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Gates Biomanufacturing Facility readies first shipment of clinical trial cancer treatments
Groundbreaking moment represents years of planning, training and biomedical expertise 

AURORA, Colo. (May 3, 2018) - The Gates Biomanufacturing Facility at the University of Colorado Anschutz Medical Campus has passed an important landmark in manufacturing its first clinical trial-grade product for direct infusion into patients.

The groundbreaking effort by the facility represents the culmination of several years of planning and work installing the requisite quality systems and trained team to deliver its first cell therapies for patient use.

The materials for a clinical trial in multiple myeloma treatment by a private research firm will soon be followed by clinical trial processing for pioneering teams at the Gates Center for Regenerative Medicine at the University of Colorado Anschutz Medical Campus. 

“It’s the first product we’ve produced to infuse into a patient,” said Ryan Crisman, interim facility director at the Gates Biomanufacturing Facility. 

The treatment, based on the production of CAR-T cells to attack cancer, is shipped to the locations of clinical trials around the nation. 

“It’s a big benchmark for our facility, for the Gates Center and for the university,” Crisman said. 

CU Chancellor Donald M. Elliman Jr. agreed.

"The Gates Biomanufacturing Facility has reached another important milestone in collaborative efforts at the CU Anschutz Medical Campus to be a leading bench-to-bedside research and treatment center,” he said. “This first material delivery should be a harbinger of opportunity and promise for our talented investigators and clinicians, for our campus and for patients. It's exciting to be part of the safe and expedited translation of scientific discovery into new human therapies and cures."

Gates Center Director Dennis Roop, Ph.D., who also conducts team research on inherited skin diseases with treatments headed for clinical trials, lauded the manufacturing success.

“Since we established the Gates Center of Regenerative Medicine in 2007, my dream has been to build a facility that would allow the translation of basic research into therapies that would benefit patients. This achievement by The Gates Biomanufacturing Facility has now brought this dream to fruition,” Roop said. “My new dream is that this is only the beginning.”    

The Gates Biomanufacturing Facility also expects soon to assist recently recruited researcher Terry J. Fry, M.D., in producing materials for additional clinical trials. 

Terry J. Fry, M.D., one of the nation’s leading cancer researchers, was named Co-Director of the Human Immunology and Immunotherapy Initiative on the CU Anschutz Medical Campus in February. 

Dr. Fry was among the first scientists to investigate the potential to insert modified genes into a child’s own T-cells to combat lymphoblastic leukemia. Approved by the FDA for pediatric use in August 2017, the therapy achieved an astonishing 80 percent remission rate in kids with otherwise unresponsive cases of the leukemia. Dr. Fry is now working to develop targeted treatments to decrease resistance and increase durability of remission. He’s also working to apply CAR-T technology to other types of cancer. 

The Gates Biomanufacturing Facility is one of six combined cell therapy and protein manufacturing facilities in the United States and the only one of its kind within an 800-mile radius: http://gatesbiomanufacturing.com/​. The facility has been a key element in the recruitment and retention of some of the nation’s top regenerative medicine researchers for the CU Anschutz Medical Campus.

“It’s a very highly regulated field,” Crisman said. “Any time you are doing cutting edge research and clinical trials, you want to make sure the process is not in question. “We are proud of our efforts to eliminate the process as a variable, so we can focus on the clinical efficacy for the patient.”​


CU Anschutz scientists awarded $3.8 million Department of Defense grant to manufacture stem cell therapies
String of major recent grants underlines promise of new potential treatments for Epidermolysis Bullosa and other chronic skin wounds

AURORA, Colo. (April 12, 2018) – Scientists from the  Gates Center for Regenerative Medicine at the University of Colorado School of Medicine are part of a consortium awarded $3.8 million from the U.S. Department of Defense to move discoveries in stem cell-created skin grafts into the manufacturing stage, bringing further hope to victims of debilitating inherited skin diseases. 

The major grant for the Epidermolysis Bullosa (EB) iPS Cell Consortium, which includes research teams from the University of Colorado Anschutz Medical Campus, Stanford University School of Medicine and Columbia University Medical Center, will move production of stem cells into the Gates Biomanufacturing Facility at CU Anschutz.

The $3.8 million grant follows recent awards for the same investigators by the 21st Century Cures Act and the California Institute of Regenerative Medicine, boosting research that could not only benefit EB sufferers, but also countless patients with severe chronic skin wounds.

In February, CU Anschutz’s EB researchers reported a more efficient approach to reprogramming a patient’s diseased skin cells into stem cells, raising hopes for future clinical trials and potential cures. The results were published in Nature Communications.

In announcing the new grant, Department of Defense (DoD) reviewers issued one of the most emphatic research endorsements possible, saying, “This study is based on the strongest cutting-edge scientific rationale in the field of wound care and dermatology. It is also a collaborative effort among top physician-scientists, scientists, health care providers, epidermolysis bullosa patients, families, and charities across the United States.” 

One evaluator wrote: “The proposed research has the highest probability of success of bringing gene-corrected tissue to patients in the hospital  . . .”

