Inspirna to Present Clinical Data from Phase 1b/2 Study of Ompenaclid (RGX-202) in Advanced Colorectal Cancer at ESMO Congress 2023

Inspirna, Inc., a clinical stage biopharmaceutical company developing first-in-class cancer therapeutics, announced today that data from the ongoing Phase 1b/2 study of ompenaclid (RGX-202) in combination with FOLFIRI and bevacizumab (BEV) in RAS-mutated (RASm) advanced or metastatic colorectal cancer (CRC) will be presented at the European Society for Medical Oncology (ESMO) Congress 2023 being held October 20-24, 2023 in Madrid, Spain.

Ompenaclid is a first-in-class oral inhibitor of the creatine transport channel SLC6A8, a novel target that is enriched under hypoxic conditions and provides tumor cells with an additional energy source. Ompenaclid triggers tumor regressions in CRC patients by inducing apoptosis of tumor cells. The Phase 1b/2 study of ompenaclid in combination with FOLFIRI/BEV in second-line (2L) advanced or metastatic CRC patients has completed enrollment, with an ongoing follow up period. The primary endpoint of the study is to determine maximum tolerated dose (MTD), objective response rate (ORR), and treatment-emergent adverse events (TEAEs). In the dose escalation stage of the study, two dose levels of ompenaclid with FOLFIRI/BEV have been evaluated in patients with CRC with disease progression after a first-line oxaliplatin-containing regimen.

Poster Presentation Details

Title: Phase 1b/2 study of ompenaclid (RGX-202-01), a first-in-class oral inhibitor of the creatine transporter SLC6A8, in combination with FOLFIRI and bevacizumab (BEV) in RAS mutated (RASm) second-line (2L) advanced/metastatic colorectal cancer (mCRC)
Presenter: Andrew Hendifar, M.D., Assistant Professor of Medicine at Cedars-Sinai Medical Center and Study Principal Investigator
Onsite Poster Display Date: Sunday, October 22, 2023 at 9:00 AM CEST
Presentation Number: 646P

Conference Call and Webcast

Inspirna will host a virtual KOL panel on Sunday, October 22, 2023 at 6:30 PM CEST / 12:30 PM ET with Andrew Hendifar, M.D., to discuss these clinical data. The event may be accessed by registering at https://inspirna-esmo-2023-kol-panel.open-exchange.net/registration. A webcast of the event will be available on the "Events and Presentations" page of the Company's website at https://inspirna.com/news-events/. The archived webcast will be available on the Company's website within 24 hours after the event.

About Inspirna

Inspirna, Inc., is a privately-held clinical-stage biopharmaceutical company focused on the discovery and development of novel cancer drugs that target key pathways in cancers of high unmet need. The company is pursuing several first-in-class drug candidates. Inspirna's lead drug candidate, ompenaclid (RGX-202), is an orally-administered small molecule that targets the CKB/SLC6A8 pathway. This pathway becomes activated in the tumors of select patients where it enables the generation of the energy molecule ATP in response to tumor hypoxia. Ompenaclid is currently being tested in a Phase 1b/2 clinical trial in combination with standard-of-care FOLFIRI and bevacizumab for the second line treatment of patients with advanced or metastatic RAS mutant colorectal cancer.

Inspirna's second clinical stage drug candidate, abequolixron (RGX-104), is an oral small molecule activator of LXR/APOE that inhibits angiogenesis and tumor myeloid derived suppressor cells to enhance the immune response against tumors. Abequolixron is currently being tested in a Phase 1b/2 clinical trial in patients with advanced or metastatic lung cancer in combination with docetaxel and endometrial cancer in combination with ipilimumab through a clinical collaboration with Bristol Myers Squibb.

Inspirna identifies novel cancer targets using its microRNA-based target discovery platform, RNA-DRIVEr, which was originally developed by Inspirna's scientific co-founders at The Rockefeller University and exclusively licensed to Inspirna. The Company brings together distinguished scientific founders, a seasoned board of directors, and a leadership team comprised of experienced drug developers. The Company is funded by leading biotechnology investors, including Novo Holdings A/S, Sofinnova Partners, Sands Capital, Vivo Capital, Lepu Holdings Limited, Sixty Degree Capital, Silicon Valley Bank, K2 HealthVentures, Oceanpine Capital, WuXi PharmaTech Healthcare Fund I, LP, Alexandria Venture Investments, LLC, Dreavent 6, Exor Seeds, and the Partnership Fund for New York City. For more information, please visit https://inspirna.com/.