Orphan Drug Status Granted to Promising Mesothelioma Drug

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Published on September 29, 2022

Days after being approved for its first-in-human trials, Verismo’s SynKIR-110 immunotherapy drug has been granted orphan drug designation for the treatment of patients with mesothelin-expressing mesothelioma. The designation provides special financial incentives to drug companies, and is reserved for medications designed to treat conditions that are so rare that drug development would otherwise be financially untenable. 

SynKIR-110 is First-In-Class T-Cell Immunotherapy Candidate for Mesothelioma

SynKIR-110 uses a modified natural killer-like receptor platform that specifically targets solid tumors like those of malignant mesothelioma. Laboratory testing has demonstrated improved persistence and effectiveness of the drug, which uses a dual-chain CAR T-cell therapy. 

Speaking of being granted the orphan drug designation, Verismo Chief Executive Officer Bryan Kim, DMD, said, “Mesothelioma is a rare and deadly disease for which few other treatment options currently exist. We look forward to working with the mesothelioma community to advance SynKIR-110 as a potential treatment while we continue to expand clinical investigation of this novel platform in other cancers in the solid tumor space.”

Lab Testing of Mesothelioma Drug Showed Promise

Though the drug has not yet been tested on humans with mesothelioma, the U.S. Food and Drug Administration recently approved a first-in-human trial following preclinical models that demonstrated that it maintained antitumor T-cell activity in challenging tumor environments. Importantly, the platform can be combined with other innovative cancer treatments, including in vivo gene editing and combination therapies.

In addition to testing the drug on patients with malignant mesothelioma, the FDA has approved SynKIR-110’s testing on patients with mesothelin-expressing ovarian cancer and cholangiocarcinoma. Those tests are slated to begin in early 2023. 

The FDA’s granting of orphan drug designation for this type of innovative mesothelioma treatment provides hope for those who have been diagnosed with malignant mesothelioma. For information on other resources and treatment options, contact the Patient Advocates at Mesothelioma.net today at 1-800-692-8608.

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Written by Terri Oppenheimer

Terri Heimann Oppenheimer

Terri Heimann Oppenheimer is the head writer of our Mesothelioma.net news blog. She graduated from the College of William and Mary with a degree in English. Terri believes that knowledge is power and she is committed to sharing news about the impact of mesothelioma, the latest research and medical breakthroughs, and victims’ stories.

Learn more about and contact Terri