Kelonia Therapeutics has reached a significant milestone by dosing the first patient in its Phase 1 inMMyCAR clinical trial, which is evaluating KLN-1010, a novel in vivo CAR T-cell therapy for patients with relapsed and refractory multiple myeloma. This trial is particularly groundbreaking because it aims to make the benefits of CAR T-cell therapy more accessible to patients. Unlike traditional CAR T-cell treatments, which are highly complex and involve lengthy manufacturing processes and toxic pre-conditioning chemotherapy, KLN-1010 is designed to generate anti-BCMA CAR T-cells directly inside the patient's body with a single infusion. This approach could eliminate the need for extensive manufacturing and the toxic chemotherapy regimens, potentially making the therapy available at virtually any hospital worldwide and at a much faster pace.

The inMMyCAR study is an open-label, dose-escalation trial being conducted at multiple centers, starting with sites in Australia. Its primary objective is to assess the safety and tolerability of a single dose of KLN-1010 and to establish the recommended dose for a future Phase 2 trial. Secondary endpoints will evaluate preliminary efficacy and other pharmacological measures. The first patient was dosed at Royal Prince Alfred Hospital in Sydney, Australia. Both the lead investigator, Professor Simon Harrison, and the investigator who dosed the first patient, Professor Joy Ho, highlighted the transformative potential of in vivo CAR T-cell therapies for multiple myeloma patients, a disease characterized by drug resistance and high rates of relapse. They believe that this therapy offers a new and urgently needed option for patients who have exhausted other treatment options.

Kelonia's technology, known as the in vivo Gene Placement System (iGPS®), is at the heart of KLN-1010. This platform uses an advanced lentiviral vector to enable efficient and tissue-specific gene delivery directly within the body. By pioneering this approach, Kelonia hopes to revolutionize not only CAR T-cell therapies for blood cancers but also a wide range of other genetic medicines, with the ultimate goal of making them accessible to patients wherever and whenever they are needed. The successful dosing of the first patient represents a critical step toward validating this innovative approach and brings the company closer to its mission of transforming medicine.