OnQuality Pharmaceuticals to Present on NOVA-II Trial Evaluating OQL011 at the 2021 ASCO and MASCC/ISOO Annual Meetings

SEATTLE, May 19, 2021 /PRNewswire/ — OnQuality Pharmaceuticals («OnQuality»), a targeted cancer supportive care company developing medications to address specific…

SEATTLE, May 19, 2021 /PRNewswire/ — OnQuality Pharmaceuticals («OnQuality»), a targeted cancer supportive care company developing medications to address specific side effects and improve the quality of life for patients receiving anti-cancer medications, today announced that abstracts for the NOVA-II clinical trial evaluating OnQuality’s lead candidate, OQL011, have been selected for presentations at two upcoming meetings: a Trial in Progress poster presentation at the American Society of Clinical Oncology (ASCO) Annual Meeting, being held virtually from June 4-8, 2021, and an oral presentation at the Multinational Association of Supportive Care in Cancer and International Society of Oral Oncology (MASCC/ISOO) Annual Meeting, being held virtually from June 24-26, 2021. The abstracts for both presentations include an update on the ongoing Phase II clinical trial and are both titled «A Study to Investigate OQL011 on VEGFR Inhibitor-Associated Hand-Foot Skin Reaction in Cancer Patients (NOVA-II).»

«It is an honor for OnQuality to be selected for participation in the ASCO and MASCC/ISOO Annual Meetings,» said Michael McCullar, Ph.D., the Chief Executive Officer of OnQuality. «We are grateful to all of the investigators, healthcare providers, patients, and everyone else involved in this trial. We look forward to the continued development of OQL011 and our pipeline of targeted cancer supportive care treatments.»

NOVA-II is a multicenter, randomized, double-blinded, placebo-controlled, dose-ranging Phase II clinical trial of OQL011, designed to assess the safety and efficacy of OQL011 as a topical ointment in treating Hand-Foot Skin Reaction (HFSR) for subjects currently receiving VEGFR inhibitor-based anticancer therapy (monotherapy or combination therapy), and whose HFSR severity (per NCI CTCAE v5.0 grading of palmer-plantar erythrodysesthesia) is grade 2 or higher.

Key objectives in the study include determining the efficacy, safety, pharmacokinetics of OQL011, and improvement in patient-reported outcomes including pain. Please refer to www.clinicaltrials.gov (NCT04088318) for additional details.

Information about the ASCO and MASCC presentations can be read below.

Title: A phase II study to evaluate the safety and efficacy of OQL011 on VEGFR inhibitor-associated hand-foot skin reaction in cancer patients

For ASCO, 2021

Abstract Number: TPS12132

Poster Session: Symptoms and Survivorship

Date: Virtual meeting; Available June 4, 2021, at 9:00 AM Eastern

Location: https://meetinglibrary.asco.org/record/201369/abstract  

Authors: Mario E. Lacouture, Milan J. Anadkat, Omkar Marathe, Nicholas J. Vogelzang, Elaine T. Lam, Benjamin H. Kaffenberger, Jennifer N. Choi, Mark L. Webb, Robert C. Tyler, Juegang Ju, Hong Tang, Jie Luo, Anisha B. Patel

Presenter: Mario Lacouture, MD, Memorial Sloan Kettering Cancer Center

For MASCC/ISOO, 2021

Presentation Session: Oral and Dermatologic Toxicity of Immunotherapy (Oral Proffered Paper 3)

Date: Virtual meeting; Available On Demand, Friday, June 25, 2021

Location: 2021 Program Friday, June 25 (mascc.org)

Authors: Mario E. Lacouture, Milan J. Anadkat, Omkar Marathe, Nicholas J. Vogelzang, Elaine T. Lam, Benjamin H. Kaffenberger, Jennifer N. Choi, Mark L. Webb, Robert C. Tyler, Juegang Ju, Hong Tang, Jie Luo, Anisha B. Patel

Presenter: Anisha Patel, MD, MD Anderson Cancer Center

About OQL011

OQL011 is a proprietary nitroglycerin-based ointment that activates VEGF downstream signaling pathways. Vascular-endothelial cells are normally maintained via VEGF signaling. VEGFR inhibitors impair the vascular repair mechanisms especially in areas exposed to high pressure and repetitive force, such as the palms and soles, where blood vessels are more likely to be damaged and more in need of intact vascular repair mechanisms. Nitroglycerin, as the nitro oxide donor, is hypothesized to improve or restore VEGF signaling in cell viability and functionality impacted by VEGFR inhibitors.

About Hand-Foot Skin Reaction

Hand-Foot Skin Reaction (HFSR) commonly occurs with tyrosine kinase inhibitors such as vascular endothelial growth factor receptor (VEGFR) inhibitors. It is characterized by redness, swelling, discomfort or pain, and even 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.

Current treatment strategies are focusing on symptom relief using moisturizing cream, cold packs, urea cream or topical steroids. In cases of severe HFSR, dose reduction or discontinuation is required. There is currently no FDA-approved therapy for the treatment of HFSR.

About OnQuality Pharmaceuticals

OnQuality Pharmaceuticals is dedicated to pioneering the discovery and development of targeted cancer supportive care therapies that address treatment-related toxicities at their molecular source. OnQuality’s targeted cancer supportive care therapies may have the potential to improve both quality-of-life and outcomes for cancer patients. By treating on-target toxicities of the anti-cancer treatments, we believe OnQuality’s targeted supportive care candidates have the potential to reduce the severity and incidence of adverse events while sustaining the efficacy of the cancer treatments. OnQuality is advancing several oncodermatology and oncogastroenterology pipeline products to address leading skin and gastrointestinal toxicities such as VEGFR inhibitor-induced Hand-Foot Skin Reaction, capecitabine-induced Hand-Foot Syndrome, epidermal growth factor receptor (EGFR) inhibitor-induced 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.

Media Contacts

Ignacio Guerrero-Ros, Ph.D.

Russo Partners, LLC

(646) 942-5604

Ignacio.Guerrero-Ros@russopartnersllc.com

David Melamed, Ph.D.

Russo Partners, LLC

(212) 845-4225

David.Melamed@russopartnersllc.com

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