Pelotonia funds have also supported four major statewide initiatives, including two that are well underway, one that is just beginning and one that is complete. Here’s a look at the PIIO and the four statewide initiatives:
Pelotonia Institute for Immuno-Oncology (PIIO)
Since it was established in July 2019 with the support of a five-year, $102,265,000 pledge from Pelotonia, the PIIO — a bench-to-bedside research initiative focused on harnessing the body’s immune system to fight cancer at all levels — has developed a strategic plan and recruited several staff members and scientists with expertise ranging from development of cancer vaccines to bioinformatic and statistical modeling for high-throughput immunogenomic screening. These scientists brought the total number of researchers working on immuno-oncology approaches to clinical trials at the OSUCCC – James in 2020 to over 60.
Moreover, PIIO members in 2020 had obtained $16 million in annual funding from new grants (including $13 million from the NIH), published more than 265 peer-reviewed articles, launched some 20 clinical trials, added 10 technologies to the institute’s Immune Monitoring and Discovery Platform (IMDP), and entered research agreements with corporations such as Alphamab Oncology, Heat Biologics, Genentech and others. In addition, the PIIO initiated a cancer immunotherapy cohort database that will help scientists determine risk factors associated with efficacy and adverse drug events related to cancer immunotherapies.
“We are passionate, curious and driven in our pursuit of unleashing the potential of immunotherapy in cancer care,” says PIIO director Zihai Li, MD, PhD. “We have a strong framework and enhanced research capabilities that position our team to make big strides in the coming years. Now it is time to do the next phase of fundamental and translational work.”
That work includes plans to open up to 130 immuno-oncology clinical trials over the next five years and to create a pipeline of novel cancer immunotherapeutics, many of them driven by Ohio State discoveries that will be tested at patient bedsides. To guide PIIO research efforts, the institute has organized into four interconnected centers of excellence: Cancer Immuno-Genomics, Cell Therapy, Systems Immuno-Oncology and Translational Immuno-Oncology.
Ohio Colorectal Cancer Prevention Initiative (OCCPI)
A five-year statewide initiative to screen newly diagnosed colorectal cancer (CRC) patients and their biological relatives for Lynch syndrome (LS) has been completed, but researchers were still analyzing data and publishing overall results.
Funded over five years by $4.3 million from Pelotonia, the Ohio Colorectal Cancer Prevention Initiative (OCCPI) established a network of 50 community hospitals around the state to accommodate screenings for LS, an inherited genetic condition that predisposes to colorectal, endometrial, ovarian, stomach and other cancers. The LS screenings identify patients and family members who may be at risk for these cancers so they can take precautionary measures, such as heightened surveillance (e.g., colonoscopies) for early detection.
“While we are closed to enrollment, and all of the screening is done, we are still analyzing and publishing data from this study,” says OCCPI director Heather Hampel, MS, LGC, associate director of the Division of Human Genetics at Ohio State. Hampel says the study enrolled over 3,300 newly diagnosed CRC patients, of whom 143 tested positive for LS. She says 204 of their relatives also tested positive, and another 101 CRC patients were found to have a hereditary cancer syndrome other than LS.
“Our study findings demonstrate the value of screening early-onset CRC patients for LS,” Hampel says, noting that her team is working to help launch this screening approach nationally.
Beating Lung Cancer in Ohio (BLC-IO)
Researchers are relying on the same network of Ohio community hospitals that was established for the OCCPI for recruiting patients in a statewide clinical research initiative that takes aim at lung cancer, the No. 1 cancer killer among men and women in the United States.
Supported by $3 million from Pelotonia, the Beating Lung Cancer – In Ohio (BLC-IO) initiative is led by Peter Shields, MD, deputy director of the OSUCCC; David Carbone, MD, PhD, director of the Thoracic Oncology Program at the OSUCCC – James; Mary Ellen Wewers, RN, PhD, MPH, member of the Cancer Control Program at the OSUCCC – James; and Barbara Andersen, PhD, also in the Cancer Control Program.
BLC-IO has two aims: to assess the impact of advanced gene testing and to provide expert advice to help each patient’s treating physician determine the best therapy for stage IV lung cancer patients in hopes of prolonging survival; and to improve smoking-cessation rates among smokers with lung cancer and their family members (determine the impact of centralized telephone counseling and provider support on cessation).