The DoD award will allow the EB research team to further investigate best manufacturing practices for larger-scale production of stem cell-created skin grafts, utilizing the best-in-class resources of the Gates Biomanufacturing Facility on the CU Anschutz Campus. 

The goal now is to move the technology from the laboratory into clinical trials. Gates Center Director Dennis Roop, PhD, is a lead researcher on the team making great progress on promising new corrective stem cell-based therapies for currently incurable diseases, such as Epidermolysis Bullosa (EB). 

Dr. Roop has had a long-standing interest in finding a permanent cure for EB, a group of inherited skin diseases that results in severe blistering and scarring. EB affects thousands of people across the United States and worldwide, and is characterized by chronic skin wounds similar in property to thermal burns, and indistinguishable from burns induced by chemical agents such as mustard gas. Many children afflicted with recessive dystrophic EB, one of the most painful and disfiguring forms of the condition, do not survive their teens after lives compromised by chronic, debilitating pain.

The consortium is funded by the U.S.-based EB Research Partnership (EBRP),) and EB Medical Research Foundation (EBMRF) and the Sohana Research Fund from Great Britain.

“We are very excited to receive such a strong endorsement from the U.S. Department of Defense,” said Dr. Ganna Bilousova, PhD, assistant professor of Dermatology at the CU School of Medicine and member of the EB Consortium. “It is extremely difficult to advance any type of novel therapies into the clinic without the benefit of compelling government interest and support.”


CU SCIENTISTS’ DISCOVERY COULD SPEED THE CLINICAL TRANSLATION OF STEM CELL THERAPIES 
Researchers find a new method to reprogram adult cells into induced pluripotency with an unprecedented efficiency 

AURORA, Colo. (Feb. 21, 2018) – A team of scientists from the University of Colorado School of Medicine and the Charles C. Gates Center for Regenerative Medicine has reported a more efficient approach to reprogramming a patient’s diseased skin cells into stem cells, raising hopes for future clinical trials and potential cures for critical illnesses. 

The results were published on February 21, 2018 in Nature Communications (Link). The team is reporting a clinically safe approach that consistently reprograms healthy and disease-associated patient’s skin cells into induced pluripotent stem cells (iPSCs) with an unprecedented efficiency.

Since its initial discovery in 2006 by Shinya Yamanaka, M.D., Ph.D., iPSC reprogramming technology has created considerable interest in the field of regenerative medicine for its potential of providing an unlimited source of patient-specific cells suitable for transplantation. This technology involves the reprograming of adult skin cells taken from a donor into immature embryonic stem cell-like iPSCs. These iPSCs can be grown outside the body, genetically manipulated, converted into a variety of adult cell types and then either transplanted back to the same patient as an autograft or used as a platform for drug screening and research. 

Despite significant advances, current methods for reprogramming adult cells into iPSCs are extremely inefficient and inconsistent, with less than 1 out of every 500-1000 adult human cells becoming iPSCs. The low efficiency of these protocols, coupled with the length of time in culture, increase the chances of accumulating harmful mutations in iPSCs, thus compromising the safety of this technology for clinical applications. 

To address the issue of low reprogramming efficiency, the University of Colorado team optimized the cellular delivery of modified mRNAs, encoding several reprogramming factors in combination with microRNAs, and improved cell culturing conditions to enhance the growth of cells undergoing conversion into iPSCs.

“Many groups had previously attempted to improve reprogramming efficiency by identifying novel modulators of the process,” said Ganna Bilousova, Ph.D., an assistant professor of dermatology and one of the study’s lead scientists. “Instead of looking for new reprogramming enhancers, we took advantage of the versatility of RNA molecules to control the precise levels of reprogramming factors and microRNAs in cells during their conversion into iPSCs. We were surprised at how simple manipulations of the timing and dosing of the RNA molecules could affect the efficiency of reprogramming.” 

The researchers showed that the fine-tuning of RNA delivery and cell culturing conditions dramatically enhanced the efficiency of reprogramming and improved the consistency of the process for disease-associated skin cells.

 “Initiating reprogramming at a reduced cell density was critical for improving reprogramming efficiency in our study,” said Igor Kogut, Ph.D., an assistant professor of dermatology at the Gates Center. Dr. Kogut is also one of the paper’s lead authors. “There is a direct correlation between the rate of cell division and the efficiency of reprogramming. Our optimal, combinatorial RNA delivery regimen, which reduced the toxicity of the protocol, made it possible to initiate the process at a reduced cell density, down to individually-plated single cells.”

The goal now is to move the technology from the laboratory into clinical trials. Gates Center Director Dennis Roop, Ph.D., who is also one of the lead authors on the paper, recognizes the magnitude of the team’s work. He believes it holds great potential for the development of new corrective stem cell-based therapies for currently incurable diseases, such as Epidermolysis Bullosa (EB). Dr. Roop has had a long-standing interest in finding a permanent cure for EB, a group of inherited skin diseases that results in severe blistering and scarring. EB affects thousands of people across the United States and worldwide, and is characterized by chronic skin wounds similar in property to thermal burns, and indistinguishable from burns induced by chemical agents such as mustard gas. 

