Nexcella Completes Initial NXC-201 Engineering Batch at its U.S. CAR-T Manufacturing Site
Supports planned expansion of its ongoing NEXICART-1 (NCT04720313) NXC-201 CAR-T clinical trial to the U.S. LOS ANGELES, July 10, 2023 — Nexcella, Inc. (“Nexcella”, “Company”, “We” or “Us”), today announced the completion of its initial CAR-T NXC-201 engineering batch at its U.S. manufacturing site. This represents an important step forward in the planned U.S. expansion […]
Nexcella Completes Pre-IND Meeting with FDA on NXC-201 US Clinical Trial
LOS ANGELES, June 26, 2023 — Nexcella, Inc. (“Nexcella”, “Company”, “We” or “Us”), a biopharmaceutical company pioneering cell therapies targeting oncology and other diseases, today announced it has completed a Pre-Investigational New Drug (“Pre-IND”) meeting with the FDA. The subject of the Pre-IND meeting was planned NXC-201 US manufacturing and US clinical trials in AL […]
Nexcella Appoints Edward J. Borkowski, former Chief Financial Officer of Mylan N.V, to Board of Directors
Mr. Borkowski joins the Nexcella, Inc. Board of Directors with more than 30 years of experience in the pharmaceutical and healthcare industry, including 7 years as Chief Financial Officer of Mylan N.V. Mr. Borkowski is also the former Chief Financial Officer of CareFusion, which was ultimately acquired by Becton Dickinson for $12.2 billion LOS ANGELES, […]
Nexcella Appoints Jeffrey H. Cooper, former Chief Financial Officer of BioMarin, to Board of Directors
Mr. Cooper joins the Nexcella, Inc. Board of Directors with more than 30 years of experience in the pharmaceutical industry, including 5 years as Chief Financial Officer of BioMarin Pharmaceutical Mr. Cooper is a former independent director of Sierra Oncology, acquired by GlaxoSmithKline for $1.9 billion in 2022 and Tobira Therapeutics, acquired by Allergan (now […]
Nexcella Appoints Mary Sue Coleman, former Johnson & Johnson Independent Director, to Board of Directors
Dr. Coleman joins the Nexcella, Inc. Board of Directors with over a decade of experience as an Independent Director of Johnson & Johnson from 2003-2016 Dr. Coleman is President Emerita of the University of Michigan where she was named one of “10 Best College Presidents” by TIME Magazine and served as President of the University […]
Nexcella Appoints Henry McKinnell, Jr., former Chairman & CEO of Pfizer Inc., to Board of Directors
Dr. McKinnell joins the Nexcella, Inc. Board of Directors with 35 years of experience at Pfizer, Inc., including 6 years as Chairman and Chief Executive Officer Dr. McKinnell is a former independent director of ChemoCentryx, acquired by Amgen for $3.7 billion in 2022 and former Chairman/CEO of Optimer Pharmaceuticals, acquired by Cubist (now Merck & […]
Nexcella Announces Commencement of NXC-201 Engineering Batches at its U.S. CAR-T Manufacturing Site
U.S. engineering batches support planned expansion of its ongoing NEXICART-1 (NCT04720313) NXC-201 CAR-T clinical trial to the United States Engineering batches are the first step in transferring the Company’s existing CAR-T GMP manufacturing process to the United States Commencement of U.S. engineering batches follows selection of U.S. GMP manufacturer in February 2023 LOS ANGELES, May […]
Nexcella Announces Positive NXC-201 Clinical Results at ASGCT: 100% Overall Response Rate in DARZALEX-Relapsed/Refractory AL Amyloidosis with Zero ICANs in Ongoing NEXICART-1 Phase 1b/2a Clinical Trial
8 AL Amyloidosis patients relapsed/refractory to DARZALEX®-based regimens were treated with CAR-T NXC-201 100% (8/8) overall response rate and 63% (5/8) complete response (MRD 10-5) was demonstrated by NXC-201 with zero ICANs, zero grade 4 CRS 62% (5/8) had NYHA classification III or IV heart failure prior to treatment with NXC-201 Best responder duration of […]
Nexcella Announces Late-Breaking NXC-201 Clinical Data Abstract Accepted for Oral Presentation at the 26th Annual Meeting of The American Society of Gene and Cell Therapy (ASGCT)
Updated clinical data for next-generation CAR-T NXC-201 in AL amyloidosis will be presented in Los Angeles May 16-20, 2023 LOS ANGELES, May 04, 2023 — Nexcella, Inc. (Nasdaq: IMMX) (“Nexcella”, “Company”, “We” or “Us”) today announced that updated NXC-201 clinical data has been selected for presentation at the upcoming 26th Annual Meeting of The American […]
Nexcella Announces Positive 58-Patient NXC- 201 Clinical Data: 100% Overall Response Rate in light chain (AL) Amyloidosis; 92% Overall Response Rate in Multiple Myeloma at the EBMT 49th Annual Meeting in Paris
Multiple Myeloma 92% was the overall response rate produced by NXC-201 in relapsed/refractory multiple myeloma patients treated at the therapeutic dose of 800 million CAR+T cells in its ongoing phase 1b/2a NEXICART-1 clinical trial (NCT04720313) who were not exposed to prior BCMA-targeted therapy, producing a median progression free survival (mPFS) of 12.3 months as of […]