SEATTLE, WA, United States

Presage Biosciences, Inc.

www.fhcrc.org
SEATTLE, WA, United States

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Patent
Presage Biosciences, Inc. | Date: 2016-08-05

Methods for multiplexed delivery of agents to a solid tissue in vivo followed by assessment of efficacy with mass spectrometry are described.


Grant
Agency: Department of Health and Human Services | Branch: | Program: STTR | Phase: Phase II | Award Amount: 1.21M | Year: 2011

DESCRIPTION (provided by applicant): Over 90% of cancer patients that enroll in Phase I or II clinical trials experience no benefit from the experimental therapies, yet are exposed to drug toxicity and other challenges related to treatment. For over 50 years, physicians have used patient-specific information about drug resistance and sensitivity to select antibiotics for patients with infections, but this personalized approach has evaded the oncology community because cancer cell behavior in vitro drug sensitivity assays does not correlate with in vivo response to therapy in most cases. We have developed technologies that enable oncology drug sensitivity/resistance testing of multiple drugs or drug combinations in vivo during the days prior to surgical resection of a tumor. This approach allows drugs to interact with cancer cells while the latter are in their native tumor microenvironment. Our broad long-term goal is to develop reliable in vivo-based oncology drug sensitivity/resistance assays for patients with many types of solid tumors. Our overall goal of the STTR Phase I and II projects are to develop and test devices that are suitable for human lymphoma patients and to initiate human clinical trials. Our Specific Aim for the Phase I portion is to develop a single use (disposable) porous needle array and demonstrate that it meets drug delivery precision specifications. Provided that quantitative milestones are met in Phase I, Phase II will proceed with the following Aims: Aim 1) To develop a prototype suitable for use in human lymphoma patients; and Aim 2) to conduct a pilot first in humans clinical trial. The significance of the proposed work is that it will reduce the frequency of cancer patients being exposed to drugs that cause toxicity but offer no clinical benefit. The commercialization potential is described in a comprehensive business plan. We provide letters from highly respected individuals in the biotechnology, life sciences and personalized medicine fields to attest to the commercial potential of this technology. PUBLIC HEALTH RELEVANCE: Project Narrative It is estimated that approximately 1.4 million new cases of cancer will be diagnosed in the United States in 2008. Improved methods for prioritizing cancer therapeutics based on patient-based indicators of efficacy are needed. We are proposing to develop a device which enables comparison of multiple drugs or combinations in vivo, with the tumor micro-environment intact. The long-term goal of this research is to develop reliable in vivo- based oncology drug sensitivity/resistance assays for patients with many types of solid tumors. This technology will reduce the frequency of cancer patients being exposed to drugs that cause toxicity but offer no clinical benefit. This personalized treatment approach will improve patient outcome and enhance the quality of care for millions of individuals that suffer from cancer.


Patent
Presage Biosciences, Inc. | Date: 2014-07-10

Methods and devices for delivering an agent to a solid tissue in vivo for assessment of efficacy are described. One method involves withdrawing of a needle from and injecting of the agent into the solid tissue; another method involves delivering the agent using a plurality of microdialysis probes to a solid tissue.


Patent
Presage Biosciences, Inc. | Date: 2013-12-05

An administration device comprising an array of needles, one or more fluid agents, and at least one hydrogel is described. The device can simultaneously deliver a plurality of fluid agents along respective axes into a tissue. The use of hydrogel leads to constrained delivery of the fluid agents. The constrained delivery of an agent is also achieved by depositing a drug implant into a tissue. The effect of an agent on the tissue can be evaluated thereafter. In addition, the invention is directed to treating muscle diseases by delivering a therapeutic agent in vivo, and the use of reporter tissues for candidate drug evaluation, detecting and characterizing resistance.


Patent
Presage Biosciences, Inc. | Date: 2013-11-13

Methods for multiplexed delivery of agents to a solid tissue in vivo followed by assessment of efficacy with mass spectrometry are described.


Patent
Presage Biosciences, Inc. | Date: 2014-08-20

An administration device comprising an array of needles, one or more fluid agents, and at least one hydrogel is described. The device can simultaneously deliver a plurality of fluid agents along respective axes into a tissue. The use of hydrogel leads to constrained delivery of the fluid agents. The constrained delivery of an agent is also achieved by depositing a drug implant into a tissue. The effect of an agent on the tissue can be evaluated thereafter. In addition, the invention is directed to treating muscle diseases by delivering a therapeutic agent in vivo, and the use of reporter tissues for candidate drug evaluation, detecting and characterizing resistance.


Patent
Presage Biosciences, Inc. | Date: 2013-08-08

Disclosed herein are devices and methods for delivering agents to a solid tissue.


