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Patent
Blaze Bioscience, Inc. and Washington State University | Date: 2014-09-17

The present disclosure provides methods for detecting a tumor microenvironment, a peritumoral tissue, or a portion thereof using a chlorotoxin conjugate. Also provided are chlorotoxin peptides and variants thereof conjugated to a detectable label for use in detecting a tumor microenvironment, a peritumoral tissue, or a portion thereof.


Patent
Blaze Bioscience, Inc. | Date: 2015-09-15

Compositions, formulations and kits comprising chlorotoxin conjugate compounds are provided, including native and modified variants of chlorotoxin peptide conjugated to reporter molecules including fluorescent dyes. Methods of detecting and treating cancers and tumors with chlorotoxin conjugate compounds are also provided, including methods of imaging tumor tissues and cells. Dosing and pharmacokinetic profiles for therapeutic and diagnostic applications using chlorotoxin conjugate compounds are also provided.


Grant
Agency: Department of Health and Human Services | Branch: | Program: SBIR | Phase: Phase II | Award Amount: 1.50M | Year: 2014

Not Available


Grant
Agency: Department of Health and Human Services | Branch: | Program: SBIR | Phase: Phase I | Award Amount: 248.55K | Year: 2012

Tumor Paints for real-time intraoperative visualization of solid tumors enable more complete resection while sparing surrounding normal tissue. For brain tumors this is of paramount importance, since removal of additional tissue can unnecessarily increasecognitive and functional impairment. The Tumor Paint CyTP007 is a peptide-fluorophore conjugate that specifically binds to multiple solid tumor types and fluoresces in the near-infrared range, minimizing light scatter and signal attenuation. Our overall long-term objectives are to determine the effective dose of CyTP007 for imaging during tumor resections (Phase 1), and to evaluate candidate intraoperative imaging devices (Phase 2). The proposed Phase 1 study is a dose-ranging study in dogs with solid tumors. Dogs undergoing tumor resection will receive CyTP007 intravenously 24 hours before surgery, and tissue will be imaged ex vivo after surgery. Specific aims: (1) Assess tolerability in the context of general anesthesia and surgery; (2) Determine optimal dose for imaging canine tumors; (3) Quantitate fluorescence in tumors; and (4) Assess specificity for cancer cells and signal-to-background ratio. Anticipated results include safety at an effective imaging dose; signal intensity in different tumor types; confirmation that CyTP007 penetrates the blood-brain barrier; and sensitivity and specificity for discrimination of cancer from normal cells.


