Nexcella Announces Complete Response in 9th Relapsed/Refractory AL Amyloidosis Patient in NXC-201 Clinical Trial at IMS 20th Annual Meeting
100% (9/9) overall response rate and 67% (6/9) complete response rate (MRD 10-5) observed in heavily pre-treated patients with daratumumab relapsed/refractory AL Amyloidosis as of the September 20, 2023 data cutoff 100% (4/4) overall response rate and 75% (3/4) complete response rate observed in t(11;14) relapsed/refractory AL Amyloidosis Best responder duration of response was 19.2 […]
Nexcella Announces 72-Patient NXC-201 Clinical Data at the IMS 20th Annual Meeting, 95% Overall Response Rate in Multiple Myeloma
95% overall response rate observed in relapsed/refractory multiple myeloma patients not previously treated with BCMA-targeted therapy. Median progression free survival (mPFS) was 12.9 months as of the July 17, 2023 data cut-off 90% overall response rate observed in relapsed/refractory multiple myeloma at the therapeutic dose including patients with, and without prior BCMA-targeted therapy Class-Leading Response […]
U.S. Food and Drug Administration Approves Orphan Drug Designation for Nexcella NXC-201 as a Treatment for Amyloid Light Chain (AL) Amyloidosis
FDA Orphan Drug Designation (“ODD”) qualifies one-time treatment NXC-201 for: 7 years of U.S. market exclusivity after approval Tax credits for qualified clinical testing Waiver of the Prescription Drug User Fee (currently at almost $3 million for a new drug) The Amyloidosis market was $3.6 billion in 2017, expected to reach $6 billion in 2025, […]
Nexcella Completes 2nd NXC-201 Engineering Batch at its U.S. CAR-T Manufacturing Site
Successful completion supports expansion of its ongoing NEXICART-1 (NCT04720313) NXC-201 CAR-T clinical trial to the U.S. Plan for NXC-201 to expand into earlier lines of therapy, and beyond the 5% of U.S. hospitals that offer CAR-T today LOS ANGELES, Sept. 19, 2023 — Nexcella, Inc. (“Nexcella”, “Company”, “We” or “Us”), a clinical-stage biopharmaceutical company engaged […]
Nexcella to Present at the Bank of America 2023 Healthcare Trailblazers Private Company Conference
LOS ANGELES, Sept. 07, 2023 — Nexcella, Inc. (“Nexcella”, “Company”, “We” or “Us”), a clinical-stage biopharmaceutical company engaged in the discovery and development of novel cell therapies for oncology and other indications, today announced that Nexcella NXC-201 clinical data will be presented by Ilya Rachman MD PhD and Gabriel Morris at the Healthcare Trailblazers Private […]
Nexcella Announces Dr. Suzanne Lentzsch, Director of the Multiple Myeloma and Amyloidosis Program at the College of Physicians and Surgeons of Columbia University and at New York Presbyterian Hospital in New York, Joins Scientific Advisory Board
Dr. Lentzsch joins the Nexcella Scientific Advisory Board with decades of experience treating patients with AL Amyloidosis and multiple myeloma and serving as a principal investigator on clinical trials for novel agents. Dr. Lentzsch is an internationally recognized expert in multiple myeloma and AL Amyloidosis; Co-Chairs the National Cancer Institute Myeloma Steering Committee; is an […]
U.S. Food and Drug Administration Approves Orphan Drug Designation for NXC-201 as a Treatment for Multiple Myeloma
FDA Orphan Drug Designation (“ODD”) qualifies NXC-201 for: 7 years of U.S. market exclusivity after approval Tax credits for qualified clinical testing Waiver of the Prescription Drug User Fee (currently at almost $3 million for a new drug) The $13.9 billion Multiple Myeloma market in 2017 is expected to reach $28.7 billion in 2027 according […]
Nexcella Announces Dr. Heather Landau, Memorial Sloan Kettering Cancer Center Amyloidosis Program Director, Joins Nexcella Scientific Advisory Board
Dr. Landau joins the Nexcella Scientific Advisory Board with decades of hematology/oncology clinical trial experience at Memorial Sloan Kettering Cancer Center Dr. Landau is a recognized thought leader in CAR-T cell therapy, bone marrow and solid organ transplantation and novel treatment approaches to plasma cell disorders including AL Amyloidosis and Multiple Myeloma LOS ANGELES, Aug. […]
Nexcella Announces Additional NXC-201 AL Amyloidosis Clinical Data Accepted for Oral Presentation at the 20th International Myeloma Society Annual Meeting (September 27-30, Athens Greece)
LOS ANGELES, Aug. 16, 2023 — Nexcella, Inc. (“Nexcella”, “Company”, “We” or “Us”), a clinical-stage biopharmaceutical company engaged in the discovery and development of novel cell therapies for oncology and other indications, today announced that additional NXC-201 clinical data for relapsed/refractory AL Amyloidosis has been selected for oral presentation at the 20th International Myeloma Society […]
Nexcella Announces NXC-201 Multiple Myeloma Clinical Data Abstract Accepted for Presentation at the 20th International Myeloma Society Annual Meeting
Updated clinical data for next-generation CAR-T NXC-201 in relapsed/refractory Multiple Myeloma will be presented in Athens September 27-30, 2023 LOS ANGELES, July 25, 2023 — Nexcella, Inc. (“Nexcella”, “Company”, “We” or “Us”), today announced that updated NXC-201 relapsed/refractory multiple myeloma clinical data has been selected for presentation at the upcoming 20th International Myeloma Society Annual […]