Grant
Agency: Department of Health and Human Services | Branch: National Institutes of Health | Program: SBIR | Phase: Phase II | Award Amount: 1.05M | Year: 2016

DESCRIPTION provided by applicant Improvements in cancer diagnostics and therapeutics have positively impacted outcomes for oncology patients within select clinical niches However significant therapeutic uncertainty awaits the majority of todayandapos s oncology patients who present in the clinic with cancer that will relapse after exhibiting an initial response or whose cancer is already refractory to standard of care SOC therapy Unfortunately the absence of technology that accurately predicts a patientandapos s non response to SOC means many patients will experience toxic side effects to systemic therapy without receiving clinical benefit Such patients will also lose valuable time and money that could be used to identify and finance more effective treatments and in some cases under the selective pressure induced by suboptimal therapy will develop pan resistance rendering alternate treatments ineffective Successful translation of Presageandapos s innovative CIVO technology into the oncology clinic will provide a personalized system that identifies patients whose cancer is not going to respond to SOC thereby limiting unwarranted exposure to costly ineffective therapy and its associated toxicity while increasing time available for evaluation of new therapeutic modalities at earlier stages of disease Specifically CIVO is a hand held microinjection device engineered to deliver minute amounts of up to eight drugs or drug combinations directly into a patientandapos s solid tumor CIVO is complemented by an automated analytical package that measures tumor cell specific and microenvironment alterations at the single cell level revealing comprehensive profiles of an individualandapos s tumor response to each injected agent Furthermore CIVO is superior to alternative platforms developed to predict tumor response to chemotherapy due to CIVOandapos s enablement of evaluating drug response in vivo in the patients living tumor in the natural context of native tumor stroma and the host immune system The CIVO clinical trial detailed in this application is designed to establish the negative predictive value NPV of CIVO in diffuse large B cell lymphoma DLBCL patients who are candidates for one of three second line SOC therapies The initial training stage of the trial will be a non blinded retrospective study used to establih CIVO quantitative thresholds for determining if a patientandapos s lymphoma is andquot non responsiveandquot to microinjected drug in relation to the patientandapos s response to systemic therapy The second stage or andquot Testandquot phase of the trial will employ the quantitative threshold s obtained from the training stage to determine if CIVO can predict non response to systemic second line therapy SBIR support in establishing CIVO clinical NPV in DLBCL will build the clinical foundation required to expand translation of CIVO into additional tumor types serving to drive more efficient and cost effective patient segregation and therapeutic selection in the oncology clinic PUBLIC HEALTH RELEVANCE Every year millions of cancer patients experience the harm of being treated with therapeutics that induce various systemic toxicities while producing no clinical benefit Successful translation of Presageandapos s innovative CIVO microinjection technology into the oncology clinic will provide a personalized system that identifies patients whose cancer is not going to respond to standard of care therapies thereby limiting unwarranted financial costs unwanted systemic toxicity and a decrease in valuable time available for evaluation of new therapeutic modalities at earlier stages of disease Clinical translation of CIVO and its expanded use in various solid tumor types will serve to meet a currently unmet medical need for oncology patients whose cancer is resistant to standard of care therapies by driving more efficient patient segregation and therapeutic selection


Grant
Agency: Department of Health and Human Services | Branch: | Program: SBIR | Phase: Phase I | Award Amount: 288.69K | Year: 2013

DESCRIPTION (provided by applicant): With few exceptions, extensive characterization of signal pathway alterations in cancer, and advances in our capacity to identify potent modulators of distinct molecular targets, has not translated into breakthrough drugs. In a recent New York Times article (Nov. 14, 2009), Mervyn Turner, Chief Strategy Officer for Merck was quoted: We invest far too long in bad ideas. It is really important to stop that at an earlier stage in the cycle . This is particularly evidentin cancer drug development where over 90% of new anti-cancer drugs fail in the clinic. Our experiences in this area lead us to believe that one reason fo this problem is the lack of an efficient, clinically predictive platform for validating hypotheses ndmaking program advancement decisions at the earliest stages of the drug development process. Current in vivo models are resource intensive and rate limiting. Furthermore, current in vivo drug efficacy testing requires substantial investment in chemistry tooptimize compounds for systemic delivery. Thus the majority of early drug development is heavily dependent on in vitro tumor cell models most of which are grown under conditions, such as in serum, which do not represent the native tumor environment. It iswell accepted that these models do not reliably predict clinical efficacy. A second fundamental issue is that almost all tumors acquire resistance to single agent targeted therapies by rewiring signaling networks to reestablish effective oncogenic output.Proactive and rapid identification of alternative druggable pathway nodes would enable a shift in focus from developing drugs that target specific molecules to devising strategies to shut down oncogenic networks. To address these issues, we are developingan end-to-end platform that enables comprehensive functional interrogation of cancer pathways of interest to drug developers, compatible with rapid validation of findings in vivo co-clinical model at the earliest stages of cancer drug development. In Aim1, we will employ a gene trap vector to generate tumor models that emit light only upon specific inhibition of key oncogenic pathway nodes. In Aim 2, we will use our porous needle array technology to demonstrate capacity to test, compare, and validate multiple agents, in the context of a single tumor grown in vivo, for anti-pathway and anti-tumor efficacy. Drs. Klinghoffer and Olson (Presage Biosciences Inc., and the Fred Hutchinson Cancer Research Center), who developed the porous needle array technology,have joined forces with Dr. Finney (Xactagen LLC), whose optimized gene trap vector system permits capture of pathway modulation via endogenous gene regulation with sensitivity amenable to in vivo analysis. Successful coupling of the porous needle array with high fidelity, high sensitivity gene trap derived oncogene pathway reporters will facilitate a paradigm shift from the current heavy reliance on standard in vitro based models early in the drug discovery process to more predictive and disease relevant in vivo models. Our platform will improve rational advancement of drug development projects, and in doing so, will increase the clinical success rate of new treatments that improve the health of cancer patients. PUBLIC HEALTH RELEVANCE PUBLIC HEALTH RELEVANCE: The top 20 oncology companies spend over 14B per year on new oncology drug development yet over 90% of new anti-cancer drugs fail in clinical trials. We believe that this failure rate is unacceptable and is due to 1) an over reliance on testing new compounds and hypotheses in models that do not represent cancers seen in the clinic and 2) focus on inhibiting specific molecular targets instead of shutting down entire cancer pathways. The expected outcome of our proposal is that our drug development partners would be provided with an advanced platform for making better program advancement decisions early in the development process and this will increase the rational promotion of projects with the best chance to improve the well-being of patientsin need of novel life-saving medicines.


