Merck KGaA Darmstadt, Germany entered into a licensing agreement with Inspirna, Inc. for ompenaclid (RGX-202), a first-in-class oral inhibitor of the creatine transport channel SLC6A8, and SLC6A8-targeting follow-on compounds. Ompenaclid is currently being evaluated in a Phase II study for the second-line treatment of RAS-mutated (RASmut) advanced or metastatic colorectal cancer (mCRC).

Merck KGaA will receive an exclusive license to ompenaclid outside of the U.S. and an option to co-develop and co-promote ompenaclid in the U.S.

Inspirna will receive $45 million upfront and is eligible to receive milestone payments and royalties on sales outside of the U.S. Inspirna is eligible to also receive development, regulatory and sales milestones for each follow-on compound targeting SLC6A8 along with royalties on sales outside of the U.S.

Merck KGaA is developing M9140, a CEACAM5-targeting antibody-drug conjugate with an exatecan payload, which is currently being evaluated in an ongoing Phase Ia/b study in patients with 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, head, development unit, oncology for the healthcare business sector of Merck KGaA, Darmstadt, Germany. “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.”

Usman “Oz” Azam, CEO of Inspirna said, “We are excited to partner with Merck KGaA, Darmstadt, Germany, 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. 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 KGaA, Darmstadt, Germany, as we continue to evaluate ompenaclid in the ongoing Phase II randomized controlled trial.”