IDE196 has been generally well tolerated in the Phase 1/2 clinical trial. As of December 11, 2020, four patients in the monotherapy arm of the trial have had drug-related adverse events classified as Grade 3 or higher: one patient experienced two events of Grade 3 diarrhea (classified as definitely drug-related to IDE196), one patient experienced Grade 3 syncope (classified as possibly drug-related to IDE196), one patient experienced Grade 3 worsening anemia (classified as possibly drug-related to IDE196), and one patient experienced Grade 3 alanine aminotransferase, or ALT, increase (classified as probably drug-related to IDE196).
As of December 11, 2020, one patient in the IDE196 and binimetinib combination arm of the trial has had possibly drug-related adverse events classified as Grade 3 or higher: the patient experienced Grade 4 blood bilirubin increase, Grade 3 painless jaundice, Grade 3 ALT increase and Grade 3 aspartate aminotransaminase, or AST, increase (all four adverse events classified as possibly drug-related to both IDE196 and binimetinib). The Grade 3 painless jaundice was subsequently updated to Grade 4 acute cholestatic hepatitis following a liver biopsy. The etiology and causality of these adverse events are under further investigation due to the patient’s past medical history and underlying liver disease.
IDE196 was initially developed by Novartis, and we obtained an exclusive, worldwide license to IDE196 from Novartis in September 2018. Pursuant to our license agreement with Novartis, except for Novartis’ sponsored Phase 1 clinical trial evaluating IDE196 in MUM, for which enrollment is complete, we control all future clinical development, and all commercial rights to IDE196, and may rely on and incorporate data previously submitted to the FDA by Novartis into our own regulatory submissions.
We are continuing our preclinical evaluation of IDE196 in Sturge-Weber Syndrome, or SWS, a rare neurocutaneous disorder characterized by capillary malformations and associated with mutations in GNAQ. Our preclinical evaluation will include potential feasibility for pediatric use.
Intellectual Property
Intellectual property, including patents, trade secrets, trademarks and copyrights, is important to our business. We endeavor to establish, maintain and enforce intellectual property rights that protect our business interests.
Our patent portfolio, including patents owned by or exclusively licensed to us, is built on a program-by-program basis with a goal of establishing broad protection that generally includes, for each product candidate compound and for selected alternative back-up compounds, claims directed to composition of matter, pharmaceutical compositions, and methods of treatment using such pharmaceutical compositions. For some programs, our portfolio may also include claims directed to methods of treatment involving biomarker-enabled patient identification or selection, methods of treatment involving particular dosing approaches, polymorphs, formulations and/or methods of synthesis. We are seeking and maintaining patent protection in the United States and key foreign jurisdictions.
We own or exclusively in-license patents and patent applications, protecting our technology across our pipeline. As of December 31, 2020, excluding applications that we are not currently prosecuting, our portfolio consists of six issued U.S. patents, approximately 22 pending U.S. applications, 11 pending applications under the Patent Cooperation Treaty, or PCT, 19 issued foreign patents and approximately 49 pending foreign applications in approximately 27 foreign jurisdictions, including without limitation countries included in major markets in North America, Europe, and Asia, each having a nominal expiration ranging from 2035 to 2041. The nominal expiration of our patents and patent applications does not account for any applicable patent term adjustments or extensions.
About IDEAYA
We were founded in June 2015 as a Delaware corporation. Our principal executive offices are located at 7000 Shoreline Court, Suite 350, South San Francisco, California 94080, and our telephone number is (650) 443-6209. Our website address is www.ideayabio.com. The information on, or that can be accessed through, our website is not part of this prospectus supplement and is not incorporated by reference herein. We have included our website address as an inactive textual reference only.