On November 30, 2021 Athenex, Inc., (NASDAQ: ATNX), a global biopharmaceutical company dedicated to the discovery, development, and commercialization of novel therapies for the treatment of cancer and related conditions, reported that it will host a virtual key opinion leader (KOL) event on its CAR-NKT technology on Monday, December 13th, at 9:00 am ET (Press release, Athenex, NOV 30, 2021, View Source [SID1234596245]).
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The webinar will feature presentations by KOLs Leonid Metelitsa, M.D., and Carlos Ramos, M.D., both from Baylor College of Medicine, and Sattva Neelapu, M.D., from MD Anderson Cancer Center. Dr. Metelitsa will provide an overview of Athenex’s CAR-NKT cell-based approaches. Dr. Ramos will discuss the interim data from the ongoing ANCHOR study evaluating KUR-502 in relapsed or refractory lymphoma and leukemia. These data will also be featured in a poster presentation at the American Society of Hematology (ASH) (Free ASH Whitepaper) Annual Meeting and Exposition, being held from December 11th to December 14th. Dr. Neelapu will discuss the current treatment landscape and unmet medical needs in lymphoma/myeloma.
Presentations from Kurt Gunter, M.D., Chief Medical Officer for Cell Therapy at Athenex, and Daniel Lang, M.D. President, Athenex Cell Therapy, will follow. Dr. Gunter will discuss clinical milestones and company objectives.
A question-and-answer session will follow the formal presentations. To register for the webinar, please click here.
Presenting Key Opinion Leaders:
Dr. Carlos Ramos is currently an Associate Professor of Medicine in the Center for Cell and Gene Therapy at the Baylor College of Medicine, and an Attending Physician in the Blood and Marrow Transplantation Service at the Houston Methodist Hospital. As a faculty member, he has focused his research efforts on T-cell therapy for malignancies and viral infections. He has broad experience in cellular therapy for hematologic cancers, being the principal investigator in trials using chimeric antigen receptor (CAR)-modified T cells targeting CD19, CD30 and kappa light chain as therapy for non-Hodgkin and Hodgkin lymphoma and multiple myeloma. He is also implementing cellular therapy approaches for patients with Human Papilloma Virus (HPV)-associated malignancies, using HPV-specific T cells. Dr. Ramos earned his Medical Degree with Honors from the University of Lisbon, Portugal, and was a Resident in Internal Medicine at the Baylor College of Medicine, in Houston. He completed Fellowships in Hematology and Medical Oncology at the Memorial Sloan-Kettering Cancer Center, in New York, and in Blood and Marrow Transplantation at the University of Texas M. D. Anderson Cancer Center, in Houston.
Dr. Leonid Metelitsa is involved in research focused on understanding the role of Vα24-invariant natural killer T cells (iNKTs) in tumor immunity. Using clinical samples from neuroblastoma patients, his lab demonstrated for the first time that iNKTs localize to primary tumors and their presence at the tumor site is associated with good outcome. In the pursuit of the underlying mechanistic basis for the observed association between iNKTs and clinical outcome, Dr. Metelitsa’s group has published a series of high-impact papers that revealed the mechanisms of iNKT cell tumor localization and function in the tumor microenvironment. In one of these studies, they discovered the mechanism by which iNKTs attack tumor-associated macrophages (TAMs). That study has had a major impact in the fields of NKT cell and neuroblastoma research. First, it explained how iNKTs can mediate antitumor activity against CD1d-negative tumors, the majority of solid tumors in humans. Second, it showed for the first time that macrophages infiltrate primary tumors in a subset of neuroblastoma patients, their products directly support tumor growth, and their presence at the tumor site is associated with poor clinical outcome. This discovery has been validated in large international study validated using large independent cohorts of patients, concluding that the presence of M2-like macrophages is associated with a novel inflammatory signature in neuroblastoma that serves as an independent prognostic factor of extremely poor outcome. Most recently, Dr. Metelitsa has been focused on the development of therapeutic applications using iNKTs and their synthetic ligands.
