSs). The invention further relates to the means and methods for the identification of the IMSs for preventing or treating disease, more particularly the treatment and prevention of autoimmune or inflammatory diseases. The invention also relates to the treatment or prevention of disease comprising the administration of the immune modulatory nucleic acids alone or in combination with a polynucleotide encoding self-protein(s), -polypeptide(s) or -peptide(s). The present invention also relates to methods and compositions for treating diseases in a subject associated with one or more self-protein(s), - polypeptide(s) or -peptide(s) that are present in the subject and involved in a non-physiological state.


Patent
Bayhill Therapeutics and Stanford University | Date: 2011-08-10

This invention relates to methods and compositions for treating or preventing disease comprising the administration of immune modulatory nucleic acids having one or more immune modulatory sequences (IMSs). The invention further relates to the means and methods for the identification of the IMSs for preventing or treating disease, more particularly the treatment and prevention of autoimmune or inflammatory diseases. The invention also relates to the treatment or prevention of disease comprising the administration of the immune modulatory nucleic acids alone or in combination with a polynucleotide encoding self-protein(s), -polypeptide(s) or -peptide(s). The present invention also relates to methods and compositions for treating diseases in a subject associated with one or more self-protein(s), - polypeptide(s) or -peptide(s) that are present in the subject and involved in a non-physiological state.


News Article | December 31, 2008
Site: www.xconomy.com

Bayhill Therapeutics Inc. is focused on the translation of research into therapeutics by developing novel drugs for the treatment of autoimmune diseases.


News Article | January 23, 2009
Site: techcrunch.com

Venture capital firms tightened their purse strings in the fourth quarter of 2008, according to the latest MoneyTree Report released by the National Venture Capital Association and PricewaterhouseCoopers. The total dollar amount invested in venture financings was $5.4 billion, down 33 percent from the fourth quarter of 2007 (when it was $8.09 billion) and down 26 percent from the third quarter of 2008 (when it was $7.3 billion). For the entire year, the total venture capital invested into startups was $28.3 billion, down 8 percent. The decline in investing mapped the decrease in exit options, even though VCs are supposed to have a 5 to 7 year investment horizon. More money continued to flow into later stage deals. And broken down by sector, venture dollars going into Internet deals fell 26 percent quarter over quarter as well to $787 million across 170 deals (a 20 percent decline from the third quarter). Even investments in clean tech startups dipped 14 percent sequentially to $909 million across 62 deals. For the year, Internet financings were pretty much flat at $4.9 billion, while the dollars going into clean tech deals increased 52 percent to $4.1 billion. The ten largest venture fundings in the quarter were: Interactive iCharts and the entire slide deck is embedded below:

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