Merck expands colorectal cancer portfolio with ompenaclid

Business agreement

Merck has agreed a deal with Inspirna 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).

“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.”

Ompenaclid is a first-in-class oral inhibitor of the creatine transport channel SLC6A8. Data from the Phase Ib/II study of ompenaclid 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, as of the September 2023 data cutoff, median progression-free survival was 10.2 months and median overall survival was 19.1 months across all 41 patients with RASmut mCRC.

Of the 30 patients evaluable for response, the objective response rate was 37%, with 11 partial responses.

Inspirna has initiated a Phase II double-blind randomised controlled trial in second-line RAS-mutant advanced or metastatic CRC comparing ompenaclid versus placebo plus FOLFIRI and bevacizumab.

Merck already has marketing rights outside the US and Canada for IgG1 monoclonal antibody Erbitux for mCRC. The company is also developing M9140, a CEACAM5-targeting antibody-drug conjugate with an exatecan payload currently being evaluated in an ongoing Phase Ia/b study in patients with mCRC.

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