ALVR109 / Kalaris Therapeutics - LARVOL DELTA

Allogeneic, Off-the-Shelf, SARS-CoV-2-specific T cells (ALVR109) for the treatment of COVID-19 in high risk patients. (PubMed, Haematologica) - P1 | "The feasibility of making and safely utilizing such VSTs clinically was assessed by administering partially HLAmatched, third-party, cryopreserved SARS-CoV-2-specific T cells (ALVR109) in combination with other antiviral agents to 4 individuals who were hospitalized with COVID-19. In conclusion, this study establishes the feasibility of preparing and delivering off-the-shelf SARS-CoV-2-directed VSTs to patients with COVID-19 and supports the clinical use of VSTs outside of the profoundly immune compromised setting (ClinicalTrials.gov number, NCT04401410)."

Journal • Infectious Disease • Novel Coronavirus Disease • Respiratory Diseases

SUCCESSFUL TREATMENT OF REFRACTORY COVID19 WITH “SARS-COV2 SPECIFIC OFF-THE-SHELF T CELLS (VST)” IN A HEMATOLOGIC MALIGNANCY (HM) AND AN ALLOGENEIC HEMATOPOIETIC CELL TRANSPLANT (HCT) PATIENT (EBMT 2023) - " Patient 1 – 74-year-old, male, had Juno CD-19 CAR-T in March 2019 for CLL, complicated by pure red cell aplasia refractory to rituximab, cyclosporine, and antithymocyte globulin. COVID19 was diagnosed in May 2022, treated with nirmatrelvir/ ritonavir for 5 days, followed by remdesivir in June for 10 days...Patient 2 – 48-year-old male had allogenic HCT in October 2015 complicated by severe cGVHD treated with ruxolitinib, extracorporeal photopheresis, prednisone 10 mg/ daily, tacrolimus and sirolimus... In our patients, ALVR109 was well tolerated and effective. Adjunctive therapy with ALVR109 is an attractive therapeutic option in treatment of COVID19 infections in severely immunocompromised patients with defective B and T cell immunity and should be explored as an upfront therapeutic option to prevent progression to LRTI and in the setting of refractory illness."

Clinical • Chronic Graft versus Host Disease • Graft versus Host Disease • Hematological Disorders • Hematological Malignancies • Infectious Disease • Novel Coronavirus Disease • Oncology • Pneumonia • Respiratory Diseases • Transplantation • CD19

Early Clinical Experience With Alvr109, A Partially Hla-matched Sars-cov-2 Specific T-cell Therapy, In Immunocompromised Patients With Covid-19 (ATC 2022) - "Prior to ALVR109, pts 1 and 3 had progressive COVID-19 and ongoing SARS-CoV-2 viremia despite monoclonal antibodies (mABs) and remdesivir. This initial experience suggests a potential role of ALVR109 in the treatment of IC and tx pts with COVID-19. SARS-CoV-2-specific T-cells appear to be safe and may control viremia in IC pts. Larger studies are needed to confirm this observation, define the best candidates for ALVR109, and determine optimal timing of administration."

Clinical • Late-breaking abstract • Hematological Malignancies • Infectious Disease • Lymphoma • Novel Coronavirus Disease • Oncology • Respiratory Diseases • Transplantation

AlloVir Research Presented at the 2021 Transplantation & Cellular Therapy Meeting Digital Experience (Businesswire) - "These data are being presented in an oral presentation during the Transplantation & Cellular Therapy (TCT) Meeting of the American Society for Transplantation and Cellular Therapy (ASTCT) and the Center for International Blood & Marrow Transplant Research (CIBMTR)....A poster presentation at the conference demonstrated the in vitro effector and safety profile of ALVR109, an allogeneic, off-the-shelf investigational VST therapy designed to target SARS-CoV-2...A clinical trial evaluating these banked, off-the-shelf SARS-CoV-2 specific T cells has been initiated..."

Preclinical • Trial status • Infectious Disease • Novel Coronavirus Disease

Preclinical Data Demonstrate Anti-Viral Activity of AlloVir’s ALVR109, an Allogeneic, Off-the-Shelf SARS-CoV-2 Specific T Cell Therapy (Businesswire) - "Data presented in an oral presentation at the 62nd American Society of Hematology Annual Meeting; These data suggest the potential for using these cells to treat COVID-19 in hospitalized high-risk patients...The data show ALVR109 is comprised almost exclusively of CD3+ T cells, with a mixture of cytotoxic (CD8+) and helper (CD4+) T cells. T cells fight viruses in two ways – helper CD4+ T cells spur B cells and other immune defenders into action and killer CD8+ T cells seek out and destroy the virus. In preclinical assessments ALVR109 was Th1-polarized, polyclonal, polyfunctional and selectively able to kill viral antigen-expressing targets indicative of both the selectivity of these cells and potential for safe clinical use."

Preclinical • Infectious Disease • Novel Coronavirus Disease

AlloVir Reports Third Quarter 2020 Financial Results (GlobeNewswire) - "ALVR109 Program Highlights: Initial clinical trial manufacturing runs of ALVR109 have been released and the proof-of-concept clinical trial with ALVR109 has been initiated; Pre-clinical data on this program will be presented in an oral session at ASH and will be featured in the conference press program. ALVR106 Program Highlights....The POC clinical trial will now initiate in 2021 as the company is assessing the impact of the COVID-19 pandemic on the incidence, diagnosis and treatment of the respiratory viral infections which ALVR106 targets."

New trial • Preclinical • Trial status • Infectious Disease • Novel Coronavirus Disease

AlloVir Announces the FDA Clearance of Investigational New Drug Application (IND) for ALVR109 for the Treatment of High-Risk COVID-19 Patients (GlobeNewswire) - "Proof-of-concept clinical trial with ALVR109 to begin in Q42020; AlloVir...announced that the U.S. Food and Drug Administration (FDA) has cleared the Investigational New Drug application (IND) for ALVR109....'At AlloVir...we are working with a great sense of urgency to leverage our highly innovative virus-specific T-cell platform to advance ALVR109 into a proof-of-concept study in high-risk COVID-19 patients'....BCM submitted a complete response to the questions identified in the clinical hold and the FDA has removed the hold allowing the clinical study to start."

IND • New trial • Infectious Disease • Novel Coronavirus Disease