News Article | April 21, 2014
Site: www.geekwire.com

It’s time to kick off the voting in another key GeekWire Awards category — Geek of the Year. This is a special award, designed to recognize not just technical prowess but also efforts to strengthen the broader technology community. Reflecting that spirit, the voting in this category last year resulted in a rare tie, with computer scientist Oren Etzioni and cancer researcher Rebecca Gardner sharing the “Geek of the Year” honors. This year’s finalists have all made significant contributions to the community through their work in technology, startups and science. The finalists are Seaton Gras of SURF Incubator; Dr. Jim Olson of the Fred Hutchinson Cancer Research Center; Hadi Partovi of Code.org; Julie Sandler of Madrona Venture Group and Seattle Entrepreneurial Women’s Network; and serial entrepreneur Dan Shapiro, creator of the Robot Turtles board game. A big thanks to GeekWire Awards presenting sponsor Wave Business Solutions for making the Geek of the Year category possible. As with each of our categories, the five finalists below were nominated by the community and then selected with the input of our panel of judges. The winners will be announced May 8th at the GeekWire Awards, taking place at the EMP Museum in Seattle. Cast your ballot below for Geek of the Year, continue reading for more background on each finalist, and sign up below to join us on May 8 to see who wins. Also check out the special Haiku Deck for this category. Seaton Gras, SURF Incubator: The brainchild of Seaton Gras, SURF Incubator stands for “Start Up Really Fast.” It’s an appropriate moniker given the growth SURF has been experiencing. Hosting nearly 70 companies and organizations who pay a monthly fee to be a part of the community, SURF outgrew its original location at the Exchange Building and is moving to the Wells Fargo building across the street in downtown Seattle. Gras came up with the idea for SURF Incubator five years ago, conceiving a place where entrepreneurs could co-exist, learn from each other and even share a war story or two over the water cooler. Dr. Jim Olson, Fred Hutchinson Cancer Research Center: Olson is pediatric brain cancer specialist based at the Fred Hutchinson Cancer Research Center who also works at Seattle Children’s. He spends time not only in the clinic but also in the lab — not just treating patients but also leading efforts to find more effective treatments through cutting-edge research. His work has spawned two biotech companies, Presage Biosciences and Blaze Bioscience, and his “Project Violet” gives the public the opportunity to “adopt” drug candidates for $100 each to help fund the development of new cancer treatments derived from natural organisms. Hadi Partovi, Code.org: Led by Hadi Partovi and his brother, Ali, the non-profit group Code.org made huge strides in the past year to put the issue of computer science education on the minds of the nation’s kids, adults and educators. Leveraging the power of celebrities, including Bill Gates and Mark Zuckerberg, Code.org introduced millions of students to the basics of computer science through initiatives including “Hour of Code.” Julie Sandler, Madrona Venture Group and Seattle Entrepreneurial Women’s Network: Julie Sandler, one of the top women in Seattle’s venture capital community, has emerged as a leading voice for women in technology as a founding member of the Seattle Entrepreneurial Women’s Network and leader of Startup Weekend Women’s Edition. She’s also a regular speaker and leader of events that encourage young girls to explore potential careers in technology and computer science. A former member of Amazon’s Kindle team, Sandler is also an adjunct faculty member at the University of Washington, teaching a course on Entrepreneurship at the Foster School of Business. Dan Shapiro, Robot Turtles: Dan Shapiro has made his mark as a Seattle software entrepreneur, creating startups such as Ontela and Sparkbuy. But he’s also the father of young twins, and his most recent project is targeted to his kids and their peers — with an eye toward alleviating one of the technology industry’s biggest long-term challenges. It’s a board game, Robot Turtles, that “sneakily” teaches the fundamentals of computer programming to kids between the ages of three to eight. The project blew past its fundraising goals on Kickstarter and shipped on time to backers. Vote in previous categories: Startup of the Year; CEO of the Year; App of the Year; Innovation of the Year; Bootstrapper of the Year; Young Entrepreneur of the Year and Perk of the Year.

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