As a result, Merck will receive an exclusive license to ompenaclid outside of the U.S. and an option to co-develop and co-promote ompenaclid in the US.
Inspirna will receive an upfront payment of $45 million, with additional milestone payments upon development and sales targets.
“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, 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 is a first-in-class oral inhibitor of the creatine transport channel SLC6A8.
An earlier study of the drug, in combination with FOLFIRI and bevacizumab, showed ‘encouraging’ efficacy and safety for second-line treatment of RASmut mCRC.
Results presented at the 2023 European Society for Medical Oncology (ESMO) Congress showed that median progression-free survival was 10.2 months and median overall survival was 19.1 months across all 41 patients with RASmut mCRC.
According to Merck, its latest collaboration with Inspirna builds on the company’s long-standing commitment to the colorectal cancer community, particularly the heritage of mCRC treatment ERBITUX, for which Merck has marketing rights outside the U.S. and Canada.
“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 Azam, CEO 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 2 randomized controlled trial.”