Glyciome LLC, a biotech startup developing microbiome-based genital health products, has moved a major portion of its federally funded clinical trials away from Harvard Medical School and into the Inland Northwest — a shift its founder and CEO, Joanna Ellington, says was made possible through partnerships and help from the Health Sciences & Services Authority of Spokane County. 

The move positions Spokane to play a central role in testing PreBioGyn, a novel personal lubricant designed to support the genital microbiome and reduce cervical cancer risk and vaginal infection risks, especially for people in low-resource settings and with poor access to health care. Backed by $3.4 million in grants to date, including $2.3 million from the National Cancer Institute, Spokane-based Glyciome is partnering with the University of Washington School of Medicine, Providence Sacred Heart Medical Center, and the Spokane Teaching Health Center to run part of its randomized controlled trial.

Clinical trials are expected to start in 2026 in Spokane in addition to Puerto Rico, a region that Ellington says has some of the highest cervical cancer rates in the world.

Ellington, 66, says that one of the goals of PreBioGyn is to become the first safe lubricant for use during pregnancy, as pregnancy can be a high-risk time for bacterial vaginosis, resulting in preterm labor and cancerous changes to the cervix. Currently, there are no personal lubricants on the market that are legally allowed to be claimed as safe for use during pregnancy, she says.

According to the National Institutes of Health, cervical cancer is the fourth most frequent female cancer worldwide, and the U.S. is experiencing a dramatic rise in death rates among specific demographics, despite decades of decline due to screening and prevention.

“Our team’s expertise in reproductive physiology will expedite this process,” Ellington says. “Our plan is to launch PreBioGyn with sequentially expanding claims as continued studies and discussions with the (Food and Drug Administration) allow.”

Ellington’s path to women’s health began decades before Glyciome was established. Trained as a veterinarian, she became a reproductive physiologist at Cornell University, where she earned her Ph.D. and helped pioneer early computer-assisted sperm analysis and culture media for embryo transfer. Later, she formed Bio-OriGyn LLC, which developed Pre-Seed, the first sperm-safe fertility lubricant, prompting the FDA to create a new medical device category. She later sold Bio-OriGyn to an international company; the product continues to be an international best seller, Ellington says.

A portion of Glyciome’s research continues at Harvard through its long-standing collaboration with Raina Fichorova, a professor and leading reproductive immunologist at Harvard Medical School and Brigham & Women’s Hospital, in Boston. Fichorova was the first to identify how conventional lubricants and spermicides damage genital tissues and increase HIV and sexually transmitted diseases. This discovery is foundational to Glyciome’s technology, Ellington says. Fichorova’s lab will provide a third-party evaluation to determine whether PreBioGyn reduces inflammation and supports healthy vaginal cells compared with commercial lubricants.

HSSA has played a critical role in Glyciome’s growth and survival, Ellington says. In 2023, Glyciome completed a National Cancer Institute Phase I feasibility study. The following year, HSSA awarded Glyciome a $455,000 matching grant based on its Phase I work. 

The company was set to receive its Phase II grant award in the first quarter of this year; however, on Jan. 22, President Trump issued an executive order freezing new grant approvals and specific grant reviews from the National Institutes of Health. Glyciome used its HSSA grant to “keep the lights on,” Ellington says, but also to develop the partnerships in Spokane that would allow the company to bring its clinical trials to the region, scale its manufacturing capabilities, and complete the required studies for PreBioGyn's FDA review, she says.

“Spokane’s willingness to collaborate has been critical to our success,” Ellington says.  

Erin Williams Hueter, HSSA executive director, says moving part of the company’s clinical trials to Spokane is an impressive and unheard-of feat to celebrate. Additionally, Glyciome’s work aligns perfectly with HSSA’s mission of creating health outcomes and stimulating Spokane’s economy.

“It’s not always easy to get clinical trials in Spokane as regional health systems are overwhelmed,” she says. “Joanna is a person deeply committed to the mission of her work and justice, and lives it.”

Hueter notes that Glyciome’s Spokane partnerships go beyond working with the entities directly involved with the clinical trials. Ellington has collaborated with Spokane-based Sonderen Packaging Inc. to improve how its products are wrapped and disposed of. Glyciome has also worked with Clark Kogan, a statistical scientist and owner of Spokane-based StatsCraft LLC, on the company’s statistical design and analysis.

Glyciome is located in a 1,500-square-foot space at Evergreen Bioscience Innovation Cluster's headquarters and business incubator at 10220 N. Nevada, in North Spokane. The company was co-founded in 2017 by Ellington and her husband, Dennis Clifton, chief operating officer and a former Washington State University interim dean of pharmacy and department chair, and her son, Rayne Ellington-Lawrence.

Ellington says Glyciome’s formation was impacted by her knowledge of the genital microbiome and how it's shared between partners and passed on to their babies, and the continued high sales of vaginal douches in the U.S. despite knowledge that genital douches increase sexually transmitted disease infection rates and genital cancer development. 

Ellington also worked on a project with a high school student that looked at the skin pH following the use of wet wipes for people from farm families on the Palouse. In medical literature, the skin pH of people is typically between 5.5 to 7, making it neutral. However, the data from farmers on the Palouse consistently came back much lower. Ellington was then able to unearth papers that also found a low skin pH in indigenous communities, which suggested their low pH was due to a more neutral ecosystem exposure and less use of products that were stripping away the acidic coating of our skin, she says.

The discovery led Glyciome to develop a prebiotic technology cleanser that avoids common rashes from most cleansers and wet wipes. Under the name of Wouche Away, now Wild & Pure, the product won the 2021 Idaho Innovation Awards' Consumer Product of the Year.

“Using a personal lubricant that optimizes a healthy genital microbiome is pointless if cleansers are used that just turn around and disrupt the ecosystem day after day,” Ellington says. “Although consumer awareness of ‘proper pH’ for vaginal care products has increased, this is only a small part of what can be harmful with genital products. Ingredients, packaging, and physical properties are also critical, and what we have improved on with this product line.”

The company now has 11 patents, issued and pending, for its technology that supports healthy urogenital and skin bacteria, and reduces the burning and irritation many users notice when using existing personal care products, Ellington says.

The Wild & Pure products are sold online and at the Small Biz Shoppe at Riverpark Square. Ellington says she plans to expand to additional retail locations in 2026.