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.
Agency: Department of Health and Human Services | Branch: | Program: SBIR | Phase: Phase II | Award Amount: 1.50M | Year: 2014
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.
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.
News Article | July 7, 2015
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.