U.S. IND represents the second regulatory clearance for KLN-1010 and enables the first multi-center clinical trial in the U.S. for an anti-BCMA in vivo CAR-T program

Kelonia Therapeutics, Inc., a clinical-stage biotechnology company pioneering in vivo gene delivery, today announced that the U.S. Food and Drug Administration (FDA) has cleared the Investigational New Drug (IND) application for KLN-1010 for the treatment of patients with relapsed and refractory multiple myeloma.

KLN-1010 is a novel in vivo gene therapy designed to generate anti-BCMA CAR-T cells directly within patients following a single infusion, without the requirement of preparative chemotherapy or bespoke CAR-T cell manufacturing. FDA clearance of the IND enables Kelonia to expand its ongoing inMMyCAR™ Phase 1 clinical trial, which is currently enrolling patients in Australia, to multiple clinical sites across the United States.

“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.”

About KLN-1010

KLN-1010 is an investigational in vivo gene therapy that generates anti-BCMA CAR-T cells, targeting the BCMA protein expressed on the surface of multiple myeloma cells. Unlike traditional CART treatments, KLN-1010 is administered to patients via direct infusion and is designed to generate durable CART cells inside the body after a single dose, potentially eliminating the need for long wait times to receive treatment. This may overcome several limitations faced by current CAR-T approaches, including limited access to treatment and the requirement of preconditioning chemotherapy.

About inMMyCAR

inMMyCAR is a Phase 1, open-label, dose-escalation clinical trial designed to assess the safety, tolerability, pharmacology and preliminary efficacy of a single dose of KLN-1010 in up to 40 patients. The primary endpoints are incidence and severity of treatment-emergent adverse events (TEAEs), including dose limiting toxicities (DLTs), and to establish the recommended Phase 2 dose of KLN-1010. Additional information and study site information may be found on clinicaltrials.gov (NCT07075185).

About Relapsed and Refractory Multiple Myeloma

Multiple myeloma is a hematologic malignancy characterized by the proliferation of plasma cells in the bone marrow, leading to bone destruction, anemia, renal dysfunction, and immunosuppression. It is driven by complex genetic and epigenetic alterations that promote malignant cell survival and resistance to apoptosis. Relapsed and refractory multiple myeloma is characterized by clonal evolution, drug resistance, and increased disease heterogeneity, heightening the need for accessible, personalized therapeutic strategies.

About Kelonia Therapeutics

Kelonia Therapeutics is a clinical-stage biotechnology company pioneering a new wave of genetic medicines using its in vivo gene placement system (iGPS^®). Kelonia’s elegant, cutting-edge in vivo gene delivery technology uses an advanced lentiviral vector particle harboring envelope modification to improve in vivo gene transfer efficiency and tropism molecules to facilitate tissue-specific delivery. Kelonia is building a pipeline of genetic medicines across a range of diseases, with the bold goal of making CAR-T cell therapies accessible to every patient in need, when and where they need them. Kelonia’s lead candidate, KLN-1010, is an in vivo anti-BCMA CAR-T therapy for multiple myeloma being evaluated in a Phase 1 clinical trial.

Learn more at keloniatx.com and follow Kelonia on LinkedIn and X.

Kelonia, iGPS, and inMMyCAR are trademarks of Kelonia Therapeutics, Inc.

View source version on businesswire.com: https://www.businesswire.com/news/home/20260107179212/en/