SEATTLE--(BUSINESS WIRE)--Blaze Bioscience, the Tumor Paint Company®, a biotechnology company focused on guided cancer therapy, today announced that the company has received Orphan Drug Designation for BLZ-100 from the Office of Orphan Products Development of the U.S. Food and Drug Administration (FDA) for malignant brain tumors. “Improvements in brain cancer surgery represent one of the highest unmet medical needs for both adults and children with brain cancer,” said Blaze co-founder and CEO Heather Franklin. “We continue to enroll patients in our ongoing Phase 1 studies in adult and pediatric patients with brain cancer and our goal is to rapidly advance the development of BLZ-100 to address the needs of these patients with the added support of the FDA’s Orphan Drug program.” The FDA grants Orphan Drug Designation status to products for rare diseases and disorders, providing incentives to sponsors developing drugs or biologics. The FDA defines rare diseases as those affecting fewer than 200,000 people in the United States at any given time. Orphan Drug Designation provides the sponsor certain benefits and incentives, including greater access to FDA staff, a period of marketing exclusivity if regulatory approval is ultimately received for the designated indication, potential tax credits for certain activities, eligibility for orphan drug grants, and the waiver of certain administrative fees. The receipt of Orphan Drug Designation status does not change the regulatory requirements or process for obtaining marketing approval. BLZ-100 is the first product candidate from Blaze’s Tumor Paint platform and consists of an Optide (optimized peptide), which binds and internalizes into cancer cells, and a fluorescent dye, which emits light in the near-infrared range. Tumor Paint products are designed to provide real-time, high-resolution intraoperative visualization of cancer cells, enabling more precise, complete resection of cancer throughout surgery. Preclinical utility of Tumor Paint technology has been demonstrated in a wide range of cancer types, including brain, lung, breast, prostate, and colorectal. BLZ-100 is currently in multiple Phase 1 proof-of-concept clinical studies to evaluate the safety and imaging characteristics of BLZ-100 in solid tumor cancers. Blaze Bioscience, Inc. is a privately held biotechnology company focused on guided cancer therapy. Blaze was founded in 2010 by Dr. Jim Olson, a pediatric neuro-oncologist at the Fred Hutchinson Cancer Research Center and Seattle Children’s Hospital, and Heather Franklin, a former member of the executive management team at ZymoGenetics. Blaze is working to develop Tumor Paint products and Optide-based therapeutics. Surgery is first-line therapy for most solid tumor cancers and Tumor Paint products intend to improve cancer surgery by providing real-time, high-resolution visualization of cancer cells throughout surgery. The ability to see cancer cells in real time and high resolution throughout surgery should enable better detection and more complete and precise surgical removal of cancer—while sparing surrounding normal tissue. In addition to the Tumor Paint platform, Blaze is collaborating with the Fred Hutchinson Cancer Research Center to discover and develop products based on knottin peptides as part of the Optides platform. This program extends the expertise gained in developing the Tumor Paint platform to optimized knottin peptides for therapeutic and imaging applications. For additional information, please visit www.blazebioscience.com.


SEATTLE--(BUSINESS WIRE)--Blaze Bioscience, Inc., a biotechnology company focused on guided cancer therapy, announced today that the company’s Senior Vice President of Development, Dennis Miller, Ph.D., will present at the 73rd Annual Meeting of the American Academy of Dermatology (AAD) on March 23, 2015, in San Francisco, CA. Dr. Miller will present results on BLZ-100 from the company’s Phase 1 study in subjects with skin cancer. The poster presentation, entitled “First in Human Phase 1 Safety Study of BLZ-100 in Subjects with Skin Cancer,” will be held at E-Poster Presentation Center 1 at 12:15 p.m. PDT. E-Posters will be available at www.aad.org beginning Friday, March 20, at 7:00 a.m. PDT. “This first-in-human study has been successful in providing key safety, dose and scheduling data on BLZ-100 which will inform our broad solid tumor program—including our ongoing Phase 1b brain cancer program underway in the U.S. and Australia,” said Blaze Bioscience President and CEO Heather Franklin. “Our goal is to demonstrate clinical proof of concept for Tumor Paint BLZ-100 in brain cancer by the end of 2015.” BLZ-100 is the first product candidate from Blaze’s Tumor Paint platform and consists of an Optide (optimized peptide), which binds and internalizes into cancer cells, and a fluorescent dye, which emits light in the near-infrared range. Tumor Paint products are designed to provide real-time, high-resolution intraoperative visualization of cancer cells, enabling more precise, complete resection of cancer throughout surgery. Preclinical utility has been demonstrated in a wide range of cancer types, including brain, lung, breast, prostate, colorectal and sarcomas. Blaze Bioscience, Inc. is a privately held biotechnology company focused on guided cancer therapy. Blaze was founded in 2010 by Dr. Jim Olson, a pediatric neuro-oncologist at the Fred Hutchinson Cancer Research Center and Seattle Children’s Hospital, and Heather Franklin, a former senior business executive from ZymoGenetics, and is working to develop Tumor Paint™ products and Optide-based guided cancer therapeutics. Surgery is first-line therapy for most solid tumor cancers, and Tumor Paint products intend to improve cancer surgery by providing real-time, high-resolution visualization of cancer cells throughout surgery. The ability to see cancer cells in real time and high resolution throughout surgery should enable better detection and more complete and precise surgical removal of cancer—while sparing surrounding normal tissue. In addition to the Tumor Paint platform, Blaze is collaborating with the Fred Hutchinson Cancer Research center to discover and develop guided cancer therapeutics as part of the Optides platform. This program extends the expertise gained in developing the Tumor Paint platform to optimized knottin peptide conjugates for therapeutic and imaging applications. For additional information, please visit www.blazebioscience.com.


