With the costs of developing a new drug or device now running into the hundreds of millions of dollars, developers are constantly looking to embrace concepts that shorten the timelines, reduce risk, conserve resources, and save money for both preclinical research and clinical trials. In a notable example, Regeneron has created a genetically altered mouse that has been bioengineered with human traits so that it responds like a human being would when used in preclinical drug testing.

One young company that is already making its mark in condensing the discovery process and derisking the translational and clinical steps is Glauconix, whose patented 3D human (cadaver) tissue models can accurately measure the effects of drugs and devices on intraocular pressure (IOP) and glaucomatous pathology at an early in vitro stage of the drug discovery and development process. The company has already seen its services used by such major companies as Aerie Pharmaceuticals, Shire, and Nicox, and it has been able to help translate not only into the clinic but also into a commercial product.

“Our data have shown correlation with the data produced in clinical trials,” says Kimberly Southern, Glauconix CEO. “Our clients get data rapidly (within 8 to 12 weeks), and it helps them make a ‘go or no go’ decision on compound selection for clinical trials, as well as potentially patient selection and entry criteria.”

Companies can use the data Glauconix compiles for such development goals as identifying IOP-lowering ability, mechanism of action, dose/response, efficacy, safety/toxicity, and more.

Glauconix was started in 2014 by Karen Torrejon, who was then a PhD candidate in nanotechnology at SUNY (Albany), and Feryan Ahmed, PhD, who had many years of experience in leading drug discovery projects at Albany Molecular Research.

Dr. Torrejon invented the Glauconix platform technology along with the SUNY Research Foundation in response to what she saw as an unmet need in drug discovery and development and in hopes of bringing more effective therapies to patients. She worked in drug discovery for 3 years prior to launching Glauconix. Dr. Torrejon has been recognized by MIT Technology Review as an “Innovator under 35” and by the Albany Business Review in its “40 under 40” list of regional entrepreneurs. She has received more than 20 scientific and technical awards, as well as authored many peer-reviewed articles.

Processing the Tissue

Glauconix obtains donor tissue from many sources and, according to the needs of the client, can specify factors such as age or ethnicity in the tissue that is to be tested.

“We first culture the human cells and then seed those cells onto a porous scaffold,” says Southern. The result is a 3D trabecular meshwork tissue that physically replicates the conventional outflow/trabecular meshwork filter-like structure within the human body.

“We begin with healthy trabecular meshwork tissue and are then able to disease the tissue into a fibrotic glaucomatous state using steroids or various growth factors.”

When running the tests to determine the effect of any new drug or device on IOP, Glauconix will use multiple different samples of donor tissue to ensure that the results accurately reflect an appropriate sample size.

Plans to Expand Services

Although still an early stage company, Glauconix was profitable in 2019. The company had early funding from a $600,000 seed investment from the Eastern NY Angels, $100,000 in the NY Business Plan Competition, and $975,000 in phase 1 and phase 2 SBIR grants. The company is now seeking new venture capital and/or partner funding to expand its tissue models to the back of the eye for retinal diseases and, ultimately, to other organs.

“Our goal now is to create additional models,” concludes Southern. “We see significant potential with our platform human tissue technology and are only at the beginning.” GP