“There are no effective therapies for EB, and iPSC technology provides an opportunity to develop a permanent corrective stem cell-based therapy for these severe skin-blistering diseases”, said Dr. Roop. “Our breakthrough in developing a highly-efficient reprogramming method, that avoids the use of viral vectors, may allow us to get FDA approval for one of the first iPSC-based clinical trials in the US.”

To accelerate getting iPSC-based therapies for EB into the clinic, the Colorado team has established a consortium comprised of the University of Colorado, Stanford University (Dr. Anthony Oro) and Columbia University (Dr. Angela Christiano). The “EB iPS Cell Consortium” was initially supported by the EB Research Partnership (EBRP), the EB Medical Research Foundation, and the SOHANA Research Fund. More recently the Consortium has received funding from the National Institute of Arthritis and Musculoskeletal and Skin Diseases through the 21st Century Cures Act for the Regenerative Medicine Innovation Project, and the California Institute for Regenerative Medicine’s Partnering Opportunity for Translational Research Projects. The research teams at both Stanford and Columbia have adopted the University of Colorado’s reprogramming technology as the method of choice for generating patient-specific iPSCs for future clinical trials, and thus are setting the standards for future iPSC-based therapies for other diseases.


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Seven-year study pays off with ‘most detailed’ picture of head and neck cancer stem cells to date

AURORA, Colo. (Sept. 19, 2016) – Cancer stem cells resist therapy and are a major cause of relapse, long after the bulk of a tumor has been killed. A University of Colorado Cancer Center study published in the Journal of the National Cancer Institute provides the most comprehensive picture to date of head and neck cancer stem cells, identifying genetic pathways that cancer stem cells hijack to promote tumor growth and visualizing the process of “asymmetric division” that allows a stem cell to create tumor tissue cells while retaining its own stem-like profile. The study is the result of seven years of research and innovation, including the development of novel techniques that allowed researchers to identify, harvest and grow these elusive stem cells into populations large enough to study. This major body of work provides specific targets for the development of new cancer therapeutics.

“We wanted to determine the relationships between key genetic alterations and how head and neck cancer stem cells harness those alterations to drive initiation and growth,” says CU Cancer Center investigator Antonio Jimeno, MD, PhD, the Daniel and Janet Mordecai endowed professor for cancer stem cell research, director of the University of Colorado School of Medicine’s Head and Neck Cancer Clinical Research Program, and the paper’s senior author. The current project was performed in collaboration with the Gates Center for Regenerative Medicine of which Dr. Jimeno is a faculty member. Jimeno started his work with cancer stem cells as a post-doc at Johns Hopkins University, but as he explains, “I focused on head and neck cancer stem cells because there has been an increase in head and neck cancer incidence of about fifty percent over the past ten years in the U.S. and we need to better understand what is at the root of this disease.”

Previously, a major challenge in characterizing cancer stem cells has been gathering a cell population large enough to study.

“There is a lot of ‘noise’ in cells and you need a lot of them because with only a few cells, it’s impossible to tell which of these genetic differences are meaningful features of cancer stem cells and which are just genetic noise,” says first author Stephen Keysar, PhD, research assistant professor in the Jimeno lab.

To solve this problem, the group first gathered tumor samples from a larger number of head and neck cancer patients – 10 patients in all – more than in any previous study. These samples represented both tumors associated with alcohol and tobacco use and tumors caused by the human papilloma virus (HPV).

“It is important to always remember that we were able to make a difference thanks to the generosity of our patients, who enabled us to work with representative cancer models,” Jimeno says.

These tumors were then grown in mice. Subsequently, the group undertook the painstaking process of isolating enough cells for genetic studies and one-by-one transplanting these patient-derived tumor samples onto new mice to study how cancer stem cells initiate tumor growth.

“Sometimes it took a year just to get enough cells to study,” Keysar says.

“Antonio is a great example of perseverance,” says Dennis Roop, PhD, director of the Gates Center and also an investigator at the CU Cancer Center and the individual whom Jimeno credits with ‘much of the philosophy behind this work.’ “Antonio was submitting all these grants, and the reviewers were saying, ‘There’s no way you can do this; there’s no way you’ll get enough cells to characterize.’ He simply found ways to prove them wrong.”

This included leveraging private research funding, primarily from the Gates Center for Regenerative Medicine, the Daniel and Janet Mordecai Foundation and the Peter and Rhondda Grant Fund.

“Private funding allowed Antonio to do the groundwork and develop the techniques that eventually made his proposals to the NIH so compelling that he was able to get support. In the case of those of us who are driven to do what we do, you just find a way to get these things accomplished. This is a great example of how bridge funding from the private sector can move research forward,” Roop says.