SEATTLE--(BUSINESS WIRE)--Blaze Bioscience, the Tumor Paint Company®, a biotechnology company focused on guided cancer therapy, today announced open enrollment for the first clinical study of Tumor Paint BLZ-100 in children with brain cancer. The study, entitled “A Phase 1 dose-escalation and expansion study of BLZ-100 in pediatric subjects with primary central nervous system tumors,” will be conducted at Seattle Children’s Hospital under the direction of principal investigator Dr. Sarah Leary. The Phase 1 trial, which is operating under the company’s open Investigational New Drug (IND) application with the U.S. Food and Drug Administration (FDA), will enroll up to twenty-seven (27) patients, from infants through young adults under age 30 who have been diagnosed with a brain tumor, and will evaluate the safety and imaging characteristics of BLZ-100. “We are very excited to advance the development of Tumor Paint BLZ-100 into pediatric brain cancer—a serious and rare disease that represents the most common solid tumor type within the pediatric population,” said Senior Vice President of Development, Dennis Miller, Ph.D. “Initiation of this study is an important milestone for the Tumor Paint platform.” “Since the beginning, the Blaze team has been inspired by the needs of children with brain cancer and their families. Tumor Paint technology was envisioned and invented by our co-founder, Dr. Jim Olson, who was driven by the needs of his pediatric brain cancer patients at Seattle Children’s. A pediatric brain cancer study has always been a goal of ours and to have it conducted at Seattle Children’s is deeply gratifying,” said Heather Franklin, co-founder, CEO, and Executive Chair of Blaze Bioscience. “We would also like to thank Gateway for Cancer Research for making this trial possible by providing a grant to Seattle Children’s.” BLZ-100 is the first product candidate from Blaze’s Tumor Paint platform and consists of an Optide (optimized peptide), which binds and internalizes into cancer cells, and a fluorescent dye, which emits light in the near-infrared range. Tumor Paint products are designed to provide real-time, high-resolution intraoperative visualization of cancer cells, enabling more precise, complete resection of cancer throughout surgery. Preclinical utility of Tumor Paint technology has been demonstrated in a wide range of cancer types, including brain, lung, breast, prostate, and colorectal. BLZ-100 is currently in multiple Phase 1 proof-of-concept clinical studies to evaluate the safety and imaging characteristics of BLZ-100 in solid tumor cancers. Blaze Bioscience, Inc. is a privately held biotechnology company focused on guided cancer therapy. Blaze was founded in 2010 by Dr. Jim Olson, a pediatric neuro-oncologist at the Fred Hutchinson Cancer Research Center and Seattle Children’s Hospital, and Heather Franklin, a member of the executive management team at ZymoGenetics. Blaze is working to develop Tumor Paint products and Optide-based guided cancer therapeutics. Surgery is first-line therapy for most solid tumor cancers and Tumor Paint products intend to improve cancer surgery by providing real-time, high-resolution visualization of cancer cells throughout surgery. The ability to see cancer cells in real time and high resolution throughout surgery should enable better detection and more complete and precise surgical removal of cancer—while sparing surrounding normal tissue. In addition to the Tumor Paint platform, Blaze is collaborating with the Fred Hutchinson Cancer Research Center to discover and develop guided cancer therapeutics as part of the Optides platform. This program extends the expertise gained in developing the Tumor Paint platform to optimized knottin peptide conjugates for therapeutic and imaging applications. For additional information, please visit www.blazebioscience.com.


