Merck KGaA, Darmstadt, Germany, has entered into a licensing agreement with Inspirna, Inc., New York, for the development of ompenaclid (RGX-202), an inventive oral inhibitor targeting the creatine transport channel SLC6A8, and related follow-on compounds. Ompenaclid is under evaluation in a Phase II study for the second-line treatment of RAS-mutated advanced or metastatic colorectal cancer (mCRC).

Victoria Zazulina, MD, Head of Development Unit, Oncology at Merck KGaA, highlighted the lack of significant innovation in treating RAS-mutated CRC, which affects a significant portion of the second-line patient population. The collaboration with Inspirna offers an opportunity to improve patient outcomes with a potential new first-in-class therapy.

The efficacy and safety data of ompenaclid, in combination with FOLFIRI and bevacizumab, presented at the 2023 European Society for Medical Oncology (ESMO) Congress, showed promising results. With these findings, Inspirna has begun a Phase II double-blind, randomized trial for second-line RAS-mutant mCRC with ompenaclid versus placebo with FOLFIRI and bevacizumab.

The partnership between Inspirna and Merck KGaA is part of Merck’s longstanding commitment to the colorectal cancer community, a commitment reflected in their marketing of ERBITUX® and the development of M9140, a CEACAM5-targeting antibody-drug conjugate in Phase Ia/b study in patients with mCRC.

Dr. Usman “Oz” Azam, MD, CEO of Inspirna, expressed enthusiasm for the partnership, which is expected to leverage their proprietary target discovery platform, RNA-DRIVEr™. They aim to work closely with Merck KGaA to bring ompenaclid, a potential first-class therapy, to patients with advanced colorectal cancer.

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Ferry Darma
Ferry Darma is Director of Media Relations at The Clinical Trial Vanguard. Ferry, a computer data scientist, focuses on the latest clinical trial industry news and trends.