CLEO Granted U.S. Patent for Key Novel Ovarian Cancer Biomarker

Ovarian cancer diagnostics company Cleo Diagnostics Limited (ASX: COV) (CLEO, or the Company) is pleased to announce the grant of U.S. Patent No: US 11,725,048, "CXCL10 Binding Proteins and Compositions Thereof" (Patent), by the U.S. Patents and Trademarks Office (USPTO).

Highlights

• U.S. Patent secures IP protection in one of the world's largest diagnostics markets
• Supports CLEO's commercialisation pathway into its primary U.S. target market
• Further patents are pending in additional countries

The granted Patent covers CLEO proprietary biomarkers and antibody formulations, which comprise the core technology of the Company’s ovarian cancer diagnostic blood test. This Patent family is directed towards C‐X‐C motif chemokine ligand 10 (CXCL10) binding proteins and methods of diagnosing a condition, such as a malignancy, comprising determining a level of CXCL10 in a subject. Determination of the level of CXCL10 may also be utilised to monitor tumour burden, malignancy progression or likelihood of tumour recurrence in a subject.

The U.S. Patent expands the Company’s Intellectual Property (IP) portfolio, adding to the patent granted in Australia earlier this year (patent number 2020404453). Additional patent applications are currently pending in Europe, China, India, Japan, Korea, Israel, New Zealand and Singapore.

U.S. MARKET OPPORTUNITY

The U.S. is the largest diagnostic market in the world, and represents the Company’s primary target market for its potentially lifesaving simple diagnostic blood test. Ovarian cancer survival rates are much lower than other cancers that affect women, largely due to the fact that existing testing is insufficient to identify early stage cancers or differentiate from benign disease. Diagnosis is only made following radical surgery to remove the ovaries. The 5 year survival rate for ovarian cancer is 49%, compared to 92% for breast cancer1 where early detection screening exists.

A significant unmet clinical need exists and CLEO plans to bring to market a suite of ovarian cancer diagnostic blood tests based on the novel patented CXCL10 biomarker, which is expressed early and at high levels by ovarian cancers, but not in non- malignant disease. The tests aim to distinguish benign from malignant growths in a standard format that will be readily compatible with existing equipment used by pathology laboratories worldwide.

The U.S. Patent complements CLEO’s regulatory approval strategy designed to access target markets and secure a path to reimbursement approvals in the future. The Company is also currently preparing for the submission of a 510(k) U.S. Food and Drug Administration (FDA) application.

CLEO is initially targeting the delivery of its blood test for the surgical triage market, however has a staged execution strategy that de-risks a pathway to all ovarian cancer diagnostic markets:

• Surgical Triage - Distinguishes benign from malignant disease to allow appropriate design of treatment before surgical intervention is considered;
• Recurrence - Identifies relapse for earlier intervention to control/manage disease progression;
• High Risk Screening - Testing women with known BRCA status or extensive family history; and
• Early Stage Screening - Systematic national screening to identify early stage ovarian cancers in patients without symptoms, to allow medical intervention before cancer spreads.

Commenting on the U.S. Patent grant, CLEO CEO, Richard Allman, said:

“Securing a U.S. Patent not only expands the Company’s IP portfolio, but it also marks an important milestone which effectively activates our commercialisation plans to pursue market entry in the largest diagnostics market in the world.

CLEO’s simple blood test for accurate and early detection of ovarian cancer has the potential to transform the standard of care for women globally.”

Click here for the full ASX Release

This article includes content from CLEO Diagnostics, licensed for the purpose of publishing on Investing News Australia. This article does not constitute financial product advice. It is your responsibility to perform proper due diligence before acting upon any information provided here. Please refer to our full disclaimer here.