Merck has recently entered into a licensing agreement with Inspirna, Inc. for ompenaclid (RGX-202), a groundbreaking oral inhibitor of the creatine transport channel SLC6A8, along with SLC6A8-targeting follow-on compounds.
The focus of ompenaclid is currently on a Phase II study, evaluating its efficacy as a second-line treatment for RAS-mutated (RASmut) advanced or metastatic colorectal cancer (mCRC).
“Over the past decade, the treatment paradigm for patients with RAS-mutated CRC, accounting for approximately 45% of the second-line population, has not seen major innovation,” said Victoria Zazulina, MD, Head, Development Unit, Oncology for the Healthcare business sector of Merck. “With our expertise in the treatment of CRC, and based on the encouraging early data for ompenaclid, this agreement with Inspirna offers the opportunity to advance a potential new first-in-class therapy that may improve outcomes for patients.”
Ompenaclid, an oral inhibitor of the creatine transport channel SLC6A8, demonstrated encouraging efficacy and safety in a Phase Ib/II study. Combining ompenaclid with FOLFIRI and bevacizumab showed promising results in the second-line treatment of RASmut mCRC.
Presented at the 2023 European Society for Medical Oncology (ESMO) Congress, data revealed a median progression-free survival of 10.2 months and median overall survival of 19.1 months across 41 patients with RASmut mCRC. Inspirna initiated a Phase II randomized controlled trial comparing ompenaclid to placebo plus FOLFIRI and bevacizumab.
Merck's commitment to the colorectal cancer community is evident through its longstanding involvement, with ERBITUX® being a backbone treatment for mCRC for two decades. The company is also actively developing M9140, a CEACAM5-targeting antibody-drug conjugate. This compound is currently under evaluation in an ongoing Phase Ia/b study in patients with mCRC.
“We are excited to partner with Merck, a leader in the oncology field with global drug development and commercial expertise in colorectal cancer specifically, to help bring our novel therapies to more patients in need,” said Dr. Usman “Oz” Azam, MD, Chief Executive Officer of Inspirna. “The data to date validates our belief in ompenaclid as a potential first-in-class therapy for advanced colorectal cancer and underscores the power of our proprietary target discovery platform RNA-DRIVEr™. We look forward to working closely with Merck as we continue to evaluate ompenaclid in the ongoing Phase II randomized controlled trial.”
The license agreement outlines that Merck will obtain exclusive rights to ompenaclid outside the United States, with an option to co-develop and co-promote it in the US. Additionally, both parties will collaborate on Inspirna’s SLC6A8 follow-on compounds, with Inspirna retaining US co-development and co-commercialization rights.
Inspirna will receive an upfront payment of $45 million, with potential milestone payments based on development and sales achievements. For ompenaclid, Inspirna may receive milestone payments and tiered royalty rates in the low teens on net sales outside the US.
