Hyalinosis, Systemic

SEATTLE, April 28, 2023 /PRNewswire/ -- OnQuality Pharmaceuticals ("OnQuality"), a targeted oncology supportive therapy company developing innovative medications to address unmet needs in oncodermatology and oncogastroenterology (cancer therapy-induced toxicities occurring in the skin and gastrointestinal tract) and to improve the quality of life for patients receiving anticancer medications, today announced that the U.S. Food and Drug Administration (FDA) has cleared our Investigational New Drug (IND) application for OQL036, a potential prophylactic treatment for capecitabine-induced hand-foot syndrome (HFS). Capecitabine, a chemotherapy drug, commonly used to treat colorectal and breast cancers, can cause HFS, a potential dose-limiting skin toxicity characterized by redness, swelling, pain, and even blistering, fissuring, or bleeding on the palms of the hands and soles of the feet. HFS can severely impact the quality of life, that may necessitate dose reduction, dose interruption or permanent discontinuation of capecitabine. There are no agents with FDA-approved labeling to prevent or treat capecitabine-induced HFS. OQL036, a first-in-disease topical agent designed by our proprietary AI-enabled CARE platform is to prevent the development of HFS in patients receiving capecitabine by selectively targeting key pathways leading to capecitabine-induced HFS in addition to reducing local inflammation. "We are excited to receive IND clearance for OQL036, which is a significant step forward in our efforts to address the urgent and growing unmet needs in oncodermatology, and make it accessible to the patients," said Hong Tang, MD, FACP, Chief Medical Officer at OnQuality. "We believe that OQL036 has the potential to make a meaningful difference in the lives of cancer patients by reducing the incidence and severity of HFS, allowing them to maintain their cancer treatment." Upon receiving FDA's clearance, OnQuality plans to initiate a global multi-center, double-blind, placebo-controlled Phase 2 trial in the coming months to evaluate the safety and efficacy of the drug in cancer patients who plan to receive capecitabine-based therapy. "We are committed to bringing innovative and effective therapies to the market that address the unmet needs of cancer patients," said Michael McCullar, Ph.D., CEO of OnQuality. "The clearance of our IND application for OQL036 is another important milestone in this mission, and further strengthens our oncodermatology pipeline. We look forward to rapidly advancing this drug candidate through clinical development and hopefully to improving the lives of patients living with cancer." About Hand-Foot Syndrome and OQL036 Hand-Foot Syndrome (HFS) is a common side effect of fluoropyrimidine chemotherapy, such as capecitabine and fluorouracil (5-FU). Capecitabine is an oral chemotherapy drug that is used in the treatment of several types of cancer, including colorectal and breast cancer. HFS, also known as palmar-plantar erythrodysesthesia. The incidence of HFS induced by fluoropyrimidine chemotherapy, such as capecitabine, can be as high as 60% of patients. HFS may be a dose-limiting toxicity, which requires dose reduction, dose interruption or permanent discontinuation of fluoropyrimidine treatment, which may impact the effectiveness of the cancer therapy. There is currently no FDA-approved therapy for the prevention of HFS and the effectiveness of current symptom relief strategies remains limited. OQL036 is a novel topical agent that locally alleviates the toxicities induced by capecitabine metabolites, and reduces the inflammation associated with HFS. OnQuality aims to keep patients in cancer treatment and to improve their 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 VEGFR inhibitor-induced Hand-Foot Skin Reaction, capecitabine-induced Hand-Foot Syndrome, epidermal growth factor receptor (EGFR) inhibitor-induced skin rash, chemotherapy-induced diarrhea and gastrointestinal side effects of immunotherapies. For more information about OnQuality Pharmaceuticals, please visit . 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. SOURCE OnQuality Pharmaceuticals