SEATTLE--(BUSINESS WIRE)--Blaze Bioscience, the Tumor Paint Company®, a biotechnology company focused on guided cancer therapy, today announced that the company has received Orphan Drug Designation for BLZ-100 from the Office of Orphan Products Development of the U.S. Food and Drug Administration (FDA) for malignant brain tumors. “Improvements in brain cancer surgery represent one of the highest unmet medical needs for both adults and children with brain cancer,” said Blaze co-founder and CEO Heather Franklin. “We continue to enroll patients in our ongoing Phase 1 studies in adult and pediatric patients with brain cancer and our goal is to rapidly advance the development of BLZ-100 to address the needs of these patients with the added support of the FDA’s Orphan Drug program.” The FDA grants Orphan Drug Designation status to products for rare diseases and disorders, providing incentives to sponsors developing drugs or biologics. The FDA defines rare diseases as those affecting fewer than 200,000 people in the United States at any given time. Orphan Drug Designation provides the sponsor certain benefits and incentives, including greater access to FDA staff, a period of marketing exclusivity if regulatory approval is ultimately received for the designated indication, potential tax credits for certain activities, eligibility for orphan drug grants, and the waiver of certain administrative fees. The receipt of Orphan Drug Designation status does not change the regulatory requirements or process for obtaining marketing approval. BLZ-100 is the first product candidate from Blaze’s Tumor Paint platform and consists of an Optide (optimized peptide), which binds and internalizes into cancer cells, and a fluorescent dye, which emits light in the near-infrared range. Tumor Paint products are designed to provide real-time, high-resolution intraoperative visualization of cancer cells, enabling more precise, complete resection of cancer throughout surgery. Preclinical utility of Tumor Paint technology has been demonstrated in a wide range of cancer types, including brain, lung, breast, prostate, and colorectal. BLZ-100 is currently in multiple Phase 1 proof-of-concept clinical studies to evaluate the safety and imaging characteristics of BLZ-100 in solid tumor cancers. Blaze Bioscience, Inc. is a privately held biotechnology company focused on guided cancer therapy. Blaze was founded in 2010 by Dr. Jim Olson, a pediatric neuro-oncologist at the Fred Hutchinson Cancer Research Center and Seattle Children’s Hospital, and Heather Franklin, a former member of the executive management team at ZymoGenetics. Blaze is working to develop Tumor Paint products and Optide-based therapeutics. Surgery is first-line therapy for most solid tumor cancers and Tumor Paint products intend to improve cancer surgery by providing real-time, high-resolution visualization of cancer cells throughout surgery. The ability to see cancer cells in real time and high resolution throughout surgery should enable better detection and more complete and precise surgical removal of cancer—while sparing surrounding normal tissue. In addition to the Tumor Paint platform, Blaze is collaborating with the Fred Hutchinson Cancer Research Center to discover and develop products based on knottin peptides as part of the Optides platform. This program extends the expertise gained in developing the Tumor Paint platform to optimized knottin peptides for therapeutic and imaging applications. For additional information, please visit www.blazebioscience.com.


