Merck, a prominent science and technology company, has recently entered into a licensing agreement with Inspirna, Inc. based in New York, NY, for ompenaclid (RGX-202), an innovative oral inhibitor targeting the creatine transport channel SLC6A8 and related compounds. Ompenaclid is currently undergoing Phase II evaluation for the second-line treatment of RAS-mutated (RASmut) advanced or metastatic colorectal cancer (mCRC).

Victoria Zazulina, MD, Head of Development Unit, Oncology for Merck, underscored the lack of significant innovation in the treatment of RAS-mutated CRC over the past decade, constituting approximately 45% of the second-line population. The licensing agreement with Inspirna offers a promising opportunity to advance a potential first-in-class therapy, ompenaclid, with encouraging early data that may enhance outcomes for patients.

Ompenaclid, the oral inhibitor of the creatine transport channel SLC6A8, demonstrated positive efficacy and safety in a Phase Ib/II study when combined with FOLFIRI and bevacizumab for second-line treatment of RASmut mCRC. Results from the 2023 ESMO Congress revealed a median progression-free survival of 10.2 months and median overall survival of 19.1 months across 41 patients with RASmut mCRC. Ompenaclid exhibited a well-tolerated profile, with no dose-limiting toxicities observed.

Inspirna has initiated a Phase II double-blind randomized controlled trial comparing ompenaclid versus placebo, both in combination with FOLFIRI and bevacizumab, for second-line RAS-mutant advanced or metastatic CRC.

The collaboration with Inspirna aligns with Merck's longstanding commitment to the colorectal cancer community, celebrating the 20th anniversary of ERBITUX® as a backbone treatment in mCRC. Merck is also actively involved in clinical trials evaluating ERBITUX® and developing M9140, a CEACAM5-targeting antibody-drug conjugate.

Dr. Usman “Oz” Azam, CEO of Inspirna, expressed excitement about partnering with Merck and the validation of ompenaclid's potential as a first-in-class therapy for advanced colorectal cancer.

Under the license agreement, Merck gains exclusive rights to ompenaclid outside the U.S. and an option to co-develop and co-promote it in the U.S. Inspirna will retain U.S. co-development and co-commercialization rights for its SLC6A8 follow-on compounds. An upfront payment of $45 million will be made to Inspirna, with additional milestone payments and royalties based on the development and sales of ompenaclid and follow-on compounds.

ERBITUX  is a monoclonal antibody targeting the epidermal growth factor receptor (EGFR) and has market authorization in over 100 countries for treating RAS wild-type metastatic colorectal cancer and squamous cell carcinoma of the head and neck. Merck obtained the right to market ERBITUX outside the U.S. and Canada in 1998.

 

Source: businesswire.com

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