Here is what the group found:

First, head and neck cancer stem cells are, in fact, distinct from the rapidly dividing cells that form the bulk of tumors, and there is little difference between cancer stem cells in HPV- and HPV+ cancers. Both are marked by CD44 expression and aldehyde activity, and both use the key pathway PI3K to drive their survival, growth and resistance to anti-cancer therapies. The group found that the PI3K pathway, which is the most common alteration in head and neck cancer, then deploys SOX2, a transcription factor, to activate programs that modulate ‘stemness’ within the cell’s nucleus. For example, SOX2 was found to control aldehyde activity, which is a common cancer stem cell marker and a well-known driver of cancer stem-cell-mediated tumor growth.

“In normal cells, PI3K is used as a sensor for energy,” Jimeno explains. “For a cancer cell to act cancerous, it needs metabolic flexibility – it needs to be able to over-use energy – and so this ‘energy sensor’ is a pathway it wants to hijack. After chemo, PI3K helps the cell shut down and weather the storm. Then when the chemo is gone, PI3K helps cancer stem cells start back up again.”

Chemotherapies kill rapidly-dividing cells. PI3K shuts down a cancer stem cell’s metabolism, placing the cell in a dormant state. This gives cancer stem cells the ability to evade the trap of chemotherapy.

So what happens when you remove this ability? When the group eliminated SOX2 in mouse models of head and neck cancer, tumors became sensitive to therapies that previously had failed. But when the group amplified SOX2, tumors became even more resistant.

“This molecular thread from PI3K to SOX2 to aldehyde was responsible for all the features that define cancer stem cells,” Keysar says. Further, “Since SOX2-expressing cells fully behave like cancer stem cells, we now have a new laboratory tool to study cancer stem cell biology and therapeutics.”

The work also allowed the group to witness an event of the stem cell cycle that had, at best, been only partially characterized in head and neck cancer.

“It was like the snow leopard of the Himalayas,” Jimeno says. “We knew it existed because of the tracks, but no one had taken a picture of it – that is, until someone patiently perched on a frozen ridge for two years with a camera. We did just that.”

The event Jimeno refers to is “asymmetric division” of cancer stem cells. When a normal cell divides, it creates two identical copies of itself. However, if stem cells divided symmetrically, it would result in two stem cells but no differentiated cells, or two differentiated cells with the loss of the original stem cell. In either case, symmetrically dividing stem cells would not be able to promote tumor growth while also retaining their stemness.

The group was able to document that when cancer stem cells divide, “they don’t divide into two of the same,” Jimeno says. “One cell retains a stem profile, and the other goes a step beyond into differentiation.”

Overall, this seven-year line of inquiry offered three major advances:  it characterized head and neck cancer stem cells; it documented asymmetric division in head and neck cancer stem cells; and it identified genetic mechanisms that allow these cancer stem cells to grow and resist therapy. Importantly, identifying these genetic mechanisms of resistance may also help researchers and doctors overcome it.

“SOX2 and aldehyde inhibitors are now under exploration, and we’ve also done trials of early PI3K inhibitors here at CU Cancer Center,” Jimeno says.

“This has been an excellent example of team science,” Roop says. “You have Antonio – a brilliant young clinician-scientist – leading a group that includes basic scientists, pathologists, bio-informaticians and statisticians, and their expertise can combine to attack a problem in a way that no individual would be able to do on their own. This work will provide the basis for the development of new therapeutic strategies.”

About the Gates Center for Regenerative Medicine 

The Gates Center for Regenerative Medicine was established in 2006 with a gift in memory of Denver industrialist and philanthropist, Charles C. Gates, who was captivated by the hope and benefit stem cell research promised for so many people in the world.  The Gates Center aspires to honor what he envisioned—by doing everything possible to support the collaboration between basic scientific researchers and clinical faculty to transition scientific breakthroughs into clinical practice as quickly as possible.  

Led by Founding Director Dennis Roop, PhD, the Gates Center is a multi-institutional consortium headquartered on the University of Colorado Anschutz Medical Campus – the only comprehensive academic health sciences center in Colorado, the largest academic health center in the Rocky Mountain region, and one of the newest education, research and patient care facilities in the world.  Operating as the only comprehensive Stem Cell Center within a 500-mile radius, the Gates Center shares its services and resources with an ever-enlarging membership of researchers and clinicians from the University of Colorado Anschutz Medical Campus and CU Boulder campus, Colorado School of Mines, National Jewish Health and private industry. This collaboration is designed to draw on the widest possible array of scientific exploration relevant to stem cell technology focused on the delivery of innovative therapies in Colorado and beyond.



Brand-new Gates Biomanufacturing Facility promises to be a ‘game changer’ on the Anschutz Medical Campus
 

CU SCIENTISTS’ DISCOVERY COULD LEAD TO NEW CANCER TREATMENT
Researchers find method to expand blood stem cells 
 
AURORA, Colo. (Sept. 2, 2014) – A team of scientists from the University of Colorado School of Medicine has reported the breakthrough discovery of a process to expand production of stem cells used to treat cancer patients. These findings could have implications that extend beyond cancer, including treatments for inborn immunodeficiency and metabolic conditions and autoimmune diseases.
In an article published Aug. 29 in PLOS ONE, researchers from the Charles C. Gates Center for Regenerative Medicine and Stem Cell Biology and Taiga Biotechnologies, Inc. said they have uncovered the keys to the molecular code that appear to regulate the ability of blood stem cells to reproduce and retain their stem-like characteristics.
 
