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READY FOR PARTNERING! NCI Technologies Related to Liver Cancer – Annual Report to the Nation Highlights Increase in Liver Cancer Death Rates

April 1, 2016

In March 2016, the NCI, in collaboration with the American Cancer Society, the Centers for Disease Control and Prevention, and the North American Association of Central Cancer Registries, released its Annual Report to the Nation on the Status of Cancer, 1975 - 2012.  

The report reflects progress and improving trends in the survival rate for most cancers; however, it highlights an increase in the death rate for liver cancer.   

NCI has technologies ready for collaboration with commercial partners that could positively impact the fight against liver cancer.  Contact us to learn more about these technologies and how to partner with us.

AVAILABLE TECHNOLOGY:  Monoclonal Antibodies for the Treatment of Cancer
 

AVAILABLE TECHNOLOGY:  Novel Diagnostic Marker for Improving Treatment Outcomes of Hepatitis C


NCI Recipient of 2015 Federal Laboratory Consortium (FLC) Mid-Atlantic Region Awards

November 25, 2015

The Federal Laboratory Consortium for Technology Transfer(FLC) of the Mid-Atlantic Region recognized outstanding efforts in the field of technology transfer, including honoring NCI TTC with two awards, at its November 2015 annual meeting in Maryland. NCI TTC received the “Excellence in Technology Transfer” honors for its work supporting two efforts, entitled: “First FDA approval:  combination therapy for rare childhood cancer, Neuroblastoma,” and “Development of First Immunotherapy to Treat Chordoma, Rare Bone Cancer.” http://www.flcmidatlantic.org/awards/2015/

The FLC for Technology Transfer (FLC) is the nationwide network of federal laboratories that provides the forum to develop strategies and opportunities for linking laboratory mission technologies and expertise with the marketplace. The FLC “Excellence in Technology Transfer” award “recognizes employees of FLC member laboratories and non-laboratory staff who have accomplished outstanding work in the process of transferring federally developed technology.”

To learn more about the “First FDA approval:  combination therapy for rare childhood cancer, Neuroblastoma,” see:

To learn more about “Development of First Immunotherapy to Treat Chordoma, Rare Bone Cancer,” see:

 


SBIR-Technology Transfer: Extramural Funding for Small Businesses to Support Commercial Development of NCI Inventions

November 9, 2015

NIH recently announced that the Small Business Innovation Research-Technology Transfer (SBIR-TT) extramural grants mechanism is available for the commercial development of inventions of the National Cancer Institute intramural research program.  The NCI SBIR and the NCI Technology Transfer Center (TTC) look forward to helping small companies and NCI researchers with project selection and research plan development.

SBIR-TT is a relatively new program whereby inventions from the NCI Intramural Research Program are licensed to qualified small businesses with the intent that those businesses develop the inventions into commercial products that benefit the public.  These inventions would be commercially promising but for identifiable research gaps that have delayed their commercialization.  The SBIR-TT grantee awarded under this Program Announcement will address these research gaps under a license from NIH, working closely with the NCI inventor(s), who will provide limited assistance during the award period.

The Program Announcement encourages small businesses to submit grant applications for projects to transfer technology out of the NCI intramural research labs into the private sector. Under the SBIR-TT grants mechanism, an NCI Principal Investigator can develop a research plan with a company interested in commercializing the technology. If selected for SBIR Phase I funding, the company will be granted a royalty-free, non-exclusive patent license agreement for internal research use for the term of and within the field of use of the SBIR Phase I award (generally 6 months) to technologies held by NIH, with the intent that the company will develop the invention into a commercial product to benefit the public. Companies that are successful in SBIR Phase I may apply for larger amounts of SBIR funding (from NCI SBIR) and for a commercialization license (from NCI TTC) offering the rights to sell the product over the long term.

The Program Announcement that describes the cross-NIH SBIR-TT program is available online.

Browse to the NCI TTC website to view licensing opportunities, or call NCI TTC for more information on research opportunities.

