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NCI Scientists Recognized by National Academy of Inventors (NAI) – George Pavlakis and John Schiller Elected to 2016 Fellow Status

December 16, 2016

George N. Pavlakis, M.D., Ph.D., head of NCI’s Vaccine Branch and John T. Schiller, Ph.D., deputy chief of NCI’s Laboratory of Cellular Oncology, were recognized as leaders of academic invention by the National Academy of Inventors (NAI) and were elected to NAI Fellow status in December 2016.  Both Dr. Pavlakis and Dr. Schiller have made significant scientific contributions in their respective fields. Dr. Pavlakis “has authored more than 200 publications and is named as an inventor on more than 50 US and International Patents.” Dr. Schiller, along with NCI’s Douglas Lowy, Ph.D., is known for leading “the initial development and characterization of human papillomavirus (HPV) prophylactic vaccines that ultimately became the commercial vaccines Cervarix and Gardasil.” HPV is the most common sexually transmitted infection in the United States, and a few types can lead to cervical and other cancers. 

The NCI Technology Transfer Center is proud to continue to support the scientific discovery and invention development efforts for Drs. Pavlakis and Schiller, two of NCI’s leading scientists and prolific inventors. Technologies from their invention portfolios that are available for development through collaboration and/or licensing include:

To learn more about these technologies and others invented by Drs. Pavlakis and Schiller available for development through collaboration and/or licensing, please contact: TTC Invention Development and Marketing.

To learn more the NAI Fellowship announcement, see: National Academy of Inventors Announces 2016 Fellows.

NCI Staff Win Federal Laboratory Consortium (FLC) "Excellence in Tech Transfer" Award, Featured in Videos

December 7, 2016

Update: The National Cancer Institute is honored by the Federal Laboratory Consortium's 2016 “Excellence in Technology Transfer” Awards. Awardees discuss their award-winning collaborations in these two new videos: 

NCI – Development of First Immunotherapy to Treat Chordoma, a Rare Cancer

Discovery to Commercialization: A New Immunotherapy for a Rare Childhood Cancer, Neuroblastoma

The National Cancer Institute (NCI) was the recipient of two "Excellence in Technology Transfer" awards at the  Federal Laboratory Consortium (FLC) Annual Meeting in April, 2016. The award “recognizes employees of FLC member laboratories and non-laboratory staff who have accomplished outstanding work in the process of transferring federally developed technology,” explains the FLC. To learn more about why NCI received this recognition as well as the individuals behind them, see below.

AWARD WINNER:

“Development of First Immunotherapy to Treat Chordoma, Rare Bone Cancer”

“Development of First Immunotherapy to Treat Chordoma, a Rare Bone Cancer” was selected for exemplifying excellence in technology transfer process because of the complexity and the dedication of the team involved. To help advance NCI’s discovery of a vaccine capable of inducing a specific, targeted immune response against cancer cells expressing the brachyury protein, NCI formed collaborations with three commercial partners to develop brachyury vaccines. These collaborations led to the rapid translation of investigational therapeutic vaccines with the potential to revolutionize how researchers and physicians treat many cancers. Furthermore, the collaborations led to new intellectual property, licensing activities, and the management of several issued patents and pending patent applications. While NCI’s commitment to collaborate with multiple partners is helping to realize the discovery’s full potential, the resulting, rapid scientific process has required careful management of a complex technology transfer process. To learn more about the outcome from one of the collaborations, see: Vaccine Therapy for Unresectable Chordoma.

WINNERS:
Mojdeh Bahar, J.D., U.S.Department of Agriculture (formerly of the NIH Office of Technology Transfer)
Kevin Brand, J.D., Center for Disease Control and Prevention (formerly of the NCI Technology Transfer Center)
Kevin W. Chang, Ph.D., NCI Technology Transfer Center
Sabarni Chatterjee, Ph.D., NCI Technology Transfer Center
James Gulley, M.D., Ph.D., Genitourinary Malignancies Branch, Center for Cancer Research, NCI
Christopher Heery, M.D., Clinical Trials Group,Laboratory of Tumor Immunology and Biology, Center for Cancer Research, NCI
Claudia Palena, Ph.D., Laboratory of Tumor Immunology and Biology, Center for Cancer Research, NCI
Michael Pollack, Ph.D., NCI Technology Transfer Center
Jeffrey Schlom, Ph.D., Laboratory of Tumor Immunology and Biology, Center for Cancer Research, NCI

Branch Vaccine team picture

Pictured left to right: Mojdeh Bahar (winner), Kevin Brand (winner); Paul Zielinski, FLC Executive Board Chair; Christopher Heery (winner); Claudia Palena (winner); Thomas Stackhouse, Ph.D., NCI; Sabarni Chatterjee (winner); Mark Reeves, FLC Vice Chair; Ana Amar, NIH Agency Representative to the FLC

AWARD WINNER:

“Discovery to Commercialization: New Immunotherapy for Rare Childhood Cancer, Neuroblastoma”

Prior to a groundbreaking discovery by scientists supported by the NCI, fewer than 40 percent of children with high-risk neuroblastoma lived five years after diagnosis. Now an immunotherapy 30 years in the making, ch14.18, UnituxinTM (dinutuximab), is providing new hope for infants and children with this rare cancer. On March 10, 2015, the U.S. Food and Drug Administration approved Unituxin™ (dinutuximab also known as ch14.18) as part of first-line therapy for pediatric patients with high-risk neuroblastoma, a rare cancer that most often occurs in young children. On August 17, 2015, the European Commission (EC) also granted Marketing Authorization for Unituxin. “Discovery to Commercialization: New Immunotherapy for Rare Childhood Cancer, Neuroblastoma” was recognized by the FLC for exemplifying T2 excellence. It was a remarkably productive, collaborative effort between the National Cancer Institute (NCI), the Frederick National Laboratory for Cancer Research (FNLCR), the Children's Oncology Group, and United Therapeutics Corporation (UTC) resulting in commercialization and approval.