The team developed protein products that can be directly administered to blood stem cells to encourage them to multiply without permanent genetic modifications.
 
“Use of stem cells to treat cancer patients who face bone marrow transplants has been a common practice for four decades,” said Yosef Refaeli, Ph.D., an associate dermatology professor and one of the study’s lead scientists. “The biggest challenge, however, has been finding adequate supplies of stem cells that help patients fight infection after the procedure.”
 
Gates Stem Cell Center Director Dennis Roop, Ph.D., recognized the magnitude of the team’s work.  
 
“Researchers have long attempted to increase the number of blood stem cells in a lab,” Roop said. “Most of those approaches have been limited by the nature of the resulting cells or the inadequate number of cells produced.”
 
The technology described in the PLOS ONE article has worked with blood stem cells obtained from cord blood, adult bone marrow or peripheral blood from adults.
 
“The ability to multiply blood stem cells from any source in a dish will be critical for adoption of this new technology in clinics,” said Brian Turner, Ph.D., MHS, Taiga Biotechnologies’ chief scientific officer. Dr. Turner is also one of the paper’s lead authors.
 
The goal now is to move the technology from the lab into clinical trials. Taiga Biotechnologies is in the process of setting up first-in-human clinical trials with the blood stem cell expansion approaches described in the article. The clinical applications for expanded human blood stem cells vary from inborn immunodeficiency conditions, like SCID and sickle cell anemia, to metabolic conditions, like Hurler’s disease or Gaucher syndrome. Autoimmune diseases that could be affected include severe multiple sclerosis and lupus. And the types of cancer that could be treated as a result of this research include leukemia, lymphoma, myeloma and other types of solid tumors.
 
 
About the Charles C. Gates Center for Regenerative Medicine and Stem Cell Biology
 
The Charles C. Gates Regenerative Medicine and Stem Cell Center was established in 2006 with a gift in  memory of Denver industrialist and philanthropist, Charles C. Gates, who was captivated by the hope and benefit stem cell research promised for so many people in the world.  The Gates Center aspires to honor what he envisioned—by doing everything possible to support the collaboration between basic scientific researchers and clinical faculty to transition scientific breakthroughs into clinical practice as quickly as possible. 
 
Led by Founding Director Dennis Roop, PhD, the Gates Center is located at the University of Colorado’s Anschutz Medical Campus, the largest new biomedical and clinical campus in the United States. Operating as the only comprehensive Stem Cell Center within a 500-mile radius, the Gates Center shares its services and resources with an ever-enlarging membership of researchers and clinicians at the Anschutz Medical Campus, which includes University of Colorado Hospital, Children’s Hospital Colorado and the future Veterans Administration Medical Center, as well as the Boulder campus, Colorado State University, the Colorado School of Mines, and business startups.  This collaboration is designed to draw on the widest possible array of scientific exploration relevant to stem cell technology focused on the delivery of innovative therapies in Colorado and beyond.
 
About Taiga Biotechnologies, Inc.
 
Taiga Biotechnologies, Inc. is a biotechnology company based in Aurora, CO. Taiga Biotechnologies’ mission is to develop novel approaches to treat complex diseases, including cancers, immunodeficiencies and infectious agents such as Influenza and HIV.  The company is currently developing six core programs, all enabled by the company’s proprietary stem cell technologies: the development of  laboratory expanded donor blood stem cells for indications that include congenic or acquired immunodeficiency and cancer; a novel immunotherapeutic for improvement of outcomes following vaccination for infectious diseases or cancer; a novel biological that may expedite recovery from bone marrow stem cell transplantation; a novel approach for the expansion of human T-cells in a dish without genetic modification, to be used for passive immunotherapy for cancer or infectious disease; red blood cell pharming from blood stem cell lines for clinical use in civilian and military applications; therapeutic antibodies based on a novel approach for development of antibody specificities for difficult protein targets.
 
About the University of Colorado School of Medicine
 
Faculty at the University of Colorado School of Medicine work to advance science and improve care. These faculty members include physicians, educators and scientists at University of Colorado Hospital, Children’s Hospital Colorado, Denver Health, National Jewish Health, and the Denver Veterans Affairs Medical Center. The school is located on the Anschutz Medical Campus, one of four campuses in the University of Colorado system. To learn more about the medical school’s care, education, research and community engagement, visit its web site.

 

The Skin Disease Research Center sponsored an International Symposium on the Advancement of Basic and Clinical Skin Research on March 21st, 2014 at the University of Colorado Anschutz Medical Campus.  There were presentations by six international specialists in skin research.

The Gates Stem Cell Center held an iPSC Culture Course at the University of Colorado Anschutz Medical Campus on March 10-17, 2014. 
If you would like to inquire into participating in this course in the future, please contact iPSCore@ucdenver.edu.