Please call NCI SBIR for information on SBIR grants.

Contact information:

  • John D. Hewes, Ph.D., Technology Transfer Specialist, Technology Transfer Center, Tel. 240-276-5515, Email: john.hewes@nih.gov
  • Christie Canaria, Ph.D., Program Director, SBIR Development Center, Tel.: 240-276-5720, E-mail: christie.canaria@nih.gov

Kite Pharma Signs New License with NIH

October 21, 2015

Kite Pharma Inc. announced on Oct. 20 that it had entered into another exclusive commercialization license with the National Institutes of Health. This license covers T cell receptor immunotherapy technologies developed in collaboration with the National Cancer Institute's Surgery Branch, led by Dr. Steven Rosenberg, MD, PhD, for the treatment of lung, gastric, pancreatic and breast cancer. As part of the licensing agreement, Kite Pharma will give the NIH an upfront payment and royalties on product sales and clinical and regulatory milestone payments.

The National Cancer Institute, under a cooperative research and development agreement with Kite, is conducting two clinical trials of candidates for T cell immunotherapies that would target melanoma-associated antigens.


Neuro Startup Challenge Winners Advance

June 1, 2015

Thirteen winners of the Neuro Startup Challenge (NSC), an open innovation competition designed to bring promising neuro-related inventions to market, were announced on May 21. The second challenge of its kind, the NSC was established by a collaboration formed by NIH, the Center for Advancing Innovation (CAI) and Heritage Provider Network, based on the successful framework of the Breast Cancer Startup Challenge (BCSC). The winning teams were selected based on their business plans, financial models and live pitches and will move forward to phase three of the challenge to launch new businesses to commercialize 16 NIH-conceived and developed inventions. These inventions include therapeutics, diagnostics, prognostics and medical devices designed to improve brain health. Three of the NSC inventions are from the National Cancer Institute technology portfolio.

More than 578 students and entrepreneurs in 70 teams competed in the challenge that launched in August 2014. Teams competed in two phases during which they were mentored by experts to produce business plans, financial models and live pitches. In the final phase, the winning teams will be mentored to launch their startups, incorporate their business, apply for licensing and execute development and regulatory requirements. The winning teams are:

Challenge #1: A novel compound for treatment of disorders with cognitive dysfunction for example attention-deficit/hyperactivity disorder
Winner-Tulane University 1A
Finalist-Wake Forest University 1,2A

Challenge #2: A novel therapy for neurodegenerative diseases for example Alzheimer's disease
Winner- Johns Hopkins University 2A

Challenge #3: A method of treating an enzyme deficiency disorders which causes neurodegeneration with small molecule
Winner- California Institute of Technology 3A

Challenge #4: Novel Dopamine D2 Receptor Antagonists and Methods of Their Use
Winner- University of North Carolina at Chapel Hill 4A

Challenge #5: A device to simulate the impact of brain trauma for explosive blast-induced Traumatic Brain Injury (TBI) and early stage TBI diagnosis
Winner- University of Pennsylvania 5A

*Challenge #6: A novel drug delivery method for treatment of brain injury and disease - focusing on Central Nervous System (CNS) disorders, such as stroke, hemorrhage, or TBI
Winner-Northwestern University 6A

*Challenge #7: A novel treatment for vascular disease/injury/inflammation in vasculature such as carotid artery that supplies blood to the brain
Winner-Tulane University 7A

*Challenge #8: A brain cancer specific target that can be used in diagnostics and potentially therapeutic applications
Winner- University of Pennsylvania 8A

Challenge #9: A tumor diagnostic marker for new blood vessels formation that can be used for early detection of brain tumors
Winner-Medical College of Wisconsin 9A
Finalist-Cambridge CCN 9A

Challenge #10: A new compound for treatment of Neurofibromatosis Type 1
Winner-University of Texas at Houston 10A

Challenge #14: A motion correction method to reduce MRI artifacts during brain inspection
Winner-Buckeye SmarterImage 14A

Challenge #15: A novel MRI contrast agent to improve the visibility of internal body structures during MR imaging
Winner- Duke University 15A

Challenge #16: Multiplex Assay for Detection of JC Virus
Winner- Washington University in St. Louis 16A

For more information on the challenge, please see: http://www.neurostartupchallenge.org/ and Neuro Startup Challenge Winners Announced press release.