Dr. Sattva Neelapu is professor and deputy chair of Lymphoma and Myeloma at The University of Texas MD Anderson Cancer Center in Houston, Texas. As a physician-scientist at MD Anderson, Dr. Neelapu is focused on clinical and translational development of novel immunotherapies for B-cell malignancies. His laboratory characterized some of the major immunosuppressive mechanisms in the tumor microenvironment of B-cell malignancies, identified TCL1 as a novel shared tumor-associated antigen for B-cell lymphomas, and investigated novel targets for CAR T-cell therapy in lymphoma and myeloma. His work on the pivotal trial of axicabtagene ciloleucel CD19 CAR T-cell therapy in aggressive B-cell lymphomas led to its FDA approval as the first CAR T therapy for lymphoma. Dr. Neelapu has authored or co-authored over 150 publications.
Presenting Athenex Cell Therapy Management:
Dr. Dan Lang has over 25 years of medicine, healthcare investment as well as leadership and business experience. Prior to joining Athenex, Dan was the Chief Investment Officer of the RS Value franchise focused on domestic equity strategies. Dan was on the executive team of RS Investment Management (RSIM) that led the sale of RSIM to Victory Capital in 2016. Prior to joining RSIM in 2009, he was an analyst at Farallon Capital Management covering biotech, medical device, pharma, and healthcare services globally. Previously, he was a senior associate at a venture capital firm, Brilleon Capital and the co-founder and CFO of Sapient Medical Group. Dan’s 25+ years of business and investment experience is preceded by a distinguished career in medicine. He was a post-doctoral research and clinical fellow in cardiology at the University of California, San Francisco and the Gladstone Cardiovascular Research Institute. He was board certified in internal medicine and a Chief Medical Resident at Mount Sinai Hospital in New York. Dan holds a BA in Chemistry from Cornell University and an MD from Cornell University Medical College.
Dr. Kurt Gunter has devoted his career to the development of cell and gene therapies and brings significant experience to Athenex from his previous positions at Kuur Therapeutics, Hospira, ViaCell, and Transkaryotic Therapies. As past President of the International Society for Cellular Therapy (ISCT), Dr. Gunter played a worldwide leadership role in promoting understanding of the clinical, regulatory, manufacturing, and marketing requirements for the successful development of cell and gene therapies. Prior to his biotech career, he worked at the United States Food and Drug Administration as a Medical Officer in the Center for Biologics and was appointed Acting Deputy Director of the Division of Cell and Gene Therapy within the Center for Biologics Evaluation and Research. He also served for 5 years on FDA’s Cellular, Tissue and Gene Therapies Advisory Committee. He earned his MD from the University of Kansas and also has a BS in biological sciences, with distinction, from Stanford University. His postdoctoral training included Johns Hopkins and the US National Institutes of Health.
ASH Poster Presentation:
Session Name: 704. Cellular Immunotherapies: Clinical: Poster II
Date: Sunday, December 12, 2021
Presentation Time: 6:00 PM – 8:00 PM
Location: Georgia World Congress Center, Hall B5
About the Phase I Study of KUR-502 (Allogeneic CD19 CAR-NKT Cells) in Patients with Relapsed or Refractory B-Cell Malignancies (ANCHOR)
The phase I study is an open-label, dose-escalation study. NKT cells were isolated from the leukapheresis product of one HLA-unmatched healthy individual, transduced with the CAR, expanded ex vivo for 14 days (99.8% NKT purity), and cryopreserved. Patients received 107 (DL 1) or 3×107 (DL 2) CAR-NKT cells per square meter of body surface area following lymphodepleting conditioning with cyclophosphamide/fludarabine. Adverse events were evaluated per NCI criteria. When accessible, patients underwent core biopsies of an involved site at 2-5 weeks post-infusion. Response to therapy was assessed at 4 weeks per Lugano Criteria (for NHL) or NCCN guidelines (for ALL).
For further information about the study, visit ClinicalTrials.gov, identifier: NCT03774654.