Project leaders anticipate more than 2,000 newly diagnosed patients with stage IV non-small cell lung cancer will enroll in BLC-IO via the community hospital network. Enrollees receive free testing for more than 300 genes in their cancer specimens, and physicians who treat them receive expert support for interpreting test results and determining treatments. BLC-IO also provides smoking-cessation support for up to three years to all participating patients and family members.
Ohio Prevention and Treatment of Endometrial Cancer (OPTEC)
Supported by $1.5 million in Pelotonia funds, OPTEC aims to recruit up to 1,000 women with endometrial (uterine) cancer from partner hospitals across the state and screen them for Lynch syndrome (LS) and other inherited genetic conditions linked to greater risk of endometrial, colorectal, stomach and ovarian cancers.
Their tumor samples undergo molecular profiling to identify targeted treatments personalized to each patient’s tumor characteristics. Patients with LS and their at-risk family members will be educated about the importance of genetic testing and cancer-prevention strategies based on their increased risk for LS-associated cancers. Women whose tumors have defective DNA mismatch repair will be considered for immunotherapy clinical trials for endometrial cancer.
OPTEC is led by David E. Cohn, MD, MBA, chief medical officer at the OSUCCC – James, and Paul Goodfellow, PhD, of the Molecular Carcinogenesis and Chemoprevention Program, and is assisted by multiple collaborators from Ohio State (e.g., Casey Cosgrove, MD, lead oncologist and member of the Translational Therapeutics Program) and from Nationwide Children’s Hospital (NCH) Research Institute. OPTEC will conduct its LS screening with a one-step genetic sequencing technique developed by Elaine Mardis, PhD, a geneticist at the NCH Research Institute and also a member of the Translational Therapeutics Program. Genetic profiling will help identify patients who are most likely to benefit from new therapies, including immunotherapy drugs that target certain proteins.
OPTEC also is supported by a five-year grant awarded by the National Cancer Institute in 2018 to principal investigators Goodfellow, Mardis and Heather Hampel, MS, LGC, to study “Combined NGS Tumor-Based Detection of Germline Lynch Syndrome Mutations and Prognostic Classification of Endometrial Cancers.” This grant extends research supported by Pelotonia and supports the study of additional tumors from women with endometrial cancer.
Turning the PAGE on Breast Cancer in Ohio
The newest statewide initiative supported by Pelotonia is Turning the PAGE on Breast Cancer in Ohio (Population-Level Precision Prevention Strategies for Preventing Aggressive Breast Cancer). Co-led by Electra Paskett, PhD, MSPH, associate director for population sciences and community outreach at the OSUCCC – James, and Heather Hampel, MS, LGC, this project will use a multi-level approach in 12 Ohio counties to provide breast cancer education and facilitate access to risk assessment, genetic counseling and testing, appropriate screening/surveillance, follow-up for abnormal tests, and prompt and proper treatment for African American women who are at greater risk of breast cancer mortality.
Collaborators with the OSUCCC – James include the Ohio Association of Community Health Centers, Susan G. Komen and the North Central Region American Cancer Society. Participating counties will include Franklin, Fairfield, Clark, Butler, Hamilton, Lake, Cuyahoga, Lorain, Trumbull, Summit, Stark and Mahoning. Several strategies (e.g., Facebook ads, referrals from providers or community organizations) will be used to direct interested women to a website where they can place information about themselves, after which their risk for breast cancer will be assessed and they will receive a personal prescription for breast health.
Paskett says this study will use geographic predictors (county) of aggressive disease to identify and target women who live in high-risk counties, train providers at Federally Qualified Health Centers (FQHCs) to facilitate breast health strategies and deliver personalized breast cancer prevention strategies to women based on their risk stratification, and help women adhere to these strategies via telephone patient navigation.
“We will determine whether there were significant increases in the percentage of women who are up-to-date with risk-appropriate breast cancer screening in the 12 counties, the number of referrals to genetic counseling/genetic testing within the FQHCs, any change in breast-health knowledge among FQHC providers, and the number of community organizations involved in breast health, community events and policy efforts,” Paskett says.