Breast Cancer Start-up Challenge
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      • 1 Diagnostic from biopsies with software analysis
      • 2 Immunotherapy Using Modified Self Tumor Cells
      • 3 Combination of Tissue Reconstruction and Recurrence Prevention
      • 4 Human monoclonal Antibody Based Cancer Therapies
      • 5 Immunotherapy Using Granulysin Activated Monocytes
      • 6 Anti-cancer Toxin
      • 7 Versatile Delivery Method for Cancer Therapeutics
      • 8 Genomic Based Diagnostic Assay
      • 9 Tissue-based Diagnostic Assay
      • 10 Diagnostic Kit for Therapy Benefit Prediction
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Inventions

Please DO NOT contact Inventors directly.  All contact to inventors should be made through the CAI team

#1 - Diagnostic from Biopsies with Software Analysis

Title:  Breast Cancer Diagnostic Based on Spatial Organization of Genes in the Cell Nucleus

NIH Reference No.: E-283-2008

Executive Summary

  • Category: Diagnostics/Health IT
  • Disease Focus: Breast Cancer using tumor biopsies  
  • Basis of Invention: Gene (DNA) 
  • How it works:  Uses the 3D placement of genes to detect breast cancer in tissue
  • Patent Status: Patent issued in Europe (validated in Germany, UK, France), pending in US, Canada
  • Lead Inventor: Tom Misteli, PhD
  • Development Stage:  In vitro and retrospective in vivo with each of 8 biomarkers evaluated in up to 100 human tissues: a combination of normal, benign and cancer tissues
  • Novelty: New class of cancer biomarkers that allow quantitative analysis of tissue sample rather than qualitative.  Requires a very small tissue sample (150-200 cells) and no prior knowledge of tumor makeup
  • Clinical Application: Could be used as a first-line diagnostic tool, potentially as a replacement for or adjunct to traditional histological diagnosis procedures. Could be used in combination with established diagnostic method to achieve increased accuracy

#2 - Immunotherapy Using Modified Self Tumor Cells

Title:  Cancer Immunotherapy Using Oligonucleotides Conjugated to Apoptotic Tumor Cells

NIH Reference No.: E-266-2009

Executive Summary:

  • Category: Therapeutic
  • Disease Focus: Cancer treatment, broadly, by slowing the growth of tumors and preventing metastasis following surgery
  • Basis of Invention: Tumor Cells
  • How it works:  Uses an immunotherapeutic linked to patient tumor cells to enhance a patient’s immune reaction to cancer
  • Patent Status:  U.S. Patent Pending
  • Lead Inventor: Dennis Klinman, M.D., Ph.D.
  • Development Stage:  Preclinical in mice, tested both pre- and post-immunization with viable tumor cells from four different cancer cell lines
  • Novelty: Personalized medicine with immune system stimulators conjugated to apoptotic tumor cells specific to the individual undergoing treatment.  Therapy can be generated from a biopsy sample as it only requires a small amount of cells to create therapy
  • Clinical Application: Could be administered to tumor-presenting patients to reduce tumor size, to prevent recurrence and metastasis following surgical resection of tumors, or to prevent tumor development in patients at risk of developing certain types of cancer

#3 - Combination of Tissue Reconstruction and Recurrence Prevention

Title:  Anti-Cancer Properties for Reconstructed Breast Tissue 

AF Reference No.: 02-2009-078, 02-2011-085

Executive Summary: 

  • Category: Device/Therapeutic
  • Disease Focus: ER positive breast cancer
  • Basis of Invention: Combination device, platform
  • How it works: A platform for new bioactive breast tissue lumpectomy and mastectomy reconstructive options targeting cancer recurrence prevention
  • Patent status: Patent granted (#6,991,652) for a biocompatible composite for use in a living subject, comprising a material selected from the group consisting of alginate, collagen, polylactide, polyethylene glycol, polycaprolactone, polydioxanone, and derivatives, and copolymers thereof and having a diameter of about 1.5 mm or less distributed within a carrier.  No patent for Tannic acid (TA)-collagen per se, however issued patent anticipates the incorporation of active agents i.e. Tannic Acid.   Patent also granted (# 8,293,531) for a benchtop diagnostic system for testing therapies, devices, vaccines.
  • Lead Inventor: Karen Burg
  • Development Stage:  Pre-clinical. Crosslinked collagen beads using varying concentrations of TA. Demonstrated that TA induces apoptosis in breast cancer cells grown in 2D culture.
  • Novelty: Uses of a tannic acid-collagen composite tissue replacement material as a reconstruction platform with anti-tumor capabilities.
  • Clinical Application: Could be used as a novel method of recurrence prevention for ER-positive breast cancer after mastectomy.  Could be used in a benchtop diagnostic to personalize treatment by identifying cancer cell types within a tumor.