To learn more about NCI technologies for collaborative development, please see: https://techtransfer.cancer.gov/availabletechnologies.

*Inventions from the NCI invention portfolio.


Technology transfer's important role in discovery-to-commercialization story of FDA-approved immunotherapy to treat rare childhood cancer

April 17, 2015

An immunotherapy drug 20 years in the making called dinutuximab (ch14.18) is providing a newly approved treatment for infants and children with neuroblastoma, a rare cancer. The NCI Technology Transfer Center played an important role in this discovery-to-commercialization story through negotiation of a Cooperative Research Agreement (CRADA). Specifically, ch14.18 was provided for NCI-funded clinical studies through NCI’s Biopharmaceutical Development Program (BDP), and produced under NCI contracts/sub-contracts.  A TTC-negotiated CRADA allowed for transfer of the NCI BDP's evolving drug production process to United Therapeutics Corp., (UTC), a company that would take the product to licensure. The TTC-negotiated CRADA also allowed for NCI and UTC’s cooperative conduct of late-stage clinical trials of Ch14.18 that supported commercial development of Ch14.18 as a treatment in children with high-risk neuroblastoma.

Read more to learn about how ch14.18, now commercially known as Unituxin, received FDA approval. 

Also see: Harnessing the Power of Our Immune Systems to Treat Neuroblastoma: Discovery of Ch14.18 Immunotherapy

Reprinted from the Poster, NCI Frederick. (See http://ncifrederick.cancer.gov/about/theposter/content/fda-approves-immunotherapy-cancer-affects-infants-and-children)

FDA Approves Immunotherapy for a Cancer that Affects Infants and Children

By Frank Blanchard, Staff Writer

The U.S. Food and Drug Administration (FDA) recently approved dinutuximab (ch14.18) as an immunotherapy for neuroblastoma, a rare type of childhood cancer that offers poor prognosis for about half of the children who are affected. The National Cancer Institute’s (NCI) Biopharmaceutical Development Program (BDP) at the Frederick National Laboratory for Cancer Research produced ch14.18 for the NCI-sponsored clinical trials that proved the drug’s effectiveness against the disease.

“It’s pretty cool,” said Doug Gaum, director of Quality Assurance at BDP, which also provided technical and regulatory support in transferring the technology, under an NCI Cooperative Research and Development Agreement, to United Therapeutics Corporation of Silver Spring, Md., and Research Triangle Park, N.C., for commercial production.

Neuroblastoma arises in infants and young children as a tumor of immature cells of the peripheral nervous system. More than 650 cases are diagnosed each year in North America, mostly in children under age 5, and more than one-third of these cases are diagnosed in infants, according to NCI. Half of all patients have a high-risk form of the disease and a poor prognosis. Dinutuximab is designed to benefit these high-risk patients.

Approval Was 25 Years in the Making

It was a long road to clinical approval. The lead scientist and study chair of the clinical trials, Alice Yu, M.D., Ph.D., University of California, San Diego, began pursuing ch14.18 as a cancer treatment about 25 years ago. BDP began producing the antibody for human testing in 1997.

During the Phase III trial in 2009, an interim analysis of results showed that ch14.18, given along with two immune-stimulating agents, was definitively effective. Among the 226 patients (median age 3.8 years) who received the combined therapy, 66 percent were alive and free of neuroblastoma after two years, compared with 46 percent in the control group, who received only the standard therapy.

As a result, the control group began to receive the combined therapy right away, and this became the new standard of treatment for pediatric neuroblastoma. Patients from the United States, Canada, Australia, and New Zealand enrolled in the trial to receive the drug, and BDP manufactured additional supplies to meet the demand. Results of the clinical trial were published in the New England Journal of Medicine in September 2010.