SEATTLE--(BUSINESS WIRE)--Blaze Bioscience, the Tumor Paint Company®, a biotechnology company focused on guided cancer therapy, today announced expansion of its Phase 1 program into multiple additional tumor types. The study, which is open for enrollment, is titled “A Phase 1 exploratory study of the safety and ex vivo fluorescence of BLZ-100 administered by intravenous injection in adult subjects with solid tumors undergoing surgery,” and will enroll up to thirty (30) patients. The study is currently active at Overlake Medical Center in Bellevue, WA under the direction of principal investigator Kristi Harrington, M.D., Ph.D. Further information on the study can be found at www.clinicaltrials.gov. This is the third Phase 1 study of BLZ-100 under the company’s open Investigational New Drug (IND) application with the U.S. Food and Drug Administration (FDA) and will evaluate the safety and imaging characteristics of BLZ-100 in breast, lung, prostate, colorectal, and other cancers. “We are passionate about finding the best treatment options for our patients. Innovative technologies such as Tumor Paint BLZ-100 could improve our ability to see cancer in real time during surgery, which could result in better tumor resection and improved surgical outcomes for our patients,” said Dr. Kristi Harrington, a breast surgeon at Overlake Medical Center and the principal investigator of the study. “We believe this study will provide additional clinical validation of the positive preclinical and veterinary results showing broad utility of Tumor Paint BLZ-100,” said Heather Franklin, co-founder and CEO of Blaze Bioscience. “It is an important milestone in our mission to improve the lives of the millions of cancer patients undergoing surgery every year.” BLZ-100 is the first product candidate from Blaze’s Tumor Paint platform and consists of an Optide (optimized peptide), which binds and internalizes into cancer cells, and a fluorescent dye, which emits light in the near-infrared range. Tumor Paint products are designed to provide real-time, high-resolution intraoperative visualization of cancer cells, enabling more precise, complete resection of cancer throughout surgery. Preclinical utility of Tumor Paint technology has been demonstrated in a wide range of cancer types, including brain, lung, breast, prostate, and colorectal. BLZ-100 is currently in multiple Phase 1 proof-of-concept clinical studies to evaluate the safety and imaging characteristics of BLZ-100 in solid tumor cancers. Blaze Bioscience, Inc. is a privately held biotechnology company focused on guided cancer therapy. Blaze was founded in 2010 by Dr. Jim Olson, a pediatric neuro-oncologist at the Fred Hutchinson Cancer Research Center and Seattle Children’s Hospital, and Heather Franklin, a former member of the executive management team at ZymoGenetics. Blaze is working to develop Tumor Paint products and Optide-based therapeutics. Surgery is first-line therapy for most solid tumor cancers and Tumor Paint products intend to improve cancer surgery by providing real-time, high-resolution visualization of cancer cells throughout surgery. The ability to see cancer cells in real time and high resolution throughout surgery should enable better detection and more complete and precise surgical removal of cancer—while sparing surrounding normal tissue. In addition to the Tumor Paint platform, Blaze is collaborating with the Fred Hutchinson Cancer Research Center to discover and develop products based on knottin peptides as part of the Optides platform. This program extends the expertise gained in developing the Tumor Paint platform to optimized knottin peptides for therapeutic and imaging applications. For additional information, please visit www.blazebioscience.com.


Seattle Children’s hospital opens enrollment for the first clinical trial of the phase I BLZ-100 drug. Funded by Gateway for Cancer Research, this clinical trial aims to improve the detection and removal of solid tumors without harming the surrounding healthy tissue that can lead to serious long-term side effects. BLZ-100 drug, dubbed “Tumor Paint,” uses a protein derivative of a Deathstalker Scorpion’s venom that inherently bonds to tumor cells and glows when exposed to laser light and imaged with a near-infrared camera system. This culmination of unrelated technologies now provides surgeons with a clear picture of the cancer cells to be surgically removed. “Tumor Paint” innovation helps to better identify cancer sites for improved removal of tumors while decreasing the risk of removing precious healthy brain tissue. Ultimately, this new treatment may reduce complications of future childhood development and reduce the risk of cancer returning to the brain. “Tumor Paint has the potential to completely revolutionize surgical oncology,” said Dr. Jim Olson, inventor of Tumor Paint technology, co-founder of Blaze Bioscience, a pediatric neuro-oncologist at Seattle Children’s and Fred Hutch and a researcher in the Center for Clinical and Translational Research at Seattle Children’s Research Institute. About Gateway for Cancer Research℠ Gateway for Cancer Research is a nonprofit 501(c)(3) organization committed to funding innovative cancer research studies that help today’s cancer patients feel better, live longer and conquer cancer TODAY!. Thanks to generous underwriting by Cancer Treatment Centers of America®, 99 cents of every dollar Gateway receives directly funds phase I and phase II cancer clinical trials at leading research institutions across the country and abroad. Since 1991 Gateway has supported more than 120 clinical trials and funded millions in leading-edge research, including blending the best of conventional, and complementary and alternative therapies. Get involved today by visiting GatewayCR.org, like us on Facebook at facebook.com/demandcures and join the conversation on Twitter @DemandCures. #BeAGateway.

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