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Q BioMed Inc., a biomedical acceleration and development company, along with researchers at Washington University in St. Louis have begun evaluating the feasibility of GDF-15, a novel biomarker for monitoring glaucoma, as a companion diagnostic to a small molecule currently in development for the topical treatment of glaucoma.

Primary Care Optometry News spoke with Denis Corin, CEO of Q BioMed, and George Nikopoulos, PhD, MBA, CEO and president of Mannin Research, about this innovative partnership and the potential behind the promising biomarker.

PCON: How does GDF-15 work for monitoring glaucoma? How can it work in tandem with the MAN-01 technology?

Nikopoulos: Mannin Research and Q BioMed have been working on the MAN-01 program for a small molecule to treat glaucoma with an eye drop. The GDF-15 biomarker can be used to detect and determine the progression of glaucoma as a disease, over time. It’s a protein found in the aqueous humor of the eye and was identified by Rajendra S. Apte, MD, PhD, the Paul A. Cibis distinguished professor of ophthalmology and visual sciences at Washington University in St. Louis.

How and why it appears and determining the level or progression of glaucoma are still being worked on. However, the data from clinical samples have shown a relationship to progression of glaucoma over time. If you have a patient undergoing treatment for glaucoma and you need to make decision on how that patient is treated, this biomarker enables a more precise decision-making process. It is the idea of precision medicine.

In relation to our small molecule (MAN-01 from Mannin), you’re moving from blanket usage of a pharmaceutical in all patient cohorts to targeting needs of specific patients, addressing their needs in a precise method over time and watching the progression with those biomarkers. They work as a companion diagnostic to the MAN-01 program for small molecule for glaucoma.

PCON: How did the partnership with Washington University come about?

Nikopoulos: Q BioMed and Mannin have been working to develop a small molecule, as it is an unmet need for new treatments in patients with glaucoma. In our evaluation of the industry, we wanted to make sure we were meeting the needs of patients and physicians. One of the challenges has been determining how to find patients who have glaucoma and looking at them over time for progression of glaucoma. We were looking for partnerships with companies that had biomarkers applicable to glaucoma and were lucky to meet Dr. Apte’s group through the University of Washington’s Technology Transfer office. They were able to explain how her discoveries can be applied to physician and patient needs in glaucoma relating to detection and progression.

Corin: Right now, we are evaluating the technology from a Q BioMed standpoint. All of our partnerships, collaborations and licenses are built around evaluating a technology, testing the commercial viability and moving to the next stage of building that collaboration with the potential partner around a commercial asset. It’s not just all research and development; there has to be a business proposition behind it and a reason behind entering into a more substantial agreement. We have an option to license the technology after it’s been evaluated. We are in that process right now. When we are more comfortable that it has commercial viability and provides value to us and our platform and the ophthalmology vertical within Q BioMed, then we would move into a full licensing deal with Washington University. We’ve already sort of mapped out what those terms would look like. Then, the collaboration would be more formalized, and our teams would work even more closely together to lay out the commercial and clinical plan to make it into a viable commercial product.

PCON: What kind of timeline are you hoping for?

Nikopoulos: We’ve given ourselves around 6 months to do some testing, work with the clinicians at Washington University, get our heads around the technology and commercial potential, and understand the science and deliverables. At that point, sometime in summer, we would expect to make the decision for the license agreement.

Corin: At which point we’d have a clearer map as to how the commercialization pathway works toward the development of the companion diagnostic.

Nikopoulos: The intention for Q BioMed and Mannin is that this is a companion diagnostic to leverage the existing platform we have, which is why we are doing it in a stepwise fashion.

PCON: If FDA approved, what kind of an impact could this have for patients and eye care providers?

Nikopoulos: The impacts are felt at the patient level because physicians can make better decisions. Those better decisions are translated into better health outcomes, which can translate into more efficient use of health care dollars and healthier patients.

Corin: It’s really a nice hand-and-glove result. If you can be more precise in your decision-making and treating options, in how you’re planning that treatment, you’re really driving value and addressing the needs of patients. It helps every aspect of the health care system, especially the needs of the patient in treating their disease.

Nikopoulos: From the technology side, we’d like optometrists to know that there is a well understood need to help the field address the complex needs of glaucoma patients. We know that physicians need better tools to make decisions to better treat their patients. Q BioMed has demonstrated that it is ready to address those needs as part of its ophthalmology vertical and leveraging on the small molecule that Mannin is addressing in the development of a new small molecule to treat glaucoma. Until recently, with the Rhopressa (Aerie Pharmaceuticals) release, we have not seen many new innovations in this space. Q BioMed with Mannin is there to innovate in the space and ultimately address the needs of patients. – Interviewed by Abigail Sutton

Disclosures: Corin is CEO of Q BioMed, and Nikopoulos is CEO and president of Mannin Research.