“After decades of pursuits, I am pleased to see that dinutuximab has received FDA approval and may now benefit high-risk neuroblastoma patients,” Yu said in a news release from United Therapeutics Corporation, which will manufacture and market the drug under the brand name UnituxinTM.

“This is not only the first successful immunotherapeutic to target a non-protein antigen, but also to be developed from an Investigational New Drug application through Phase III trials largely through investigator-initiated effort and NCI support,” Yu said.

The FDA approval calls for using Unituxin in combination with two immune-boosting compounds (IL-2 and GM-CSF) and the anticancer drug cis-retinoic acid. Unituxin links to cells of the immune system (natural killer cells and granulocytes) and directs those cells to attack and kill tumor cells.

Several members of BDP have been instrumental in supporting this project over the years. For Beverly Keseling, manager, Cell Culture, it was one of her first assignments when she joined Leidos Biomed, then named SAIC-Frederick, in the 1990s. Steve Giardina, Ph.D., a former employee, worked directly with NCI, the FDA, and Health Canada on issues of patient safety and product characterization. Keseling, Samir Shaban, manager, Manufacture, and their teams managed the bioreactor and purification units that worked extraordinary hours to ensure that the supply of ch14.18 met the demand for the drug during the transitional period prior to FDA approval. Sheryl Ruppel, director, Regulatory Affairs, and her group worked extensively with NCI’s Cancer Therapy Evaluation Program, the FDA, and Health Canada in developing regulatory submissions and ensuring that reviews stayed on track.


Annual Report to the Nation Shows Continuing Declines in Most Cancer Death Rates (L3)

March 31, 2015

The latest Annual Report to the Nation on the Status of Cancer, 1975-2011 (ARN) is now available, and key highlights can be found in cancer.gov. In addition to reporting rates and trends for the most common cancers, this year’s ARN includes a special section on breast cancer by molecular subtype. Breast cancer subtypes have major implications for determining treatment and may hold important clues to the origins of breast cancer.

This is an extraordinary time for the Technology Transfer Center at NCI facilitating interactions and partnerships between researchers, academia and industry to further develop cancer technologies. We believe that our efforts have had a positive impact on these findings. Major findings from this year's report include:

Continuing declines in cancer death rates for both men and women, for children, and for most major cancer sites.
Continuing declines in the combined annual rate of new cases of cancer for men and women.
Trends that require greater evaluation, including increasing rates of thyroid, kidney, liver, oral/oropharyngeal, and cervical cancers.
National data on the incidence of breast cancer subtypes.

The Annual Report to the Nation was published online March 30, 2015, in the Journal of the National Cancer Institute.


Award-Winning Breast Cancer Startup Challenge Inspires Neuro Startup Challenge Launch

November 20, 2014

In July 2014, the Breast Cancer Startup Challenge (BCSC) was selected by Health and Human Services (HHS) Secretary Sylvia Mathews Burwell as one of three "Secretary's Picks" in the  HHS Innovates competition, an HHS-sponsored award program that identifies and recognizes HHS employees for their innovative work. Read the HHS IDEA Lab blog to learn more about the progress of the BCSC and how it enabled the launch of a new challenge, the Neuro Startup Challenge.

 


NCI Researchers Receive National Medal of Technology and Innovation for HPV Vaccine Advances

October 7, 2014

The NCI scientists whose discovery was the basis of the technology transfer to commercially develop HPV vaccines are among the recipients of this year’s National Medal of Technology and Innovation. Douglas R. Lowy, M.D., and John T. Schiller, Ph.D., received their medals at a White House ceremony on Nov. 20, 2014


Hear NCI Scientists Discuss their Discoveries - Featured Videos (L3)

August 21, 2014

Five new videos profiling NCI researchers have been added to the NCI YouTube channel:

These technologies may contain NCI inventions that are available for licensing and/or co-development collaborations. Please contact the NCI Technology Transfer Center for more information.


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