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OnQuality Announces FDA Clearance of IND Application for OQL025 for the treatment of EGFR Inhibitor-Induced Acneiform Rash

SEATTLE, Jan. 4, 2024 /PRNewswire/ -- OnQuality Pharmaceuticals ("OnQuality"), a leading targeted oncology supportive therapy company dedicated to addressing unmet needs in oncodermatology and oncogastroenterology to improve the quality of life for patients receiving anticancer medications, announced today that the U.S. Food and Drug Administration (FDA) has granted clearance for our OQL025 Investigational New Drug (IND) application, with an indication to treat Epidermal Growth Factor receptor (EGFR) inhibitor-induced acneiform rash, a common toxicity affecting patients treated with EGFR inhibitor therapy.

EGFR inhibitors are widely used to treat various cancers, such as lung and colorectal. Treatment often leads to acneiform rash, which manifests mainly on the face, neck, upper chest, and upper back. Acneiform rash is characterized by redness, swelling, itchingness, and even blistering or infection on the face, neck, upper chest, and upper back. It can negatively impact quality of life and may necessitate dose reduction, dose interruption, or permanent discontinuation of the patient's anticancer therapy.

OQL025 is a first-in-disease topical agent to treat moderate to severe acneiform rash in patients receiving EGFR inhibitors. It was developed using our proprietary AI-enabled CARE platform. OQL025 works by selectively targeting the key pathways that lead to EGFR inhibitor-induced rash.

"We are thrilled to receive IND clearance for OQL025. This is another significant milestone to advance our pipelines. This program will address unmet needs in oncodermatology," said Hong Tang, MD, FACP, Chief Medical Officer at OnQuality. "We are committed to developing effective therapies for patients grappling with the dose-limiting toxicities of cancer treatments."

"With the clinical clearance of OQL036 and OQL051 last year, the addition of the OQL025 IND will allow us to further advance our drug development program to explore how these drugs may improve patients' quality of life from both oncodermatology and oncogastroenterology perspectives," added Jacob Song, PhD, Global Regulatory Lead and Director.


About EGFR Inhibitor-Induced Acneiform Rash and OQL025

EGFR inhibitor-induced acneiform rash is a prevalent side effect of the target therapy, affecting patients with various cancers, including lung and colorectal.

The incidence of this rash ranges from 20% to over 90% among patients undergoing EGFR inhibitor therapy. It is a dose-limiting toxicity, which may impact the effectiveness of the cancer treatment due to the necessity of dose reduction, dose interruption or permanent discontinuation of the targeted anticancer therapy to manage the side effect when it is moderate or severe.

OQL025, a novel topical agent developed by OnQuality, aims to locally alleviate the toxicity by reducing inflammation associated with the acneiform rash, allowing patients to continue their cancer treatments and improve their overall quality of life.


About OnQuality Pharmaceuticals

OnQuality Pharmaceuticals is dedicated to pioneering the discovery and development of targeted supportive oncology therapies that address treatment-related toxicities at their molecular source. By treating on-target toxicities of the anti-cancer treatments, OnQuality's targeted supportive therapy candidates have the potential to reduce the severity and incidence of adverse events while sustaining the efficacy of the cancer treatments. OnQuality's targeted therapies, therefore, have the potential to improve both quality of life and outcomes for cancer patients. 

OnQuality is leveraging its proprietary, AI-enabled CARE (Computation-Aided dRug-target-toxicology sEarch methodologies) platform to identify targets and drug candidates, to develop first-in-disease targeted supportive therapies addressing unmet medical needs in the emerging areas of oncodermatology and oncogastroenterology. This includes OQL011 for VEGFR inhibitor-induced Hand-Foot Skin Reaction (HFSR), OQL036 for capecitabine-induced Hand-Foot Syndrome (HFS), OQL025 for EGFR inhibitor-induced acneiform rash, and OQL051 for chemotherapy-induced diarrhea. For more information about OnQuality Pharmaceuticals, please visit www.onqualityrx.com


Cautionary Note Regarding Forward-Looking Statements

This press release contains forward-looking statements that are often identified by the words "may", "might", "believes", "thinks", "anticipates", "plans", "expects", "intends" or other similar expressions. In addition, expressions of our strategies, intentions or plans are also forward-looking statements. Although forward-looking statements contained herein are based on what OnQuality Pharmaceuticals believes are reasonable assumptions, there can be no assurance that forward-looking statements will prove to be accurate, as actual results and future events could differ materially from those anticipated in such statements. OnQuality undertakes no obligation to update forward-looking statements if circumstances or management's estimates or opinions should change except as required by applicable securities laws. The reader is cautioned not to place undue reliance on forward-looking statements.

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