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UMB’s Seed Grant Program Addresses Critical Gap in Funding from Translational Research Towards Commercialization

Monday, July 9, 2018

Academic medical research often paves the way to discovery of the next generation of therapies and medical devices. Translating this vast potential of research discoveries into commercially relevant applications is often limited by a lack of funding for certain intermediate stages of development. There are a number of groups and programs that have tried to address this ‘translational funding gap.’ At the University of Maryland, Baltimore (UMB), the “UM Ventures Seed Grant Program” was designed as one solution.

The UM Ventures Office of Technology Transfer (OTT) at UMB leads and manages the fund for the program, which was set up in 2014. In the past four years, 50+ grants were awarded to UMB inventors to enable them to complete critical work such as building prototypes of new medical devices and gathering proof-of-concept experimental data on new therapies.

“One of the greatest hurdles for a biotech or medical device researcher is obtaining the early-stage funding necessary to help make the leap from promising translational research to a serious commercialization project,” says Phil Robilotto, Chief Commercialization Officer with OTT. “Our Seed Grant Program is playing an important role in jumpstarting inventors who are on the forefront of medical technology innovation.”

The most recent award grantees show promise in a few intractable areas of healthcare: safer and more effective radiology treatment for cancer patients, early-stage lung cancer diagnosis and a much-needed therapy for Duchenne Muscular Dystrophy (DMD).

Following is a window into some success stories that began with UM Ventures Seed Grants. If you are a UMB inventor with an invention disclosure and a commercially promising program, contact the OTT at [email protected] to learn about additional funding opportunities.

Project: Diagnostic test for early-stage lung cancer

Principal

  • Feng Jiang, MD, PhD, Professor of Pathology, UMB School of Medicine

Healthcare Challenge: Physicians currently have limited ways to screen for early-stage lung cancer, when patients would have the most treatment options. If lung cancer is diagnosed in the later stages, it may be too late to effectively cure the patient. For high-risk Medicare patients, the Low Dose Computed Tomography (LDCT) scan is an approved, reimbursable procedure; however its utility is limited by its low specificity. The LDCT highlights nodules in the lung that indicate cancer risk. Depending on the location of the nodule, biopsies may be possible, yet this invasive technique can do more harm than good. LDCT scans, while more effective than chest x-rays for detecting cancer, still have gaps and may be reserved for high risk patients, such as heavy smokers aged 55 and older. This reality makes it difficult to detect lung cancer early enough for effective treatment in the broader population.

Goal: Dr. Jiang developed a diagnostic test and prediction model based on the measurement of RNA biomarkers found in blood or sputum samples. Detecting cancer from a “liquid biopsy” (e.g., blood sample) is a groundbreaking concept in healthcare. If the technology succeeds in the marketplace, it may serve as a companion test to the LDCT, delivering a more accurate assessment of cancer risk and the need for further testing. The prediction model has been validated in hundreds of patient samples to date, and demonstrates high sensitivity and specificity. Dr. Jiang’s recent research has been published in two clinical journals.

Next Steps:  Following his seed grant-funded project, Dr. Jiang was able to qualify for additional state funding.  He’s currently collaborating with staff at theUniversity of Maryland Medical Center’s Molecular Diagnostics Laboratory to translate the test into a clinically-approved format ready for screening patient samples. Ultimately, the goal of OTT and Dr. Jiang is to attract a licensing partner and commercialize this new lung cancer diagnostic test for the benefit of many patients.

Project: Proton Therapy Modulator for more precise, safe cancer treatment

Principals

  • Ulrich Langner, PhD, Assistant Professor, Department of Radiation Oncology, UMB School of Medicine
  • Byong Yong Yi, PhD, Professor, Department of Radiation Oncology, UMB School of Medicine
  • Warren D’Souza, PhD, MBA, Professor and Chief of Medical Physics, Department of Radiation Oncology, UMB School of Medicine

Healthcare Challenge: Proton radiation therapy is currently the most advanced approach to radiation treatment, specifically for inoperable tumors, pediatric cancers, or other conditions for which traditional x-ray radiation cannot be used.  This treatment approach, a type of external beam radiotherapy, allows for higher radiation doses to be delivered to the tumor with greater precision while minimizing exposure to healthy tissues and surrounding organs. The Maryland Proton Treatment Center is one of 27 proton treatment centers currently in the United States, with more than 20 new facilities of this type under construction. As this form of radiotherapy is more widely prescribed, new treatment planning techniques and devices are being developed to advance upon the unique benefits of proton therapy to achieve a more targeted, effective, and personalized treatment plan as well as reduce treatment time for patients.

Goal: The UMB research team has developed a prototype device that can modulate the energy of the proton beam. The modulator allows for multiple angles of proton beam delivery, with the ability to refine the energy levels as needed to improve the accuracy and efficacy of the treatment dose. The increased number of treatment angles allows for lower regional doses of radiation and potentially a shorter treatment time. This is safer for the patient and may result in reduced side effects. Through the help of the seed grant, the team was able to develop a prototype device and show early technical success of the modulator across various cancer types. The team also published a scientific manuscript with the results and presented the prototype data at a technical conference.

Next Steps:  The principal investigators plan to continue their research with the UM Ventures Seed Grant-funded device, to include collecting additional supportive clinical data in a range of cancer types as well as pursue benchmarking efforts to comprehensively compare the advantages over current clinical practices. The research will also focus on integrating and testing the expanded therapy options this device provides with current radiation treatment planning software to gain further insight on clinical implementation and impact.

Project: Novel therapies for Duchenne Muscular Dystrophy

Principals:

  • Joseph P. Y. Kao, PhD, Professor and Associate Director, Center for Biomedical Engineering & Technology and Dept. of Physiology, Univ. of Maryland School of Medicine
  • Christopher W. Ward, PhD, Associate Professor, School of Nursing and School of Medicine
  • Ramzi J. Khairallah, PhD, Co-Founder, President Myologica, LLC 

Healthcare Challenge: Duchenne Muscular Dystrophy (DMD) is a debilitating neuromuscular disease affecting approximately 1 in 3500 male births worldwide. Those afflicted have progressive muscle degeneration and weakness, due to a lack of dystrophin. There is no cure for DMD and just one FDA-approved treatment to help alleviate symptoms: Eteplirsen. However, this therapy works in only 13% of DMD cases. This leaves a large unmet need for helping the remaining 87% of patients.

Goal: The team has identified a novel therapeutic strategy to slow the progression and reduce the severity of DMD. This strategy involves using pro-drugs of colchicine, a regulator of microtubule polymerization, to target the microtubule network of muscle cells which becomes dysregulated early in the progression of the disease. While colchicine is used as a drug to treat Gout and familial Mediterranean fever (FMF) its pharmacokinetic profile is not ideal for conditions that require chronic treatment such as DMD. The team has developed colchicine pro-drugs with improved bioavailability, increased drug half-life, and decreased secondary effects on the GI tract, properties that are ideal for chronically used drug candidates. The team’s seed grant from UMV enabled initial testing of the new colchicine pro-drugs resulting in sufficient data to apply for a NIH Small Business Innovation Research (SBIR) grant. The application was successful, and now the team is working diligently on testing these new pro-drug colchicine formulations in clinically relevant models of DMD. Pro drugs are pharmacologically inactive medications that are metabolized into an active form within the body and which can improve how a medicine is absorbed and distributed.

Next Steps: The team plans to apply for a phase II SBIR grant, which if awarded, will provide funding for pre-clinical studies that can be included in an Investigational New Drug (IND) application to the U.S. Food and Drug Administration.

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