#4 - Human monoclonal Antibody Based Cancer Therapies

Title: Human monoclonal antibody targeted to mesothelin for the treatment of cancer

NIH Reference No.: E-236-2012

Executive Summary

  • Category: Therapeutic, Diagnostic 
  • Disease Focus: Applicable to many cancer types (breast, liver, pancreas, mesothelioma, ovarian) but limited to breast cancer for the Challenge
  • Basis of Invention: Antibody 
  • How it works:  Binds specifically to a target on cancer cells and inhibits the growth of tumors 
  • Patent Status:  U.S. Patent pending
  • Lead Inventor: Mitchell Ho, Ph.D.
  • Development Stage: In vitro inhibition of tumor cell growth; Evaluated in mouse xenograft models
  • Novelty: Fully human monoclonal antibody which targets a different region of mesothelin than the current clinical candidates 
  • Clinical Application:  As a cancer therapeutic either alone or in combination.  Potential use in antibody-drug conjugates or in vaccines. Potential use in generation of a diagnostic kit for mesothelin-expressing cancers

*Special Note:  For this invention, breast cancer is the only field of use available for the start-up phase of the challenge.  Teams may use the background data associated with this invention related to other cancers in order to fully understand the toxicology, efficacy, and other scientific parameters as well as to understand how the commercialization, development and regulatory landscape may evolve based on the invention as a whole

#5 - Immunotherapy Using Granulysin Activated Monocytes

Title:  Use of 15 kDa Granulysin as an Adjuvant through Activation of Dendritic Cells 

NIH Reference No.: E-158-2009

Executive Summary:

  • Category:  Therapeutic
  • Disease Focus: Cancer broadly, Infectious Diseases, Autoimmune Diseases
  • Basis of Invention: Recombinant Protein, Cells
  • How it works:  Monocytes are isolated from individual patients and treated with a 15 kD granulysin, a molecule that induces the formation of dendritic cells which are injected back into the patient to stimulate the immune system
  • Patent Status:  Patent Pending in US, Canada, Australia, and Europe
  • Lead Inventor:  Alan Krensky, M.D.
  • Development Stage: Preclinical in mice; dendritic cells have been generated from human monocytes ex vivo
  • Novelty:  Use of granulysin as an adjuvant to produce monocyte-derived dendritic cells for immunotherapy is particularly useful in such sub-optimal immune response conditions as tumor tissue
  • Clinical Application:  Activation of dendritic cells from isolated monocytes for stimulation of immune response for tumor inhibition, and as a anti-tumor vaccine adjuvant

Video on Invention #5

#6 - Anti-cancer Toxin 

Title:  Potent, Easy-to-Use, Targeted Toxins for Anti-tumor Agents

NIH Reference No.: E-160-2006

Executive Summary

  • Category:  Therapeutic
  • Disease Focus:  Cancer broadly
  • Basis of Invention:  Small Molecule
  • How it works:  A small molecule to attach to a known targeting drug to enhance its effectiveness
  • Patent Status: Issued U.S. Patent, Pending EP
  • Lead Inventor:  Nadya Tarasova, Ph.D.
  • Development Stage: Preclinical, the toxin has been conjugated with trastuzumab (Herceptin®) and tested in cells, in vitro data available
  • Novelty: The toxin is easy to synthesize, is stable in circulation, and is cell permeable.  The compounds have a mechanism of action distinct from those of the currently used toxins
  • Clinical Application: For use as the toxin in antibody-drug conjugates or targeted nanoparticles-drug conjugates


Video on Invention #6

#7 - Versatile Delivery Method for Cancer Therapeutics

Title:  Virus-Like Particles as a Platform for Efficient Delivery of Proteins and RNA 

NIH Reference No.: E-264-2011 and E-010-2008

Executive Summary:

