BOSTON — Kelonia Therapeutics announced that the U.S. Food and Drug Administration has cleared the company’s Investigational New Drug application for KLN-1010, an in vivo BCMA-directed CAR-T therapy being developed for patients with relapsed and refractory multiple myeloma.
The U.S. IND clearance represents the second regulatory authorization for KLN-1010 and enables Kelonia to initiate the first multi-center clinical trial in the United States for an anti-BCMA in vivo CAR-T program. The clearance allows the company to expand its ongoing inMMyCAR Phase 1 clinical trial, which is currently enrolling patients in Australia, to multiple clinical sites across the U.S.
KLN-1010 is designed to generate anti-BCMA CAR-T cells directly inside patients following a single infusion, without the need for preparative chemotherapy or individualized CAR-T cell manufacturing. Kelonia said this in vivo approach is intended to simplify treatment delivery and broaden patient access compared with conventional CAR-T therapies.
“This IND clearance is an important milestone for KLN-1010 and for the broader field of in vivo CAR-T therapy,” said Kevin Friedman, Ph.D., chief executive officer and founder of Kelonia. “Last month, we presented initial safety and efficacy data from the first four patients treated in our Phase 1 study, all of whom achieved MRD-negative responses at one month, with durability extending through three months in the patients with the longest follow-up. The FDA’s clearance allows us to accelerate enrollment across multiple geographies and brings us a meaningful step closer to our goal of democratizing CAR-T therapies for patients with multiple myeloma.”
Kelonia said the expansion of the Phase 1 program into the United States will support broader evaluation of KLN-1010’s safety, tolerability, and early signs of clinical activity in patients with relapsed and refractory multiple myeloma. (Source: IANS)
