OnQuality Pharmaceuticals Reports Topline Data from Phase 2 Trial of Treatment for Cancer [...]

Therapy Induced Skin Toxicity that Met Expectations


- Part 1 of the Phase 2 NOVA-II clinical trial evaluating OQL011 met the company's primary safety and efficacy expectations

- OnQuality is set to begin Part 2 of NOVA-II in Q1 2022

- CEO Michael McCullar, Ph.D., to present at the virtual investor conferences Biotech Showcase 2022 and the H.C. Wainwright Bioconnect Conference in January


SEATTLE, Wash., Jan. 4, 2022 /PRNewswire/ -- OnQuality Pharmaceuticals ("OnQuality"), an oncology company developing targeted supportive therapies 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 that Part 1 of the Phase 2 NOVA-II clinical trial evaluating OQL011 met the company's expectations of safety, efficacy and the patient reported outcome of Hand-Foot Skin Reaction (HFSR)-related pain.


NOVA-II is a multicenter, randomized, double-blinded, vehicle-controlled, dose-ranging Phase 2 clinical trial designed to assess the safety and efficacy of OQL011 as a topical ointment in treating VEGFR inhibitor-associated HFSR. Patients eligible for the NOVA-II study must be receiving VEGFR inhibitor-based anticancer therapy (monotherapy or combination therapy) and have HFSR severity (per NCI CTCAE v5.0 grading of palmar-plantar erythrodysesthesia, or PPE) of grade 2 or higher.


"While the outlook for many types of cancer has improved in recent years, largely due to advancements in anticancer treatments, the new and painful side effects of these treatments have not been addressed accordingly. The first part of our Phase 2 trial demonstrated the potential of OQL011 in helping patients who are suffering from Hand-Foot Skin Reaction," said Hong Tang, M.D., Chief Medical Officer and co-founder of OnQuality Pharmaceuticals. "Completing part one of this proof of concept study is a significant milestone, supporting our approach in cancer supportive drug development and bringing us one step closer to fulfilling our mission of bringing innovative new therapies to patients."


"Due to the debilitating side effects of VEGFR inhibitor treatment to combat cancer, up to 30% of patients reduce their therapy dose and up to 17% completely discontinue treatment. We are working to balance the scale in cancer therapy and provide a much-needed solution to side effects that will allow more patients to remain in treatment," added Michael McCullar, Ph.D., Chief Executive Officer of OnQuality Pharmaceuticals. "We are looking forward to advancing QOL011 to Part 2 of the study at a higher dose level."


Dr. McCullar will be discussing the novel targeted supportive therapies in OnQuality's pipeline in presentations at two virtual investor conferences this month: Biotech Showcase 2022 (January 10-12 and 17-19) and the H.C. Wainwright Bioconnect Conference (January 10-13).


OnQuality is working with the U.S. Food and Drug Administration (FDA) to utilize the data from Part 1 to inform and update its protocols for Part 2 of the NOVA-II study. OnQuality will present its findings from Part 1 at a future conference and Part 2 is set to begin in Q1 2022. For additional details, please refer to www.clinicaltrials.gov (NCT04088318).


About OQL011 and Hand-Foot Skin Reaction


Hand-Foot Skin Reaction (HFSR) is a common side effect of tyrosine kinase inhibitors, including vascular endothelial growth factor receptor (VEGFR) inhibitors, used for the treatment of cancer. VEGFR inhibitors impair vascular repair mechanisms, which are especially important in areas exposed to high pressure and repetitive force, such as the palms and soles. VEGFR inhibitor-associated HFSR is characterized by redness, swelling, discomfort or pain, and blistering in the palms of the hands or the soles of the feet. Depending on the inhibitor used, incident rates can exceed 50% of patients treated. In cases of severe HFSR, dose reduction or discontinuation is required. There is currently no FDA-approved therapy for the treatment of HFSR and the effectiveness of current symptom relief strategies remains limited. OQL011 is a proprietary ointment that is designed to locally activate VEGF downstream signaling pathways to treat HFSR. We believe OQL011 improves or restores VEGF signaling in cell viability and functionality with VEGFR inhibitors to alleviate HFSR symptoms. By addressing side effects, 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. Using computation-aided drug-target-toxicology search methodologies to identify targets and drug candidates, OnQuality is developing first-in-disease targeted supportive therapies to address 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-induce skin rash and 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.

SOURCE OnQuality Pharmaceuticals


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