  • Category:  Vaccine or Drug Delivery (Protein or RNA)  
  • Disease Focus:  Cancer broadly
  • Basis of Invention:  Virus-like Particle (VLP)
  • How it works:  A platform technology for delivery of proteins or RNA to cancer cells 
  • Patent Status:  PCT Application filed; U.S. Patent Pending 
  • Lead Inventor: Stanislaw J Kaczmarczyk, Ph.D. and Deb Chatterjee, Ph.D.
  • Development Stage: Preclinical, in vitro data available for both miRNA and protein delivery; verified robust protein delivery, robust protein expression, miRNA mediated inhibition of gene expression and expression of innate immune response provoking proteins using coding RNA in target cells in vitro.  Pre-clinical in-vitro studies for protein delivery with human prostate cancer cell lines.  Mouse in vivo data using 4T1 mouse mammary carcinoma cell line as a model system for cancer immunotherapy
  • Novelty: Less toxic and more target specificity than current delivery methods; eliminates the need for expensive antigen purification methods
  • Clinical Application: Delivery of proteins or miRNA or coding RNA into cells, direct antibody production by in vivo injection of replicons, in vivo cancer treatment by converting cancer cells into antigen presenting cells.

#8 - Genomic Based Diagnostic Assay

Title: Prediction of Breast Cancer Survival Using Expression Levels of Six Genes

NIH Reference No.: E-023-2009

Executive Summary

  • Category: Diagnostics and prognostic
  • Disease Focus: Breast and lung cancer broadly with no limitations on tumor type or stage
  • Basis of Invention: Gene (DNA) 
  • How it works:  Uses amount of genes present to detect presence of cancer
  • Patent Status:  U.S. Patent pending
  • Lead Inventor: Steven Libutti, M.D., FACS
  • Development Stage: Preclinical, 338 cumulative samples in two separate experiments; independently validated in human breast cancer data sets, statistically significant.  Six-gene model applied to six independent human lung cancer data sets
  • Novelty: Only six genes are used to diagnose and predict the reoccurrence of breast cancer versus 16 to 70 genes.  Broadly applicable as the test is not specific to a certain type of breast cancer.  The six gene model is also applicable to lung cancer and was tested in six lung cancer data sets.  May also be applicable in other cancers
  • Clinical Application: Can be used when patients have been diagnosed with cancer to predict disease progression and, therefore, guide treatment decisions.  A future application could also be to identify new therapeutics for breast cancer.  Since it works in breast and lung cancer, the test has potential to work in other tumor types as well 

#9 - Tissue-based Diagnostic Assay

Title: Ratio Based Biomarkers for the Prediction of Cancer Survival

NIH Reference No.: E-025-2009

Executive Summary

  • Category: Diagnostic 
  • Disease Focus: Cancer broadly
  • Basis of Invention: Protein  
  • How it works:  Combines two to four biomarkers to predict a patient’s survival and determine treatment course
  • Patent Status: Pending in U.S., Canada, Europe, Australia, Japan, Israel, and New Zealand
  • Lead Inventor: Stephen M. Hewitt, M.D., Ph.D.
  • Development Stage: The biomarkers have been evaluated in 221 patients with extrahepatic cholangiocarcinoma (EHCC), in 220 lung cancer patients, in 946 patients with gastric cancer, as well as in cervical and kidney cancers.    
  • Novelty: Novel biomarkers that predict patient survival
  • Clinical Application: Prognostic / predictive biomarkers for survival and prediction of response to targeted therapies.  Identification of patients who may benefit from mTOR analog-based chemotherapy or agents directed against Akt

#10 - Diagnostic Kit for Therapy Benefit Prediction

Title:  Biomarker for the Prediction of Taxane-based Chemotherapy Outcome

NIH Reference No.: E-191-2009

Executive Summary:

  • Category:  Diagnostic
  • Disease Focus:  Cancers treated with taxane-based chemotherapies
  • Basis of Invention:  Protein
  • How it works:  Uses a marker in patient pre-treatment tumor samples to predict benefit from the addition of a taxane-based chemotherapy in breast cancer patients
  • Patent Status:  U.S. Patent Allowed; Pending in Europe, Canada, Australia, and Japan
  • Lead Inventor: Sherry Yang, MD., Ph.D.
  • Development Stage: The biomarker was evaluated in 1581 primary tumor tissue samples from node-positive operable breast cancer patients who participated in a randomized clinical trial
  • Novelty: AKT phosphorylation at Ser473 (pAKT) has been identified as a biomarker that predicts treatment benefit from sequential addition of a taxane (paclitaxel or docetaxel) to doxorubicin and cyclophasphomide (AC) chemotherapy to assist physicians in making treatment decisions for high-risk and node-positive breast cancer patients
  • Clinical Application: Identification of patients by examining pAKT expression status in pre-treatment surgical tumor specimens or tumor biopsies to receive a taxane if patients have pAKT-positive tumors or spare a taxane if patients have pAKT-negative tumors
The Center for Advancing Innovation, INC 2013