Preclinical toxicology and pharmacology data demonstrating OQL051, a gut-restricted CDK4/6 inhibitor, as a potential prophylactic treatment for chemotherapy-induced diarrhea Preclinical data demonstrating OQL036, a topical gel that inhibits skin toxicity associated with fluorouracil/capecitabine, as a potential prophylactic treatment for fluoropyrimidine-induced hand-foot syndrome SEATTLE, Oct. 14, 2022 /PRNewswire/ -- OnQuality Pharmaceuticals ("OnQuality"), a targeted oncology supportive therapy company developing innovative medications to address unmet needs in oncodermatology and oncogastroenterology (cancer therapy-induced side effects occurring in the skin and gastrointestinal tract, respectively) and to improve quality of life for patients receiving anticancer medications, today announced it will present two posters at the 34th EORTC-NCI-AACR Symposium, October 26 – 28, 2022. The first poster presents preclinical toxicology and pharmacology data for its therapeutic candidate OQL051, a gut-restricted CDK4/6 inhibitor for the prevention of chemotherapy-induced diarrhea (CID). The second poster features in vitro and in vivo preclinical data for its therapeutic candidate OQL036, a topical gel designed to prevent skin toxicity associated with 5-fluorouracil/capecitabine. CID is a potentially life-threatening adverse effect of chemotherapy, often requiring dose reduction or disruption of treatment. To address multiple unmet needs in cancer supportive care, we use OnQuality's AI-enabled CARE (Computation-Aided dRug-target-toxicology sEarch methodologies) platform to aid with the discovery of multiple candidates. OnQuality is developing OQL051, a gut-restricted CDK4/6 inhibitor with the potential to prevent CID while minimizing interference with systemically administered chemotherapy regimens. Previously presented preclinical data demonstrate that OQL051 can decrease CID and protect the intestinal epithelium and act as prophylactic, protecting gastrointestinal tissue from chemotherapy damage and preserving microbial communities. The poster at the EORTC-NCI-AACR Symposium will present preclinical toxicology and pharmacology data supporting OQL051's potential as an effective treatment for CID. Hand-foot syndrome (HFS), also known as palmoplantar erythrodysesthesia, is an adverse effect that affects 43 – 71% of patients treated with single-agent capecitabine chemotherapy and can lead to dose reduction, interruption, or discontinuation of anticancer therapy. Capecitabine is a commonly used anticancer agent and is the standard of care in treating breast and GI cancers. There are no FDA-approved treatments for this condition. OnQuality is developing OQL036, a topical gel, to potentially prevent this skin toxicity. The poster presented at the EORTC-NCI-AACR Symposium will present results from in vitro and in vivo preclinical studies that support OQL036's promise as a therapeutic for the prevention of fluoropyrimidine-induced HFS. Animal studies demonstrated that daily application of OQL036 delayed the onset of HFS and effectively reduced the severity of the condition. "We're thrilled to present positive preclinical data for two of our programs that address these unmet needs in cancer therapy," said Robert C. Tyler, Ph.D., Senior Medical Director of OnQuality. "While our industry has made significant strides in developing new approaches to treat cancer, very little attention is paid to treating the side effects of these therapies, which can often be severe enough to lead to dose reduction or discontinuation of anticancer therapies." Details regarding the poster presentations can be found below. Title: A preclinical toxicology and pharmacology study of OQL051, a gut-restricted CDK4/6 inhibitor for the prophylaxis of chemotherapy-induced diarrhea Abstract Number: 217 Abstract Authors: Wenqin Zeng, Wenxi Li, Shilan Liu, Liping Chen, Robert Tyler, Hong Tang, Shiyi Zhang Session Title: Molecular Targeted Agents Session Date and Time: 27 October 2022; viewing time 10.00-17.00; author present 11:30 -13:30 Presenter: Robert Tyler Title: OQL036 topical gel inhibits the skin toxicity associated with 5-fluorouracil/capecitabine: results from in vitro and in vivo preclinical studies Abstract Number: 215 Abstract Authors: Liping Chen, Wenxi Li, Kun Fang, Shilan Liu, Jiahu Wu, Jie Luo, Robert Tyler, Shiyi Zhang Session Title: Molecular Targeted Agents Session Date and Time: 27 October 2022; viewing time 10.00-17.00; author present 11:30 -13:30 Presenter: Robert Tyler 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 the 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 VEGFR inhibitor-induced Hand-Foot Skin Reaction, capecitabine-induced Hand-Foot Syndrome, epidermal growth factor receptor (EGFR) inhibitor-induced skin toxicity, chemotherapy-induced diarrhea and gastrointestinal side effects of immunotherapies. For more information about OnQuality Pharmaceuticals, please visit . 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. SOURCE OnQuality Pharmaceuticals