Inherent Biosciences awarded NIH SBIR Phase I Grant to commercialize innovative diagnosis of non-obstructive azoospermia (the most severe form of sperm dysfunction)
April 14, 2022
Salt Lake City, Utah (Newswire.com) — Inherent Biosciences, a biotechnology company pioneering epigenetic medicine, today announced an award from the National Institute of Child Health and Human Development’s (NICHD) Fertility and Infertility Branch to develop a clinical assay for improved diagnosis of non-obstructive azoospermia (NOA). NOA is present in 10-15% of infertile men where no sperm are present in the ejaculate due to failure of sperm production (spermatogenesis). Thus, this Small Business Innovation Research (SBIR) project focuses on an intractable clinical problem for specialists in reproductive medicine seeking to treat severe male factor infertility due to NOA. Importantly, there is increasing evidence to show that certain causes of male infertility may be associated with an increased risk of serious health conditions.
“The causes of NOA are not fully understood. A semen analysis will reveal the absence of spermatozoa in an ejaculate, yet for most men with NOA, the cause of their spermatogenic failure is ‘idiopathic’ or an unknown cause,” said Dolores Lamb, Ph.D., professor of molecular biology in urology at Weill Cornell Medicine, collaborator on the project and a highly recognized NIH-funded researcher, whose areas of investigation focus on the genetics of human male infertility.
Kristin Brogaard, Ph.D., Co-founder and CSO of the company, and Principal Investigator for the project added: “Dr. Lamb’s laboratory discovered a novel epigenetic cause for about 18% of men with NOA making it a fairly prevalent cause of NOA. The results of Dr. Lamb’s translational research findings provide the basis for this newly funded-SBIR project to develop a clinical epigenetic diagnostic test, ultimately with the goal of becoming standard-of-care for NOA patients.”
Spermatogenic deficiency can be associated with a variety of health conditions including cancer, cardiovascular disease, diabetes mellitus, and immune disorders. Indeed, studies of men with NOA show that these men have a 2.9-fold increased risk of cancer. It is believed that there are common causal factors for infertility and cancer development, such as deficient homologous recombination mechanisms. For example, men with an epigenetic diagnosis of the cause of their NOA may benefit from increased screening for cancer, resulting in earlier diagnosis and treatment.
“Innovation in male reproductive health diagnosis has been lacking and looking for sperm with a microscope is necessary, but no longer sufficient to diagnose a cause of spermatogenic failure,” said Andy Olson, Co-founder and CEO. “We’re committed to raising the standard of care to include epigenetic assays that improve both clinical and health economic outcomes.”
About Inherent Biosciences
Inherent Biosciences, Inc. is a biotechnology company pioneering epigenetic medicine for complex diseases. Gene dysregulation, a hallmark of complex disease, has been difficult to detect and treat, until now. The company’s epigenetic platform detects dysregulation across multiple genes and related pathways to pioneer a new category of diagnostics and therapeutics that leverage epigenetics, biology’s inherent mechanism for gene regulation, to radically transform how we diagnose and treat complex diseases like infertility.