OL-101 / Overland Therapeutics - LARVOL DELTA

OL-101, a BCMA/GPRC5D dual-targeting autologous CAR-T for relapsed/ refractory multiple myeloma (R/R MM): Results from a Phase I study (ASH 2025) - P1 | "We report preliminary data from an ongoing phase I, first-in-human, dose-escalation and dose-expansion study (NCT06644118). Patients with R/R MM who had received ≥3 prior lines of therapies underwent standardlymphodepletion (fludarabine/cyclophosphamide) followed by a single OL-101 infusion at 3 dose levels(DL1: 1.0×106, DL2: 2.0×106, DL3: 1.5×106 cells/kg)...At the 2.0×106 cells/kg dose level, 1 of 6 patientsexperienced a DLT, manifested as grade 4 CRS with onset on Day 3 post-infusion, which resolved by Day17 following treatment with tocilizumab, steroids, plasma exchange and other supportive care... OL-101, a novel bispecific BCMA/GPRC5D VHH CAR-T, demonstrates promising efficacy (100%ORR, 100% MRD negativity) and manageable safety (CRS manageable, no ICANS) in heavily pretreated,triple-class exposed R/R MM patients, with no new safety signals identified than those with previouslyreported BCMA or GPRC5D targeting CAR-T cells. Notably,..."

IO biomarker • P1 data • Hematological Disorders • Hematological Malignancies • Infectious Disease • Inflammation • Multiple Myeloma • Neutropenia • Plasmacytoma • Thrombocytopenia • GPRC5D

Rapid emergence, transmission, and evolution of KPC and NDM coproducing carbapenem-resistant Klebsiella pneumoniae. (PubMed, Microbiol Res) - "The outbreak was sustained by ST11-KL47-OL101 KPC-2-NDM-5-CRKPs, which exhibited non-susceptible to all antimicrobials available in mainland China...Phylogenetic evaluation was carried out with a total of 327 KPC-NDM-CRKP genomes to provide a global perspective on such strains, and potential transmission events in other global regions were also observed during the COVID-19 period. The outbreak of such strains in the real world and the co-transfer of blaKPC and blaNDM would exacerbate the dispersal of KPC-NDM-CRKPs, which poses a severe threat to public health."

Journal • Infectious Disease • Novel Coronavirus Disease • Pneumonia

Clinical and genomic characterization of Klebsiella pneumoniae infections in Dhaka, Bangladesh. (PubMed, J Glob Antimicrob Resist) - "Our findings suggest alarming levels of AMR among Kpn isolates in Bangladesh and a critical need for improved treatment modalities and vaccine development."

Journal • Infectious Disease • Nephrology • Pneumonia • Respiratory Diseases • Septic Shock

Genomics of Klebsiella pneumoniae and Escherichia coli in pediatric infectious diseases in Pakistan (ASTMH 2024) - "40 distinct K-loci were identified, of which predominant K-loci included KL81 (n=13, 12.6%) & KL64 (n=11, 10.6%); 10 distinct O-loci were identified, predominant O-loci included O1/O2v2 (n=29, 28.1%), O1/02v1 (n=25, 24.2%), & OL101 (n=18, 15.3%)... This study underscores need for vaccines targeting Klebsiella pneumoniae and Escherichia coli , significant contributors to neonatal sepsis and MDR. Genome sequencing can help identify patterns related to virulence and factors that contribute to immunity or successful vaccine response"

Clinical • Late-breaking abstract • Infectious Disease • Pediatrics • Pneumonia • Septic Shock