OnQuality Pharmaceuticals to Present NOVA-II Phase 2 Trial Update and Oncologist Survey Demonstrating Oncodermatology Unmet Need at ASCO GU

- OnQuality will present an update on its NOVA-II Phase 2 clinical trial investigating OQL011, a proprietary ointment designed to treat HFSR, including findings from Part 1 and plans for Part 2 of the study

- The company will also present findings from a survey of practicing oncologists demonstrating that Hand-Foot Skin Reaction (HFSR) represents a significant unmet need for cancer patients undergoing VEGFR inhibitor therapy

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OnQuality Pharmaceuticals

Feb 14, 2022, 17:00 ET

SEATTLE, Feb. 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 be presenting two posters on Hand-Foot Skin Reaction (HFSR), including a Trial in Progress on its NOVA-II Phase 2 study and the results of an oncologist survey, at the American Society of Clinical Oncology - Genitourinary Cancers Symposium (ASCO GU). The symposium will be held virtually and in San Francisco, Calif. from Feb. 17-19, 2022.

HFSR is an oncodermatological condition associated with the use of VEGFR inhibitor (VEGFRi) cancer therapies, impacting both quality of life and the consistency of VEGFRi treatment. To evaluate this impact, OnQuality surveyed 51 practicing oncologists about their practice patterns and identified unmet therapeutic needs. The majority of oncologists (4% always, 65% sometimes/frequently) responded that they start VEGFRi at a lower dose and titrate up to prevent HFSR. Furthermore, when treating patients with HFSR, many practicing oncologists either reduced VEGFRi dosage or stopped treatment entirely. According to the survey results, 59% of practicing oncologists considered VEGFRi dose reduction as a treatment option for Grade 2 HFSR. Furthermore, for patients not responding to standard therapies for HFSR, 78% of oncologists chose dose interruption of VEGFRi treatment. The survey also found a high willingness to try innovative agents to prevent and/or treat HFSR. These results demonstrate a significant unmet need for HFSR treatment strategies that allow cancer patients undergoing VEGFRi treatment to remain on therapy.

OnQuality is currently investigating OQL011 in the NOVA-II Phase 2 clinical trial. NOVA-II is a multicenter, randomized, double-blinded, vehicle-controlled, dose-ranging study to assess the safety and efficacy of OQL011 as a topical ointment in treating VEGFRi-associated HFSR. The first part of the NOVA-II trial found OQL011 (0.2%) was safe and well tolerated for the treatment of moderate to severe HFSR. Improvement in HFSR grade was observed in patients receiving OQL011 starting on Week 1 of the treatment. Based on the results from NOVA-II Part 1, OnQuality is planning to launch the NOVA-II Part 2 study in Q1 of 2022 to investigate OQL011 at a higher dose (0.5%).

"When it comes to treating cancer, it is important to maintain dose intensity of cancer treatment. Unfortunately, oncodermatology conditions like Hand-Foot Skin Reaction often force us to make those difficult decisions, and the survey being presented at ASCO GU demonstrates the significant unmet need in this space," said Dr. Nicholas Vogelzang, MD, Medical Oncologist at Comprehensive Cancer Centers of Nevada. "I am glad to see the NOVA-II trial is moving forward to Part 2 to evaluate OQL011 at a higher dose level."

"OnQuality is committed to developing innovative new therapies to address the toxicities of cancer medication," said Michael McCullar, Ph.D., Chief Executive Officer of OnQuality. "The survey results reinforce OnQuality's mission, showing us just how important it is to address these toxicities. We look forward to sharing these findings and the work we have done developing OQL011 at the upcoming ASCO GU conference."

Details regarding the two poster presentations can be found on the ASCO GU website and below.

Presentation Details

Title: A survey study of prevention and treatment patterns by academic and community oncologists for hand-foot skin reaction associated with vascular endothelial growth factor receptor inhibitor (VEGFRi) therapy.
Session: Poster Session C: Renal Cell Cancer; Adrenal, Penile, Urethral, and Testicular Cancers
Time: February 19, 2022, 7:00 a.m. PST
Presented by: Mario E. Lacouture, M.D.
Abstract Number: 205582

Title: Part 1 results from NOVA-II, a randomized, double-blind, vehicle-controlled phase II study evaluating the safety and efficacy of OQL011 on VEGFR inhibitor associated hand-foot skin reaction in cancer patients.
Session: Trials in Progress Poster Session C: Renal Cell Cancer; Adrenal, Penile, Urethral, and Testicular Cancers
Time: February 19, 2022, 7:00 a.m. PST
Presented by: Mario E. Lacouture, M.D.
Abstract Number: 205910

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, which 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 locally activates VEGF downstream signaling pathways to treat HFSR. 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-induced skin rash, chemotherapy-induced diarrhea and gastrointestinal side effects on immunotherapies. For more information about OnQuality Pharmaceuticals, please visit www.onqualityrx.com.

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SOURCE OnQuality Pharmaceuticals