Colorado Representative Mike Coffman Draws Attention to Cutting Edge Research at the Gates Center.
Link to Article >>

University of Colorado Cancer Center Opens Phase I Clinical Trial with Investigational Anti-Cancer Stem Cell Agent OMP-54F28

The University of Colorado Cancer Center, together with other participating academic medical centers, recently opened a phase I human clinical trial of the drug OMP-54F28 in patients with advanced solid tumor cancers. OMP-54F28, a candidate investigational drug discovered by OncoMed Pharmaceuticals, targets cancer stem cells (CSCs), also known as tumor-initiating cells, which many researchers believe are at the root of tumor occurrence and growth. These CSCs are notoriously resistant to existing chemotherapies and so may survive current treatments to repopulate a tumor, leading to relapse and metastasis. 

"It's a terrific opportunity to put a drug targeting cancer stem cells in the clinic, especially a drug with as much promise in preclinical studies as this one," says Antonio Jimeno, MD, PhD, Associate Professor of Medicine/Oncology, director of the university's Cancer Stem Cell-Directed Clinical Trials Program, and principal investigator of the clinical trial at the CU Cancer Center site. “It is a privilege to work with such a science-focused partner, whose vision totally aligns with ours: bringing to the clinic cutting-edge drugs and ideas that are supported by robust scientific data. In the context of the collaboration between the Gates Center for Stem Cell Biology and the CU Cancer Center this will be the second clinical trial we will be offering to our patients with the specific intent to target the CSCs in their tumors."

Specifically, OMP-54F28 is an antagonist of the Wnt pathway, a key CSC signaling pathway that regulates the fate of these cells. The Wnt pathway has been intensively studied and is now known to be inappropriately activated in many major tumor types, including colon, breast, liver, lung and pancreatic cancers, and is thought to be critical for the function of CSCs. Because of this extensive preclinical validation, the Wnt pathway has been a major focus of anti-cancer drug discovery efforts. OMP-54F28 and a sister compound also developed by OncoMed, OMP-18R5, are believed to be two of the first therapeutic agents targeting this key pathway to enter clinical testing. Both OMP-54F28 and OMP-18R5 are part of OncoMed’s Wnt pathway strategic alliance with Bayer Pharma AG.

In multiple preclinical models, OMP-54F28 has shown its effectiveness in reducing CSC populations, leading to associated anti-tumor activity, either as a single agent or when combined with chemotherapy. 

The Phase I clinical trial of OMP-54F28 is an open-label dose escalation study in patients with advanced solid tumors for which there is no remaining standard curative therapy. These patients are assessed for safety, immunogenicity, pharmacokinetics, biomarkers, and initial signals of efficacy. The trial is being conducted at Pinnacle Oncology Hematology in Scottsdale, Arizona, the University of Michigan Comprehensive Cancer Center, Ann Arbor, Michigan, and the CU Cancer Center under the direction of Principal Investigators Dr. Michael S. Gordon, Dr. David Smith and Dr. Antonio Jimeno, respectively. 

"We all hope and expect this drug to live up to its preclinical potential," Jimeno says. "And if it does, we will have a powerful new therapy, exploiting a novel pathway to target this most dangerous subpopulation of cancer cells." 

About OncoMed Pharmaceuticals 

OncoMed Pharmaceuticals is a clinical-stage company that discovers and develops novel therapeutics targeting cancer stem cells, the cells shown to be capable of driving tumor growth, recurrence and metastasis. OncoMed has advanced four anti-cancer therapeutics into the clinic, anti-DLL4 (demcizumab, OMP-21M18), anti-Notch2/3 (OMP-59R5), anti-Fzd7 (OMP-18R5) and Fzd8-Fc (OMP-54F28), which target key cancer stem cell signaling pathways Notch and Wnt. In addition, OncoMed’s pipeline includes several novel preclinical product candidates targeting multiple validated cancer stem cell pathways, including the RSPO-LGR pathway. OncoMed has formed strategic alliances with Bayer Pharma AG and GlaxoSmithKline. Privately held, OncoMed’s investors include: US Venture Partners, Latterell Venture Partners, The Vertical Group, Morgenthaler Ventures, Phase4Ventures, Delphi Ventures, Adams Street Partners, De Novo Ventures, Bay Partners and GlaxoSmithKline. Additional information can be found at the company’s website: www.oncomed.com

About the University of Colorado Cancer Center: 

Headquartered on the University of Colorado Anschutz Medical Campus, the CU Cancer Center is a consortium of three state universities and six institutions. Together, our more than 440 members are working to ease the cancer burden through cancer care, research, education and prevention and control. 

Additionally, nearly all researchers who participate in cancer-related basic, translational, clinical, population and behavioral research in Colorado are CU Cancer Center members. This statewide inclusiveness of cancer researchers and academic institutions provides great scientific breadth and depth strengthening the CU Cancer Center's research. 

