On January 4, 2024 Inspirna, Inc., a clinical stage biopharmaceutical company developing first-in-class cancer therapeutics, reported a licensing agreement with Merck KGaA, Darmstadt, Germany, for ompenaclid (RGX-202), a first-in-class oral inhibitor of the creatine transport channel SLC6A8, currently in development for RAS mutated (RASm) second-line (2L) advanced or metastatic colorectal cancer (mCRC) and SLC6a8 targeting follow-on compounds (Press release, Inspirna, JAN 4, 2024, View Source [SID1234638974]).
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"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," said Dr. Usman "Oz" Azam, M.D., Chief Executive Officer 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 KGaA, Darmstadt, Germany, as we continue to evaluate ompenaclid in a Phase 2 randomized controlled trial."
"Over the past decade, the treatment paradigm for patients with RAS-mutated CRC, accounting for approximately 45% of second-line population, has not seen major innovation," said Victoria Zazulina, M.D., Head, Development Unit, Oncology for the Healthcare business 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."
Under the terms of the license agreement, Merck KGaA, Darmstadt, Germany will receive an exclusive license to ompenaclid outside of the United States and an option to co-develop and co-promote ompenaclid in the US. Furthermore, the parties agreed to collaborate on Inspirna’s SLC6A8 follow-on compounds for which Inspirna will retain US co-development and co-commercialization rights. Inspirna will receive an upfront payment of $45 million. Upon the achievement of certain development and sales milestones for ompenaclid, Inspirna is eligible to receive milestone payments with tiered royalty rates in the low teens on net sales outside of the US. Inspirna is eligible to also receive development, regulatory and sales milestone payments for each follow-on compound targeting SLC6A8 along with up to double-digit royalties on net sales outside of the US.
Inspirna most recently presented clinical data from the Phase 1b/2 study of ompenaclid in combination with FOLFIRI and bevacizumab at the European Society for Medical Oncology (ESMO) (Free ESMO Whitepaper) Congress in October 2023. Results as of the September 18, 2023 data cutoff showed encouraging efficacy and safety data, including a median progression-free survival of 10.2 months and median overall survival of 19.1 months across all 41 patients with 2L RASm mCRC. Of the 30 evaluable patients for response, the objective response rate was 37%, with 11 partial responses. Ompenaclid was well-tolerated, with no dose-limiting toxicities observed in the dose-escalation cohort and combination safety profile comparable to FOLFIRI plus bevacizumab backbone treatment.
Inspirna has initiated a Phase 2 double-blind randomized controlled trial in 2L RAS mutant advanced or metastatic mCRC comparing ompenaclid versus placebo plus FOLFIRI and bevacizumab.