As of September 2014, if you walk into a CVS, Walgreen, or RiteAid, you will likely find SpermCheck, an at-home test for men that indicates whether an individual should schedule an appointment with his doctor to talk about his fertility. This tremendous step forward in family planning is thanks to the cell and molecular biology research of Dr. John Herr, a Professor of Cell Biology, Urology and BioMedical Engineering at U.Va. Besides founding the Lymphocyte Culture Center and the Center for Research in Contraceptive and Reproductive Health, Herr holds 26 patents, he and his team have named over 30 genes in the human genome, and he has founded three Charlottesville biotechnology companies: Humagen, ContraVac, and most recently Neoantigenics. This latest effort promises a breakthrough in cancer diagnosis and treatment.
What is SpermCheck?
SpermCheck is a simple, at-home male fertility test. Somewhere in the world, each week now, 1,850 people buy and use a SpermCheck product. That means more than 90,000 couples are using SpermCheck as part of their family planning program now each year. Patients do the test in the privacy of the home and seek professional help if the test is negative. I receive feedback from infertility specialists who have patients come to their practices having used a SpermCheck test at home, had a negative result, and next seek professional help.
What was the inspiration for Spermcheck?
SpermCheck grew out of a basic science-clinical collaboration between one of U.Va.’s lead experts in male infertility, urologist Dr. Stewart Howards, Dr. Charles Flickinger, and me. The three of us were studying basic and clinical aspects of reproductive immunology. In the late 1980s, Dr. Howards pointed out the need for a way to detect sperm at home. Chance favors the prepared mind. Alerted to this idea, when my lab began sifting through human genes in the late 1980s for signature molecules that were found only in sperm and not in any other cell in the adult body, we were ready to envision the application for these biomarkers in sperm quantification. When a signature biomarker molecule was identified (SP10 protein), the team began to conduct proof-of-concept experiments and to file patent applications on the results, laying a foundation for future commercialization.
What was the biggest setback?
The biggest setback concerned marketing. Even after FDA approvals of the SpermCheck products, it was unclear if the products would be successful in the marketplace. The company [ContraVac] had given marketing rights to SpermCheck Fertility to a marketing company. This company[JCH1] did not execute successfully on market introduction and marketing rights to SpermCheck had to be returned. This process lost two years of valuable time. It required more capital to be raised and restructuring of the company.
When did you begin to suspect this could be a success?
Management always believed in SpermCheck and that a market was there. But SpermCheck was a first-in-category product, and pharmacies were reluctant to stock the product. Walgreens was the first big pharmacy to stock it. Their success has led others to follow. It has only become clear in the last 18 months or so that there is a strong and sustainable market. CVS rolls out SpermCheck on its family planning shelves this month, September 2014.
Have you founded other businesses or initiatives?
I founded Neoantigenics, a cancer focused company. Like SpermCheck, Neoantigenics is founded on the discovery of a unique signature protein found only in eggs and cancer cells. Neoantigenics has a breakthrough therapeutic approach that permits killing of cancer cells while limiting unwanted side effects on normal healthy cells. A leading pharmaceutical company is a seed investor in Neoantigenics. Neoantigenics is seeking additional seed capital to develop its new drug entity: an antibody-drug conjugate that targets a surface protein found in cancers originating in many organs including breast, lung, pancreatic, ovary, uterus, and kidney.
How do you define Founding?
Founding begins with conception of a novel and useful purpose; progresses to embodiment of this purpose in a new venture and, most importantly, must be supported by deliberate, disciplined action to insure its success.
What brought you to Charlottesville, and what keeps you here?
I was hired in 1981 at U.Va. in the Anatomy department. I had three assignments in my offer letter: to found the University of Virginia Lymphocyte Culture Center; to teach gross anatomy; and to conduct basic research. I undertook to fulfill all three assignments. There have been several supportive administrators at U.Va. and at the State level who were open to my ideas. Chairman of Anatomy and Cell Biology Charles Flickinger was the main reason I stayed. He was a terrific collaborator. And he was open to my ideas for translational research. U.Va. Patent Foundation Directors Bob MacWright and Michael Straightiff were supportive. Leonard Sandridge was encouraging. There were many faculty with basic interests who encouraged me to grow. Dr. Tom Parsons encouraged me to embrace molecular biology. Dr. Don Hunt’s discoveries in protein mass spectrometry encouraged me to use proteomics as a major discovery tool. At the state level, Governor Charles Robb, Economic Development Officer David O’Donnel, Nancy Verona at CIT, and Mike Grisham at VBHRC are just a few names of helpful supporters. Most importantly, U.Va.’s policies on support of faculty patenting and its willingness to give preference in licensing to faculty startups has been a key element.
My team is opening a new field of cancer research called cancer-oocyte neoantigens and developing a pathbreaking cancer therapeutic and companion diagnostic. We have arrived at a fundamental new insight into the nature of cancer derangement. This is the discovery that many cancers, when they go awry, begin to express proteins found only in growing eggs in the ovary. In effect cancer cells revert back to the “mother cell”. This insight is providing new targets for cancer drugs that selectively act on tumors. We are developing a first-in-class antibody-drug conjugate directed to a tumor cell surface protein antigen named SAS1B.