We are committed to transforming cancer research and practice in the state of Colorado by creating an integrated interdisciplinary nexus of clinicians and scientists across our statewide consortium that can leverage, synergize, marshal and focus resources and expertise to discover new ways to prevent and treat cancer.


​Dr. Karin A. Payne to Direct the Regenerative Orthopaedics Laboratory

AURORA, Colorado – July 13, 2012 - The University of Colorado School of Medicine Department of Orthopaedics is pleased to announce the arrival of Karin A. Payne, PhD to its research faculty as of July 1, 2012. Dr. Payne graduated from the University of Montreal with a MS in Bioengineering, received her PhD in Bioengineering from the University of Pittsburgh, and completed her postdoctoral training in articular cartilage tissue engineering in the Department of Orthopaedic Surgery at the University of Pittsburgh. Dr. Payne has over 10 years of multidisciplinary research experience in the areas of stem cell biology, gene therapy and biomaterials for bone and articular cartilage regenerative medicine. She brings to the department exceptional recognized leadership and knowledge, and a history of scientific publications and presentations throughout the United States and abroad.

The addition of Dr. Payne to the Department of Orthopaedics at the University of Colorado School of Medicine will provide additional research and grant opportunities. Dr. Payne will direct the Regenerative Orthopaedics Laboratory (ROL) within the Department of Orthopaedics, whose goal will be to discover new technology for the preparation of regenerative cell-based products for clinical orthopaedic use to improve musculoskeletal health. The initial research taking place in the ROL focuses on optimizing the musculoskeletal regenerative potential of bone marrow stem cells, and also investigates alternative and novel cell sources, such as induced pluripotent stem cells. Dr. Payne will also foster and facilitate basic and translational stem cell-related research projects within the Department of Orthopaedics and with inter-department collaborations by working with members of the Charles C. Gates Center for Regenerative Medicine and Stem Cell Biology, the Department of Cell and Developmental Biology, and Children’s Hospital Colorado.


Nature Medicine Podcast features interview highlighting Gates Center Investigator Xiao-Jing Wang's paper on oral mucositis. Link to Podcast >>

Gates Center Director Dennis R. Roop, PhD honored at FIRST 2012 Testimonial Dinner. 
View Full Article >>

Dennis Roop's Stem Cell Research Gives Hope to EHK Patient

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Stem Cell Blood Research Underway

Watch FOX 31 News Exerpt >>


Anschutz Medical Campus researchers discover new process to cultivate adult blood cells.

Researchers on the Anschutz Medical Campus have discovered a scientific process that could make blood drives a thing of the past.

Yosef Refaeli and Brian Turner, co-founders of Taiga Biotechnologies Inc., have developed a new method in which they use their proprietary blood stem-cell lines from cord blood to generate mature, adult red blood cells in the lab in 14 days.

The blood stem-cell lines are cultured in tissue-culture dishes with a special mixture that supports stem-cell growth and placed in an incubator that aims to mimic conditions in the human body. Typically, the mixture has salts and nutrients that enable cells to grow in a dish. View Denver Post Article >>


Aastrom Announces Collaboration with CPC Clinical Research for the Phase 3 REVIVE Study in Critical Limb Ischemia

ANN ARBOR, Mich., [May 25, 2011] - Aastrom Biosciences, Inc. (Nasdaq: ASTM), a leading developer of patient-specific, expanded multicellular therapies for the treatment of severe, chronic cardiovascular diseases, today announced a collaborative agreement with CPC Clinical Research (CPC), a non-profit, Academic Research Organization led by William Hiatt, M.D. CPC will provide services related to the execution of Aastrom’s Phase 3 REVIVE clinical studies for ixmyelocel-T, the company’s expanded multicellular therapy. View full press release >>


Don Elliman Joins Gates Center for Regenerative Medicine and Stem Cell Biology

The former chief operating officer for the state of Colorado has joined the Charles C. Gates Center for Regenerative Medicine and Stem Cell Biology. Don Elliman will serve as the center’s executive director. The center is a world-class research organization focused on adult stem cell biology and regenerative medicine located at the University of Colorado Medical School on the Anschutz Medical Campus. View full Campus News article >>


Don Elliman brings business background to hub of science research in Aurora

Colorado's former economic development chief has landed at the Anschutz Medical Campus in Aurora, where he's bringing his business acumen to the region's scientific mecca. View full Denver Post article >>


Rats' mobility restored in CU spinal-cord study

Support cells strained from human stem cells and transplanted into paralyzed lab rats repair damaged nerve systems remarkably quickly and help the rats walk again, according to CU researchers, who say the experiments could extend to injured humans within two years. View Denver Post article >>


Colorado researcher Li discovers key mechanism for transforming adult cells into stem-like cells

In 2006, Dr. Shinya Yamanaka of Kyoto University in Japan set the stem cell and regenerative medicine research world on fire when he successfully transformed differentiated mouse skin cells into cells that looked and behave like embryonic stem cells. Embryonic stem cells, the subject of much controversy when used in research, have the ability to differentiate into any type of tissue. Please read the full PDF or follow the Colorado Cancer Blogs post >>


Stem-cell research pushed to top of Congress' agenda

Despite a packed legislative calendar, quashing a recent court ruling that bans federal funding for embryonic stem-cell research has suddenly risen to the top of Congress' pre-election to-do list.