To learn more see: https://techtransfer.cancer.gov/aboutttc/successstories/dinutuximabunituxin and FDA Approves First Therapy for High-Risk Neuroblastoma

WINNERS:

Sherry Ansher, Ph.D., Regulatory Affairs Branch, Cancer Therapy Evaluation Program, Division of Cancer Treatment and Diagnosis, NCI
Donna Bialozor, NCI Technology Transfer Center
Jan Casadei, Ph.D., Cancer Therapy Evaluation Program, Division of Cancer Treatment and Diagnosis, NCI
Beverly Keseling, Leidos Biomedical Research, Inc., Frederick National Laboratory for Cancer Research (FNLCR)
Karen Muszynski, Ph.D., Biological Resources Branch, Developmental Therapeutics Program, Division of Cancer Treatment and Diagnosis, NCI
Samir Shaban, M.S., Leidos Biomedical Research, Inc. Frederick National Laboratory for Cancer Research
Malcolm Smith, M.D., Ph.D., Clinical Investigations Branch, Cancer Therapy Evaluation Program, Division of Cancer Treatment and Diagnosis, NCI
L. Mary Smith, Ph.D., United Therapeutics Corp.
Alice Yu, M.D., Ph.D., University of California in San Diego Medical Center

Unituxin team picture

Pictured from left to right: Malcom Smith (winner); L. Mary Smith (winner); Paul Zielinski, FLC Executive Board Chair; Donna Bialozor (winner), Alice Yu (winner); Tom Stackhouse (NCI Associate Director); Beverly Keseling (winner); Karen Muszynski (winner); Mark Reeves, FLC Vice Chair; Ana Amar, NIH Agency Representative to the FLC; Samir Shaban (winner)

NCI Technology Transfer Center Receives Director’s Award

November 3, 2016

The National Cancer Institute’s Technology Transfer Center (TTC) received a Group Award for “The Establishment of a Patenting and Licensing Program at the National Cancer Institute.”  The award was presented to Karen Maurey, Director of the NCI Technology Transfer Center, at the NCI Director’s Awards Ceremony on October 20th, 2016 on the NIH Campus in Bethesda, MD. 

The citation merits special honor since patenting and licensing of inventions is a primary mechanism to translate NIH discoveries into health care products in support the NIH.  For over 25 years, the NIH Office of Technology Transfer has conducted patenting and licensing for NIH and its Institutes and Centers.  On October 1, 2015, these patenting and licensing functions were decentralized into nine offices embedded in the NIH Institutes, including NCI’s TTC.  The staff of TTC are commended for their extraordinary achievements in successfully launching the first patenting and licensing program at the National Cancer Institute.

Specifically, the NCI TTC assumed responsibility for 5,883 active patents and patent applications and 120 open license negotiations on behalf of NCI and nine Client Institutes within TTC’s service center (serving NCCIH, NEI, NIA, NICHD, NIDA, NIMHD, NIHCC, NIHCIT, and NLM).  Combined, this constitutes the largest of the decentralized docket, comprising 55% of the total NIH program.  Transitioning operations for this complex portfolio – while concurrently meeting statutory deadlines and maintaining agreement negotiations – required sustained and exceptional performance and teamwork.  TTC’s administrative staff and contractors worked together to implement critical operational components for the expanded functions.  

Within the first six months of the re-organization, NCI’s patenting and licensing program achieved exceptional milestones, including:

  • ~700 new task orders initiated for patent related work;
  • completed over 1,000 new technology transfer agreements including 56 new licenses;
  • developed and implemented a more efficient process for review of new inventions and for patent applications reaching review milestones that integrates information from Licensing and Patenting Managers, Technology Transfer Specialists, contract law firms, marketing and NCI’s Technology Review Group; and
  • established a new Invention Development and Marketing Unit to provide resources and specialized expertise in opportunity analysis that helps to produce more informed patenting decisions and costs.  This new Unit will also increase the visibility of NCI’s inventions for partnering through digital marketing, the Startup Challenges program, the Invention Development Program.

Winners Announced - National Cancer Institute and Center for Advancing Innovation Launch Nanotechnology Startup Challenge in Cancer (NSC2)

July 31, 2016

Update July 2016: Winners of Nanotechnology Startup Challenge in Cancer Announced

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The National Cancer Institute has partnered with the Center for Advancing Innovation (CAI) to launch the Nanotechnology Startup Challenge in Cancer or NSC2. The Challenge is centered on commercially viable, nanotechnology cancer-related inventions conceived by the NCI. Once accepted into the Challenge, international teams will compete by selecting one of these intramural inventions, and creating a business plan to launch a startup. Alternatively, teams may also elect to bring other commercially viable, nanotechnology cancer-related inventions into the challenge that are not from NCI. The primary goal of the Challenge is to stimulate the creation of start-up businesses to advance development and commercialization of these nanotechnology inventions. NSC2 started accepting entries on October 12, 2015 and will continue to accept them until March 14, 2016. Those teams will then move into the second phase of the challenge and work to create and present their business plans and pitch to a panel of judges spanning industry, venture capital, serial entrepreneurship, government and more . To learn more about NSC2, the inventions, and how to enter, visit http://www.NSCsquared.org.

NSC2 is the third NIH Startup Challenge and is based upon the award-winning model created by the Breast Cancer Startup Challenge, followed by the Neuro Startup Challenge (see Challenge.gov Celebrates Five Years of Open Innovation).

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.

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