OQL-036

SEATTLE, June 6, 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, announced today the U.S. Food and Drug Administration (FDA) has cleared its Investigational New Drug (IND) application for its drug candidate, OQL051, for the prophylaxis of chemotherapy-induced diarrhea (CID). CID is a common and often debilitating toxicity affecting up to 90% of patients receiving chemotherapy. CID can cause dehydration, electrolyte imbalance, malnutrition, and infection, which may lead to hospitalization, cardiovascular compromise, and in some cases death. Prevention of moderate to severe CID often requires dose reduction. Treatment of CID may require interruption or even permanent discontinuation of chemotherapy, and potentially compromising the effectiveness of cancer therapy. OQL051 – a first-in-disease, oral, gut-restricted CDK4/6 inhibitor – is designed to prevent the development of CID in patients receiving cytotoxic chemotherapies. The drug works by temporarily arresting the rapidly dividing intestinal mucosal cells in G1 phase. OQL051 locally targets cells of the digestive tract, transiently preventing cell division. This protects the intestinal lining from chemotherapy damage. Preclinical studies have demonstrated that OQL051, when given prior to chemotherapy, delays the onset and reduces the severity of CID without compromising the anti-tumor activity of chemotherapy agents. "We are delighted to receive IND clearance for OQL051. This is a significant milestone for OnQuality and for patients suffering from CID," said Hong Tang, MD, FACP, Chief Medical Officer at OnQuality. "Prevention of CID is a major unmet medical need. We believe that OQL051 has the potential to make a meaningful difference in the lives of patients who suffer from cancer and the toxic effects of cancer treatment." "Along with the OQL036 (for the prophylaxis of capecitabine-induced hand-food syndrome in onco-dermatology) clinical clearance by FDA in April this year, the newly cleared OQL051 allows us to advance our drug development in onco-gastroenterology, the second pillar of OnQuality pipeline," added by Jacob Song, Global Regulatory Lead and Director. OnQuality plans to initiate a Phase I/II clinical trial in coming months to evaluate the safety in healthy volunteers, as well as safety and preliminary efficacy of the drug in cancer patients who plan to receive fluorouracil (5-FU) and irinotecan-based chemotherapy. About Chemotherapy-Induced Diarrhea and OQL051 Chemotherapy-induced diarrhea (CID) is a common toxicity of chemotherapy, which plays a crucial role in the treatment of cancer. CID can range in severity from mild to severe, and can cause symptoms such as frequent bowel movements, abdominal pain, which may lead to dehydration, electrolyte imbalance, infection, and other potentially serious complications. There are currently no FDA-approved therapies for prevention of CID. The effectiveness of current symptom relief strategies is limited. OQL051, a first-in-disease, oral, gut-restricted CDK4/6 inhibitor, is designed to prevent the development of CID in patients receiving cytotoxic chemotherapies. The drug works by temporarily arresting the rapidly dividing intestinal mucosa cells in the G1 phase throughout chemotherapy administration. This protects the intestinal lining from chemotherapy damage. Preclinical studies demonstrated that OQL051, when given prior to chemotherapy, delayed the onset and reduced the severity of CID in animal models. Due to its low systemic exposure, the anti-tumor activity of chemotherapeutic agents was not affected. 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. Related link: OnQuality Announces FDA Clearance of IND Application for OQL036 (onqualityrx.com) SOURCE OnQuality Pharmaceuticals

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