Rep. Diana DeGette of Denver said Democratic leaders in the House are looking favorably on the idea of moving a bill quickly to the floor in time for a vote before Congress recesses Oct. 8. Denver Post >>


CPC Move Creates Partnership with Stem Cell Center at University of Colorado School of Medicine to Help Drive Critical Research

CPC Announcement: Pictured, from left to right, are Dr. Dennis Roop, Dr. William Hiatt and State Senator Morgan Carroll from Aurora

The fight against disease through stem-cell research in Colorado is about to get a big boost Friday (July 23, 2010) at the Anschutz Medical Campus with the arrival of an academic research organization that will be able to manage future clinical trials in this cutting edge area of science. Full Article >> (Also covered in the Denver Business Journal.)


Mile-High Dreams: The Denver area is trying to overcome the isolation factor and meager funding to excel as a bioscience hub.

The recently opened and still-expanding Anschutz campus is one of several attempts to invigorate Denvers life-science enterprise.

On a clear day, researcher Yosef Refaeli can see the distant, white- capped Rocky Mountains from his office window in Aurora, Colorado. Those scenic peaks, he says, were one of the main reasons he came to the Denver area, and to the new Anschutz Medical Campus at the University of Colorado Denver. Another was the adjacent fledgling biotech park. Full Article >>


First-in-nation program focuses on anti-cancer stem cell therapies

Cancer and stem cell biology researchers at the University of Colorado are launching the nations first program focused on identifying and testing drugs that target and destroy cells thought to be at the root of cancercancer stem cells (CSCs). Full Article >> (Also covered in the Denver Post.)


The 2010 Rothman Awardee is Dennis Roop, PhD, Professor of Dermatology and Director of the Regenerative Medicine and Stem Cell Biology Program

The 2010 Rothman Awardee

The Stephen Rothman Memorial Award is presented annually for distinguished service to investigative cutaneous medicine. The recipient of this award has made major scientific achievements and excelled as a teacher and recruiter of outstanding dermatologists. The recipient is an individual who has distinctly altered the course and image of dermatology or its allied fields. It is the Society's highest award. Full Article >>


The New Health Technology: The face of the bioscience industry is changing rapidly and nowhere more so than in Colorado

Denver Magazine - Jan 2010

CU-AMC boasts specialized centers such as the Charles C. Gates Regenerative Medicine and Stem Cell Biology Program. Dr. Dennis Roop was recruited to direct the program with the goal of transforming CU into one of the country's premier stem cell research centers. Full Article >>


Regional stem-cell center launched by University of Colorado School of Medicine

A new center at the University of Colorado School of Medicine promises to expand one of the frontiers of medicine stem cell research and treatment. Full Article >> (Also covered in the Denver Business Journal.)


C3: Collaborating to Conquer Cancer - The Root of the Matter

UCCC C3 Newsletter

Do cancer stem cells drive cancer recurrence? And how do you kill them? UCCC scientists are collaborating on crucial studies to find out.   ...full PDF >


Plan to establish a Core facility that will generate mouse and human "induced pluripotent stem" (iPS) cells

The purpose of this message is to find out whether there is sufficient interest within the faculty to support this Core. If you are interested in using Core-provided iPS cells (human or mouse) , please fill out the short survey.


Researchers find safer way to transform skin cells into stem cells

The Denver Post

In a paper released this week in the online version of Stem Cells, University of Colorado Denver?s School of Medicine researchers Wenbo Zhou, PhD, and Curt Freed, MD, have created ?human induced pluripotent stem cells? (iPS cells)?reprogrammed to look and act like embryonic stem cells?from human skin fibroblasts using a common cold virus.   ...more >


Scientists celebrate reversal of policy

The Denver Post

Stem-cell researcher Dr. Dennis Roop was teaching a class on bioethics Monday morning when he glanced at his watch ? the next 15 minutes, he told his medical students, would revitalize science.   ...more >


Stem Cell Research ? KWGN News

KWGN-TV

KWGN2 News interviewed Stem-cell researcher Dr. Dennis Roop after the announcement of the reversal of the stem cell research policy.
-March 10, 2009   ...more >


Rep. DeGette Pursues New Stem-Cell Legislation

7News

Colorado Democratic congresswoman Diana DeGette plans to meet with party leaders in the House to discuss her bill that would put into law a new executive order allowing federal funding for stem cell research.   ...more >


Great potential forecast ? Hopes are alive that policy leads to cures.

The Pueblo Chieftain

Dr. Curt Freed, professor and director of clinical pharmacology in the medical school at the University of Colorado Denver, said his research continued throughout the Bush ban because the project, started in 2002, isn't federally funded and didn't involve any of the stem cell lines listed in former President George W. Bush's ban.   ...more >

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