Company also announces Fast Track Designation from FDA for investigational candidate KLN-1010 in relapsed and refractory multiple myeloma
BOSTON, Mass., May 21, 2026– Kelonia Therapeutics, Inc., a clinical-stage biotechnology company pioneering in vivo gene delivery, today announced new clinical data from the company’s Phase 1 inMMyCAR (NCT07075185) study of its investigational in vivo gene therapy in relapsed and refractory multiple myeloma, KLN-1010, will be presented at the upcoming 2026 American Society of Clinical Oncology (ASCO) Annual Meeting, taking place May 29-June 2 in Chicago, Illinois. Additionally, the company will present clinical data at the European Hematology Association (EHA) 2026 Congress, taking place June 11-14 in Stockholm, Sweden.
The company also announced that the U.S. Food and Drug Administration (FDA) has granted Fast Track designation for KLN-1010 in relapsed and refractory multiple myeloma.
KLN-1010 was developed through Kelonia’s in vivo gene placement system (iGPS) platform and is 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 manufacturing. The ongoing inMMyCAR study is assessing the safety and preliminary efficacy of KLN-1010.
“We are thrilled to present our latest clinical data on KLN-1010 at these two important medical meetings,” said Kevin Friedman, Ph.D., Chief Executive Officer and Founder of Kelonia. “With KLN-1010, Kelonia is beginning to realize the potential of democratizing CAR-T cell therapy. Our dataset is growing quickly, with accelerating patient accrual in both the United States and Australia, and we are excited about the opportunity to advance an off-the-shelf therapy designed to improve both the patient experience, by removing the traditional burdens of CAR-T therapy, and the patients’ ease of access to these medicines. The FDA’s Fast Track designation is further support for our efforts toward that vision for patients.”
Fast track is a process designed to facilitate development and expedite the review of therapeutics to treat serious conditions and fill an unmet medical need. The purpose is to get important new therapies to patients earlier. Investigational drug candidates that received Fast Track designation are eligible for more frequent communications with the FDA and, if relevant criteria are met, Accelerated Approval and Priority Review.¹
Lilly’s proposed acquisition of Kelonia Therapeutics was previously announced and is pending transaction close.
Details for the presentations at the 2026 ASCO Annual Meeting and EHA 2026 Congress are as follows:
2026 ASCO Annual Meeting
Rapid Oral Presentation
Title: Updated results from inMMyCAR, the ongoing first-in-human phase 1 study of KLN-1010 in patients (pts) with relapsed and refractory multiple myeloma (RRMM)
Session: Hematologic Malignancies—Plasma Cell Dyscrasia
Presenter: ProfessorP. Joy Ho, MBBS (Hons), D.Phil (Oxon), FRACP, FRCPA, FFSc (RCPA), inMMyCAR Investigator and Director of Research, Royal Prince Alfred Hospital, Sydney Australia
Date and Time: Sunday, May 31, 9:45am – 11:15am CDT / 10:45am – 12:15pm EDT
EHA 2026 Congress
Oral Presentation
Title: Successful in vivo CAR-T generation and minimal residual disease (MRD) clearance with KLN-1010 across diverse baseline T cell phenotypes in relapsed/refractory multiple myeloma (RRMM)
Session: T cell redirected therapy in multiple myeloma
Presenter: Professor Andrew Spencer, MBBS, FRACP, FRCPA, DM, inMMyCAR Investigator and Head of Myeloma Research, The Alfred Hospital, Melbourne, Australia
Date and Time: Thursday, June 11, 4:45pm – 6:00pm CEST / 10:45am – 12:00pm EDT
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 CAR-T treatments, KLN-1010 is administered to patients via direct infusion and is designed to generate durable CAR T-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. 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. For more information, please visit: https://www.keloniatx.com/.
Kelonia, iGPS, and inMMyCAR are trademarks of Kelonia Therapeutics, Inc.
References
1 U.S. Food and Drug Administration website accessed May 19, 2026, link https://www.fda.gov/patients/fast-track-breakthrough-therapy-accelerated-approval-priority-review/fast-track
Contact
Joe Tierney
jtierney@keloniatx.com